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日本メドトロニック株式会社CRHF事業部 108-0075 東京都港区港南1-2-70

26th Annual Meeting of the International Society for M

echanical Circulatory Support (ISMCS2018) ABSTRACT BO

OK

HILTON

TOKYO

OD

AIBA, Japan

表紙.indd 1 2018/10/24 16:00:11

26th Annual Meeting of the International Society for Mechanical Circulatory Support

(ISMCS2018)

DREAM IS ALIVE

PeriodWednesday, October 31 – Friday, November 2, 2018

VenueHILTON TOKYO ODAIBA, Japan

135-8625, TOKYO, 1-9-1, DAIBA, MINATO-KU, JAPAN

In Conjunction with56th Annual Meeting of the Japanese Society for Artificial Organs (JSAO2018)

Scientific SecretariatDr. Mitsutoshi Kimura

The University of Tokyo7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

TEL : +81-3-3815-5411

Congress SecretariatC/o Japan Convention Services, Inc.

Daido Seimei Kasumigaseki Bldg. 1-4-2,Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

TEL : +81-3-3508-1214 FAX : +81-3-3508-1302E-mail: [email protected]

1

Welcome to the 26th Congress of the International Society for Mechanical Circulatory Support

Minoru Ono, M.D., Ph.D.Congress President of ISMCS2018Professor and Chairman, Department of Cardiac SurgeryDirector, Cooperative Unit of Medicine and Engineering ResearchGraduate School of Medicine, The University of Tokyo

Dear Members and Guests,

As the Program Chairman of the International Society for Mechanical Circulatory Support (ISMCS) 2018, which is held from October 31 to November 2, 2018 at Hilton Tokyo Odaiba, I whole-heartedly welcome you to the very beautiful bay area of the city of Tokyo. The 26th Annual Congress of the ISMCS convenes conjoinedly with the 56th Annual Meeting of the Japanese Society for Artificial Organs in the same timeframe. The mission statement of our Society says: The mission of the ISMCS is to provide a broad international forum for intensive discussion of research, development, clinical use and social acceptance of rotary blood pumps and all related forms of mechanical circulatory support. The ultimate goal is to provide technologies and applications, and clinical procedures for rotary blood pumps and related systems for saving lives, improving the life quality of recipients and for cost-efficient availability of the emerging therapies.The slogan for the meeting is “Dream is alive”. Many VADs and MCS devices and peripherals have been developed, come into clinical arena, and some of them were withdrawn from the market or replaced by a successor device which enables more durable and reliable support by more compact system. Where is a final goal? It is becoming more and more technologically and socially demanding to develop a new VAD. However, dream is still alive, and we definitely have to make our dream sustainable. There are 140 presentations, including 114 abstracts, 11 keynote and 5 invited lectures in this meeting. You will enjoy the status quo of MCS clinical applications and the emerging cutting-edge technologies.Tokyo is being renovated to move forward to the Olympic Games in 2020. There are many historical places in and around the city, and nice hot springs by a short trip. We believe each of you will be immersed in cutting-edge presentations in daytime and smack your lips with excellent Japanese cuisine in the evening. We hope all of you will enjoy staying Tokyo, world-leading city of Japan.

Best Regards,

Minoru Ono, M.D., Ph.D.Congress President of ISMCS2018

2

Welcome Message

Dr C. Sivathasan MBBS, FRCS(Eng), FAMSPresident,International Society for Mechanical Cardiac Support.Director,Mechanical Cardiac Support ad Transplantation,National Heart Centre, Singapore.

On behalf of the International society for Mechanical Cardiac Support (ISMCS) it is my pleasure to invite you all to attend the 26th annual congress of the society.

As we all know, ISMCS is unique because it brings together, the engineers, researchers, clinicians, associated health care workers and the industries to a common platform with the aim of providing a near normal active life style to the patients suffering from advanced heart failure. Although the adaptation of MCS therapy has become a reality in the current era, we are still faced with issues associated with materials, biocompatibility, haemocompatibility, infections, issues with drive lines and hardware. The field of MCS requires even more research and clinical applications to get over the hazards of MCS.

Professor Minoru Ono and his team have been working hard over the last one year along with ISMCS, to provide an excellent programme which will broaden the knowledge of MCS as well as promote discussions on new ideas and help us to think out of the box.

The beautiful venue chosen for the congress is Tokyo and the delicious Japanese cuisine will no doubt contribute towards a memorable stay in Tokyo.I hope that you will find the conference and your stay in Tokyo both valuable and enjoyable.

3

Organization

Congress PresidentMinoru Ono, Japan

ISMCS BoardPresident Cumaraswamy Sivathasan, SingaporePresident-Elect Francesco Moscato, AustriaImmediate-Past President Minoru Ono, JapanSecretary General Geoffrey Tansley, AustraliaTreasurer Tomonori Tsukiya, Japan

Organizing CommitteeHirofumi Anai, Japan Aly El Banayosy, USABojan Biocina, Croatia Kiyotaka Fukamachi, USAShaun David Gregory, Australia Takashi Isoyama, JapanTim Kaufmann, Germany Suha D. Küçükaksu, TurkeyShunei Kyo, Japan James Long, USAOsamu Maruyama, Japan Toru Masuzawa, JapanGoro Matsumiya, Japan Bart Meyns, BelgiumFrancesco Moscato, Austria Takashi Nishimura, JapanChristoph Nix, Germany Minoru Ono, JapanYoshikatsu Saiki, Japan Heinrich Schima, AustriaThomas Schlöglhofer, Austria Stefan Schueler, UKAkira Shiose, Japan Cumaraswamy Sivathasan, SingaporeMarvin Slepian, USA Ulrich Steinseifer, AustraliaEisuke Tatsumi, Japan Yoshiyuki Taenaka, JapanYoshiaki Takewa, Japan Geoffrey Tansley, AustraliaDaniel Timms, USA Koichi Toda, JapanTomonori Tsukiya, Japan Richard K. Wampler, USAGeorg Wieselthaler, USA Takashi Yamane, JapanKenji Yamazaki, Japan Tomoyuki Yambe, Japan

Congress Scientific SecretariatMitsutoshi Kimura, Japan

4

Congress Registration

Registration DeskThe Registration Desk will be located in the Foyer, 1F, Hilton Tokyo Odaiba and will be operating as follows:October 31, Wednesday 8:00-17:00November 1, Thursday 8:00-19:00November 2, Friday 8:00-15:00

Registration Fees

Pre-Registration On Site Gala Dinner *4

ISMCS / JSAO Member JPY55,000 JPY65,000 Included

ISMCS / JSAO Non-member JPY60,000 JPY70,000 Included

Allied Health / CE / Nurse /Co-medical *1 JPY20,000 JPY25,000 JPY5,000

Students *2 JPY15,000 JPY20,000 JPY5,000

Accompanying Person *3 JPY15,000 JPY15,000 JPY5,000

*1 Allied Health, CE, Nurse, Co-medical are required to send a certificate written by their immediate superior to the registration desk by fax or e-mail to prove their status.

*2 Student participants are also required to send student ID to the registration desk by fax or e-mail.*3 Authors can not be allowed to register as accompanying persons.*4 Gala Dinner: Date & Time: Thursday, November 1 Place: Hilton Tokyo Odaiba

The Registration Fee Includes• Registration fee for Members, Non-members, Allied Health/CE/Nurse/Co-medical and Students includes:

1. Admission to Scientific programs of ISMCS2018 and JSAO20182. Admission to the Exhibition3. Documentation including a book of abstracts4. Welcome Reception5. Registration fee for Members and Non-members includes Gala Dinner on November 1.6. Networking Evening Party7. Coffee Breaks

• Registration fee for Accompanying persons includes:1. Welcome Reception2. Coffee Breaks* Accompanying persons will not be admitted to scientific programs.

Confirmation of RegistrationRegistration confirmation and receipt will be available to download and print out from the registration page after payment is confirmed. Personal ID and password set at first log-in will be required again.Please remember to bring your registration confirmation to the congress venue to pick up your congress kit upon arrival.

5

Contact for RegistrationISMCS2018 Registration Deskc/o Japan Convention Services, Inc.Tel: +81-3-3508-1251Fax: +81-3-3508-1756E-mail: [email protected]

6

Congress Information

Official LanguageEnglish

LunchLunch will be provided at the luncheon seminars on a first-come, first-served basis. Lunch boxes with vegetarian meal will be also available.

ExhibitionA technical and commercial exhibition will be held during the following hours at Sirius, 1F.October 31, Wednesday 13:00-17:30November 1, Thursday 8:00-17:00November 2, Friday 8:00-18:00

CloakCloak will be located at 1F, near the Registration Desk during the congress.

Mobile PhonesPlease turn off your mobile phones or switch it to the silent mode, and refrain from talking on the phone during the program.

SmokingSmoking is prohibited anywhere except in the designated smoking areas.

Social Events・Welcome Reception

- Fee: Included in the registration fee- Date: October 31, Wednesday- Time : 20:00-22:00- Place: Room "Sirius", 1F

・Gala Dinner- Fee: Included in the registration fee for Member and Non-member JPY5,000 for Allied Health/CE/Nurse/Co-medical, Students and Accompanying Persons- Date: November 1, Thursday- Time : 19:15-- Place: Room "Pegasus AB", 1F- Prize-giving Ceremony will be conducted during the Dinner.

・Networking Evening Party- Fee: Included in the registration fee- Date: November 2, Friday- Time : 19:00-21:00- Place: Room "Pegasus A", 1F

7

Instruction for Speakers and Chairpersons

Oral SessionLength of Presentation

■Oral Presentation-Keynote : 12 minutes, Discussion: 3 minutes, Total: 15 minutes-Rapid Fire: 4 minutes, Discussion: 2 minutes, Total: 6 minutes-Regular : 7 minutes, Discussion: 3 minutes, Total: 10 minutes■Helmut Ruel Young investiagtors session : 8 minutes, Discussion: 4 minutes, Total: 12 minutes■Other Sessions: Announced by the Congress Secretariat

EquipmentOS : Windows 10 PowerPoint ver. : 2010-2016

Speaker Preparation Desk-Speakers Preparation Desk is located at Foyer, 1F, Hilton Tokyo Odaiba.- All speakers are requested to come to the Speaker Preparation Desk at least 30 minutes in advance of their presentations to verify if the data functions properly on the equipment provided.

- Speakers will use PowerPoint presentations. All presentations will be loaded onto a server (At the Speaker Preparation Desk) and distributed to an appropriate session room at an appropriate time via a LAN.

PowerPoint Presenters- Bring your presentation on a Windows readable USB flash Drive. In case you use video files, you should bring your own laptop and make sure that the data is applicable to Windows Media Player.

- Only the standard fonts with Windows 10 (OS) (e.g., Helvetica, Arial, Times New Roman) are accepted for your presentation file, and unusual fonts may not be displayed properly on the computers in session rooms.

- Include any external files utilized (e.g. movie files) in the same folder as your presentation. Copy the entire folder to the USB flash Drive.

- Video clips (other than certain animated gif files) are not embedded in PowerPoint presentations; you will need to bring the separate video files (WMV type is recommended) with you and submit them along with your presentation file.

-In order to avoid virus infection, please scan your presentation file with updated anti-virus software beforehand.

Users of Macintosh Computers:- You should bring your own Macintosh since there would be technical issues that can arise when PowerPoint files created on a Macintosh are run on a Windows PC.

Laptops- Speakers using their own laptops MUST HAVE a VGA D-sub 15pin female output. Special video output cable is required for some laptops to use the D-sub 15pin to connect to external monitors and data projectors. Please note that we are not equipped with that special cable and you must bring it in case it is necessary. The laptop output resolution should be no more than XGA (1024x 768). The higher resolutions than the native resolution (1024 x 768) would possibly lose some information or not project by forcing the data projector into a compression mode.

-You should have your data backed up in case of computer trouble.-Please turn off the screen-saver and energy saving mode beforehand.

8

Poster SessionPresentation Schedule

Poster Session 1A/1B October 31,Wednesday 15:45-16:30Poster Session 2A/2B November 1, Thursday 8:00- 8:45 Mounting : October 31,Wednesday 11:00-13:00 Removal : November 2, Friday 15:30-17:00

Length of Presentation 3 minutes, Discussion : 2 minutes, Total: 5 minutes

- Presenters are requested to stand by at their own poster(s) during the session period to answer any questions from the participants. Poster program number will be posted on your assigned board.

-Please present a label showing the title, institution and the speaker's name.-Pins for mounting will be available at the venue.

Display- Posters should be brought to the congress and not mailed, as the Organizing Committee cannot be responsible for any loss or mishandling.

-Please refer to following poster image for your poster.

20㎝

90㎝

70㎝

20㎝ No. Title, Institution, name

190㎝

210㎝

9

Floor Map

Cloak

Hilton Tokyo Odaiba 1F

Registration Desk

SpeakerPreparation Desk

Sirius

FujiFujiHeadquater Office

Oral Session

Poster Session / Exhibition

Pegasus C

Pegasus AB

JupiterNurse / Coordinator Session

10

Room9:00 10:00 11:00 12:00 13:00 14:00 15:00 16: 00 17:00 18:00 19:00 20:00 21:00 22:00 23:00

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

Pegasus C9:00-10:30

Young Investigators' Pre-symposium

10:30-11:00Discussion

12:00-12:50Tokyo

Memorial Lecture

Sponsored by Abbott Medical

Japan

12:55-13:30Opening

Ceremony

13:30-14:45Helmut Ruel Young Investigator Award

14:45-15:15Special

Lecture 1

15:15-15:45Special

Lecture 2

15:45-16:30Coffee break

16:30-17:20Oral 1

Hemocom-patibility 1

Sirius15:45-16:30Poster1A / 1B

20:00-Welcome Reception

Wednesday, October 31

Program at a glance

Thursday, November 1

Room8:00 9:00 10:00 11:00 12:00 13:00 14: 00 15:00 16:00 17:00 18:00 19:00 20:00 21:00

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

Pegasus AB 19:15-Gala Dinner

Pegasus C

9:00-9:50Oral 2Total

Artificial Heart

9:50-10:40Oral 3MCS on Acute

Presentation

10:40-11:45Oral 4

Physiological Control

12:00-13:00Luncheon Seminar 1

Sponsored by Sun Medical Technology Research

13:00-14:05Oral 5

Engineering 1

14:05-14:35Special

Lecture 3


15:00-16:05Oral 6Clinical

Application

16:05-16:35Special

Lecture 4

17:00-18:00General

assembly

Jupiter 10:00-12:00Nurse / Coordinator Session 1

16:00-18:00Nurse / Coordinator Session 2

Sirius8:00-8:45

Poster2A / 2B

12

Room9:00 10:00 11:00 12:00 13:00 14:00 15:00 16: 00 17:00 18:00 19:00 20:00 21:00 22:00 23:00

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

Pegasus C9:00-10:30

Young Investigators' Pre-symposium

10:30-11:00Discussion

12:00-12:50Tokyo

Memorial Lecture

Sponsored by Abbott Medical

Japan

12:55-13:30Opening

Ceremony

13:30-14:45Helmut Ruel Young Investigator Award

14:45-15:15Special

Lecture 1

15:15-15:45Special

Lecture 2


16:30-17:20Oral 1

Hemocom-patibility 1

Sirius15:45-16:30Poster1A / 1B

20:00-Welcome Reception

Room8:00 9:00 10:00 11:00 12:00 13:00 14: 00 15:00 16:00 17:00 18:00 19:00 20:00 21:00

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

Pegasus AB 19:15-Gala Dinner

Pegasus C

9:00-9:50Oral 2Total

Artificial Heart

9:50-10:40Oral 3MCS on Acute

Presentation

10:40-11:45Oral 4

Physiological Control


Sponsored by Sun Medical Technology Research

13:00-14:05Oral 5

Engineering 1

14:05-14:35Special

Lecture 3



Application

16:05-16:35Special

Lecture 4

17:00-18:00General

assembly

Jupiter 10:00-12:00Nurse / Coordinator Session 1

16:00-18:00Nurse / Coordinator Session 2

Sirius8:00-8:45

Poster2A / 2B

13

Room8:00 9:00 10:00 11:00 12:00 13:00 14: 00 15:00 16:00 17:00 18:00 19:00 20:00 21:00

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

Pegasus C8:00-9:00

Oral 7Engineering 2

9:00-10:00Oral 8

ECMO/ECLS

10:00-11:00Oral 9

Pedatric Ventricular

Assist Device


Experience/simulation


Sponsored by Century Medical

13:00-14:05Oral 11

Hemocompati-bility 2

14:05-14:55Oral 12Patient

Management


15:20-16:10Oral 13

Monitoring

16:10-17:15Oral 14

Engineering 3

17:15-18:30Device Update

Pegasus A 19:00-21:00Networking Evening Party

18:30-18:40Closing Ceremony

Friday, November 2

14

Room8:00 9:00 10:00 11:00 12:00 13:00 14: 00 15:00 16:00 17:00 18:00 19:00 20:00 21:00

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

Pegasus C8:00-9:00

Oral 7Engineering 2

9:00-10:00Oral 8

ECMO/ECLS

10:00-11:00Oral 9

Pedatric Ventricular

Assist Device


Experience/simulation


Sponsored by Century Medical

13:00-14:05Oral 11

Hemocompati-bility 2

14:05-14:55Oral 12Patient

Management


15:20-16:10Oral 13

Monitoring

16:10-17:15Oral 14

Engineering 3

17:15-18:30Device Update

Pegasus A 19:00-21:00Networking Evening Party

18:30-18:40Closing Ceremony

15

October 31, Wednesday

9:00 - 11:00 : Young Investigators' Pre-symposiumModerators: Tomonori Tsukiya (National Cerebral and Cardiovascular Center, Japan)

Daniel Timms (BiVACOR, Inc., USA) PS-1 - Reduction of von Willebrand factor in Response to Shear Stress loading and Evaluation of Bleeding Risk prior to LVAD ImplantationKo Sakatsume (Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Japan)

PS-2 - An Optimal Magnetic Coupling System for Percutaneous Ventricular Assist DevicesFredy Munoz (Faculty of Medicine, University of Queensland, Australia)

PS-3 - ELEVATED VON WILLEBRAND FACTOR MULTIMERS ARE ASSOCIATED WITH LVAD THROMBOSISSamson Hennessy-Strahs (Division of Cardiovascular Surgery, Hospital of The University of Pennsylvania, USA)

PS-4 - Design of an axial blood pump with a large-gap passive levitation technology utilizing a combination of magnetic force and thrust forceKazuma Shoji (Department of Mechanical Engineering, School of Engineering, Tokyo Institute of Technology, Japan)

PS-5 - Clinical Outcomes of Implantable Left Ventricular Assist Device as Bridge-to-Transplant TherapyMasaki Komatsu (Department of Surgery, Division of Cardiovascular Surgery, Shinshu University School of Medicine, Japan)

PS-6 - Bond Graph Modelling of a Cardiovascular System + TAH: “A New Way to Look at Things” to Improve System DesignMengtang Li (Department of Mechanical Engineering, Vanderbilt University, Nashville, USA)

PS-7 - Clinical outcome of HeartMate II in Nagoya UniversityMasato Mutsuga (Department of Cardiac Surgery, Nagoya University, Gradate School of Medicine, Japan)

PS-8 - Interleukin-6, 8 levels during ex vivo heart perfusion using Blood cardioplegia or Custodiol for heart transplantZhuldyz Nurmykhametova (National Research Center for Cardiac Surgery, Astana, Kazakhstan)

PS-9 - Quantification of DNA Damage in Heart Tissue as a Novel Prediction Tool for Therapeutic PrognosisToshiyuki Ko (Department of Cardiovascular Medicine, The University of Tokyo Hospital, Japan)

PS-10 - Validation of CFD methods for intraventricular flow fields and the prediction of intraventricular thrombosisMojgan Ghodrati (Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria)

16

12:00 - 12:50 Tokyo Memorial LectureModerator : Minoru Ono (The University of Tokyo, Japan)

TL -History and Perspective of MCS: The trail blazed and the pathway aheadJames Long (INTEGRIS Baptist Medical Center, Oklahoma City, USA)Sponsored by : Abbott Medical Japan Co., Ltd.

12:55 - 13:30 Opening CeremonySpeakers : Cumaraswamy Sivathasan (National heart centre, Singapore)

Minoru Ono (The University of Tokyo, Japan)

13:30 - 14:45 : Helmut Ruel Young Investigator AwardModerators:�Geoffrey�Tansley�(Griffith�University,�Australia)

Toru Masuzawa (Ibaraki University, Japan) YIA-1 - Shear-Mediated GpIIb/IIIa-Rich Platelet Microparticle Generation: A Mechanism Validating Inability of GpIIb/IIIa Blockade to Limit MCS ThrombosisYana Roka-Moiia (Department of Medicine and Biomedical Engineering, Sarver Heart Center, University of Arizona, Tucson, AZ, USA)

YIA-2 - Accurate Quantitative evaluation of Aortic Insufficiency during LVAD support by thermodilution analysisDaichi Akiyama (Department of Cardio-thoracic Surgery, The University of Tokyo Hospital, Japan / National Cerebral and Cardiovascular Center, Research Institute, Department of Artificial Organs, Japan)

YIA-3 - MCS program in Kazakhstan: current status and future perspectivesAssel Medressova (National Research Cardiac Surgery Center, Astana, Kazakhstan)

YIA-4 - Prevention of thrombus formation inside a magnetically levitated centrifugal blood pump using impeller vibrational excitationTomotaka Murashige (Department of Mechanical Engineering, School of Engineering, Tokyo Institute of Technology, Japan)

YIA-5 - Echocardiographic Particle Image Velocimetry in the Isolated Pig HeartPhilipp Aigner (Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria / Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, Austria)

YIA-6 - Next Generation Ultra-Compact Centrifugal Pediatric VAD Using Maglev motor with Improved Design to Enhance Energy EfficiencyMasahiro Osa (Department of Mechanical Systems Engineering, Ibaraki University, Japan)

14:45 - 15:15 Special Lecture 1Moderator: Kiyotaka Fukamachi (Cleveland Clinic, USA)

SL1 - Continuous long-term health-monitoring by wearable sensorsTakao Someya (Electrical and Electronic Engineering and Information Systems, The University of Tokyo, Japan / Thin-Film Device Laboratory & Center for Emergent Matter Science (CEMS), RIKEN, Japan)

17

15:15 - 15:45 Special Lecture 2Moderator: Shunei Kyo (Tokyo Metropolitan Institute of Gerontology, Japan)

SL2 - “Futurability” for Cardiology and Cardiovascular surgeryYoshiki Sawa (Osaka University, Japan)

16:30 - 17:20 Oral 1 : Hemocompatibility 1Moderators: Thomas Schlöglhofer (Medical University of Vienna, Austria)

Osamu Maruyama (National Institute of Advanced Industrial Science and Technology (AIST), Japan)

O1-1 - High intensity transient signals (HITS) on transcranial Doppler (TCD) as an early sign of thrombosis in a rotary blood pumpBojan Biocina (Department of Cardiac Surgery, School of Medicine, University of Zagreb, Croatia)

O1-2 - Risk analysis of stroke in the acute phase after Left Ventricular Assist Device ImplantationTakaaki Samura (Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan)

O1-3 - Rethinking the Hemolysis Test Loop: Adjusting the Design for High Pulsatility PumpsNicole Byram (Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA)

O1-4 - On the representation of effective stress for computing hemolysisPeng Wu (Artificial Organ Technology Lab, Bio-manufacturing Research Centre, Soochow University, Suzhou, China)

O1-5 - Hemolysis test of MU-Centrifugal Blood Pump with an Amplitude Variation for Mimic a Physiological Blood Flow Phornphop Naiyanetr (Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Thailand)

18

November 1, Thursday

9:00 - 9:50 Oral 2 : Total Artificial HeartModerators: Kiyotaka Fukamachi (Cleveland Clinic, USA)

Geoffrey�Tansley�(Griffith�University,�Australia) O2-Keynote - Total Artificial Hearts: An Overview and Future PerspectiveKiyotaka Fukamachi(Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA)

O2-RF2 - Update on RealHeartTM’s Progress Towards Chronic In Vivo StudiesIna Laura Pieper (R&D, Scandinavian Real Heart AB, Sweden)

O2-RF3 - Cleveland Clinic Continuous Flow Artificial Heart: Current Perspectives and Device UpdateJamshid Karimov (Cleveland Clinic, USA)

O2-4 - Characterization of the RealHeartTM Total Artificial Heart with a Hybrid Cardiovascular SimulatorLibera Fresiello (Department of Cardiac Surgery, KU Leuven, Leuven, Belgium)

O2-5 - Computational Fluid Dynamics Analysis of the RealHeartTM Demonstrates Low Power Consumption and Low Thrombosis RiskIna Laura Pieper (R&D, Scandinavian Real Heart AB, Sweden)

9:50 - 10:40 Oral 3 : MCS on Acute PresentationModerators: Aly El Banayosy (INTEGRIS Baptist Medical Center, USA)

Koichi Toda (Osaka University, Japan) O3-Keynote - Aly El Banayosy (INTEGRIS Baptist Medical Center, USA)

O3-RF2 - Ventricular assist device therapy using MERA Monopivot Centrifugal Pumps for cardiogenic shock patients in INTERMACS profile-1Tatsuki Fujiwara (Department of Cardiovascular Surgery, Tokyo Medical and Dental University, Japan)

O3-RF3 - Central ECMO with LV vent for acute heart failureTatsuichiro Seto (Department of Surgery, Division of Cardiovascular Surgery, Shinshu University School of Medicine, Japan)

O3-4 - Preclinical evaluation of extracorporeal ventricular assist device system for bridge-to-decisionTomonori Tsukiya (Department of Artificial Organs, National Cerebral and Cardiovascular Center, Japan)

O3-5 - Early Experience of Percutaneous Left Ventricular Assist Device “Impella” in JapanShohei Yoshida (Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Japan)

19

10:00 - 12:00 Nurse / Coordinator Session 1

10:40 - 11:45 Oral 4 : Physiological ControlModerators: Francesco Moscato (Medical University of Vienna, Austria)

Ulrich Steinseifer (Monash University, Australia) O4-Keynote - Physiologically adaptive control of rotary blood pumps: Conclusions from clinical studies and observationsHeinrich Schima (Medical University of Vienna, Austria)

O4-2 - A physiological control system for an LVAD that can accommodate interpatient and intrapatient variationMasoud Fetanat (Graduate School of Biomedical Engineering, UNSW, Sydney, Australia)

O4-3 - The effects of VAD pressure sensitivity on exercise physiology: evaluation with a computational modelLibera Fresiello (Department of Cardiac Surgery, KU Leuven, Leuven, Belgium)

O4-4 - Automatic Flow Control Method for the Cleveland Clinic Continuous-Flow Total Artificial HeartBarry Dean Kuban (Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA)

O4-5 - In-Vitro Evaluation of a Rotary Blood Pump Management System that Balances Circulatory Volumes and Delivers Pulsatile FlowEric L Wu (Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia / School of Medicine, The University of Queensland, Brisbane, Australia)

O4-6 - Cardiovascular Peristalsis?: Nonaxial Peristaltic Total Occlusion As a Mechanism for Blood PropulsionZack D. Frankman (Department of Biomedical Engineering, The University of Arizona, Tucson, AZ, USA)

12:00 - 13:00 Luncheon Seminar 1 :Moderator : Minoru Ono (The University of Tokyo, Japan)

LS1 - EVAHEART TIP-LESS New Generation of LVAD Cannula

Tadashi Motomura (EVAHEART, Inc., USA)Sponsored by : Sun Medical Technology Research Corp.

13:00 - 14:05 Oral 5 : Engineering 1Moderators: Heinrich Schima (Medical University of Vienna, Austria)

Shaun Gregory (Monash University, Australia) O5-Keynote - Usability of MCS-Systems: Methods and obstacles for it´s optimization Heinrich Schima (Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria)

O5-2 - Effects of discharge angle and cross-sectional area of the impeller flow path on the hemocompatibility of a centrifugal blood pumpMasahiro Nishida (National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan)

O5-3 - 3D Intraventricular Flow Patterns During LVAD Support - A Flow Field Analysis By Means Of High Speed Stereo-PIV -Henning Kroll (Berlin Heart GmbH, Research and Development, Berlin, Germany)

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O5-4 - “There Are Loops, And Then There Are Loops”: Loop Design and Constituent Components Introduce Artifacts Impacting Overall System ThrombogenicityMengtang Li (Department of Mechanical Engineering, Vanderbilt University, USA)

O5-5 - Development of an intelligent blood pump with a self-detecting function of thrombusWataru Hijikata (Department of Mechanical Engineering, Tokyo Institute of Technology, Japan)

O5-6 - Experimental evaluation of a thrust bearing gap in a hydrodynamically levitated centrifugal blood pump for reduction of hemolysisRyo Kosaka (National Institute of Advanced Industrial Science and Technology (AIST), Japan)

14:05 - 14:35 Special Lecture 3Moderator: Yoshiyuki Taenaka (National Cerebral and Cardiovascular Center, Japan)

SL3 - Trend of Mechanical Circulatory Support in JapanTakashi Yamane (PhD, Emeritus Researcher, AIST (National Institute of Advanced Industrial Science and Technology), Japan)

15:00 - 16:05 Oral 6 : Clinical ApplicationModerators: Georg Wieselthaler (University of California, San Francisco, USA)

Goro Matsumiya (Chiba University Graduate School of Medicine, Japan) O6-Keynote - Georg Wieselthaler (University of California, San Francisco, USA)

O6-2 - Clinical Outcome of Left Ventricular Assist Device for Arrhythmogenic Right Ventricular CardiomyopathySachito Minegishi (Department of Cardiac Surgery, University of Tokyo, Japan)

O6-3 - Acute in-vivo evaluation of a suture-less inflow cannula for rapid LVAD implantationKristy May Garrick (School of Engineering and Built Environment, Griffith University, Gold Coast, Qld, Australia / The Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Chermside, Qld, Australia)

O6-4 - HeartMate II implantation with lower mini-sternotomy reduced postoperative bleeding and ventilatory supportKoichi Toda (Department of Cardiovascular Surgery, Osaka University, Japan)

O6-5 - Unloading strategies to optimize reverse remodelingBart Meyns (Department Cardiac Surgery, UZLeuven, Belgium)

O6-6 - Genetic basis of cardiomyopathy and the genotypes involved in prognosis and left ventricular reverse remodelingSeitaro Nomura (Department of Cardiovascular Medicine, The University of Tokyo, Japan / Genome Science Division, Research Center for Advanced Science and Technology, The University of Tokyo, Japan)

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16:05 - 16:35 Special Lecture 4Moderator: James Long (INTEGRIS Baptist Medical Center, Oklahoma City, USA)

SL4 - MCS Hemocompatibilty 2018: “It’s More than Just the Pump” Flow, Shear, Design, System Implantation, Drugs and All ThatMarvin J. Slepian (Departments of Medicine, Biomedical Engineering and Material Sciences and Engineering, Sarver Heart Center, University of Arizona, Tucson, Arizona USA)

16:00 - 18:00 Nurse / Coordinator Session 2

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November 2, Friday

8:00 - 9:00 Oral 7 : Engineering 2Moderators: Takashi Yamane (National Institute of Advanced Industrial Science and

Technology (AIST), Japan) Christoph Nix (ABIOMED Europe GmbH, Germany)

O7-Keynote - Dynamic movement of the magnetically levitated impeller during pulsatile operationToru Masuzawa (Ibaraki University, Japan)

O7-RF2 - Tissue integration of a novel ventricular assist device cannula using advanced manufacturingNicole Bartnikowski (The Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Chermside, Qld, Australia / School of Chemistry, Physics and Mechanical Engineering, Queensland University of Technology, Brisban, Australia)

O7-RF3 - Electrical Fields Modulate Endothelialization of Mechanical Circulatory Support Interfaces- An Electroceutical Strategy for Enhanced HemocompatibilityKaitlyn Rose Ammann (Department of Biomedical Engineering, The University of Arizona, Tucson, AZ, USA)

O7-4 - Development of a Micro Optical Thrombus Sensor for Multi-Point and Real-Time Monitoring in Mechanical Circulatory Support DevicesNobutomo Morita (Advanced Manufacturing Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Tosu, Japan)

O7-5 - Novel flow rate estimation method of a centrifugal blood pump using passive stabilization dynamics of magnetically levitated impellerShuya Shida (Graduate School of Science and Engineering, Ibaraki University, Japan)

O7-6 - The Effect of Transient Flow in Mechanical Circulatory SupportRyan Stanfield (The University of Utah, USA / VADovations, Inc, USA)

9:00 - 10:00 Oral 8 : ECMO/ECLSModerators: Aly El Banayosy (INTEGRIS Baptist Medical Center, USA)

Eisuke Tatsumi (National Cerebral and Cardiovascular Center, Japan) O8-Keynote - Bridging to lung transplantation: Current status and challengesMasaki Anraku (Department of Thoracic Surgery, The University of Tokyo Hospital, Japan)

O8-RF2 - Physiological responses of the circulation during ECLS A training simulator.Marcel CM Rutten (Department of Biomedical Engineering, TU Eindhoven, The Netherlands)

O8-RF3 - Evaluation of Microcirculation in Patients on Extracorporeal Membrane Oxygenation (proECMO Study): Pilot Study in 5 PatientsTakuma Miyamoto (Cleveland Clinic, Cleveland, OH, USA)

O8-4 - Long-term in vivo testing of extracorporeal membrane oxygenation via the pulmonary artery to the left atrium as a bridge to lung transplantationKento J. Fukumoto (Department of Thoracic Surgery, The University of Tokyo, Japan)

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O8-5 - A model of the pathological circulation under ECLS supportMarcel CM Rutten (Department of Biomedical Engineering, TU Eindhoven, The Netherlands)

O8-6 - Development Of A Compact ECMO System Consisting Of A Centrifugal Pump With Hydrodynamic Bearings And Long-term Evaluation In Animal Experiments Nobumasa Katagiri (Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Japan)

10:00 - 11:00 Oral 9 : Pedatric Ventricular Assist DeviceModerators: Toru Masuzawa (Ibaraki University, Japan)

Geoffrey�Tansley�(Griffith�University,�Australia) O9-Keynote - Pedatric Ventricular Assist DeviceAntonio Amodeo (Pediatric Hospital Bambino Gesù, Rome, Italy)

O9-2 - Current status of temporally ventricular assist device support for acute fulminant myocarditis in pediatric patientsTomomitsu Kanaya (Department of Cardiaovascular Surgery, Osaka University Graduated School of Medicine, Japan)

O9-3 - von Willebrand Factor activity:antigen ratio is a poor surrogate for multimer analysis in the detection of acquired VWS among children on ECLS devicesShiu-Ki Rocky Hui (Department of Pathology & Immunology / Department of Pediatrics / Baylor College of Medicine / Texas Children's Hospital, USA)

O9-4 - Total Artificial Heart for Pediatric Population: Cleveland Clinic Device UpdateJamshid Karimov (Cleveland Clinic, USA)

O9-5 - Implantable ventricular assist device for patients younger than 18 yearsKan Nawata (Department of Cardiac Surgery, The University of Tokyo, Japan)

11:00 - 11:50 Oral 10 : Clinical Experience/simulationModerators: Bart Meyns (UZ Leuven, Belgium)

Kenji Yamazaki (Hokkaido Cardiovascular Hospital, Japan) O10-1 - Successful Heart Transplant after Sixteen-hour ex-vivo donor heart perfusion during long distance transportationZhuldyz Nurmykhametova (National Research Center for Cardiac Surgery, Astana, Kazakhstan)

O10-2 - Sarcopenia as a predictor of mortality in Japanese patients undergoing left ventricular assist device implantationMasaki Tsuji (Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Japan)

O10-3 - Long-term outcome of HVAD left ventricular assist device- single center experience in JapanYuji Sakashita (Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Japan)

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O10-4 - Is it possible to insert the cannula into the left ventricle from outside of the human body for the VAD implant?Tomoyuki Yambe (Tohoku University, Japan)

O10-5 - Aorta - VAD Outflow Graft Anastomosis Angle Significantly Impacts MCS Prothrombosis - in vitro Validation of in silico DTE PredictionsRyan Walk (Department of Biomedical Engineering, The University of Arizona, Tucson, AZ, USA)

12:00 - 13:00 Luncheon Seminar 2 : Moderator : Minoru Ono (The University of Tokyo, Japan)

LS2- : Mechanical Circulatory Support in pediatric “low weight” patientsAntonio Amodeo (Bambino Gesù, Infant and Pediatric Hospital)Sponsored by : Century Medical. Inc.

13:00 - 14:05 Oral 11 : Hemocompatibility 2Moderators: Marvin Slepian (The University of Arizona, USA)

Tomoyuki Yambe (Tohoku University, Japan) O11-Keynote - Development of a clinically-relevant thrombogenicity testing method of an inflow cannula at the interface with left ventricle: Contribution to the approval of titanium-mesh in flow cannula of EVAHEART without clinical trialKiyotaka Iwasaki (Cooperative Major in Advanced Biomedical Sciences, Tokyo Women’s Medical University Waseda University Joint Graduate School, Waseda University, Japan / Department of Bioscience and Biomedical Engineering, Waseda University, Japan)

O11-2 - CONTINUOUS-FLOW LVAD SUPPORT ALTERS MULTIPLE ANGIOGENIC SIGNALING PEPTIDESSamson Hennessy-Strahs (Division of Cardiovascular Surgery, Hospital of The University of Pennsylvania, USA)

O11-3 - Optimal Hemodynamics during Left Ventricular Assist Device Support are Associated with Reduced Hemocompatibility-Related Adverse EventsTeruhiko Imamura (University of Chicago Medicine, USA)

O11-4 - The effect of synchronous rotary LVAD support: from the perspective of flow induced intraventricular thrombosisSam Liao (Innovative Cardiovascular Engineering and Technology Lab (ICETLAB), The Prince Charles Hospital, Chermside, Australia / Institute of Health and Biomedical Innovation (IHBI), Queensland University of Technology (QUT), Kelvin Grove, Australia / Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen University, Aachen, Germany)

O11-5 - Endothelial Cell Inflammatory Activation Enhances the Prothrombotic State of Shear-Activated Platelets: Mechanistic Implications for VAD Thrombosis?Filippo Consolo (Anesthesia and Cardiothoracic Intensive Care - Advanced Heart Failure and Mechanical Circulatory Support Program, San Raffaele Scientific Institute, Milan, Italy / Universita Vita Salute San Raffaele, Milano, Italy)

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14:05 - 14:55 Oral 12 : Patient ManagementModerators: Cumaraswamy Sivathasan (National Heart Center, Singapore)

Yoshikatsu Saiki (Tohoku University Graduate School of Medicine, Japan) O12-Keynote - Anticoagulation Quality and Frequency of INR Testing in LVAD Patients: A Correlation to Hemocompatibility Related Adverse Events and OutcomesThomas Schlöglhofer (Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria / Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, Austria / Department of Cardiac Surgery, Medical University of Vienna, Austria)

O12-RF2 - Multidisciplinary approach for right heart failure after left ventricular assist device implantation in a patient with restrictive cardiomyopathyHitoshi Inafuku (Department of Thoracic and Cardiovascular Surgery, University of the Ryukyus, Japan)

O12-RF3 - MAIN PREDICTORS OF RIGHT VENTRICULAR FAILURE IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE : SINGLE CENTER EXPERIENCESaltanat Andossova (National Research Cardiac Surgery Center, Astana, Kazakhstan)

O12-4 - Microfluidic Technology for the Development of a Point-Of-Care Diagnostic Device of Prothrombotic Platelet FunctionFilippo Consolo (Anesthesia and Cardiothoracic Intensive Care - Advanced Heart Failure and Mechanical Circulatory Program, San Raffaele Scientific Institute, Milano, Italy / Universita Vita Salute San Raffaele, Milano, Italy)

O12-5 - Driveline fracture in patients supported with HeartMate II left ventricular assist deviceShogo Shimada (Department of Cardiac Surgery, The University of Tokyo, Japan)

15:20 - 16:10 Oral 13 : MonitoringModerators: Bojan Biocina (University of Zagreb, Croatia)

Daniel Timms (BiVACOR, Inc., USA) O13-1 - The utility of thromboelastometry to monitor bivalirudin anticoagulation in children on extracorporeal circulatory support devicesJun Teruya (Division of Transfusion Medicine & Coagulation, Texas Children's Hospital, Baylor College of Medicine, USA)

O13-2 - Evaluation of Hemodynamics of Aortic Insufficiency under LVAD SupportKei IIZUKA (Department of Cardiovascular Surgery, Tokyo Women’s Medical University, Japan)

O13-3 - Imaging the contraction of mechanically supported ex vivo beating heartsLouis Fixsen (Department of Biomedical Engineering, Eindhoven University of Technology, The Netherlands)

O13-4 - Mid-term Evaluation of Hemodynamics and Exercise Tolerance after Jarvik 2000 Left Ventricular Assist Device Implantation.Togo Iwahana (Department of Cardiovascular Medicine, Chiba University Hospital, Japan)

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O13-5 - In Vitro Validation of Flowestimators for the HVAD and the HMIIIMartin Maw (Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria / Department of Cardiac Surgery, Medical University of Vienna, Austria / Ludwig-Boltzmann-Cluster for Cardiovascular Research, Vienna, Austria)

16:10 - 17:15 Oral 14 : Engineering 3Moderators: Georg Wieselthaler (University of California, San Francisco, USA)

Tomonori Tsukiya (National Cerebral and Cardiovascular Center, Japan) O14-Keynote - An Update on the OpenHeart Project - Towards the development of an Open-Source Online Research Platform to Improve Research Outcomes within the International Society for Mechanical Circulatory SupportJo Pauls (School of Medicine, The University of Queensland, Australia / Innovative Cardiovascular Engineering and Technology Laboratory (ICETLAB), Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia)

O14-2 - Development of a percutaneously deployable axial flow blood pump placed at aortic valve position: early prototype and its performanceEiji Okamoto (Sapporo Liberal Arts Center, Tokai University, Japan)

O14-3 - Evaluation of a Novel Short-Term Intraventricular Balloon Pump to Support Heart Failure Patients - an In Vitro StudyAlice Catherine Boone (School of Engineering and Built Environment, Griffith University, Queensland, Australia / Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia)

O14-4 - Effect of atrial inflow conditions on ventricular flow pattern during mechanical circulatory supportMojgan Ghodrati (Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria)

O14-5 - A study on optimal pump design of a catheter-based intravascular rotary blood pump for assisting selective renal blood circulationHirohito Sumikura (Division of Electronic Engineering, Department of Science and Engineering, School of Science and Engineering, Tokyo Denki University, Saitama, Japan)

17:15 - 18:30 Device UpdateModerators : Cumaraswamy Sivathasan (National heart centre, Singapore)

Geoffrey�Tansley�(Griffith�University,�Australia)AbbottABIOMED, Inc.Berlin Heart GmbHCH Biomedical, Inc.Evaheart, inc.JARVIK HEART, INC.Medtronic

18:30 - 18:40 Closing Ceremony

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Poster Session

10/31 15:45 - 16:30 1AModerators: Daniel Timms (BiVACOR Inc., USA)

Takashi Isoyama (The University of Tokyo, Japan) P1A-1 - The Application of AMESim and Simulink United Simulation Technology in VAD Test Equipment DesignChenqi Zhu (RocketHeart Technology Co. Ltd, Tianjin, China)

P1A-2 - The mechanical impact on blood of high and low flow rates in extracorporeal membrane oxygenationChris Hoi Houng Chan (Critical Care Research Group, The Prince Charles Hospital, Australia / Griffith University, Australia / University of Queensland, Australia / ICETLAB, Australia)

P1A-3 - Virtual Mock Loop Study Comparing LVAD and BVAD Assistance for Systolic Heart Failure ConditionsJamshid Karimov (Cleveland Clinic, USA)

P1A-4 - Evaluation of Heartmate 3 Centrifugal Pump Performance for Right Ventricular Support in Virtual ModelJamshid Karimov (Cleveland Clinic, USA)

P1A-5 - Species Differences in fibrin metabolism for preclinical animal study for cardiovascular deviceToshihide Mizuno (Department of Artificial Organs, National Cerebral and Cardiovascular Center, Institute, Japna)

P1A-6 - In vitro quantitative evaluation of platelet activation under shear stressAkiko Oota-Ishigaki (National Institute of Advanced Industrial Science and Technology, Japan)

P1A-7 - Is the ratios of VWF:RCo to VWF:Ag useful for the diagnosis of AVWS associated with LVAD ?Tsuyoshi Doman (Department of Molecular and Cellular Biology, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan)

10/31 15:45 - 16:30 1BModerators: Akira Shiose (Kyushu University, Japan)

Takashi Nishimura (Tokyo Metropolitan Geriatic Hospital, Japan) P1B-1 - Extracorporeal Membrane Oxygenation program in KazakhstanZhuldyz Nurmykhametova (National Research Center for Cardiac Surgery, Astana, Kazakhstan)

P1B-2 - Mechanical circulatory support for fulminant myocarditisTakashi Shuto (Department of Cardiovascular Surgery, Oita University, Japan)

P1B-3 - Relationship of vitamin D to profound cardiogenic shock in patients resuscitated from sudden cardiac arrestJin Wi (Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine, Korea)

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P1B-4 - A case of propranolol-induced refractory cardiac arrest and was successfully teated with extracorporeal cardiopulmonary resuscitationRyo Esumi (Department of Emergency and Disaster Medicine, University of Mie, Japan)

P1B-5 - Management of ECMO for the pediatric patients after cardiac surgeryYosuke Kuroko (Department of Cardiovascular Surgery, Okayama University Hospital, Japan)

P1B-6 - The User Experience of VAD Wearable Systems and Components: A Systematic Literature ReviewJessica Lea Dunn (School of Architecture, Design and Planning, University of Sydney, Sydney, Australia)

11/1 8:00 - 8:45 2AModerators: Yoshiaki Takewa (National Cerebral and Cardiovasular Center, Japan)

Shaun David Gregory (Monash University, Australia) P2A-1 - Development of an Electromechanical VAD Life Cycle Testing RigQinglin Fan (RocketHeart Technology Co. Ltd, China)

P2A-2 - Improving the quality of life of VAD users through interactive digital channels: A comparative content analysisKeum Hee Kimmi Ko (School of Architecture, Design and Planning, University of Sydney, Sydney, Australia)

P2A-3 - Optimization of the ceramic plate shape in ReligaHeart® ROT pump using FEM and physical validationPrzemyslaw Kurtyka (Artificial Heart Laboratory, Zbigniew Religa Foundation of Cardiac Surgery Development, Poland)

P2A-4 - Verification method of the magnetic induction distribution using mapping to control the magnetic field regularity in contact-less CF pumpsPrzemyslaw Kurtyka (Artificial Heart Laboratory, Zbigniew Religa Foundation of Cardiac Surgery Development, Poland)

P2A-5 - Applicability of Narrow Groove Theory in Conical Spiral Groove Bearing Design for Rotary Blood PumpsShelby A Bieritz (Department of Bioengineering, Rice University, USA / Texas Heart Institute, Houston, USA)

P2A-6 - Designing A Magnetically Suspended Blood Pump to Cope with Pump Tilting Movements in Patients Living An Active LifeChen Chen (Artificial Organ Technology Lab, Soochow University, Suzhou, China / CH Biomedical, Inc., Suzhou, China)

P2A-7 - Hemolysis reduction for axial-flow blood pumpsTakashi Yamane (School of Engineering, Kobe University, Japan / National Institute of Advanced Industrial Science and Technology, Japan)

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P2A-8 - Preclinical assessment of the miniaturized ventricular assist device for bridge to decision: chronic study in a bovine modelJunichi Shimamura (Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Japan / Department of Cardiothoracic Surgery, Graduate School of Medicine, University of Tokyo, Japan)

11/1 8:00 - 8:45 2BModerators: Bojan Biocina (University of Zagreb, Croatia)

Hirofumi Arai (Oita University, Japan) P2B-1 - Considerations from initial experiences of Impella in JapanMakiko Nakamura (Second Department of Internal Medicine, University of Toyama, Japan)

P2B-2 - Our Experience with conversion of the extracorporeal VAD to the implantable LVADMichiko Watanabe (Department of Cardiovascular Surgery, Chiba University Hospital, Japan)

P2B-3 - The impact of implantable left ventricular assist devices (iVAD) therapy in FukushimaAkihiro Yamamoto (Department of Cardiovascular Surgery, Fukushima Medical University, Japan)

P2B-4 - Long-term outcome of patients with durable ventricular assist device as bridge to transplantationMasatoshi Akiyama (Division of Cardiothoracic Surgery, Tohoku University Hospital, Japan)

P2B-5 - The Heartmate II implantation for the patient with congenitally corrected transposition of the great arteries and situs inversus: a case reportTomonori Ooka (Department of Cardiovascular and Thoracic Surgery, Hokkaido University Graduate School of Medicine, Japan)

P2B-6 - Pneumopericardium can be a sign of the occurrence of a serious infectionTomoki Ushijima (Department of Cardiovascular Surgery, Kyushu University Hospital, Japan)

P2B-7 - The transition of driveline and exit site management in patients with left ventricular assist deviceMamoru Arakawa (Department of Cardiovascular Surgery, Satiama Medical Center, Jichi Medical University, Japan)

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PS-1

Reduction of von Willebrand factor in Response to Shear Stress loading and Evaluation of Bleeding Risk prior to LVAD Implantation

1)Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Japan, 2)Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan, 3)Tokyo Institute of Technology, Japan, 4)Department of Molecular and Cellular Biology, Institute of Development, Aging, and Cancer, Tohoku University, Japan

Ko Sakatsume1), Masatoshi Akiyama1), Yunan Zuo1), Daisuke Sakota2), Wataru Hijikata3), Hisanori Horiuchi4), Osamu Maruyama2), Yoshikatsu Saiki1)

Background/ Purpose: Acquired von Willebrand syndrome (AVWS), characterized by reduction in von Willebrand factor (vWF) large multimers, has recently been considered as a principal mech-anism responsible for bleedings in patients with left ventricular assist device (LVAD). The hemato-logical severity of AVWS varies from case to case even if the identical device is implanted. We sought to prove our hypothesis that the diversity in hematological severity of AVWS is derived from individual variability in vWF fragility in response to shear stress.Methods: Whole blood samples derived from 20 healthy people were sheared at 20,000 to 40,000 s-1 using a custom-made shear stressor that can generate LVAD-compatible shear stress. The amount of vWF large multimers was evaluated by means of our original vWF large multimer index.Results: Significant inverse correlation was observed between the level of vWF large multimer in-dex and LVAD-compatible magnitude of shear stress exhibiting 64.7, 51.6, 31.8, 24.7 and 17.1% (median) of the index at 20,000, 25,000, 30,000, 35,000, and 40,000 s-1of shear stress, respectively. Furthermore, the values of vWF large multimer index were compatible with those derived from clinical patients having implantable LVAD (median; 28.9%).With regard to the decrease patterns of vWF large multimer index corresponding to shear stress in each subject, they showed various changes remarkably. We found the degradation patterns of the index can be characterized with three parameters, that is, the magnitude of initial drop; degree of reduction in the index at 20,000 s-1, ΔIn-dex; difference between the indices at 20,000 s-1and 40,000 s-1, and Degradation slope; slope with a linear regression model. Conclusions: Significant individual variability in vWF fragility can be demonstrated quantitatively. The combined use of the novel high shear-loading device and quantitative evaluation of vWF large multimer may enable us to predict a bleeding risk by taking blood sample from each patient prior to LVAD implantation.

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PS-2

An Optimal Magnetic Coupling System for Percutaneous Ventricular Assist Devices

1)Faculty of Medicine, University of Queensland, St Lucia, QLD 4072,Australia, 2)The Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD 4032, Australia, 3)Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), Kelvin Grove, QLD 4059, Australia,4)School of Engineering, Griffith University, Southport, QLD 4215, Australia

Fredy Munoz1,2), Sam Liao2,3), Geoff Tansley2,4), John F. Fraser1,2)

PURPOSEThe use of percutaneous ventricular assist devices (pVADs) has shown great benefits in the context of acute heart failure. These pVADs typically consist of miniature axial blood pumps that include an on-board motor and a purge line which is used to minimise the risk of direct contact between motor components and blood. However, the purge line increases the risk of vascular damage, down-stream ischemia and cannot completely seal the on-board motor. In order to eliminate these compli-cations associated with the purge line, we propose its replacement with an optimal magnetic cou-pling system (6 mm in diameter). This system allows transmission of a useful magnetic torque in a contactless manner, thus the on-board motor is completely sealed.

METHODSThree different types of magnetic coupling systems made of cylindrical and arc-shaped permanent magnets are analysed and compared against each other. These magnetic systems are constrained to a maximum diameter of 6 mm, a maximum length of 33 mm and a constant air gap of 1 mm. The torque density, which varies with the magnetization and dimensions of the permanent magnets, is used as the performance metric to determine the optimal system and its dimensions. All these stud-ies are carried out in COMSOL Multiphysics.

RESULTSOptimal torque densities are generated by arc-shaped permanent magnets. Furthermore, specific op-timal dimensions of these permanent magnets can allow the improvement of the torque density by more than 50% compared with a magnetic coupling of cylindrical permanent magnets.

CONCLUSIONSThese promising results show that the purge line and their associated complications could be over-come with an optimal magnetic coupling system that uses a minimum volume within a pVAD and can generate a useful magnetic torque. Due to their enhanced torque densities, such magnetic sys-tems could also be used to miniaturise blood pumps.

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PS-3

ELEVATED VON WILLEBRAND FACTOR MULTIMERS ARE ASSOCIATED WITH LVAD THROMBOSIS

Division of Cardiovascular Surgery, Hospital of The University of Pennsylvania, USA

Samson Hennessy-Strahs, Pavan Atluri, Christian A Bermudez, Michael A Acker, Carlo R Bartoli

BACKGROUND: Continuous-flow left ventricular assist devices (LVADs) cause pathologic von Willebrand factor (VWF) degradation that contributes to bleeding. However, the role of VWF deg-radation in LVAD thrombosis is unknown. We tested the hypothesis that VWF multimer levels are higher in patients that develop LVAD thrombosis.

METHODS: Paired whole blood samples were collected from continuous-flow LVAD patients (n=39) prior to LVAD implantation and after three months of support. Patients were followed for 749±61 days. Retrospective chart review categorized patients as clotters (n=9) or non-clotters (n=30). Plasma VWF multimers and VWF degradation fragments were resolved with gel electro-phoresis and immunoblotting.

RESULTS: Patients who developed LVAD thrombosis (clotters) exhibited less VWF degradation and higher levels of high-molecular-weight VWF multimers than non-clotters (-9±2% vs. -13±1%, p=0.04). VWF degradation fragments were not associated with LVAD thrombosis.

CONCLUSIONS: Higher levels of VWF multimers were observed in patients who developed LVAD thrombosis. Pathologic VWF degradation during LVAD support contributes to LVAD-asso-ciated bleeding and protects against LVAD thrombosis. Accumulation of VWF multimers contrib-utes to LVAD thrombosis.

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PS-4

Design of an axial blood pump with a large-gap passive levitation technology utilizing a combination of magnetic force and thrust force

Department of Mechanical Engineering, School of Engineering, Tokyo Institute of Technology, Japan

Kazuma Shoji, Tomotaka Murashige, Wataru Hijikata

Background and purposeDurability of the state-of-the-art blood pumps have been enhanced owing to magnetic or hydrody-namic bearings. However, narrow gap of these bearings have a risk of hemolysis in addition to a risk of malfunction due to feedback control of electromagnets. To overcome these issues, we pro-pose and evaluate a novel method for levitating an impeller by using thrust force, which aims to achieve the levitation with large gap.

MethodIn the proposed method, the axial thrust acting on the impeller, which changes with the axial posi-tion of the levitating impeller, is balanced with the magnetic force acting between permanent mag-nets inside the impeller and those in the housing. To validate the levitation principle, the thrust was calculated by computational fluid dynamics analyses as a function of relative position between the impeller and housing. In the proposed model, the diameter of the housing is gradually changed from 20 mm at the inlet to 30 mm at the outlet. The position of the impeller was changed from the inlet side to the outlet side. The flow rate and the rotational speed were 5 L/min and 10000 rpm, respec-tively. The thrust was also measured by experiments to confirm the validity of the analyses at a flow rate of 0.5 to 4.8 L/min at a rotational speed of 5000 and 6000 rpm.

Results In the simulated results, the thrust showed positive stiffness, that is, the thrust decreased from -5.8 to -7.0 N according to the movement of the impeller. The simulated and experimentally-measured thrust showed good agreement, i.e. the error was within less than 12%.

ConclusionWe concluded that the thrust can be positive stiffness by designing the housing configuration appro-priately. This fact implies a possibility of passive levitation without an electromagnet and a hydro-dynamic bearing.

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PS-5

Clinical Outcomes of Implantable Left Ventricular Assist Device as Bridge-to-Transplant Therapy

Department of Surgery, Division of Cardiovascular Surgery, Shinshu University School of Medicine, Japan

Masaki Komatsu, Toru Mikoshiba, Kai Machida, Haruki Tanaka, Hajime Ichimura, Takateru Yamamoto, Toshihito Gomibuchi, Noburu Ohashi, Yuiko Wada, Tatsuichirou Seto, Kenji Okada

Background and PurposeAlthough the use of implantable left ventricular assist device (iLVAD) as a bridge to heart trans-plantation (BTT) is increasing. The objective of this study is to demonstrate early and mid-term outcomes of our single-center experience with this device as a BTT.Methods and ResultsFrom March 2015 to May 2018, ten patients underwent iLVAD implantation at our institute. The median age of the patients was 48.5 years and 70.0 % were male. The cause of the severe heart fail-ure was dilated cardiomyopathy in six patients (60.0 %), dilated phase of hypertrophic cardiomyo-pathy in three patients (30.0 %), and ischemic cardiomyopathy in one patients (10.0 %). Preopera-tive mean left ventricular ejection fraction was 21.6 %, and all patients received intravenous inotropic agents. Majority of patients were at Interagency Registry for Mechanically Assisted Cir-culatory Support (INTERMACS) profile levels 3 in eight patients, and INTERMACS profile levels 2 in two patients. Postoperatively, the median duration of ventricular assist device support was 690 days. Major adverse events were observed in two patients, including neurologic or thromboembolic events in 1 (10 %), and gastrointestinal bleeding in 1 (10 %). In addition, two patients experienced pump thrombosis, and one patient needed pump exchange.There was no LVAD-related infections. One patients underwent heart transplantation after 32 months of iLVAD support. Nine patients are still supported by iLVAD. Overall survival at 1 and 3 years were both 100 %. ConclusionsEarly and mid-term outcomes were satisfactory after iLVAD implantation as a BTT at our institute.

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PS-6

Bond Graph Modelling of a Cardiovascular System + TAH: “A New Way to Look at Things” to Improve System Design

1)Department of Mechanical Engineering, Vanderbilt University, Nashville, USA,2)Department of Biomedical Engineering, University of Arizona, Tucson, USA,3)Department of Medicine, Sarver Heart Center, University of Arizona, Tucson, USA

Mengtang Li1), Eric J Barth1), Marvin J Slepian2,3)

Purpose: Though mechanical circulatory support (MCS) devices such as ventricular assist devices (VAD) and total artificial hearts (TAH) provide heart failure patients with bridges to heart trans-plantation or are alternatives to transplantation, device performance and corresponding control strategies are often difficult to evaluate. Difficulties arise due to the complex interaction of multiple domains - i.e. biological, hydraulic, hemodynamics, electromechanical, system dynamics, and con-trols. In an attempt to organize, integrate and clarify these interactions, a technique often used in hydraulic pump design is applied to describe the performance and functionality of MCS devices.Methods: A graphical modelling technique known as bond graphs, which universally describes the power/energy relationship, denoted as “effort and flow,” within any dynamic system across differ-ing domains was applied to the TAH. The causality of dynamic variables was revealed by the topol-ogy and the mathematical relationships between power variables. This causality clearly shows the energy exchange mechanisms of the system and provides important information for device and con-trol algorithm design. Results: A bond graph model was developed for the left side of a basic TAH, adopting the funda-mental structure of either a hydraulic mechanism (i.e. AbioCor/Carmat) or a pneumatic mechanism (i.e. SynCardia), combined with a systemic circulation loop. The model captures the dynamics of the membrane, the hydraulic source or pneumatic source, and the systemic circulation. The values of multiple variables were tuned and the corresponding effects were plotted. A simple control strat-egy was deployed to show the advantages of the binary relationship between effort and flow.Conclusions: Our results illustrate the generality and clarity of the bond graph modeling methodol-ogy to capture a complicated multi-domain biomechanical system. This multi-disciplinary cross-pollination of an analytical tool from the field of dynamic systems may provide important in-sight to further aid and improve the design and control of future MCS systems.

36

PS-7

Clinical outcome of HeartMate II in Nagoya University

Department of Cardiac Surgery, Nagoya University, Gradate School of Medicine, Japan

Masato Mutsuga, Kazuro Fujimoto, Hideki Ito, Wataru Uchida, Sachie Terazawa, Yoshiyuki Tokuda, Yuji Narita, Akihiko Usui

[Background] We have started the implantable LVAD since 2013. We had only used HeartMate II for all patients. The aim of this study is to evaluate the clinical outcome of our series.[Methods] From October 2013 to June 2018, 31 patients underwent HeartMate II LVAD placement, of which 8 patients required an exchange. Ten patients were bridge to bridge cases who had previ-ous extra-cardiac ventricular assist device. There were twenty-five male and six female, mean age was 45±12 years old (24-64 years old). The etiology of the heart was two Becker muscular dystro-phy, six ischemic cardiomyopathy and twenty-three dilated cardio-myopathy. [Results] There were five hospital death and one late death. Two patients had orthotopic heart trans-plant. The mean assist duration of HeartMate II was 605±475 days (19-1676 days). Overall survival at 180 days was 89.9%, at 365 days was 85.6% and at 730 days was 85.6%. Freedom from all ad-verse events at 180 days was 60%, at 365 days was 49.5% and at 730 days was 25.7%. Freedom from neurological events at 180 days was 82.5%, at 365 days was 78.7% and at 730 days was 78.7%. Freedom from all infection events at 180 days was 82.8%, at 365 days was 74.5% and at 730 days was 46%. [Conclusions] Our clinical outcome of HMII results is feasible with acceptable early and long-term survival and morbidity.

37

PS-8

Interleukin-6, 8 levels during ex vivo heart perfusion using Blood cardioplegia or Custodiol for heart transplant

National Research Center for Cardiac Surgery, Astana, Kazakhstan

Zhuldyz Nurmykhametova, Rymbay Kaliyev, Timur Lesbekov, Serik Bekbossynov, Makhabbat Bekbossynova, Timur Kapyshev, Svetlana Novikova, Linar Faizov, Zhanibek Ashyrov, Yuriy Pya

Background Interleukins (ILs) have been shown to play important roles in a series of immunological and inflam-matory responses. This study evaluated the concentration of ILs 6 and 8 during ex vivo allograft perfusion for heart transplantation with blood cardioplegia and conditioning vs. Custodiol. Methods We performed retrospective analysis of 45 patients with heart failure undergoing heart transplanta-tion and using the Organ Care System (OCS) for donor organ transport. Donor hearts were arrested using blood cardioplegia (BC) and conditioning (n = 30) or standard Custodiol (SC) solution (n = 13). Perfusion and cardiac function parameters were continuously monitored and the donor heart was perfused in the OCS.ResultsAll the donor hearts had stable perfusion and metabolic characteristics in the OCS, with similar measures between the two groups. Postoperative mean concentration of ILs 6 and 8 at 12 hours was significantly lower in BC group compared to SC group: 1.238 (± 0.6293) vs. 2.070 (± 0.7012); 95% CI, P= 0.033. However, no significant differences were found in preoperative concentrations of ILs 6 and 8 between groups. ConclusionsIn our small cohort, the survival and acceptable incidence of serious cardiac-related adverse events at 30 days postimplant demonstrated feasibility of BC use with the OCS.

38

PS-9

Quantification of DNA Damage in Heart Tissue as a Novel Prediction Tool for Therapeutic Prognosis

1)Department of Cardiovascular Medicine, The University of Tokyo Hospital, Japan,2)Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Japan

Toshiyuki Ko1), Kanna Fujita1), Seitaro Nomura1), Yukari Uemura2), Hisataka Maki1), Yumiko Hosoya1), Eisuke Amiya1), Masaru Hatano1), Issei Komuro1)

BackgroundAccumulation of DNA damage and activation of DNA damage response (DDR) have been observed in the failing heart, but these scientific findings are still far from the clinical application. Among various pathogenic signatures of DDR, Poly ADP-Ribose (PAR) is a well known functional marker. Here, we conducted immunofluorescence staining of PAR to the specimens of myocardial biopsy from DCM patients to verify its utility to anticipate the response to medical therapy.

MethodsWe retrospectively enrolled 58 DCM patients who underwent myocardial biopsy before the initia-tion of medical therapy. Data were collected by chart review to judge whether the patients achieved left ventricular reverse remodeling (LVRR) after medication or not. LVRR was defined as an abso-lute increase in the LV ejection fraction of at least 10% with a final value of >35%, accompanied by a decrease in LV end-diastolic diameter of at least 10%, as assessed by echocardiography at around 12 months after initiation of treatment. The specimens of myocardial biopsy after immunofluores-cence staining of PAR were automatically measured using image measurement software under the same conditions.

Results26(44%) patients achieved LVRR. Automatic measurements revealed that patients with LVRR showed significant fewer percentage of PAR positive nuclei in their biopsy tissue compared with those without LVRR (16.8% vs 3.6%, p < 0.0001). Multivariate analysis showed that percentage of PAR positive nuclei was an independent risk factor for both major adverse cardiovascular events and LVRR after adjustment for important confounding factors, and the cut-off value of 5.74 predict-ed LVRR in high specificity (81.5%) and sensitivity (87.1%).

ConclusionWe showed the utility of PAR staining to anticipate the probability of LVRR, providing a novel prognostic predictor of medical therapy for DCM.

39

PS-10

Validation of CFD methods for intraventricular flow fields and the prediction of intraventricular thrombosis

1)Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria, 2)Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, Austria, 3)Institute of Fluid Dynamics and Heat Transfer, Technical University of Vienna, Austria, 4)Department for Cardiac Surgery, Medical University of Vienna, Austria

Mojgan Ghodrati1), Thananya Khienwad1), Alex Maurer1), Francesco Zonta3), Francesco Moscato1,2), Heinrich Schima1,2,4), Philipp Aigner1,2)

Intraventricular flow patterns during Left Ventricular Assist Device (LVAD) support have been in-vestigated via Computational Fluid Dynamics (CFD) by several groups in the last years. Based on such simulations, specific parameters for thrombus formation risk analysis and platelet activation have been developed. However, CFD simulations of complex flow configurations require a proper validation by experiments. For this reason, a vis-à-vis comparison between Particle Image Veloci-metry (PIV) and CFD of the ventricular model has been performed in the present study.A ventricular model with a well-defined inflow section was analyzed by PIV, and replicated by CFD simulations with a tetrahedral mesh of 5 million elements. Four different modeling approaches including the Laminar, standard k-omega (SKO), shear stress transport (SST) and renormalized group k-epsilon (RNG) were applied and compared to the PIV results. The relative errors of veloci-ty were calculated for medial coronal and sagittal planes. Indicators for thrombogenic regions were compared in low velocity areas (v < 0.01m/s) and recirculation (Q-value > 0.25).Although the velocities of the laminar and k-omega methods had low relative errors compared to the experiment in the coronal (laminar: 0.17, SKO: 0.19, SST: 0.18, RNG: 0.59) and sagittal plane (laminar: 0.23, SKO: 0.26, SST: 0.29, RNG: 0.48), all numerical methods under predicted the areas of stagnation and recirculation (PIV: 4.2 cm2, laminar: 3.3 cm2, SKO: 2.9 cm2, SST: 2.4 cm2, RNG: 1.6 cm2). However, the laminar model showed the same positions as PIV, likely indicating the criti-cal areas for intraventricular thrombosis.Although several CFD methods are available for the analysis of left ventricular flow patterns, most of them (SKO, SST, RNG) failed to identify the critical areas for flow stagnation and recirculation when compared to an in-vitro model. Nevertheless, the laminar method seems to be most appropri-ate to simulate realistic intraventricular flow fields and predict risk areas for thrombosis.

40

TL

History and Perspective of MCS: The trail blazed and the pathway ahead

INTEGRIS Baptist Medical Center, Oklahoma City, USA

James Long

As the field of Mechanical Circulatory Support (MCS) reaches into its sixth decade beyond first laboratory experimentation it behooves us to pause and reflect on those pioneering advances on which the future will be leveraged. Such reflection is most valuable when it inspires the thoughtful to blaze new trails. Much has been accomplished. We are tantalizingly close to the holy grail of delivering amazing Technologies for (a) extending Life with (b) Quality and (c) Safety through (d) Cost-effective, (e) Easier-to-use therapies applied at the (f) optimum Time in (g) properly selected heart failure Pa-tients. And, yet, much remains. The good news is that the pace of progress is accelerating. Hopefully, we are in the final decade of pioneering. Survival with durable MCS devices is finally approaching that of Heart Transplantation. The vision of suitable Quality of Life is within sight. However, we are just now beginning to seriously address Safety which has been limited by unacceptable Adverse Event rates. This problem contin-ues to burden patients with Morbidity, to burden caretakers with the rigors of Management and to burden our healthcare systems with excessive Costs. All of that inhibits expansion into Earlier stag-es of Heart Failure. Despite the marvels of engineering behind today’s blood pumps, their interface with the host re-mains to be perfected. The single most important opportunity to reduce adverse events is through preventing sublethal blood damage. Advances in the science of hemocompatability as applied to device design and testing have opened the door for a next generation of devices that will overcome those factors that contribute to bleeding, thrombosis, inflammation and even decreased resistance to infection. Other device-host interfaces to be addressed include those that deliver improved Quality of life, full Implantability, Auto-regulation and expanded Heart Failure Conditions. Indeed, the future is promising. Our mission now is to deliver on the goals so long envisioned.

41

YIA-1

Shear-Mediated GpIIb/IIIa-Rich Platelet Microparticle Generation: A Mechanism Validating Inability of GpIIb/IIIa Blockade to Limit MCS Thrombosis

1)Department of Medicine and Biomedical Engineering, Sarver Heart Center, University of Arizona, Tucson, AZ, USA,2)Department of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA

Yana Roka-Moiia1), Daniel Enrique Palomares1), Alice Sweedo1), Jawaad Sheriff2), Danny Bluestein2), Marvin J Slepian1)

BACKGROUND. Post-implant thrombosis of mechanical circulatory support (MCS) is associated with serious clinical sequelae, resulting in hospital readmission and potential reoperation. Intense, augmentative anti-platelet agents are often employed to limit, reverse or disperse thrombi. While integrin GpIIb/IIIa activation is a fundamental step in platelet aggregation and thrombus formation, anti-GpIIb/IIIa agents have had limited efficacy in mitigating MCS thrombosis. We previously demonstrated that shear-mediated platelet activation (SMPA) does not result in GpIIb/IIIa activation and aggregation, rather induces platelet microparticle (PMP) generation. Here we examine the ef-fect of elevated shear stress on the distribution of GpIIb/IIIa between platelets and PMPs in com-parison to biochemical agonists. METHODS. Human platelets were exposed to continuous shear stress (70 dyn/cm2, 10min) in a hemodynamic shearing device; or to ADP (20 μM) and thrombin (1 U/ml). GpIIb/IIIa expression on platelets and PMPs was quantified by flow cytometry using anti-CD41 antibody. Among CD41+ particles single platelets and PMPs were distinguished by their FS/SS. RESULTS. Platelet exposure to supra-physiologic shear reduced the level of GpIIb/IIIa surface ex-pression, as indicated by a significant drop of CD41+ platelet number and fluorescence intensity (84.8±4.4% and 6998±728 AU vs. 93.7±2.3% and 4696±1083 AU for intact platelets; ANO-VA,p≤0.05). In contrast, ADP and thrombin resulted in an increase of GpIIb/IIIa fluorescence by 15% and 40%, respectively, indicating integrin overexpression. Moreover, SMPA, but not biochem-ical agonists, promoted evident augmentation of GpIIb/IIIa-presenting PMPs (reaching 12.5±2.8%) – demonstrating integrin shedding from the platelet surface into the microparticle fraction.CONCLUSIONS. Platelet exposure to hyper-shear induces platelet integrin GpIIb/IIIa downregu-lation and massive generation of GPIIb/IIIa-rich microparticles. The differential pattern of GpIIb/IIIa expression in hyper-shear vs. biochemical activation provides a clear mechanism for lack of ef-ficacy of these otherwise potent anti-GPIIb/IIIa agents in MCS thrombosis. Further, the reduction in platelet GpIIb/IIIa expression may also mechanistically contribute to bleeding observed with MCS.

42

YIA-2

Accurate Quantitative evaluation of Aortic Insufficiency during LVAD support by thermodilution analysis

1)Department of Cardio-thoracic Surgery, The University of Tokyo Hospital, Japan,2)National Cerebral and Cardiovascular Center, Research Institute, Department of Artificial Organs, Japan, 3)Department of Cardiac Surgery, Tokyo Metropolitan Geriatric Hospital, Japan

Daichi Akiyama1,2), Takashi Nishimura3), Kei Iizuka2), Toshihide Mizuno2), Tomonori Tsukiya2), Yoshiaki Takewa2), Minoru Ono1), Eisuke Tatsumi2)

Accuracy of the evaluation of aortic insufficiency (AI) during LVAD support is not satisfactory. New evaluation method has been developed applying thermodilution technique which is used for evaluation of shunt of congenital heart disease because LVAD-AI is also shunt formative disease. The purpose of this study is to evaluate the validity of our evaluation technique both in vitro and in vivo experiments. Both in vitro and in vivo experiment models, the magnitude of LVAD-AI was represented by recirculation rate (RR), defined by regurgitant flow divided by pump flow. Both models had the property of AI, and heart failure with full bypass LVAD drive, which meant heart did not eject forward flow across aortic valve. The magnitude of AI was controllable in both mod-els. First experiment was done using mock-circulatory model mimicking native circulation and LVAD, with AI shunt circuit attached in parallel across the aortic valve. Second experiment was performed with a large animal model, in which AI was created by letting an IVC filter open at aor-tic valve level. We placed two thermistors and one port for saline(i.e. heat) injection at outflow con-duit. After injecting liquid, value of RR is calculated by analyzing time-temperature curve of the thermistors and compared to control value of RR calculated from flowmeter. The injection and analysis was repeated with changing magnitude of AI and relation of both RR values were evaluat-ed. Good correlation was observed between two values of RR, both in vitro and in vivo evaluation (correlation coefficient = 0.977 in vitro, and 0.959 in vivo) And two values were almost the same. This technique was proved to be able to calculate RR, an index of LVAD-AI, precisely and accu-rately. This method can theoretically be done by left-sided cardiac catheterization. We are now go-ing to apply this method in a clinical setting.

43

YIA-3

MCS program in Kazakhstan: current status and future perspectives

National Research Cardiac Surgery Center, Astana, Kazakhstan

Assel Medressova, Yuriy Pya, Serik Bekbossynov, Makhabbat Bekbossynova, Saltanat Andossova, Saltanat Dzhetybayeva, Kazyna Shaimerden

Background. MCS program in Kazakhstan started in 2011 before the 1st HTx performed in 2012 in our Center. We reported the current status and future perspectives of MCS program in our country.Methods. From 2011 up to May 2018 ECMO was used in 266 patients – central in 80.8% (n=215), venous-arterial in 86.8% (n=231) cases. 260 patients received a VAD and of these, 249 patients re-ceived a device for left ventricular assist (HeartMate II, n=96, HVAD, n=55, HeartMate 3, n=98), 8 patients – for BiVAD (combination of HeartMate II, HVAD, HeartMate 3 and Levitronix Centrim-ag), and 3 patients – for total artificial heart (HVAD and 2 cases of Carmat). Maximum duration of LVAD support is more than 2200 days (patient remains ongoing). Donor hearts for HTx are deliv-ered in most cases with OCS Transmedics (n=49, 75.4%). The longest preservation time of the do-nor heart in OCS was 16 hours with subsequent successful HTx.Results. 62.4% of patients (n=166) were weaned from the ECMO, 54.13% (n=144) – were sur-vived and discharged from the hospital. Only 7 (7.3%) LVAD patients were transplanted. Kaplan-Meier survival estimates for patients with HeartMate 3 were 95.7% after 1 month, 90.1% after 1 year, 85.4% after 2 and 3 years. Survival rate for 65 patients after HTx were 91.6% after 1 month, 81.2% after 1 year, 78.5% after 2 years and 75.2% after 3 years. There have been no hemol-ysis or pump thromboses in HM 3 patients.Conclusions. ECMO is a method of treatment of cardiac and/or respiratory failure in critically ill patients after cardiac surgery. HeartMate 3 LVAD can be considered as alternative treatment to HTx. OCS is the safe method for myocardial protection in distant preservation of donor hearts. Fur-ther research is needed to investigate the OCS time possibilities.

44

YIA-4

Prevention of thrombus formation inside a magnetically levitated centrifugal blood pump using impeller vibrational excitation

Department of Mechanical Engineering, School of Engineering, Tokyo Institute of Technology, Japan

Tomotaka Murashige, Ming Jiang, Wataru Hijikata

Background and Purpose: We have developed a method for preventing thrombus formation inside a blood pump by actively vibrating an impeller using a magnetic bearing. This study aimed to in-vestigate the effect of impeller vibrational excitation on prevention of thrombus formation. Methods: Two thrombogenic tests were conducted using porcine blood anticoagulated with trisodi-um citrate. In the first test, the isolated pump without circulation was used to evaluate the effect of the impeller excitation frequency and amplitude on thrombus formation. We compared four models; (i) 0 Hz, 0μm, (ii) 70 Hz, 10 μm, (iii) 70 Hz, 50 μm, (iv) 300 Hz, 2.5 μm. In the second test, the pump incorporating the mock loop was used to assess the effect of the vibrational excitation on thrombus formation under the flow rate of 5.0 L/min and a rotational speed of 2000 rpm based on the result of the first test. The activated clotting time of the blood was adjusted to 200 s approxi-mately with calcium chloride. When the measured motor torque increased, the pump was stopped and thrombus formation inside the pump was observed. Blood coagulation time, which is defined as the time period until the motor torque increases, was compared. Besides, hemolysis test was per-formed to confirm whether hemolysis occurs by the vibration excitation. Results: In both thrombogenic tests, blood coagulation time was extended in the model with 300 Hz, 2.5 μm compared with 0 Hz, 0 μm and even approximately doubled in the second test. In the hemolysis test, there was no significant difference in the concentration of plasma free hemoglobin except for 70 Hz, 50 μm.Conclusions: We concluded that the impeller vibrational excitation with a frequency of 300 Hz and an amplitude of 2.5 μm has a potential to prevent thrombus formation inside a magnetically levitat-ed centrifugal blood pump.

45

YIA-5

Echocardiographic Particle Image Velocimetry in the Isolated Pig Heart

1)Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria, 2)Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, Austria,3)Department of Mechanical Engineering, University of Bath, UK,4)Pediatric Cardiovascular Surgery, Pediatric Heart Center, Department of Surgery, University Children’s Hospital Zurich, Switzerland, 5)Division of Surgical Research, Department of Surgery, University Hospital Zurich, University of Zurich, Switzerland

Philipp Aigner1,2), Martin Schweiger4), Kate Fraser3), Fritjof Lemme4), Nikola Cesarovic5), Heinrich Schima1,2), Michael Hübler4), Marcus Granegger4)

Investigations of ventricular flow patterns during mechanical circulatory support (MCS) are limited to in-vitro flow models or CFD simulations. Flow models cannot replicate the complex anatomy of the heart and simulations inherently rely on assumptions. Therefore, the feasibility of flow measure-ments by Echocardiographic Particle Image Velocimetry (E-PIV) was evaluated in an isolated, working heart setup.

Porcine hearts (n=4) were explanted and connected to an isolated heart setup. Hearts were resusci-tated using blood as perfusate and a rotary blood pump (HVAD) was implanted. At different support situations microbubbles were injected via the left atrium and echocardiographic 3-chamber-view B-mode images were recorded (100Hz, Philips iE33, X5-1 xMatrix probe). Flow fields were evalu-ated by iterative PIV algorithms using correlation domain averaging and beam sweep correction for the different hemodynamic situations.

The isolated heart setup facilitated adjustment of different hemodynamic situations (unsupported: 3L/min flow through the aortic valve, total Cardiac Output (tCO): 3L/min); partial support: 1L/min flow through the aortic valve, tCO 3.6L/min, pump speed 2200rpm; full support: tCO 3.6L/min, pump speed 2500rpm). Typical physiologic flow patterns were observed for the unsupported heart with redirection of flow at the hearts apex towards the left ventricular outflow tract (LVOT). With increasing support, large vortex formation is suppressed and flow directly enters the pump. There-fore, the maximum velocities in the LVOT were markedly reduced by 48% for partial support and by 85% for full support.

For the first time, flow patterns in an isolated working heart environment during MCS were visual-ized. In contrast to in-vitro setups, the contribution of the mitral valve apparatus to blood flow pat-terns especially in the LVOT, which may be linked to energy loss, thrombus formation and valve deterioration during MCS can be investigated under real life conditions. Further experiments are re-quired to verify the results ultimately leading to MCS optimization.

46

YIA-6

Next Generation Ultra-Compact Centrifugal Pediatric VAD Using Maglev motor with Improved Design to Enhance Energy Efficiency

1)Department of Mechanical Systems Engineering, Ibaraki University, Japan,2)National Cerebral and Cardiovascular Center, Japan

Masahiro Osa1), Toru Masuzawa1), Ryoga Orihara1), Eisuke Tatsumi2)

BACKGROUND: A next generation ultra-compact centrifugal ventricular assist device (VAD) for pediatric patients under 6 years old has been developed. The pediatric VAD employees magnetical-ly levitated motor, and a centrifugal impeller is completely levitated with full axis active control. The device can achieve higher torque, suspension stability and mechanical reliability by using dual motor structure. However, maximum input power of 13 W for required pump operation of the pedi-atric VAD is slightly high due to the drastically downsized maglev motor. This study investigated motor performance enhancement with refinement of the magnetic design to improve motor energy efficiency.METHODS: Design strategy of the motor improvement is to maintain the device size that is 22 mm in diameter, 33 mm in height and 13 cc in volume, and to maximize magnetic suspension force and toque by adopting motor geometries optimized with numerical simulation. The improved mo-tor was fabricated based on the design refinement. Motor energy consumption and dynamic sus-pension characteristics were then evaluated. RESILTS: The developed maglev motor levitated the rotor with the rotating speed up to 8000 rpm in water medium. The oscillation amplitude of the levitated impeller was sufficiently suppressed by the enhanced suspension force. The power consumption was then significantly reduced and less than 3 W at the maximum operating speed. Adding the power consumption measured by the torque evaluation to the input power for levitation, the maximum total power input for pediatric circulation is expected to be greatly reduced to less than 8 W.CONCLUSIONS: The successfully enhanced magnetic levitation force and rotating torque signifi-cantly contributed to the performance progress of the magnetic system and the drastic reduction of the power consumption. Circulation performance and dynamic levitation characteristics of the pediatric VAD with the improved maglev motor will have been evaluated as a next step.

47

SL1

Continuous long-term health-monitoring by wearable sensors

1) Electrical and Electronic Engineering and Information Systems, The University of Tokyo, Japan, 2) Thin-Film Device Laboratory & Center for Emergent Matter Science (CEMS), RIKEN, Japan

Takao Someya1,2)

Wearable electronics are expected to open up a new class of applications ranging from health-moni-toring, motion-capturing, and human-machine interfaces. Wearable technology can enable continu-ous, long-term monitoring and lead to the personalization of medical care that can help people stay healthy and prevent more serious health problems from happening in the first place. In order to ex-pand emerging applications of wearable technologies, soft biomedical sensors have attracted much attention recently. In order to minimize the discomfort of wearing sensors, it is highly desirable to use soft electronic materials particularly for devices that come directly into contact with the skin and/or biological tissues. Thanks to recent progress of soft electronics, intimate and conformal inte-gration of electronics with the human skin, which is referred to as a smart skin, can be created to continuously monitor health conditions. Smart skins can monitor small changes that occur very gradually over long periods and, therefore, have tremendous potential to drastically change the na-ture of the examination and treatment of medical conditions. In this talk, we will review recent pro-gress and outlook of smart skins.

48

SL2

“Futurability” for Cardiology and Cardiovascular surgery

Osaka University, Japan

Yoshiki Sawa

Although LVAD implantation and Heart transplantation have been well accepted as the ultimate lifesaving means of supporting end-staged heart failure patients, there are some limitations in such therapies. So we developed cell sheet technology experimentally and introduced this to the treat-ment of severely damaged myocardium as translational research.In a series of pre-clinical experiments, we proved that myoblast sheets could heal the impaired heart mainly by cytokine paracrine effect in cardiomyopathy model. We applied myoblast sheets to 4 DCM patient receiving LVAD and 2 patients showed the recovery from LVAD. Although we im-planted myoblast sheet to 17 heart failure patients with ischemic etiology and majority in patients showed improvement of systolic function (LVEF; pre vs 12mo=26.8±5.4 vs 30.7±6.2, p<0.05) with ameliorated exercise tolerance (6min walk test; pre vs 12mo=401±108 vs 482±154, P<0.05) and symptoms (SAS; pre vs 12mo=3.6±1.5 vs 5.3±2.1, P<0.05). Although in 24 NIDCM patients who were received myoblast sheet functional recovery was limited, good clinical outcome in selected NIDCM patients with preoperatively preserved diastolic function (PCWP: OR, 1.84; 95% CI, 1.01 to 12.7; p = 0.044) and ability of protein synthesis in myocytes accessed by expression of histone H3 lysine 4 trimethylation (H3K4me3; OR, 0.74; 95% CI, 0.36 to 0.92; P = 0.0017).) in biopsy sample. Recently myoblast sheet was approved by the government as “Heart Sheet” in the treatment for ischemic cardiomyopathy. To supply cardiomyocytes to the distressed myocardium we have developed human iPS cell derived cardiomyocyte sheet and obtained Proof of Concept with evidence of synchronous movement with recipient myocardium. And also we have established large culture system and checked safety of GMP grade iPS cell derived cardiomyocyte sheets for clinical trial by the development in new method for removal of immature iPS cells.Regenerative technology has some potentials in the clinical treatment of heart failure which has lit-tle response to the internal medical or conventional surgical treatment and these technologies may open new era in the treatment of severely damaged myocardium.

49

O1-1

High intensity transient signals (HITS) on transcranial Doppler (TCD) as an early sign of thrombosis in a rotary blood pump

1)Department of Cardiac Surgery, School of Medicine, University of Zagreb, Croatia,2)Department of Neurology, School of Medicine, University of Zagreb, Croatia,3)Department of Cardiology, School of Medicine, University of Zagreb, Croatia

Bojan Biocina1), Branko Malojcic2), Maja Cikes3), Mate Petricevic1), Hrvoje Gasparovic1), Davor Milicic3)

Ventricular assist device (VAD) thrombosis or in- pump thrombus formation is one of the most se-rious adverse events in mechanical circulatory support (MCS), and it carries significant morbidity and mortality. Every possible effort should be made to detect thrombus formation as soon as possi-ble and to apply appropriate therapy and novel diagnostic technologies are required to accomplish that goal.We present a case of otherwise uneventful implantation of Heart Mate 3 VAD in a young BTT patient who developed a sharp rise of free haemoglobin plasma level and lactate dechydrogenase (LDH) level at POD 3. TEE confirmed thrombus formation in LV around the inflow cannula. At the same time, a number of High Intensity Transient Signals (HITS) were detected on transcranial Doppler (TCD), suggesting microembolization from the pump. Number of HITS dropped after the increase of Heparin infusion rate, with the drop of free Hemoglobin and LDH also. However, when Heparin had to be stopped due to serious gastrointestinal bleeding, free hemoglobin level rose sharply again with the rise of number of HITS. The patient eventually recovered as free haemoglo-bin and LDH levels went back to normal, and HITS dissapeared from TCD.At the same time, the another uneventfully implanted HM3 patient without the sign of increased level of free hemoglobin and LDH showed no signs of HITS on TCD during the whole hospital stay. We conclude that TCD could be used as an sensitive diagnostic tool for early pump thrombosis , however further investigation is required.

50

O1-2

Risk analysis of stroke in the acute phase after Left Ventricular Assist Device Implantation

Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan

Takaaki Samura, Koichi Toda, Daisuke Yoshioka, Shigeru Miyagawa, Yasushi Yoshikawa, Hiroki Hata, Satoshi Kainuma, Shohei Yoshida, Takayoshi Ueno, Toru Kuratani, Yoshiki Sawa

Background: Stroke is one of major adverse events after left ventricular assist device (LVAD) im-plantation. Risk rate of stroke after LVAD implantation is highest in immediately after LVAD im-plantation and then increasing again in chronic periods. Although risk factors of stroke in chronic phase have been described, less is known for stroke in acute phase. In the present study, we investi-gated the incidence and risk factors of stroke in the acute phase after LVAD implantation. Methods: Between October 2005 and April 2018, consecutive 175 patients (mean age, 44 ± 13 years, female 32%) underwent continuous-flow LVADs (65 HeartMateII, 38 DuraHeart, 32 Jarvik2000, Jarvik Heart, 28 EVAHEART, 12 HeartWare) implantation in our institution. We investigated the inci-dence of stroke (both hemorrhagic and ischemic), and analyzed risk factors of symptomatic stroke in the acute phase. The acute phase was defined as the period within 90 days after LVAD implanta-tion. Results: Stroke occurred 29 patients in the acute phase after LVAD implantation. Multivariate analysis revealed that low cardiac output (Odds Ratio= 0.36 (0.17-0.81); p=0.024) during postoper-ative 24 to 36 hours was the only independent risk factor of acute stroke after LVAD implantation. On the other hand, types of LVAD, international normalization rate during any postoperative peri-ods were not risk factors of acute stroke after LVAD implantation. Patients with acute stroke had higher serum lactate dehydrogenase (LDH) level at any point until 14 days after LVAD implanta-tion. Especially for HeartMate Ⅱ patients, cardiac output during postoperative 24 to 36 hours was statistically significant negative relationship with serum LDH level at 14 days. Conclusions: Pa-tients with perioperative lower cardiac output and higher LDH level developed stroke in the acute phase after LVAD implantation. These results suggested that maintenance of sufficient LVAD flow is important in prevention of stroke which may be related to subclinical pump thrombosis.

51

O1-3

Rethinking the Hemolysis Test Loop: Adjusting the Design for High Pulsatility Pumps

1)Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA,2)Design Mentor, Inc., Pelham, New Hampshire, USA

Nicole Byram1), Joseph Adams1), Takuma Miyamoto1), Raymond Dessoffy1), Jeffrey Naber2), Matthew Murphy2), Doug Vincent2), Kiyotaka Fukamachi1)

Blood pump technology advances each year, and device hemolysis is evaluated in vitro before mov-ing into animal studies. With pulsatile operation a priority, test loop design becomes critical—loop components can harm cells as much as the device, especially with the very high pressure and flow surges seen in pulsatile pumps. We have designed a loop that determines the hemolytic potential of high-pulsatility devices.

Building upon a 1-bag in vitro hemolysis loop that complies with ASTM F1841-97, additional res-ervoirs increase the circuit’s compliance. To control afterload without extreme restriction of the tub-ing and subsequent turbulent areas of circulation, one reservoir is pressurized between two metal plates and clamps are positioned in 2 locations, one on a section of small diameter tubing [Figure, left]. Pump flow and pressures are monitored, and free hemoglobin measurements at 30-minute in-tervals are used to determine the Normalized Index of Hemolysis (NIH).

Hemolysis values of the VentriFloR True Pulse Pump (Design Mentor, Pelham, NH) using the 1-bag loop showed elevated NIH (0.20 mg/dL), likely due to a full, semi-rigid reservoir and drastic clamping of the outlet tubing to produce an afterload of 100 mm Hg. With the new design, NIH was reduced to 0.05-0.07 mg/dL). A BPX-80 (Medtronic, Inc., Minneapolis, MN) was used to validate the 3-bag loop and has similar results (NIH = 0.04 mg/dL) [Figure, right].

As blood pumps incorporate physiologic flow and pressure patterns, current standards have definite problems. During 1-bag loop tests, eddies downstream of the extreme clamping needed to match to the 100 mm Hg requirement were visible, and the reservoir was at capacity. The new loop design shows no such flow patterns and is more flexible. It could easily be adapted to fit any pump config-uration, enabling accurate prediction of hemolysis for both continuous and pulsatile flow pumps.

Rethinking the Hemolysis Test Loop: Adjusting the Design for High Pulsatility Pumps Nicole Byram, BS1, Joseph Adams, MS1, Takuma Miyamoto, MD, PhD1, Raymond Dessoffy1, Jeffrey Naber, BA2, Matthew Murphy, BS2, Doug Vincent, BS2, Kiyotaka Fukamachi, MD, PhD1 1Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio 2Design Mentor, Inc., Pelham, New Hampshire Purpose: As blood pump technology advances, in vitro hemolysis is very important. For pulsatile pumps, test design becomes critical—loop components can harm cells, especially with very high pressure and flow surges. We designed a loop that determines the hemolytic potential of high-pulsatility devices. Method: Building upon a 1-bag in vitro hemolysis loop complying with ASTM F1841-97, additional reservoirs increase circuit compliance. To control afterload without extreme tubing restriction and subsequent turbulent areas of circulation, one reservoir is pressurized between metal plates and clamps are placed in two locations, one on small diameter tubing [Figure, left]. Pump flow and pressures are monitored, and free hemoglobin measurements are used to determine the Normalized Index of Hemolysis (NIH). Results: Hemolysis values of the VENTRIFLO® True Pulse Pump (Design Mentor, Pelham, NH) using the 1-bag loop showed elevated NIH (0.20 mg/dL), likely due to a semi-rigid reservoir and drastic clamping of the outlet tubing. The new design reduced the NIH to 0.05-0.07 mg/dL. A BPX-80 (Medtronic, Inc., Minneapolis, MN), used to validate the 3-bag loop, had similar results (NIH = 0.04 mg/dL) [Figure, right]. Conclusion: Current standards have definite problems as blood pumps incorporate physiologic flow and pressure patterns. During 1-bag loop tests, eddies downstream of the extreme clamping needed for the 100 mmHg requirement were visible, and the reservoir was full. The new loop design shows no such flow patterns and is more flexible. It could easily be adapted to fit any pump configuration, enabling accurate prediction of hemolysis for both continuous and pulsatile flow pumps.

Figure: Diagram of hemolysis test loop (Left); NIH (Right).

52

O1-4

On the representation of effective stress for computing hemolysis

Artificial Organ Technology Lab, Bio-manufacturing Research Centre, Soochow University, Suzhou, China

Peng Wu

Study: Hemolysis is a major concern in blood circulating devices, which arises due to hydrody-namic loading on red blood cells from ambient flow environment. Hemolysis estimation models have often been used to aid hemocompatibility design. The preponderance of hemolysis models were formulated on the basis of laminar flows. However, flows in blood circulating devices are rather complex, can be laminar, transitional or turbulent flows. It is an extrapolation to apply these models to turbulent flows. For the commonly used power-law models, effective stress has often been represented using Reynolds stresses for estimating hemolysis in turbulent flows. This practice tends to far over-predict hemolysis. This study focused on the representation of effective stress in power-law models.

Methods: Through arithmetic manipulations from Navier-Stokes equation, we showed that effec-tive stress can be represented in terms of energy dissipation, which can be readily obtained from CFD simulations. Three cases were tested, including a capillary tube, the FDA benchmark cases of nozzle model and blood pump.

Results: The results showed that the representation of effective stress in terms of energy dissipation greatly improved the prediction of hemolysis for a wide range of flow conditions. The improvement increases as Reynolds number increases, the overshoot of hemolysis was reduced by up to an order of magnitude.

53

O1-5

Hemolysis test of MU-Centrifugal Blood Pump with an Amplitude Variation for Mimic a Physiological Blood Flow

Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Thailand

Phornphop Naiyanetr, Chitsanupong Rungsirikunnan, Kamonwan Mondee

In Thailand, an extracorporeal mechanical circulatory support device are normally implanted more than a ventricular assist device (internal device). Normally, physiological blood flow is a pulsatile flow, but a centrifugal blood pump generally generated a continuous flow (CF; constant pump speed). However, by speed variation, the pulsatile flow variation can established for mimic a physi-ological blood flow. In this study, Mahidol University Centrifugal Blood Pump (MUBP) with pul-satile flow variation (PFV) was used for a hemolysis investigation.Method: This study, anticoagulated equine blood was used with mock circulation loop. The equine blood was provided by Faculty of Veterinary Science, Mahidol University (Animal Ethics Commit-tee approved). In each test (n=3 per condition), 500 milliliter of blood was used. This experiment was control at 25℃. The MUBP speed was set at 1500 rpm (CF) 1500±500rpm (PFV) and 1500±750rpm (PFV). PFV was a sine wave pattern at 60 cycle per min. The pump flow was set around 3.5 liter per min. The system was operated for 6 hours. Blood sample was obtained every hour. The plasma-free hemoglobin (pfHb) of each speed conditions were compared. The hemolysis level was investigated by Normalized index of Hemolysis (NIH) and Modified index of Hemolysis (MIH). Results: In all conditions, pfHb level increased with the time. Both NIH level and MIH level of all 3 conditions (1500 rpm, 1500±500rpm and 1500±750rpm) shown non-significantly difference; NIH: 0.0279±0.0099, 0.0250±0.0026 and 0.0343±0.0098 (g/100L); MIH: 23.42±10.26, 22.05±3.71 and 29.52±10.25, respectively. Conclusion: The hemolysis level between pulsatile flow and continuous flow conditions was non-significantly difference. Therefore, optimum amplitude of pulsatile flow should be usable for mimic a physiological blood flow.

54

P1A-1

The Application of AMESim and Simulink United Simulation Technology in VAD Test Equipment Design

1)RocketHeart Technology Co. Ltd, Tianjin, China,2)TEDA International Cardiovascular Hospital, Tianjin, China

Chenqi Zhu1), Jian Xu1), Xuman Zhang1), Tienan Chen2), Yu Song2)

Purpose: To investigate how to simulate human blood circulation circuit reasonably, efficiently, and accurately, so as to provide supporting evidence for the development of test equipment for the ventricular assist device (VAD).Methods: Based on the AMESim and Simulink united simulation method. On one hand, AMESim is used to model the left and right atrium as well as ventricles, VAD and blood flow in the vessel, and to compare the simulation differences between lumped parameter method and one-dimensional flow method. On the other hand, Simulink is utilized to complete the control algorithm simulation of atrium and ventricle, and to compare the differences between force control and displacement control algorithm for heart beat.Result: This technique was used to simulate various pathological statuses like left heart failure, hy-pertension, aortic valve disease, mitral valve disease, right heart failure, pulmonary valve disease, and tricuspid valve disease. The effect after VAD access was also studied.Conclusion: The parameters of each simulation module can be conveniently altered. This united simulation technology can be used to predict the performance of the physical test system. And it provides theoretical and data support for the design and development of VAD test equipment in re-spects of control policy, adjustment method and hardware circuit size, etc.Key Words: United simulation, Blood circulation circuit, Ventricular assist device

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P1A-2

The mechanical impact on blood of high and low flow rates in extracorporeal membrane oxygenation

1)Critical Care Research Group, The Prince Charles Hospital, Australia, 2)Griffith University, Australia, 3)University of Queensland, Australia, 4)ICETLAB, Australia, 5)Biomedical Engineering, Institut Superieur d’Ingenieurs de Franche Comt, Besancon, France

Chris Hoi Houng Chan1,2,3,4), Katrina K Ki1,3), Margaret R Passmore1,3), Valentine Oqda5), Geoff Tansley2,4), Jacky Y Suen1,3), John F Fraser1,3,4)

Background: Extracorporeal membrane oxygenation (ECMO) is a widely accepted management strategy for severe cardiopulmonary failure. Despite the significant benefits in ECMO technology, haemolysis, thrombosis and bleeding still remain common complications during ECMO support. There is a growth in “low flow” strategies to augment native cardiac output. To enhance the current knowledge on ECMO-related complications, we investigated the undefined relationship between different ECMO flow rates on blood damage. Methods: ECMO (Permanent Life Support System, Maquet CP) was tested in vitro using heparin-ised human whole blood under standard physiological conditions for 6 hours at two flow haemody-namics: high flow at 4 L/min (normal cardiac output; n=4) and low flow at 1.5 L/min (weaning; n=4). Blood samples were collected at baseline, 1, 2, 4 and 6 hours. Haemolysis was measured by Harboe assay using spectrophotometry. Von Willebrand factor (vWF) multimers were characterized with electrophoresis and immunoblot analysis. Platelet aggregation was measured by Multiplate us-ing ristocetin, thrombin receptor activating peptide-6 (TRAP6) and adenosine diphosphate (ADP). The changes in the surface expression of platelet activation marker (CD42b) was assessed using flow cytometry.Results: Haemolysis and degradation of high molecular weight vWF in low flow were significantly higher than in high flow. ADP-, TRAP6- and ristocetin-induced platelet aggregation was signifi-cantly decreased from baseline, however there was no difference between high and low flow. The percentage of activated platelets detected by CD42b increased significantly in low flow compared to high flow overtime. Conclusion: Our in vitro study suggests that the blood damage caused by low flow may be much greater than high flow in ECMO circuit. We hypothesised that the duration of blood-ECMO circuit contact may have a larger role in the reported bleeding and thrombotic complications in patients. However, in vivo studies are required.

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P1A-3

Virtual Mock Loop Study Comparing LVAD and BVAD Assistance for Systolic Heart Failure Conditions

1)Cleveland Clinic, USA, 2)R1 Engineering, USA

Jamshid Karimov1), David Horvath2), Barry Kuban1), Nicole Byram1), Takuma Miyamoto1), Kiyotaka Fukamachi1)

BACKGROUND/PURPOSE: We developed a Virtual Mock Loop (VML), to model the interac-tions of a mechanical circulatory support (MCS) pump using combinations of patient-specific heart failure (HF) conditions. We simulated and analyzed the centrifugal left ventricular assist device (LVAD) and biventricular assist device (BVAD support over a range systolic HF conditions.METHOD: The VML was used to input blood flows, pressures, and volumes as they surge through the MCS-supported systolic HF cardiovascular system. The developed software (MATLAB; Math-WorksR) simulated the hemodynamics: using a lumped-parameter model including systemic/pul-monary circulation, impedance distribution, systolic and diastolic ventricular compliance, beat rate, blood volume, cardiac chambers and valves. LVAD support was adjusted to maintain 5.0 L/min to-tal systemic flow. For BVAD, the RVAD support was adjusted to maintain LAP-RAP at 3-5 mm Hg. RESULTS: For moderate left HF and severe right HF, BVAD support was needed to both lower atrial pressures and control the atrial pressure difference. (Fig. 1). LVAD support was the primary factor for establishing total systemic flow. In all cases of BVAD support, the RVAD flow needed to balance atrial pressures is less than the LVAD flow. CONCLUSION: The present simulation-based approach showed feasibility of reproducible assess-ment of the hemodynamic interactions in a variety of HF conditions assisted by LVAD and/or BVAD. The VML can be useful in determining whether LVAD or BVAD support is likely beneficial for controlling atrial pressure difference and to evaluate BVAD control schemes.

ISMCS 2018 Tokyo, Japan

1

Virtual Mock Loop Study Comparing LVAD and BVAD Assistance for Systolic Heart Failure Conditions Jamshid H. Karimov1, David Horvath2, Barry Kuban1, Nicole Byram1, Takuma Miyamoto1, Kiyotaka Fukamachi1

1Cleveland Clinic, Cleveland, Ohio, USA. 2R1 Engineering, LLC, Euclid, Ohio, USA BACKGROUND/PURPOSE: We developed a Virtual Mock Loop (VML), to model the interactions of a mechanical circulatory support (MCS) pump using combinations of patient-specific heart failure (HF) conditions. We simulated and analyzed the centrifugal left ventricular assist device (LVAD) and biventricular assist device (BVAD support over a range systolic HF conditions. METHOD: The VML was used to input blood flows, pressures, and volumes as they surge through the MCS-supported systolic HF cardiovascular system. The developed software (MATLAB; MathWorks®) simulated the hemodynamics: using a lumped-parameter model including systemic/pulmonary circulation, impedance distribution, systolic and diastolic ventricular compliance, beat rate, blood volume, cardiac chambers and valves. LVAD support was adjusted to maintain 5.0 L/min total systemic flow. For BVAD, the RVAD support was adjusted to maintain LAP-RAP at 3-5 mm Hg. RESULTS: For moderate left HF and severe right HF, BVAD support was needed to both lower atrial pressures and control the atrial pressure difference. (Fig. 1). LVAD support was the primary factor for establishing total systemic flow. In all cases of BVAD support, the RVAD flow needed to balance atrial pressures is less than the LVAD flow. CONCLUSION: The present simulation-based approach showed feasibility of reproducible assessment of the hemodynamic interactions in a variety of HF conditions assisted by LVAD and/or BVAD. The VML can be useful in determining whether LVAD or BVAD support is likely beneficial for controlling atrial pressure difference and to evaluate BVAD control schemes. Fig.1. VML simulation output.

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P1A-4

Evaluation of Heartmate 3 Centrifugal Pump Performance for Right Ventricular Support in Virtual Model


Jamshid Karimov1), David Horvath2), Barry Kuban1), Nicole Byram1), Takuma Miyamoto1), Kiyotaka Fukamachi1)

BACKGROUND/PURPOSE: The dynamic system platform, the Virtual Mock Loop (VML), has been developed to model the interactions of a mechanical circulatory support (MCS) pump in varia-ble patient-specific hemodynamics. Herein, we simulated and analyzed the clinically available left ventricular assist device (LVAD, HeartMate 3 [HM3]) for use as a right ventricular support device (RVAD) in right ventricular systolic heart failure (RHF). METHODS: The VML was used to input blood flows, pressures, and volumes as they surge through the system with HMIII-supported a range of systolic RHF. The developed software (MAT-LAB; MathWorksR) simulated the hemodynamics using a lumped-parameter model including sys-temic/pulmonary circulation, values for impedance, systolic and diastolic ventricular compliance, beat rate, blood volume, cardiac chambers and valves. RVAD (HM3) head curve characteristics was used for VML simulation run at normal to severe RHF conditions. RESULTS: The results indicate that pressure shifts allow both the systemic and pump flow to re-main relatively constant with pump speed over the range of pulmonary vascular resistance (Fig. 1). The atrial pressure difference also appears to be within the acceptable range (-5 to +10 mmHg) for all the cases of RVAD support in this analysis. Nevertheless, the low pump speed has an advantage because it also allows flow through the pulmonary valve. CONCLUSION: The VML platform allowed reproducible evaluation of the hemodynamic interac-tion in a range of RHF conditions assisted by RVAD (HM3).


1

Evaluation of Heartmate 3 Centrifugal Pump Performance for Right Ventricular Support in Virtual Model Jamshid H. Karimov1, David Horvath2, Barry Kuban1, Nicole Byram1, Takuma Miyamoto1, Kiyotaka Fukamachi1

1Cleveland Clinic, Cleveland, Ohio, USA. 2R1 Engineering, LLC, Euclid, Ohio, USA BACKGROUND/PURPOSE: The dynamic system platform, the Virtual Mock Loop (VML), has been developed to model the interactions of a mechanical circulatory support (MCS) pump in variable patient-specific hemodynamics. Herein, we simulated and analyzed the clinically available left ventricular assist device (LVAD, HeartMate 3 [HM3]) for use as a right ventricular support device (RVAD) in right ventricular systolic heart failure (RHF). METHOD: The VML was used to input blood flows, pressures, and volumes as they surge through the system with HMIII-supported a range of systolic RHF. The developed software (MATLAB; MathWorks®) simulated the hemodynamics using a lumped-parameter model including systemic/pulmonary circulation, values for impedance, systolic and diastolic ventricular compliance, beat rate, blood volume, cardiac chambers and valves. RVAD (HM3) head curve characteristics was used for VML simulation run at normal to severe RHF conditions. RESULTS: The results indicate that pressure shifts allow both the systemic and pump flow to remain relatively constant with pump speed over the range of pulmonary vascular resistance (Fig. 1). The atrial pressure difference also appears to be within the acceptable range (-5 to +10 mmHg) for all the cases of RVAD support in this analysis. Nevertheless, the low pump speed has an advantage because it also allows flow through the pulmonary valve. CONCLUSION: The VML platform allowed reproducible evaluation of the hemodynamic interaction in a range of RHF conditions assisted by RVAD (HM3). Fig. 1. VML Simulation output.

58

P1A-5

Species Differences in fibrin metabolism for preclinical animal study for cardiovascular device

Department of Artificial Organs, National Cerebral and Cardiovascular Center, Institute, Japan

Toshihide Mizuno, Tomonori Tsukiya, Yoshiaki Takewa, Eisuke Tatsumi

Recently, the role of preclinical testing using animal models, especially large-animal models such as piglet, calf, and goat is a very important part of the regulatory process that is used to determine the safety of devices before human clinical trials. The purpose of this study was to compare the fi-brin-polymerization or fibrinolysis function of animal models to determine which animals most ad-equately mimic human thrombosis. The fibrinogen function and fibrinolytic parameters of the different species were assessed in whole blood by in vitro thromboelastography using the clotting activators or a platelet inhibitor, such as tissue factor (extrinsic clotting screening test, EXTEM), partial thromboplastin phospholipid (in-trinsic clotting screening test, INTEM) and cytochalasin D (fibrin polymerization screening). The measurements were performed using normal blood samples from humans (n = 11), calves (n = 6), goats (n = 32) and pigs (n = 8).In fibrin polymerization screening, the maximum clot firmness (MCF) of FIBTEM in calves and goats (32.1 ± 2.0 mm and 27.8 ± 1.7 mm) was significantly higher than that of humans and pigs (9 ± 2.0 mm and 8.7 ± 1.5 mm, p < 0.01). Fibrinolysis after the firmest clot detected (Lysis index, LI60) was not observed in calves (100 %) and goats (100 %), compared to humans (94%) and pigs (96 %), p < 0.01).The increasing MCF of FIBTEM in ruminant confirmed the hyper fibrin polymerization compared with humans. As with the selection of an appropriate evaluation of anti-thrombotic performance in designing animal studies for cardiovascular devices, it is important to consider several criteria be-fore selecting a suitable animal species.

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P1A-6

In vitro quantitative evaluation of platelet activation under shear stress

1)National Institute of Advanced Industrial Science and Technology, Japan,2)Department of Mechanical Engineering, Ibaraki University, Japan

Akiko Oota-Ishigaki1), Daisuke Sakota1), Ryo Kosaka1), Osamu Maruyama1), Toru Masuzawa2), Masahiro Nishida1)

Purpose:The association between the thrombogenic rate and the degree of shear stress is unclear in animal tests for the development of blood pumps. We primarily evaluated platelet activation under shear stress because it is an important blood-coagulation reaction after shear loading. This study aimed to quantitatively evaluate platelet aggregation as a function of platelet activation, after shear loading in vitro.Methods:Porcine blood anticoagulated with sodium citrate was sheared at from 10,000 to 40,000s-1 for up to 10 min, using a coaxial cylinder type shear stressor at 37℃. Thereafter, reaction tubes containing 200 μl of sheared blood were pre-incubated for 60s at 37℃ and 22.2 μl of collagen solution (final concentration is 1.000 μg/mL) was added, followed by stimulation for 5 min. The extent of platelet aggregation in stimulated blood was measured as a minus logarithm platelet aggregately index (ML-PATI value) via a screen filtration pressure method, HEMATRACER ZEN (LMS Co. Ltd). A large ML-PATI indicates an increased extent of platelet aggregation in the measuring instrument, and the maximum and minimum value of ML-PATI are 1.0 and 0.0, respectively.Results:The ML-PATI values tended to increase for ≥20,000 s-1 at 10 min of shearing condition (ML-PA-TI:0.3～0.7). When the shearing time was ≤5 min, ML-PATI values tended to increase slightly over 30000 and 40000 s-1; however, these results were not reproducible. Therefore, shear loading at 20,000s-1 under 10 min was considered the threshold condition for platelet activation in anticoagu-lated porcine blood.Conclusions:ML-PATI values of 0.3～0.7 obtained in vitro method suggested an increase in the extent of platelet activation upon shear loading, and these values can serve as important thrombogenic indices owing to platelet activation, even in animal tests.

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P1A-7

Is the ratios of VWF:RCo to VWF:Ag useful for the diagnosis of AVWS associated with LVAD ?

1)Department of Molecular and Cellular Biology, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan,2) Department of Clinical Laboratory, Tohoku University Hospital, Sendai, Japan,3)Department of Molecular Pathogenesis, National Cerebral and Cardiovascular Center, Suita, Japan,4)Department of Blood Transfusion Medicine, Nara Medical University, Nara, Japan,5)Department of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan

Tsuyoshi Doman1), Shingo Sugawara2), Koichi Kokame3), Masanori Matsumoto4), Shin-ichi Fujimaki2), Yoshikatsu Saiki5), Hisanori Horiuchi1)

BackgroundVon Willebrand factors (VWFs) are generated as large multimers and cleaved in a shear stress-de-pendent manner. Loss of large multimers causes a hemostatic disorder called acquired von Wille-brand syndrome (AVWS). Ventricular assist devices such as LVAD cause AVWS due to excessive high shear stress inside the pump. VWF:RCo/VWF:Ag ratio less than 0.7 is used as supportive val-ues for the diagnosis of hereditary von Willebrand disease.

MethodsThree laboratories preliminarily analyzed 102 blood samples of 22 aortic stenosis patients in the Acquired von Willebrand Syndrome Associated with Cardiovascular Diseases (The AVeC) Study. VWF large multimers were evaluated using the VWF large multimer index (Tamura et al, J Athero-scl Thrombos, 2015), defined as the ratio of the large multimer area of a patient to that of a control whose plasma was analyzed in the adjacent lane in the VWF multimer analysis.VWF:RCo/VW-F:Ag was measured with an automated blood coagulation analyzer CS-5100 (Sysmex). ResultsThe VWF large multimer indices measured in three institutes were well-correlated. VWF:RCo was well correlated with VWF:Ag (R=0.779, p<0.0001). VWF:RCo/VWF:Ag was moderately correlat-ed with the VWF large multimer indices (R=0.547, p<0.0001).The maximal valve pressure gradient was moderately correlated with the VWF large multimer indices (R=−0.4378, p<0.0001) while weakly with VWF:RCo/VWF:Ag(R=-0.207, p<0.0001).41.3% of patients exhibited VWF large multimer index less than 70% while 22.3% of patients exhibited VWF:RCo/VWF:Ag less than 0.7.

ConclusionsThe VWF large multimer indices measured in three laboratories were well correlated with each oth-er. Thus, the VWF large multimer index could be reproducible values beyond laboratories.VWF:R-Co/VWF:Ag could potentially be a supportive diagnostic value for AVWS. Further improvement could be required. We are about to analyze VWF:RCo/VWF:Ag of plasmas in LVAD-treated pa-tients.

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P1B-1

Extracorporeal Membrane Oxygenation program in Kazakhstan


Zhuldyz Nurmykhametova, Timur Lesbekov, Rymbay Kaliyev, Timur Kapyshev, Linar Faizov, Nurlan Smagulov, Zhanybek Ashyrov, Yuriy Pya

Background:Extracorporeal membrane oxygenation (ECMO) is an established rescue therapy for severe respira-tory failure, cardiogenic shock, and cardiac arrest refractory to conventional therapeutic modalities including ventilatory and high dose inotropic support. In 2011, we initiated the first ECMO pro-gram in Kazakhstan, and since 2013 our Center is a member of Extracorporeal Life Support Organ-ization (ELSO). This paper describes the initial experience and early outcomes of applying ECMO in our Center.Methods: We performed a retrospective analysis of 203 patients, to evaluate clinical outcomes after ECMO between May 2011 and September 2016. Of these, adult 141 patients at a median age of 47 (22-77) years old. Indication for VV ECMO was respiratory failure in 23 patients (11%), 8 of whom were pregnant women. Indication for VA ECMO were: postcardiotomy syndrome - 134 (66%) patients, acute coronary syndrome - 7 patients (3.4%), post transplant heart graft failure - 19 (9.3%), acute heart failure in 15 (7.3%) patients. Logistic preoperative Euro Score II for patients with postcardiot-omy syndrome was 7 (4-18). The primary outcome was all-cause mortality. The secondary out-comes were stroke, bleeding, sepsis.Results: Hospital survival was 56%, adult -60%, pediatric -44%, transported patients -47%. The secondary outcomes were stroke -1.8%, bleeding -13.4%, sepsis -5.4%. Complications on ECMO are very common and as expected it is associated with significant increase in morbidity and mortality. Conclusion: Our results reflect findings from previous studies and ELSO registry. Further research in this direc-tion will be helpful to understand outcomes in different clinical subgroups.

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P1B-2

Mechanical circulatory support for fulminant myocarditis

1)Department of Cardiovascular Surgery, Oita University, Japan,2)Clinical Engineering Research Center, Oita University, Japan

Takashi Shuto1), Hirofumi Anai2), Tomoyuki Wada1), Hideyuki Tanaka1), Madoka Kawano1), Satoshi Kozaki1), Kyohei Hatori1), Kazuki Mori1), Takahiro Tajima1), Hideharu Yamauchi1), Shinji Miyamoto1)

Background: Fulminant myocarditis is a myocarditis that causes a rapid breakdown of the circulato-ry dynamics and which has a fatal course. The acute mortality rate of fulminant myocarditis is as high as 43%, and mechanical circulatory support is often required. We herein report our experience with fulminant myocarditis requiring circulatory support in our hospital.Objective: We targeted 14 cases of fulminant myocarditis requiring circulatory support that were treated in our hospital by 2017.Results: The average age was 56 years (range, 23-79 years). Seven cases were male. One case re-covered with the support of intra-aortic balloon pumping (IABP) alone; the others required circula-tory support with veno-arterial extracorporeal membrane oxygenation (VA ECMO). Organ dysfunc-tion was recognized in 7 (50%) patients who were therefore shifted to a ventricular assist device (VAD). The average support period of the 6 cases in which the patients recovered with IABP + VA ECMO was 12 days (range, 6-19 days). The average ECMO support period until VAD implantation was 2.4 days (range, 1-5 days). All 7 cases required biventricular assist device (BiVAD). The aver-age period to the right VAD (RVAD) weaning was 18 days (range, 4-50 days). The average period to the left VAD (LVAD) weaning was 75 days (range, 28-180 days). The mortality rate was 21.4% and three cases who underwent BiVAD implantation died. One patient died of multiple organ fail-ure (support period: 28 days), one patient died of sepsis (support period: 50 days), and one patient died of lung injury (support period: 38 days).Conclusion: The prognosis of patients with fulminant myocarditis that could survive with ECMO and IABP was good. Even in cases of fulminant myocarditis requiring VAD, the prognosis could be expected to be improved by attaching a VAD at an early stage.

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P1B-3

Relationship of vitamin D to profound cardiogenic shock in patients resuscitated from sudden cardiac arrest

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine, Korea

Jin Wi

Background: Vitamin D deficiency is related to various cardiovascular diseases, including sudden cardiac arrest (SCA). Profound cardiogenic shock is associated with morbidity and mortality in pa-tients with SCA. This study investigated the relationship of vitamin D to profound cardiogenic shock in patients resuscitated from SCA.Methods: We enrolled patients who were successfully resuscitated from out-of-hospital cardiac ar-rest of presumed cardiac cause. Profound cardiogenic shock was defined as hypotension requiring mechanical circulatory support such as extracorporeal membrane oxygenation (ECMO) in spite of adequate intravascular volume and high-dose vasopressor infusion. The vitamin D level was meas-ured as plasma 25(OH)D concentrations and severe vitamin D deficiency was defined as 25(OH)D <10 ng/mL. Results: A total of 123 patients were included in this study. First monitored rhythm was shockable rhythm in 76 patients (62%) and non-shockable rhythm in 47 (38%). Bystander cardiopulmonary resuscitation (CPR) was performed in 101 (82%) and mean arrest and CPR time were 27.9±22.1 and 25.3±21.8 minutes, respectively. Profound cardiogenic shock was observed in 32 patients (26%). The mean vitamin D level was 10.4±5.4 ng/mL and vitamin D deficiency was diagnosed in 67 patients (55%). Vitamin D level was significantly lower and vitamin D deficiency was observed more frequently among patients with profound shock. Patients with profound shock were likely to have longer CPR time and more non-shockable rhythm, left ventricular systolic dysfunction, and baseline renal dysfunction. In multivariate logistic analysis, vitamin D deficiency was the signifi-cant independent predictor of profound shock after SCA (OR 6.04, 95% CI 1.97-18.53, p=0.002) with left ventricular systolic dysfunction (OR 5.14, 95% CI 1.77-14.93, p=0.003) and baseline renal dysfunction (OR 3.59, 95% CI 1.06-12.10, p=0.039) after adjusting for confounding variables.Conclusion: Vitamin D deficiency was strongly related to profound cardiogenic shock in patients resuscitated from SCA.

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P1B-4

A case of propranolol-induced refractory cardiac arrest and was successfully teated with extracorporeal cardiopulmonary resuscitation

1)Department of Emergency and Disaster Medicine, University of Mie, Japan,2)Department of Cardiovascular Surgery, University of Mie, Japan,3)Department of Cardiovascular Surgery, Mie Prefecture General Medical Center, Japan

Ryo Esumi1), Yoshiaki Iwashita1), Kaoru Ikejiri1), Asami Ito1), Ken Sasaki1), Kei Suzuki1), Hisato Ito2), Masaki Fujioka1), Hideto Shinpo3), Hiroshi Imai1)

Background/PurposeThe indication of extracorporeal cardiopulmonary resuscitation (ECPR) is increasing in recent years. A good indication of ECPR is potentially reversible refractory cardiac arrest in patients. Thy-roid storm (TS) is a critical illness that may cause ventricular tachycardia. Despite early treatment with propranolol, due to a sudden suppressive effect, TS possibly causes cardiac arrest and lasts for a longer duration with poor outcomes. We report a case of TS that progressed to propranolol-in-duced refractory cardiac arrest and was successfully treated with ECPR. Case presentationA 46-year-old Japanese woman with no history of previous disease and visited a nearby hospital be-cause of dizziness, leg edema, and palpitation.On admission, she was administered propranolol 30mg/day and methimazole 15mg/day, but she be-came unconscious and was transferred to our hospital. After starting landiolo in our hospital, she experienced cardiac arrest. Despite standard CPR, the patient did not recover; thus, we started ex-tracorporeal membranous oxygenation(ECMO) (TERUMO-introduction of the 18 Fr arterial cannu-la from the left groin and 22 Fr venous cannula from the right groin). Under specific therapy, me-thimazole, iodine, and glucocorticoids), she was weaned from ECMO on 7thday after admission At 17days after admission, she underwent total thyroidectomy. At 19 days after admission, she started levothyroxine 25mg/day. She was transferred to another hospital for further rehabilitation. ConclusionsWe experienced a case of refractory cardiac arrest after TS treated with propranolol. The patient was successfully treated with ECPR. Potentially reversible refractory cardiac arrest such as pro-pranolol-induced cardiac arrest, in a patient with TS is a good indication for ECPR.

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P1B-5

Management of ECMO for the pediatric patients after cardiac surgery

1)Department of Cardiovascular Surgery, Okayama University Hospital, Japan,2)Department of Clinical Engineering, Okayama University Hospital, Japan

Yosuke Kuroko1), Hiroshi Taka2), Takuma Doguchi2), Yasuyuki Kobayashi1), Sachiko Kawada1), Naohiro Horio1), Yasuhiro Kotani1), Sadahiko Arai1), Shingo Kasahara1)

Recently we experienced improved outcome of pediatric ECMO by early placement of ECMO and rapid progress of medical technology. But major complication of ECMO such as bleeding, infection and brain damage are still need to be solved. In our hospital, the multidisciplinary ECMO team with surgeons, intensivists, nurses and medical engineers are organized to reduce the complications. We assess the outcome of ECMO for the postoperative pediatric cardiac surgery patients. Between January 2008 and December 2017, 53 pediatric patients under 18 years old were placed on ECMO after cardiac surgery. 9 patients were supported on ECMO twice. Timing of ECMO place-ment were 26 patients intraoperatively, 18 patients within 7th postoperative day and 18 patients after 8th postoperative day. We advocate early placement of ECMO to prevent terminal organ damage The median ECMO duration was 112 hours. 49 ECMO cases were successfully weaned (79%). 29 patients survived to discharge (53%). Major complications during ECMO were 11 brain damages (20%) and 5 respiratory tract bleeding (9%).We achieved excellent rate of weaning and survival to discharge in postoperative pediatric cardiac surgery patients by early placement protocol and team approach. But there are still existing compli-cations related to ECMO. In order to prevent complication and improve the quality after weaning from ECMO, we need improve management for safer and higher quality ECMO.

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P1B-6

The User Experience of VAD Wearable Systems and Components: A Systematic Literature Review

1)School of Architecture, Design and Planning, University of Sydney, Sydney, Australia, 2)Department of Mechanical and Aerospace Engineering, Monash University, Melbourne, Australia

Jessica Lea Dunn1), Keum Hee Kimmi Ko1), Karla Straker1), Erez Nusem1), Cara Wrigley1), Shaun Gregory2)

Background/PurposeDespite being a life-saving medical device worn 24 hours a day, the user experience of VADs is still far from ideal. Due to the management of wearable external components, patients may be limited when performing ordinary daily activities such as showering, eating, exercising, sleeping, and go-ing out. The purpose of this study was to conduct a systematic review answering the following questions: What are the user issues caused by wearable components of VADs, and under what use scenarios? MethodsA systematic literature review was undertaken using three databases for studies published between 2008 and 2018. The Boolean search (“ventricular assist” AND “human factors”AND “design”) re-turned 289 results from Google Scholar, 47 papers from ScienceDirect and 4 papers from Scopus. Inclusion criteria were: peer-reviewed journal and conference articles that detailed issues pertaining to the external (wearable) components of VADs; English language. After issues were identified and theoretically categorised, an analysis across studies was conducted. ResultsVAD users experience a host of issues related to the wearable components; physical and emotional scarring, difficulty showing physical affection, annoyance with alarms, driveline management, exit site injury, infection, battery management, unintentional disconnection of cables, controller usabili-ty, portability of luggage design (including balance, weight, ergonomic weight distribution of carry bags, holster, vests, custom solutions etc.), need for discretion in public situations, style and gender preferences. ConclusionsMany user issues with the wearable components of VADs are well understood from both a function-al (human factors) and emotional (patient and caregiver experience) perspective. However, a gap exists for human-centred design to address these issues synergistically. Further research is required to generate a set of design criteria around user needs, issues and use contexts, to inform the design and prototype of new solution concepts that address the needs of VAD patients, caregivers, and practitioners.

67

O2-Keynote

Total Artificial Hearts: An Overview and Future Perspective

1) Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA, 2) Medical Device Solutions, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA

Kiyotaka Fukamachi1), Jamshid H. Karimov1), Nicole Byram1), Takuma Miyamoto1), Barry Kuban1,2)

The wide acceptance of left ventricular assist devices (LVADs) to treat patients with severe heart failure has arisen largely due to the introduction of continuous-flow pumps. Such pumps have sig-nificantly improved in reliability, durability, compact size, simplicity, and clinical results compared with pulsatile LVADs. However, up to 44% of patients undergoing LVAD implantation also exhibit severe right ventricular (RV) failure. The HeartMate II investigators documented a 20% decrease in 1-year survival in such patients. Disappointingly, they often do not experience symptomatic and functional improvement, leading to the clinical justification for total artificial heart (TAH) technol-ogy. In contrast to LVADs, the few existing clinical TAHs are volume-displacement pulsatile-flow pumps: the temporary pneumatic SynCardia TAH and permanent electrohydraulically driven CAR-MAT TAH. Of significant concern are the large size and questionable durability of these pulsatile TAHs, similar to pulsatile LVADs. Therefore, new continuous-flow TAHs are under development. Cleveland Clinic’s continuous-flow TAH (CFTAH) is a double-ended centrifugal pump with a sin-gle moving part, designed to passively self-balance left/right circulations without electronic inter-vention. Chronic experiments in 2 calves demonstrated good hemodynamics and biocompatibility without anticoagulation for the intended 90-day term. The BiVACOR® TAH is also a one-piece, centrifugal pump and uses sensors to actively position the rotator to balance left/right atrial pres-sures. One 30- and one 90-day calf experiments were reported. Both CFTAH and BiVACOR use pump speed modulation to induce pulsatility. The OregonHeart TAH uses a continuously spinning rotor that shuttles between two positions to provide alternating pulsatile blood flow to the systemic and pulmonary circulations. Several short-term animal experiments have been performed. These new continuous-flow TAHs have incorporated a pulsatility feature to avoid some reported potential complications related to reduced pulsatility. Researchers in the field hope that new TAHs may soon offer patients with end-stage heart failure a better quality of life.

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O2-RF2

Update on RealHeart™’s Progress Towards Chronic In Vivo Studies

R&D, Scandinavian Real Heart AB, Sweden

Ina Laura Pieper, Fredrik Pahlm, Göran Hellers, Azad Najar

Background: RealHeartTM is a pulsatile 4-chamber TAH, designed to mimic the main pumping principle of the human heart, the atrioventricular plane displacement. Left and right sides operate independently, offering full flexibility through wide pulse and stroke volume ranges. RealHeartTM had been acutely tested in pigs, but its size and pump capacity restricted progress to chronic calf studies. The purpose was to redesign the device and evaluate the design in calves and humans.

Methods: Virtual implantation in a calf followed by implantation via median sternotomy in calf ca-davers informed how to reduce the size and design the connections. The first acute calf implant, followed by a virtual implantation of the same calf, were used to study the feasibility of a left lateral thoracotomy approach. The following three calves were used to optimise the de-airing and device start-up. Atrial pressure transducers were used to decide the cardiac output. Virtual implantations were performed in three patients followed by two human cadavers. Device performance was as-sessed in bench rig tests.

Results: The overall device size was decreased and pumping capacity was increased by reducing the device’s length and increasing the depth. RealHeartTM produced physiological systolic/diastolic blood pressures, left atrial and central venous pressures, and oxygen saturation when implanted in calves. Three animals breathed on their own whilst being kept alive by the TAH. One animal was woken up, with a pulse of 130 bpm and left /right stroke volumes of 65/61 ml. RealHeartTM fitted into two of three virtually implanted patients, and into both human cadavers. In rig tests, a pulse of 100-120 bpm resulted in a flow rate of 6.4-8.0 l/min.

Conclusions: RealHeartTM silently delivers physiological flow, pressures, and oxygen saturation at a relatively low energy consumption, and the design is suitable for the human anatomy.

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O2-RF3

Cleveland Clinic Continuous Flow Artificial Heart: Current Perspectives and Device Update


Jamshid Karimov1), David Horvath2), Barry Kuban1), Nicole Byram1), Shengqiang Gao1), Takuma Miyamoto1), Kiyotaka Fukamachi1)

BACKGROUND/PURPOSE: Heart failure (HF) is a critical healthcare issue and a primary source of cardiovascular mortality worldwide. In the US, an estimated 50,000-100,000 patients per year need heart transplantation or mechanical circulatory support, but only around 2,300 transplants are performed. To address the organ shortage, we are developing continuous-flow total artificial heart (CFTAH) at Cleveland Clinic in attempt to provide the growing population of patients with end-stage HF with viable alternative to transplantation.

METHOD: The Cleveland Clinic CFTAH is a double-ended centrifugal pump that is designed to passively self-balance left and right circulations without electronic intervention. The nominal exter-nal dimensions of the latest CFTAH design (adult configuration) tested in vivo were 98.4 mm (length), 62 mm (diameter), 160 cc (volume displacement), and 486 g (device weight with cable and connector off the scale) (Fig. 1). Device undergoing optimizations and design changes that will be presented.

RESULTS: The CFTAH biocompatibility has been previous demonstrated at intended 90-day dura-tion (n=2) without anticoagulation. The additional improvements related to right impeller design, reduced susceptibility to thrombosis and more efficient motor design are ongoing.

CONCLUSION: The implementation of this project and achievement of this important milestone suggests that single-piece, auto-regulated and sensorless devices have a significant potential to fur-ther development into a valid clinical option in heart failure patients.


1

For symposium presentation: “Update on Total Artificial Heart” Cleveland Clinic Continuous Flow Artificial Heart: Current Perspectives and Device Update Jamshid H. Karimov1, David Horvath2, Barry Kuban1, Nicole Byram1, Shengqiang Gao1, Takuma Miyamoto1, Kiyotaka Fukamachi1

1Cleveland Clinic, Cleveland, Ohio, USA. 2R1 Engineering, LLC, Euclid, Ohio, USA BACKGROUND/PURPOSE: Heart failure (HF) is a critical healthcare issue and a primary source of cardiovascular mortality worldwide. In the US, an estimated 50,000-100,000 patients per year need heart transplantation or mechanical circulatory support, but only around 2,300 transplants are performed. To address the organ shortage, we are developing continuous-flow total artificial heart (CFTAH) at Cleveland Clinic in attempt to provide the growing population of patients with end-stage HF with viable alternative to transplantation. METHOD: The Cleveland Clinic CFTAH is a double-ended centrifugal pump that is designed to passively self-balance left and right circulations without electronic intervention. The nominal external dimensions of the latest CFTAH design (adult configuration) tested in vivo were 98.4 mm (length), 62 mm (diameter), 160 cc (volume displacement), and 486 g (device weight with cable and connector off the scale) (Fig. 1). Device undergoing optimizations and design changes that will be presented. RESULTS: The CFTAH biocompatibility has been previous demonstrated at intended 90-day duration (n=2) without anticoagulation. The additional improvements related to right impeller design, reduced susceptibility to thrombosis and more efficient motor design are ongoing. CONCLUSION: The implementation of this project and achievement of this important milestone suggests that single-piece, auto-regulated and sensorless devices have a significant potential to further development into a valid clinical option in heart failure patients. Fig.1. The Cleveland Clinic CFTAH (driveline concealed).

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O2-4

Characterization of the RealHeartTM Total Artificial Heart with a Hybrid Cardiovascular Simulator

1)Department of Cardiac Surgery, KU Leuven, Leuven, Belgium,2)Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences. Warsaw, Poland,3)Scandinavian Real Heart AB, Vasteras, Sweden

Libera Fresiello1), Krzysztof Zieliński2), Ina Laura Pieper3), Fredrik Pahlm3), Azad Najar 3), Bart Meyns1)

Background/Purpose: in this work we configured a hybrid cardiovascular simulator (HCS) for the characterization of the RealHeartTM total artificial heart (TAH).Methods: the HCS, developed at the Nalecz Institute of Biocybernetics and Biomedical Engineer-ing, is a computational-hydraulic simulator representing the human cardiovascular system. It is equipped with 4 impedance transformers, real time converters of pressures and flows that simulate the hemodynamic behavior of atria, pulmonary artery, and aorta, while the rest of the circulation is reproduced numerically. RealHeartTM, a pulsatile 4-chamber TAH, mimics the main pumping principle of the human heart, the atrioventricular plane displacement. The left and right side operate independently offering full flexibility through wide pulse and stroke volume ranges.The TAH was connected to the HCS and tested at low and medium operating points: pulse) 50 and 100 bpm; stroke length) 20 and 26 mm; systole duration ratio) 0.3 and 0.5 of the TAH cycle. Results: the HCS reproduces accurately the behavior of atria, systemic and pulmonary circulations allowing to investigate the hemodynamic effects of the TAH and the left/right flow balance. The in-dependent regulation of the TAH pumping rate and stroke length permits to finely tune the average pumped flow from 2.4 to 6.2 l/min. The TAH flow shows a pulsatile behavior that translates into a pulsatile pressure in the systemic and pulmonary circulation (i.e. aortic pressure 36/54 and 88/120 mmHg for the 2.6 and 6.2 l/min flows, respectively). Conclusions: the HCS is a valuable tool to characterize the performance of a TAH in a high fidelity physiological scenario and to identify the best working condition for the device. This work was supported by the Frans Van de Werf scholarship.

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O2-5

Computational Fluid Dynamics Analysis of the RealHeartTM Demonstrates Low Power Consumption and Low Thrombosis Risk

1)R&D, Scandinavian Real Heart AB, Sweden,2)University of Bath, Bath, UK

Ina Laura Pieper1), Daniel McCree2), Fredrik Pahlm1), Azad Najar1), Katharine H Fraser2)

Background/Purpose:The RealHeartTM is a 4-chamber, pulsatile, total artificial heart (TAH) which mimics the pumping principle and output of the natural heart through cyclical displacement of the atrioventricular (AV) plane. The novel design aims to produce pulsatile flow with a low power requirement and minimal damage to the blood. In this work a computational model was used to assess those aims.

Methods: A numerical model of the left side of the RealHeartTM was created using a commercial fi-nite-element solver (Autodesk CFD). The motion of the AV plane, deformation of the chamber wall membranes, and valves, was incorporated by superimposing moving solid meshes on the fluid do-main. The inlet boundary was constant pressure (0 mmHg). At the outlet boundary a distributed re-sistance simulated the peripheral vasculature, and was set to produce aortic pressure variation of 70-120mmHg. Blood viscosity was shear thinning using a Carreau model. Simulations were run for a range of heart rates (70-120 bpm) and pump cycle systole times (33-55% systole). The mechanical power transmitted to the blood was calculated from the hydraulic force on the AV plane and mem-branes. Shear stress and stagnation risks were assessed by finding regions of the pump experiencing shear stress >13 Pa and velocity <1 mm/s.

Results:Operating at 100 bpm a flow of 6.96l/min was calculated, which is in good agreement with the ex-perimental measurement 6.41l/min. Shear stress regions were small and concentrated at the valves (maximum stress=30 Pa). Low velocity regions were small and lasted only for diastole. The me-chanical power transmitted to the blood in the simulated left half of the RealHeartTM was 4.6 W. Similar shear stress, stagnation and power results were observed for other heart rates.

Conclusions:Based on this numerical analysis, the RealHeartTM has low risk of haemolysis and thrombosis, and low power consumption.

72

O3-Keynote

INTEGRIS Baptist Medical Center, USA

Aly El Banayosy

73

O3-RF2

Ventricular assist device therapy using MERA Monopivot Centrifugal Pumps for cardiogenic shock patients in INTERMACS profile-1

1)Department of Cardiovascular Surgery, Tokyo Medical and Dental University, Japan,2)Department of Advanced Surgical Technology Research and Development, Tokyo Medical and Dental University, Japan

Tatsuki Fujiwara1), Hirokuni Arai1), Tomohiro Mizuno1), Keiji Oi1), Masafumi Yashima1), Hidehito Kuroki1), Kiyotoshi Oishi1), Masashi Takeshita1), Katsuhiro Ohuchi2)

[Background] In Japan, extracorporeal pulsatile ventricular assist devices (p-VADs) are only cov-ered by National Health Insurance for patients with INTERMACS profile-1 or not on a transplant waiting list. However, p-VADs sometimes prove insufficient to recover end-organ function due to the complicated settings, such as pulse rate, ratio of systolic time, systolic pressure, and diastolic vacuum pressure. In comparison, rotational speed is the only parameter controlling flow assistance in centrifugal pumps. As a previous study demonstrated better flow assistance from centrifugal pumps than from p-VADs, we compared p-VADs and centrifugal pumps mainly in terms of the effi-cacy of end-organ recovery during acute-phase support. [Method] From January 2005 to July 2018, 27 cardiogenic shock cases requiring VAD (non-ischemic cardiomyopathy, n=13; ischemic heart disease, n=8; fulminant myocarditis, n=6) were divided into Group-P, receiving a p-VAD (NI-PRO-VAS; NIPRO-Corp, Tokyo, Japan) intraoperatively (n=13), and Group-C, initially receiving a centrifugal pump (MERA HCF-MP23; Senko-Corp, Tokyo, Japan) as a VAD for about 1 week, be-fore replacement by the NIPRO-VAS (n=14). The NIPRO cannula was used in both groups. [Re-sults] All values are expressed as Group-P vs. Group-C. The support times of MERA pump was 9.5±4.3 days in Group-C. Preoperative ECMO support times was shorter in Group-C (4.7±3.1 vs. 3.5±2.8 days). BiVAD was required in 38% and 29% of patients. Postoperative flow assistance in-dex was higher in Group-C. Total bilirubin and creatinine levels peaked earlier in Group-C. Intuba-tion time was shorter in Group-C. Cumulative survival rates at 1 years were higher in Group-C (62 vs 70 %). [Conclusion] These results suggested that circulatory support was more effective with centrifugal pumps than with p-VADs in terms of end-organ recovery after cardiogenic shock, and acute-phase hemodynamics might influence mid-term survival rates.

74

O3-RF3

Central ECMO with LV vent for acute heart failure

1)Department of Surgery, Division of Cardiovascular Surgery, Shinshu University School of Medicine, Japan,2)Department of Cardiovascular Medicine, Shinshu University School of Medicine, Japan

Tatsuichiro Seto1), Masaki Komatus1), Kazuhiro Kimura2), Hirohiko Motoki2), Yuko Wada1), Koichiro Kuwabara2), Kenji Okada1)

BackgroundRecently Central extracorporeal membrane oxygenation (ECMO) with LV vent has been used for severely ill patients because of less invasiveness and simplicity. We discuss the results of Central ECMO with LV vent.

MethodFrom January 2015 to June 2018, Central ECMO with LV vent was applied for 7 patients with acute heart failure. The average age was 44 ± 26 (range: 11~67 years old), including 2 male subjects. As for the primary disease, there have been 5 cases of fulminant myocarditis, 1 case of DCM, and 1 case of hypertrophic cardiomyopathy (HOCM). Preoperative states for fulminant myocarditis were the following: 5 cases with intra-aortic balloon pumping support, and 4 cases with PCPS support. A patient with DCM underwent double valve replacement for aortic valve regurgitation and mitral valve regurgitation, followed by central ECMO with LV vent. As for HOCM, we performed addi-tional ascending aortic replacement for the iatrogenic acute aortic dissection during PCPS support for refractory ventricular arrhythmia, followed by central ECMO with LV vent.

Results Hospital mortality was 28.5 % (2/7). One case of fulminant myocarditis died of a cerebral hemor-rhage and the other case of HOCM died of a lethal arrhythmia. Six of 7 patients (85.7%) had weaned from Central ECMO with LV vent. Among the cases of fulminant myocarditis, 4 of 5 cases had weaned from Central ECMO with LV vent, 2 on 14 POD, 1 on 15 POD, and the other on 16 POD. As for the 2 cases after cardiovascular surgery, each of them had weaned on 8 POD and 70 POD.

ConclusionCentral ECMO with LV vent could be introduced with less invasiveness and simplicity, which suf-ficiently improved the recovery of the myocardium and vital organs in patients with severe acute heart failure.

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O3-4

Preclinical evaluation of extracorporeal ventricular assist device system for bridge-to-decision

Department of Artificial Organs, National Cerebral and Cardiovascular Center, Japan

Tomonori Tsukiya, Toshihide Mizuno, Yoshiaki Takewa, Shuichi Shimamura, Nobumasa Katagiri, Yukihide Kakuta, Eisuke Tatsumi

Background/Purpose: An extracorporeal centrifugal pump has been developed as a blood pump for temporary mechanical circulatory systems including temporary ventricular assist devices (VAD) and extracorporeal membrane oxygenation (ECMO). The pump is implemented with the novel hy-drodynamic levitation system to attain non-contacting rotation of the impeller. This study summa-rizes the results of preclinical testings for a novel temporary VAD system, including right ventricu-lar assist (RVAD) use.Method: The blood pump has the priming volume of 16 mL, made of polycarbonate. The pump is intended for the single use. The blood film in the small gaps between the impeller and the casing works as the hydrodynamic bearing to prevent mechanical contacts of the impeller to the casing wall. On the other hand, it requires a certain level of the rotational speed to avoid mechanical contact. In t RVAD cases the required speed will be lower than in LVAD cases due to the difference in systemic and pulmonary circulations, and we have to confirm that the pump runs over the minimum allowa-ble speed even in RVAD use. We employed 7mm size graft as the outflow cannula of the RVAD system.Results: Miminum pump speed was determined as 3,000 rpm by the hemolysis testings.Three cases for RVAD were both successfully carried out with the flow rates from about 3 – 5 L/min. at the speed of 3000 – 4000 rpm. The blood pumps were all free from significant thrombi, but wedge thrombi were frequently observed around the inflow cannulas.Conclusion: The ventricular assist device with the newly developed centrifugal pump with the hy-drodynamic levitation system demonstrated sufficient performances in the preclinical testings in-cluding RVAD cases.

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O3-5

Early Experience of Percutaneous Left Ventricular Assist Device “Impella” in Japan

1)Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Japan, 2)Department of Cardiology, Osaka University Graduate School of Medicine, Japan

Shohei Yoshida1), Koichi Toda1), Shigeru Miyagawa1), Yasushi Yoshikawa1), Hiroki Hata1), Daisuke Yoshioka1), Satoshi Kainuma1), Takayoshi Ueno1), Toru Kuratani1), Yasushi Sakata2), Yoshiki Sawa1)

BACKGROUND:Refractory cardiogenic shock is a major therapeutic challenge. Short-term mechanical circulatory support has been used to improve the hemodynamics of patients with cardiogenic shock. The Im-pella capable of sufficient circulatory support and left ventricular chamber unloading with minimal invasion could be used in Japan on September 2017, but the effectiveness of Impella has not been reported in Japan.METHODS:We retrospectively investigated the hemodynamic change and the outcome in 11 patients with Im-pella used for cardiogenic shock in our institute.RESULTS:The average age was 57 ± 7 year-old and 7 patients were male. They included 7 cases with end-stage cardiomyopathy, 2 cases with myocardial infarction, and 2 cases with fulminant myocarditis. Impella 2.5 was used in 2 cases for 10 ± 4 days and Impella 5.0 was used in 9 cases for 17 ± 8 days. In 6 of 11 cases, Impella was used for the progression of pulmonary congestion during percutane-ous cardiopulmonary system (PCPS) and intra-aortic balloon pumping support, resulting in disap-pearance of the pulmonary congestion. Although 3 of 6 cases required concomitant PCPS and 1 case required concomitant percutaneous right ventricular assist device due to right heart failure, these mechanical circulatory supports provided sufficient hemodynamics. In the other 5 cases, Im-pella was used for acute deterioration on end-stage cardiomyopathy as a bridge to bridge or recov-ery, increasing cardiac output to 6.0 ± 0.5L/min and SvO2 to 74 ± 5 %.Four of 11 cases had bleeding complications under the Impella support, including 1 cerebral bleed-ing. The parge-related complications had occurred in 2 cases, which needed to exchange or remove the Impella without any affection on the outcome. CONCLUSION:The Impella provided sufficient circulatory support for cardiogenic shock. Although further experi-ences are needed, this new device may provide promising outcomes for acute heart failure.

77

O4-Keynote

Physiologically adaptive control of rotary blood pumps: Conclusions from clinical studies and observations

1) Dept. of Med.Physics and Biomed.Eng.; 2) Dept. of Cardiac Surgery; 3) LBC for Cardiovasc Research; Medical University of Vienna, Austria

Heinrich Schima1,2,3), Martin Maw1,2), Christoph Gross1,3), Thomas Schlöglhofer2,3), Daniel Zimpfer2,3), Francesco Moscato1,3)

For hemodynamic support of the failing heart, rotary pumps have nearly completely replaced pulsa-tile membrane pumps. However, whereas membrane pumps provided intrinsic preload sensitivity, rotary pumps are intrinsically sensitive only to the pressure difference between inlet and outlet. As arterial pressure can change in wide range, the unloading of the failing heart changes also consider-ably. This lack of adaption is currently only compensated by the recovering regulation mechanisms of the unloaded heart itself.A datarecorder for continuous longterm recording was developed, which allows continuous record-ing of pump flow, heart rate and its variability, contractility, aortic valve opening and occasional overpumping/suction for up to 6 weeks. Further, a setup for physiologic pump control in a clinical setting at various activity situations was implemented. Two observational studies were performed (a) on suction/heartrate in outpatients, and (b) on hemodynamic reactions during exercise and he-modynamically challenging tests. Moreover, an acute study (c)with active control was performed in 19 patients.Study (a) showed that outpatients even under optimal conditions (trained, compliant, pump adjust-ed) may experience massive overpumping and suction, which can also cause extended periods of arrhythmia and elevated heart-rate. Study (b) demonstrated the existing yet very limited response of the circulation to exercise (depending on the recovery status of the assisted heart), underlining the necessities of speed control and pumps with sufficient output. Study (c) proved, that feedback con-trol can minimize overpumping, avoid suction also in critical situations and increase the pump re-sponse to exercise, however with considerable limits for overall oxygen consumption. In conclusion, at constant speed mechanical cardiac support has only very limited response to pa-tient demand and increased suction can have negative effects. Active control based on preload sen-sitivity provides adaequate reactions to patient demand. However during heavy exercise it is limited by the available output of current devices.

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O4-2

A physiological control system for an LVAD that can accommodate interpatient and intrapatient variation

Graduate School of Biomedical Engineering, UNSW, Sydney, Australia

Masoud Fetanat, Michael Stevens, Nigel Lovell

BackgroundOperating rotary left ventricular assist devices (LVADs) at a constant speed can lead to harmful ventricular suction or pulmonary congestion during changes of the patient’s hemodynamics. Al-though there are several physiological controllers which can automatically adjust speed to prevent these scenarios, none of them have been proven to provide consistent tracking performance across a different range of conditions from one patient to another. This means that the success of a physio-logical control system is patient dependent, which limits their acceptance clinically. This study pre-sents a model-free adaptive control (MFAC) system that is guaranteed to perform consistently across a range of different patient conditions.MethodsUsing a computer simulation, 86 different LVAD patients were generated by varying 43 circulatory parameters ±20% from their nominal values. The MFAC was evaluated by measuring its response to common scenarios (resistance changes and exercise transitions) across the entire simulated pa-tient cohort. Performance was quantified by the sum of squared tracking error between target flow (set by a Frank-Starling like control system) and compared against standard proportional-inte-gral-derivative (PID) control.ResultsSensitivity analysis was done by variation of 43 circulatory parameters which showed total blood volume and elastance of end systolic left ventricle had the greatest effects on control performance. Furthermore, other controllers (like PID) need an expert to design or optimize it; however, MFAC can propose about 5% better performance without any knowledge regarding designing a controller.ConclusionsThis research aims to design and assess adaptive physiological controller to adjust the speed of the VADs automatically and respond to the changes dealing with interpatient and intrapatient varieties perfectly. The results demonstrate the preference of using MFAC in comparison with other control-lers due to adjusting its parameters online leading improve the quality of patients’ lives, reduce the risk of suction and minimize VAD patient meetings with clinicians.

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O4-3

The effects of VAD pressure sensitivity on exercise physiology: evaluation with a computational model

1)Department of Cardiac Surgery, KU Leuven, Leuven, Belgium,2)ReinVAD GmbH, Aachen, Germany

Libera Fresiello1), Roland Graefe2), Bart Meyns1)

Background/Purpose: ventricular assist devices (VAD) restore patients’ hemodynamics at rest but do not provide a proper support during exercise. Aim of this work is to quantify the effects of dif-ferent VAD pressure-flow characteristics in different exercise conditions with a cardiorespiratory computational simulator (CRS).

Methods: the CRS includes physiological controls reproducing the exercise response of the heart (increase in heart rate and contractility), circulation (vasodilation) and lungs (increase in ventila-tion). The CRS can simulate the exercise response of an average heart failure patient (HF) and a weaker heart failure patient (WHF, with no chronotropic and inotropic response). Two VADs were tested at constant rotational speed: VAD1 with a pressure sensitivity (PS: average change of flow per change of pressure difference) of 0.21l/min/mmHg and VAD2 with a PS of 0.08l/min/mmHg up to 10l/min mean flow. The speed of both VADs was set to obtain the same total support of 4.8l/min at rest, then a bicycle test of 80 Watts was simulated.

Results: exercise in HF changes the working conditions of the VADs so that the flow increases, more for VAD1 (6.6l/min) than for VAD2 (5.7l/min). The left ventricle starts to eject but VAD1 as-sures a better unlading (ventricular flow=1.0l/min) than VAD2 (1.7l/min). In WHF condition, the native ventricle cannot eject so the increase in cardiac output depends on the increase of VAD flow solely, 7.0l/min for VAD1 and 6.2l/min for VAD2. VAD1 increases the hydraulic power delivered to the circulation (+112% for HF and +136% for WHF) while VAD2 power stays rather constant.

Conclusions: a higher PS assures a better VAD response to exercise, especially for patients with a poor residual contractility and chronotropic impairment whose ventricle cannot sustain the increase of cardiac output. This work was supported by the Frans Van de Werf scholarship and the Erich and Hanna Klessmann foundation.

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O4-4

Automatic Flow Control Method for the Cleveland Clinic Continuous-Flow Total Artificial Heart

1)Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA,2)R1 Engineering LLC, Euclid, Ohio, USA

Barry Dean Kuban1), David Horvath2), Nicole Byram1), Jamshid Karimov1), Takuma Miyamoto1), Kiyotaka Fukamachi1)

Background/Purpose: Automatically varying the output of a total artificial heart as flow demands change is challenging since there are no ventricles from which to monitor heart rate. Our goal was to develop a system that can automatically change pump output based on systemic vascular resist-ance (SVR). Methods: The axial position of the rotor inside the Cleveland Clinic continuous-flow total artificial heart (CFTAH) provides unique information about pressure-flow relationships. The position data as well as the left pump head curve and the pulsed motor power are used as inputs to a mathematical model that provides real-time estimates of SVR and pump output. We developed an automatic con-trol method which uses the SVR estimate as an input to an algorithm that calculates target flow. The target flow schedule is programmed by the managing physician, the example target flow sched-ule that was used in testing is shown in Fig 1. The system automatically adjusts pump speed to make the estimated flow match the target flow. Results: The flow control method was tested on the CFTAH connected to a mock loop. The SVR was varied and flow was measured at each SVR. The system auto-adjusted the output according to the schedule and maintained the new flow while SVR was constant. The method also performed as expected in an acute in vivo experiment. Conclusions: We conclude that SVR-based flow control for the Cleveland Clinic CFTAH is viable. This automatic control feature was successfully incorporated onto our pump controller platform and validations are currently ongoing.

Automatic Flow Control Method for the Cleveland Clinic Continuous-Flow Total Artificial Heart

Barry D. Kuban1, David Horvath2, Nicole Byram1, Jamshid Karimov1, Takuma Miyamoto1, Kiyotaka Fukamachi1

1Cleveland Clinic, Cleveland, Ohio, USA. 2R1 Engineering, LLC, Euclid, Ohio, USA Background/Purpose: Automatically varying the output of a total artificial heart as flow demands change is challenging since there are no ventricles from which to monitor heart rate. Our goal was to develop a system that can automatically change pump output based on systemic vascular resistance (SVR). Methods: The axial position of the rotor inside the Cleveland Clinic continuous-flow total artificial heart (CFTAH) provides unique information about pressure-flow relationships. The position data as well as the left pump head curve and the pulsed motor power are used as inputs to a mathematical model that provides real-time estimates of SVR and pump output. We developed an automatic control method which uses the SVR estimate as an input to an algorithm that calculates target flow. The target flow schedule is programmed by the managing physician, the example target flow schedule that was used in testing is shown in Fig 1. The system automatically adjusts pump speed to make the estimated flow match the target flow. Results: The flow control method was tested on the CFTAH connected to a mock loop. The SVR was varied and flow was measured at each SVR. The system auto-adjusted the output according to the schedule and maintained the new flow while SVR was constant. The method also performed as expected in an acute in vivo experiment. Conclusions: We conclude that SVR-based flow control for the Cleveland Clinic CFTAH is viable. This automatic control feature was successfully incorporated onto our pump controller platform and validations are currently ongoing.

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81

O4-5

In-Vitro Evaluation of a Rotary Blood Pump Management System that Balances Circulatory Volumes and Delivers Pulsatile Flow

1)Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia,2)School of Medicine, The University of Queensland, Brisbane, Australia,3)Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria,4)Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium,5)Graduate School of Biomedical Engineering, University of New South Wales, Sydney, Australia,6)School of Engineering and Built Environment, Griffith University, Gold Coast, Australia,7)Department of Mechanical and Aerospace Engineering, Monash University, Melbourne, Australia

Eric L Wu1,2), Martin Maw3), Libera Fresiello4), Michael C Stevens5), Bart Meyns4), John F Fraser1,2), Heinrich Schima3), Francesco Moscato3), Geoff Tansley1,6), Shaun D Gregory1,2,6,7)

Rotary blood pumps (RBPs) operated at constant speed may lead to circulatory volume imbalances, resulting in ventricular suction and/or sub-optimal unloading. To balance circulatory volumes, a Starling-like total work controller (SL-TWC) has been developed that functions by measuring left ventricular stroke work (LVSW) and preload and adjusts RBP hydraulic work to match a healthy heart. However, the SL-TWC delivers diminished pulsatile flow, causing reduced vascular pulsatili-ty and lack of aortic valve opening. This study aimed to evaluate an RBP management system (RBP-MS) that combines a SL-TWC with a pulsing mechanism.

The RBP-MS superimposed a pulse onto the output of the SL-TWC every 10 heartbeats; reducing speed by 400 RPM for two heartbeats, increasing speed by 800 RPM for one heartbeat and then re-turning to the speed set by the SL-TWC. The RBP-MS was evaluated with a HeartWare HVAD us-ing an in-vitro mock loop that reproduced changes in systemic (SVR: 800-2400 dyne∙s∙cm-5) and pulmonary vascular resistance (PVR: 50-500 dyne∙s∙cm-5) as well as exercise conditions. The RBP-MS was compared against an independent SL-TWC, independent pulsing mechanism and constant speed operation.

During rest, the RBP-MS and independent pulsing mechanism demonstrated greater pulsatility (pulse pressure both 45 mmHg) compared to independent SL-TWC and constant speed (both 10 mmHg). At PVR of 500 dyne∙s∙cm-5, constant speed and the independent pulsing mechanism result-ed in ventricular suction, whereas suction was avoided with the RBP-MS and independent SL-TWC. During exercise, the RBP-MS and independent SL-TWC delivered greater cardiac output (9.0 L/min) and LVSW unloading (0.4 J) compared to constant speed and the independent pulsing mechanism (both 8.5 L/min and 0.6 J respectively).

The RBP-MS prevented in-vitro ventricular suction and delivered pulsatile flow which improved ventricular unloading, vascular pulsatility and aortic valve opening. Future work involves evaluat-ing the RBP-MS with estimators to overcome the requirement for implantable sensors.

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O4-6

Cardiovascular Peristalsis?: Nonaxial Peristaltic Total Occlusion As a Mechanism for Blood Propulsion

1)Department of Biomedical Engineering, The University of Arizona, Tucson, AZ, USA,2)

Department of Surgery, The University of Arizona, Tucson, AZ, USA

Zack D. Frankman1), Zain Khalpey2), Marvin J. Slepian1)

Introduction: With increasing demand for mechanical circulatory support devices as therapy for advanced and end-stage heart failure, an opportunity exists for improved, simplified designs - of-fering performance but with greater economy in terms of reduced cost and need for adjunctive phar-macology. Here we investigate emulation of esophageal peristalsis as a design and driving mecha-nism for a ventricular assist device (VAD).

Methods: Two prototypes were fabricated and evaluated. A proof-of-concept prototype for a tube diameter of 30mm and a length of 400mm was constructed and tested on a mock circulation loop at a physiologic pressure head, circulating heparinized whole porcine blood. A second prototype was created for a tube diameter of 15mm and a length of 125mm to prove implantability and was tested on a Donovan mock circuit and again on a mock loop with whole pig blood. Hemolysis was evalu-ated for both designs via measurement of plasma free hemoglobin. The flow characteristics of both prototypes were analyzed using high sample rate flow metrology.

Results: The proof-of-concept prototype incorporating progressive inflatable segments, simulating peristalsis, successfully produced a range of flow patterns, delivering up to 8.5L/min of pulsatile flow, while achieving near physiologic shear. The prototype also had reduced hemolysis (2.7 mg/dL[PfHg]/100 circulations, compared to 20 mg/dL[PfHg]/100 circulations in Heartmate 3) at 3L/min physiologic levels of blood flow. Optimum operational pressure was found to be 12.5psi and a series of efficient flow chamber algorithms were developed and integrated into the second proto-type, achieving physiologic flow and shear rates.

Conclusion: Emulation of peristalsis is a viable mechanism for blood pump design, with resultant lower shear than continuous flow pumps, with potential reduced need for anti-thrombotics. Through elimination of moving parts in contact with blood, such a design may drastically lower the cost of fabrication.

83

O5-Keynote

Usability of MCS-Systems: Methods and obstacles for it´s optimization

1) Center for Medical Physics and Biomed.Eng, 2) Dept of Cardiac Surgery, 3) Boltzmann-Cluster for Cardiovascular Research, Medical University of Vienna, Austria

Heinrich Schima1,2,3), Thomas Schlöglhofer1,2,3), Zeno Hartner2), Georg Necid2), Francesco Moscato1,3), Daniel Zimpfer1,2,3)

The error-free and optimal handling of life supporting systems such as MCS in daily-life but also unusual and emergency situations handling is of crucial importance for the well-being and some-times even survival of patients. In recent years, “usability” or “human-factors” have gained increased attention in the development and surveillance of medical devices and have been even included into international standards. So, during the development, discussions, simulations and later-user surveys have to be performed. Also in our field, an increasing number of usability studies has been performed and reported. However, based on the pecularity of many of these problems, also after clinical introduction the “unexpected has to be expected”, and problems may be attributed to the clumsiness of the users or silly mistakes, or even not recognized because of hidden causality.Only very limited reporting is done due to shamefulness, liability concerns or unawareness of the problem, and standardization of reports is difficult, which hinders the inclusion into important data-bases. The current situation and potential efforts to refine the awareness for usability questions shall be discussed. Lit: Kormos et al. Circ 2017:1714-25, Schima et al. Artif. Org 2014:751-60, Geidl et al. Artif Org 2011: 773-80

84

O5-2

Effects of discharge angle and cross-sectional area of the impeller flow path on the hemocompatibility of a centrifugal blood pump

1)National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan,2)Graduate School of Engineering, Yokohama National University, Yokohama, Japan,3)Senko Medical Instruments Mfg. Co., Ltd., Kasukabe, Japan

Masahiro Nishida1), Daiki Goto2), Daisuke Sakota1), Ryo Kosaka1), Takashi Yamane1), Osamu Maruyama1), Toru Hyakutake2), Yoshihiro Yamamoto3), Katsuyuki Kuwana3)

PurposeThe effects of discharge angle and cross-sectional area of the flow paths of the impeller on the hemocompatibility of a centrifugal blood pump were investigated for longer-term use.

MethodsFour impellers that had different discharge angles of four flow paths with rectangular cross-sections were compared. Three impellers that had four or six flow paths with different cross-sectional area were then compared. Computational fluid dynamics analysis was conducted at different rotational speeds of the impeller under a flow rate of 4 L/min and a pressure head of 200 mmHg. The damage index and stagnant surface area were calculated to predict hemolysis and the anti-thrombogenecity of the pump. The head-flow rate characteristics were measured, and hemolysis tests were conducted.

ResultsSmaller discharge angle reduced high-shear regions near the outlets of the flow paths but reduced the flow rates through the washout holes, resulting in a lower damage index but larger stagnant sur-face area near the pivot bearing. Meanwhile, larger cross-sectional area of the flow paths improved the head-flow rate characteristics, thereby decreasing the rotational speed of the impeller and conse-quently reducing the velocity through the flow paths which lowered the damage index. Higher flow rate through the washout holes due to larger cross-sectional area of the flow paths reduced the stag-nant surface area, but this depended on the mixing effect according to the number of the secondary vanes.

ConclusionsA decrease in the discharge angle of the flow paths improved the hemolytic properties of a centrifu-gal blood pump. Moreover, an increase in the cross-sectional area of the flow paths improved both the hemolytic and anti-thrombogenic properties of the pump, regardless of an increase in the pump volume.

85

O5-3

3D Intraventricular Flow Patterns During LVAD Support - A Flow Field Analysis By Means Of High Speed Stereo-PIV -

Berlin Heart GmbH, Research and Development, Berlin, Germany

Henning Kroll, Tim Bierewirtz, Daniel Medart

Background/Purpose

The interaction of LVAD cannula with the left ventricular blood flow displays a complex pattern due to the unsteady and three-dimensional nature of the intraventricular flow field. In this regard the residual contractile function of the heart in LVAD patients represents a crucial parameter. From a computational point of view the cardiac pulsatility, in conjunction with the complex cardiac flow pattern, requires sophisticated methods as Fluid Structure Interaction (FSI) and extremely high computational effort. As a consequence, experimental approaches come to the fore to address this Problem.

Methods

The study aims for a detailed analysis of the interaction between left ventricular blood flow and VAD inflow, dependent on the support mode of the VAD. A transparent left ventricular simulator featuring a piston pump-driven silicone ventricle and mock circulation has been designed for the in-vestigation. The test rig mimics the anatomy of LVAD implantation and provides optical access to the interior of the ventricle and the VAD inflow cannula. Stereo-PIV measurements have been per-formed capturing the three velocity components of the intraventricular flow field and the inflow of a generic cannula geometry.

Results

Beside the well-known clockwise vortex formation, the cardiac cycle-based phase averaged veloci-ty fields reveal a periodic and three-dimensional swirling motion generated in the ventricle, depend-ent on the support level of the VAD. The tornado-like vortex structure is absorbed by the VAD and eventually results in phase-dependent three-dimensional velocity profiles inside the cannula.

Conclusions

The results of this study provide details on the fundamentals of intraventricular flow patterns during LVAD support. The interaction of LV flow field and VAD cannula results in a phase and support level dependent 3D inflow to the interior of the VAD.

86

O5-4

“There Are Loops, And Then There Are Loops”: Loop Design and Constituent Components Introduce Artifacts Impacting Overall System Thrombogenicity

1)Department of Mechanical Engineering, Vanderbilt University, Nashville, TN, USA,2)Department of Biomedical Engineering University of Arizona, Tucson, AZ, USA,3)Department of Medicine Sarver Heart Center, University of Arizona, Tucson, AZ, USA

Mengtang Li1), Ryan Walk2), Eric J. Barth1), Marvin J. Slepian2,3)

Background: Validation of mechanical circulatory support (MCS) devices requires demonstration of hemocompatibility for regulatory approval. Circulatory loops are typically utilized for this pur-pose, constructed with tubing and connector components, in addition to the VAD under testing. Theoretically “errors,” as to hemocompatibility, may be introduced in these systems with the inser-tion of connectors whose physical characteristics contribute to inadvertent platelet activation, through imparted shear stress. Here, via in-silico modeling, we examined the effect of connectors as sources of additive shear stress, as to their impact on platelet activation.

Methods: Two in-vitro candidate testing loops, one without connectors and one with two luer con-nectors, were digitally replicated using CAD software (Solidworks), and imported into CFD soft-ware (Ansys). Whole loops were meshed using triangle elements, with the walls modeled with three inflation layers and 0.01 mm roughness. The inlet and outlet boundary conditions were set accord-ing to the in-vitro experimental testing VAD HeartAssist V. Blood was treated as an incompressible Newtonian fluid with density of 1050 kg/m3 and viscosity of 3.5e-3 kg/ms. The k-epsilon turbu-lence model based Navier-Stokes equations were solved numerically to obtain the steady state solu-tions.

Results: High shear regions are introduced by the addition of two luer connectors, with the system maximum blood shear stress reaching at 25.6 Pa compared with the original 8.7 Pa. With two luer connectors, the system shear distribution is shifted towards higher values, resulting in potentially higher platelet activation.

Conclusion: Modeling demonstrates that the design and components of the loop itself may intro-duce additional shear stress regions that contribute to and “contaminate” the overall hemocompati-bility results of the VAD undergoing testing. Careful design of test loops, with in silico considera-tion of additive prothrombotic contributions of loop components and fixtures, will further improve the utility of current in vitro testing systems and approaches.

87

O5-5

Development of an intelligent blood pump with a self-detecting function of thrombus

1)Department of Mechanical Engineering, Tokyo Institute of Technology, Japan,2)School of Medicine, Tokyo Medical and Dental University, Japan,3)Department of Cardiovascular Surgery, Tokyo Medical and Dental University, Japan,4)Department of Advanced Surgical Technology Research and Development, Tokyo Medical and Dental University, Japan

Wataru Hijikata1), Tomotaka Murashige1), Takuro Maruyama1), Asato Ogata2), Tatsuki Fujiwara3), Katsuhiro Ohuchi4), Hirokuni Arai3)

Background and Purpose: One of the remaining issues in blood pumps to increase the survival rate of a patient is thrombus formation. If the thrombus can be detected in early stage, we may get a novel guideline in anticoagulant treatments as well as avoid a risk of embolism by early pump ex-changes. In this study, an intelligent function of a thrombus detection has been applied to a magnet-ically-levitated centrifugal blood pump and evaluated with porcine blood anticoagulated by heparin sodium.

Methods: By applying the sinusoidal current in the magnetic bearing, the impeller is intentionally vibrated with an amplitude of 30 μm at 70 Hz. The pump can detect the thrombus by measuring the phase difference between the current and vibrational displacement of the impeller, which has a rela-tionship with the change in the blood viscosity and fluid clearance due to the thrombus formation. To validate the proposed function, in vitro thrombus detection tests (n=3) were performed using porcine blood, which was anticoagulated by heparin sodium. The activated clotting time was de-creased to the target value of around 120 s by injecting protamine sulfate. The pump speed and flow rate were 2000 rpm and 1.0 L/min, respectively.

Results: After the circulation for several hours, the phase difference suddenly rose in the last ten minutes. At the moment when the phase difference reached two degrees, heparin sodium was inject-ed for anticoagulation and the pump was disassembled immediately. In all cases, microthrombi were observed mainly on the lower surface of the impeller after the tests. Conclusions: We achieved the detection of early-stage thrombus formation inside a magnetically levitated centrifugal blood pump. Since the proposed function requires no additional sensors, it can be installed in any magnetically-levitated blood pumps. In the next step, we will conduct an animal experiment with a porcine model.

88

O5-6

Experimental evaluation of a thrust bearing gap in a hydrodynamically levitated centrifugal blood pump for reduction of hemolysis

National Institute of Advanced Industrial Science and Technology (AIST), Japan

Ryo Kosaka, Daisuke Sakota, Masahiro Nishida, Osamu Maruyama, Takashi Yamane

Purpose: We have developed a hydrodynamically levitated centrifugal blood pump for MCS device. The pur-pose of this study is to evaluate a bearing gap of a thrust bearing in a hydrodynamically levitated centrifugal blood pump for reduction of hemolysis.

Methods: A relationship between a thrust bearing gap and hemolysis level was experimentally investigated. Five pump models, whose inner diameters of bottom shroud of a closed-impeller were 10.5 mm (ID10.5), 12 mm (ID12), 13.5 mm (ID13.5), 16 mm (ID16) and 18 mm (ID18), were prepared. First, an impeller levitation test was performed to measure a thrust bearing gap using a laser dis-placement meter. The minimum thrust bearing gap was evaluated. Second, hemolysis level was evaluated in in-vitro hemolysis test. The relative normalized index of hemolysis (NIH) ratio in com-parison with BPX-80 was calculated. These tests were performed under two driving conditions, condition A (a pressure head of 200 mmHg and a flow rate of 4 L/min) and condition B (a pressure head of 300 mmHg and a flow rate of 3 L/min).

Results: The minimum thrust bearing gaps in conditions A and B were 32 and 28 μm (ID10.5), 53 and 43 μm (ID12), 113 and 110 μm (ID13.5), 88 and 76 μm (ID16), 19 and 15 μm (ID18), respectively. The relative NIH ratios in conditions A and B were 1.36 and 1.6 (ID10.5), 0.96 and 1.53 (ID12), 0.45 and 0.43 (ID13.5), 0.77 and 1.00 (ID16), 4.88 and 5.30 (ID18), respectively. The relative NIH was reduced corresponding to the expansion of the minimum bearing gap. The pump model, ID13.5, whose minimum bearing gap was greater than 110 μm could reduce hemolysis.

Conclusions: We confirmed that low hemolysis was achieved when a thrust bearing gap was greater than 110 μm in the developed blood pump.

89

SL3�

Trend of Mechanical Circulatory Support in Japan

PhD, Emeritus Researcher, AIST (National Institute of Advanced Industrial Science and Technology)

Takashi Yamane

A short history and the present status of mechanical circulatory supports in Japan will be presented. Since Novacor withdrew out of Japan in 2006 there happened a tragedy for heart patient to lose im-plantable VADs until 2010. The Japanese academia/government/industry established guidance in 2008 to review newly developed VADs. Presently five rotary VADs are available for bridge-to-transplantation, BTT, and two pulsatile VADs are used for bridge-to-decision, BTD. A catheter pump and several centrifugal pumps have become available for circulatory support as well as for ECMO. Now 140 VADs are implanted annually in Japan and only 40 among them reach transplantation. Therefore, the patient qualification criteria will be expanded to destination therapy, DT, next year.

90

O6-Keynote

University of California, San Francisco, USA

Georg Wieselthaler

91

O6-2

Clinical Outcome of Left Ventricular Assist Device for Arrhythmogenic Right Ventricular Cardiomyopathy

Department of Cardiac Surgery, University of Tokyo, Japan

Sachito Minegishi, Osamu Kinoshita, Yasuhiro Hoshino, Hyoe Komae, Mitsutoshi Kimura, Shogo Shimada, Haruo Yamauchi, Kan Nawata, Minoru Ono

BACKGROUND: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a heart muscle disorder characterized by right ventricular enlargement, right heart failure, and ventricular arrhyth-mias which lead to sudden death with concomitant progressive fibro-fatty replacement of the myo-cardium, primarily of the right ventricle, with involvement of the left ventricle at later stages. Cur-rent recommendations for management of patients with ARVC include anti-arrhythmic drugs and insertion of an automated implantable cardioverter-defibrillator (AICD) to prevent sudden cardiac death. However, despite the use of AICD and anti-arrhythmic drugs, few patients suffer recurrent ventricular arrhythmias or heart failure unresponsive to conventional management. Heart transplan-tation is the preferred treatment for these cases, but because of the persistent donor heart shortage in Japan, the ventricular assist device (VAD) support has become an important option for the manage-ment of end-stage ARVC.METHODS: Between December 2014 and June 2018, 3 patients with ARVC underwent left ven-tricular assist device (LVAD) insertion as a bridge to transplantation. These patients' charts were retrospectively reviewed.RESULTS: Mean follow up period was 591 days. All patients survived during the period. Preoper-ative mean RV FAC was 16.7%. Preoperative mean RV EDA was 51.3 cm2. Preoperative PA pres-sure was 18.3/14.3/11.3 mmHg, Preoperative PCWP and RA pressure were 10.0 and 15.3 mmHg, respectively. Preoperative LVDd was 48 mm and CI was 1.22. Postoperative mean RV FAC was 5.7%. Postoperative mean RV EDA 42.6 cm2. Postoperative PA pressure was 19.3/16.0/12.3 mmHg, Postoperative PCWP and RA pressure were 10.7 and 16.7mmHg, respectively. Postopera-tive LVDd was 53 mm and CI was 2.01.CONCLUSIONS: LVAD support do not show apparent improvement of right heart function, but it can provide satisfactory long-term survival. During the course, appropriate ventricular pacing and administration of β-blocker are necessary.

92

O6-3

Acute in-vivo evaluation of a suture-less inflow cannula for rapid LVAD implantation

1)School of Engineering and Built Environment, Griffith University, Gold Coast, Qld, Australia, 2)The Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Chermside, Qld, Australia,3)School of Chemistry, Physics, and Mechanical Engineering, Queensland University of Technology, Brisbane, Qld, Australia,4)School of Medicine, The University of Queensland, St Lucia, Qld, Australia,5)Dept of Cardiothoracic Surgery, The Prince Charles Hospital, Chermside, Qld, Australia,6)Dept of Mechanical and Aerospace Engineering, Monash University, Clayton, Vic, Australia

Kristy May Garrick1,2), Nicole Bartnikowski2,3), Sanne Pederson2), Jo Philipp Pauls2,4), Nchafatso Gikenyi Obonyo2), Bruce Thomson5), John Francis Fraser2,4), Geoff Tansley1,2), Shaun David Gregory1,2,4,6)

PURPOSEPostoperative surgical bleeding at the inflow cannulation site can be a significant complication of LVAD support; while extended time on cardiopulmonary bypass (CPB) is associated with inferior postoperative outcomes. To address these complications, a rapidly implantable suture-less inflow cannula (SLC) was developed. The SLC includes an internal corer, which is retracted after LV api-cal insertion; forcing an internal flexible component to swage out and form an internal flange, thus compressing the myocardium against the internal flange and an external flange to create a seal. We investigated SLC efficacy in-vivo, through evaluation of surgical implantation time and acute post-operative bleeding. METHODThe SLC was implanted via a median sternotomy following implementation of CPB, completed for safety, in a healthy, acute, porcine, non-recovery (n=2) pilot study. The outflow graft was anastomo-sed to the ascending aorta and attached to a HeartWare HVAD before the SLC was implanted con-currently with apical coring. The corer was removed (retaining the apical core) and the HVAD at-tached via tubing. Animals were weaned from CPB to achieve full LV support (LVAD 5 L/min) before 6 hours of postoperative monitoring for bleeding at the cannulation site. RESULTSInflow cannulation using the SLC was achieved in under 1 minute with minimal operative bleeding. Restored haemodynamics with full LV support was maintained in both animals for the study dura-tion. Visual inspection showed absence of postoperative apical bleeding at the cannulation site throughout both in-vivo experiments. Echocardiography showed firm placement of the internal flange against the endocardium and desired orientation toward the mitral valve. CONCLUSIONSThis proof-of-concept study demonstrated successful rapid attachment of the SLC to the LV without postoperative apical bleeding in an acute in-vivo model. Future SLC work will include acute in-vi-vo implantation without CPB and chronic in-vivo evaluation.

93

O6-4

HeartMate II implantation with lower mini-sternotomy reduced postoperative bleeding and ventilatory support

Department of Cardiovascular Surgery, Osaka University, Japan

Koichi Toda, Shigeru Miyagawa, Yasushi Yoshikawa, Hiroki Hata, Daisuke Yoshioka, Satoshi Kainuma, Takushi Kawamura, Ai Kawamura, Shohei Yoshida, Yoshiki Sawa

Background: Several minimally invasive approaches have been reported for LVAD implantation. However, no technique was reported regarding lower mini-sternotomy by which concomitant mitral and tricuspid surgery could be performed. We developed a novel approach for HeartMate II implan-tation using lower mini-sternotomy and evaluated its short-term clinical outcomes in comparison with full-sternotomy. Methods: Among consecutive 62 patients who underwent HeartMate II LVAD implantation in our institute since 2013, 27 patients without previous cardiac surgery underwent isolated HeartMate II LVAD implantation with full-sternotomy (18 patients: group F) or lower mini-sternotomy (9 pa-tients: group M). In group M lower mini-sternotomy was made with 12-15cm skin incision and pump pocket was created by preperitoneal dissection 10cm caudally and 15cm laterally from the end of skin incision. After cardiopulmonary bypass was established with femoral cannulations, left ventricular apex was exposed by pulling up left side pericardium and apical cuff was anastomosed. The pump was placed in the pump pocket and inflow cannula was connected to the cuff and the outflow graft was anastomosed to ascending aorta. We retrospectively investigated the difference in short-term outcomes between group F and M.Results: No conversions to full sternotomy was required in group M. During the LVAD implanta-tion blood loss volume was lower and less transfusion was necessary in group M. Postoperatively, chest tube drainage in the first 24 hours was significantly lower (1381±646 ml vs. 962±191 ml, p=0.037) and length of ventilator support was significantly shorter in group M (59.7±66.0 hrs. vs. 21.4±10.4 hrs. p=0.022). No reoperation for postoperative bleeding or no 30 days mortality was en-countered in both groups.Conclusions: HeartMate II could be safely implanted in all 9 patients using lower mini-sternotomy with 12-15cm skin incision. This technique may be a less invasive approach with reduced postoper-ative bleeding and ventilatory support and further investigation was warranted.

94

O6-5

Unloading strategies to optimize reverse remodeling

Department Cardiac Surgery, UZLeuven, Belgium

Bart Meyns, Steven Jacobs, Joeri Van Puyvelde, Filip Rega, Erik Verbeken

Objective: Reverse remodeling of chronic failing hearts is described after LVAD implantation and considered as a potential mechanism of recovery of myocardial function. The objective of this study is to in-vestigate the effect of the degree of unloading and the use of angiotensine converting enzyme inhib-iters (ACE-I) on reverse remodeling. Methods:Chronic heart failure was obtained in 26 sheep 6 weeks after myocardial infarction by coronary li-gation. Animals were randomized in 4 groups: 1) no treatment 2) ACE-I 3) full support LVAD 4) partial support LVAD + ACE-I. Animals were supported for 6 weeks. Hemodynamic assessments, pressure volume loops and magnetic resonance imaging were performed at initiation and termina-tion. Histology of the hearts was performed on explantation. Results:Control animals (group 1) and ACE-I animals (group2) showed significant dilation of the hearts (group 1: EDV 119+4 to 135+4 ml;p=0.007; group 2: EDV132+43 to 147 +40; p=0.01). Full sup-ported animals (group 3) had no further dilation (EDV 136+33 to 139+33 ml). Group 4 (partial sup-port with ACE-I) showed a significant reduction of end-systolic and end-diastolic left ventricular volume (EDV: 163+32 to 144+22 ml;p=0.04). There was no difference in hemodynamic or contrac-tility measures (ESPVR) in any of the groups. Discussion:LVAD supports halts the further dilation and deterioration of the chronic failing heart, more than ACE-I only. Partial support + ACE-I results in a significant reverse remodeling of the chronic fail-ing heart. It is remarkable that full support does not achieve a similar result than partial support with ACE-I and this questions the current practice of unloading the heart completely. Despite sig-nificant reverse remodeling, an increase in contractility could not be observed in this model of is-chemic heart failure.

95

O6-6

Genetic basis of cardiomyopathy and the genotypes involved in prognosis and left ventricular reverse remodeling

1)Department of Cardiovascular Medicine, The University of Tokyo, Japan,2)Department of Cardiology, Tokyo Women’s Medical University, Japan,3)Genome Science Division, Research Center for Advanced Science and Technology, The University of Tokyo, Japan,4)Department of Cardiovascular Surgery, The University of Tokyo, Japan

Seitaro Nomura1,3), Takashige Tobita2), Takanori Fujita3), Hiroyuki Morita1), Masaru Hatano1), Minoru Ono4), Nobuhisa Hagiwara2), Hiroyuki Aburatani3), Issei Komuro1)

Dilated cardiomyopathy (DCM) and hypertrophic cardiomyopathy (HCM) are genetically and phe-notypically heterogeneous. Cardiac function is improved after treatment in some cardiomyopathy patients, but little is known about genetic predictors of long-term outcomes and myocardial recov-ery following medical treatment. To elucidate the genetic basis of cardiomyopathy in Japan and the genotypes involved in prognosis and left ventricular reverse remodeling (LVRR), we performed tar-geted sequencing on 120 DCM (70 sporadic and 50 familial) and 52 HCM (15 sporadic and 37 fa-milial) patients and integrated their genotypes with clinical phenotypes. Among the 120 DCM pa-tients, 20 (16.7%) had TTN truncating variants and 13 (10.8%) had LMNA variants. TTN truncating variants were the major cause of sporadic DCM (21.4% of sporadic cases) as with Caucasians, whereas LMNA variants, which include a novel recurrent LMNA E115M variant, were the most frequent in familial DCM (24.0% of familial cases) unlike Caucasians. Of the 52 HCM patients, MYH7 and MYBPC3 variants were the most common (12 (23.1%) had MYH7 variants and 11 (21.2%) had MYBPC3 variants) as with Caucasians. DCM patients harboring TTN truncating vari-ants had better prognosis than those with LMNA variants. Most patients with TTN truncating vari-ants achieved LVRR, unlike most patients with LMNA variants. We will introduce a novel method to analyze the pathogenesis of cardiomyopathy using single-cardiomyocyte RNA-seq.

96

SL4�

MCS Hemocompatibilty 2018: “It’s More than Just the Pump”Flow, Shear, Design, System Implantation, Drugs and All That

Departments of Medicine, Biomedical Engineering and Material Sciences and Engineering, Sarver Heart Center, University of Arizona, Tucson, Arizona USA

Marvin J. Slepian

Mechanical circulatory support (MCS) use continues to increase, with progressive improvements in efficacy, durability and outcomes. Despite these positive advances, adverse events continue, nota-bly related to hemocompatibility. MCS hemocompatibility is a delicate balance of thrombosis vs. bleeding. Overall, hemocompatibility is driven by the net relative contributing effects of a range of elements including device: material composition, design, flow, implantation, overall system config-uration, adjunctive pharmacology use and patient-specific local and systemic parameters. Here state-of-the art understanding of elements driving hemocompatibility will be reviewed. In particu-lar, details related issues of flow, shear, device design and shear-mediated platelet activation will be discussed. Recent device thrombosis improvements with new VADs systems, e.g. HeartMate 3, will be outlined, as well as issues related to implant and late hemocompatibility, stroke and bleed-ing. Present understanding of the efficacy and limitation of current anti-thrombotic adjunctive pharmacology will be discussed as well as issues related to bleeding. Finally, new emerging ap-proaches to further monitor and improve hemocompatibility will be highlighted.

97

P2A-1

Development of an Electromechanical VAD Life Cycle Testing Rig

1)RocketHeart Technology Co. Ltd, China, 2)TEDA International Cardiovascular Hospital, China

Qinglin Fan1), Jian Xu1), Tingbiao Zhao1), Tienan Chen2), Yu Song2)

Purpose: To develop a low cost, highly integrated, electromechanical VAD life cycle testing rig.Methods: The electromechanical VAD life cycle testing rig provided a pulsating flow with a voice coil motor as power source to simulate ventricular motion; a one-way valve was used to simulate the ventricular mitral valve, which could control the direction of the blood flow; a proportional valve was applied to serve as the body damping; besides, PMMA chambers were chosen to simulate the vascular compliance and venous compliance; a temperature control system consisted of heating rod, temperature sensor and thermostat was established to simulate human body temperature. The test bench took the upper and lower machine control mode, of which the lower computer held the real-time control of voice coil motor by the PXI real-time system. The host computer sent control commands to the lower computer, displayed and stored data.Results: The electromechanical VAD life cycle testing rig can simulate three running modes of rest, daily and exercise, and automatically switch three states at the preset duration; the device is stable and reliable for long-term working.Conclusions: The electromechanical VAD test rig is compact, simple to drive and easy to adjust. It can be used to test VAD products for long life cycle testing.Key Words: Life cycle testing rig, Electromechanical, Ventricular assist device.

98

P2A-2

Improving the quality of life of VAD users through interactive digital channels: A comparative content analysis

1)School of Architecture, Design and Planning, University of Sydney, Sydney, Australia, 2)Department of Mechanical and Aerospace Engineering, Monash University, Melbourne, Australia

Keum Hee Kimmi Ko1), Jessica Lea Dunn1), Karla Straker1), Erez Nusem1), Cara Wrigley1), Shaun Gregory2)

Background/PurposeThe journey of a VAD patient and their caregiver pre-, during and post-surgery is full of challenges. Digital channels exist to support VAD users (i.e., patients, caregivers and healthcare practitioners) at various points along this journey. The following study aimed to understand how digital channels could contribute to quality of life and subjective wellbeing outcomes for VAD users. MethodsA content analysis methodology was used to chart digital platforms being used by VAD patients, caregivers and practitioners. The authors investigated sixteen digital channels, with data emerging from these channels being analysed thematically. Following analysis, competitor positioning matrix diagrams were created to visually represent the landscape of digital platforms that support VAD us-ers. Result The most common purpose of digital channels for VAD users was daily monitoring (i.e., for com-munication between patient/caregivers and their practitioner) followed by educational (i.e., as Deci-sion Support Tools, self-training, or to aid practitioners to communicate training material to patients and caregivers). The majority of channels required manual data input, and only three channels of-fered some level of smart integration with existing apps. Most channels provided VAD maintenance strategies, however, offered limited features specifically designed to support VAD users’ quality of life and subjective wellbeing management. The majority were unable to fulfil diverse purposes and users’ needs along the VAD journey, with available features inconsistent between platforms.

ConclusionInnovation in digital channels for VADs has the potential to reduce the burden on all users by assist-ing with the decision-making process, practitioner education, patient and caregiver education, daily maintenance, self-management, remote monitoring, and enabling communication between all VAD users. This research identified opportunities and potential areas for improvement in the design of digital channels for VADs, with an emphasis on improving the overall quality of life and subjective wellbeing along each stage of the VAD journey.

99

P2A-3

Optimization of the ceramic plate shape in ReligaHeart® ROT pump using FEM and physical validation

Artificial Heart Laboratory, Zbigniew Religa Foundation of Cardiac Surgery Development, Poland

Przemyslaw Kurtyka, Maciej Gawlikowski, Jerzy Zalewski, Artur Kapis, Roman Kustosz, Malgorzata Gonsior

BackgroundThe aim of the project was to optimize the shape of zirconium plate in ReligaHeart ROT CFVAD in order to minimize the risk of the collision between impeller and pump housing.MethodsRH ROT construction provides the stabilization of the rotor position within two permanent magnet-ic bearings (PMB) and two hydrodynamic bearings (HDB). The hydrodynamic bearing generates the balanced lifting forces for the clearance starting from 50μm. In this case flatness of zirconium plates is crucial for reliability and safeness reasons of device utilization. However any increase in thickness of the ceramic increases the distance of PMB interaction. That is why it is necessary to take into account the influence of plate’s thickness on PMB forces, and balance of the impeller. The optimization process has been started from FEM analysis of the initial construction using Ansys software. Calculations were performed within the Static Structural Module with the use of material data supplied from its manufacturer. The analysis was performed for the load of F=17N according to data obtained in preliminary tests on the test stand. Then the physical studies were performed us-ing special designed test stand for identical support and load conditions. These study allowed the validation of the method. Then the optimization process was performed using numerical calcula-tions.ResultsThe obtained results showed that the initial thickness of the zirconium plate caused its mechanical deformation in the range of 12μm in the PMB region. The deflection value obtained using numeri-cal calculations and physical tests were convergent within 5% tolerance. The construction optimiza-tion allowed the selection of proper thickness to provide the required stiffness of the system and flatness of 0.005mm. ConclusionsPresented numerical analyses allowed the optimization of the ceramic construction minimizing its mechanical deformation with the acceptable loss of PMB force. AcknowledgementsProject RH-ROT/266798/STRATEGMED-II (NCBiR).

100

P2A-4

Verification method of the magnetic induction distribution using mapping to control the magnetic field regularity in contact-less CF pumps

Artificial Heart Laboratory, Zbigniew Religa Foundation of Cardiac Surgery Development, Poland

Przemyslaw Kurtyka, Pawel Pydzinski, Jerzy Zalewski, Maciej Gawlikowski, Maciej Darlak, Roman Kustosz, Malgorzata Gonsior

BackgroundThe aim of the project was to develop the reliable method to control the magnetic induction distri-bution of the magnetic system after assembling the Polish ReligaHeartR ROT (RH-ROT) centrifu-gal blood pump.MethodsIdea of the project was designing and manufacturing of the new test stand for magnetic measure-ments. The magnetic induction measurement were performed using BELL-5180 TESLAMETER with axial probe. The test stand included three linear and one rotary axis operated by stepper mo-tors. LabView application was designed to allow the control and data acquisition. The magnetic in-duction data was recorded in the range of defined radius with a given number of 400 steps in radial and 60 steps in axial direction. In order to obtain the results visualisation, a new soft-ware was de-veloped using Python. The chart using heat map type allowed to generate the induction distribution from recorded waveforms of the analyzed magnetic system. The software was mainly developed for circular magnetic systems including ring and cylindrical magnets, but it also allows to scan the whole impeller of the centrifugal blood pump as assembling quality control.ResultsThe test stand is used for verification of both individual RH-ROT pump magnets and their entire assemblies. A developed method allows the quantitative assessment of uniformity of magnetic field distribution for individual magnet systems. The resolution of the measurement is limited by created software, which is responsible for sampling. The presented example created 2400 measuring points for the impeller with diameter of 34mm.ConclusionsPresented method allows the verification of the magnetic induction distribution including visualiza-tion on 2D color maps. After the tests, the method proved to be reliable and suitable to analyze vari-ous magnetic systems and to present all deviations and irregularities in the magnetic field.Acknowledgements Project RH-ROT/266798/STRATEGMED-II (NCBiR).

101

P2A-5

Applicability of Narrow Groove Theory in Conical Spiral Groove Bearing Design for Rotary Blood Pumps

1)Department of Bioengineering, Rice University, USA,2)Texas Heart Institute, Houston, USA, 3)Johnson & Johnson, Houston, USA

Shelby A Bieritz1,2), P Alex Smith2), Yaxin Wang2), Luiz C Sampaio2), William E Cohn3), Jane Grande-Allen1), O H Frazier2)

Background/PurposeSufficient washout, or blood flow, through small gaps in LVAD geometries is necessary to avoid thrombus formation and pump failure. Flat spiral groove bearings (SGBs) have been examined for their ability to generate secondary flow paths while assuming a load-bearing role in LVADs. To es-timate SGB performance, an analytical model called the narrow groove theory (NGT) is typically employed. This study evaluates the applicability of the NGT in predicting washout performance of conical SGBs in LVAD applications. MethodsConical SGBs were 3D printed and installed in a test rig, and the flow rate generated by each SGB was compared to NGT predictions over a range of bearing gaps. SGB groove depth, groove angle, ridge to groove width ratio, conical half angle, and rotational speed were varied. The SGBs were at-tached to a motor and positioned in a fluid reservoir with a mating journal surface. A 3-axis stage allowed adjustment of the bearing gap. The reservoir was connected to a flow loop with a flow probe, and a force transducer measured axial load capacity of the SGBs.ResultsThe NGT is less accurate with an increase in bearing speed and conical half angle, suggesting that centrifugal forces are not adequately considered in the analytical model. The NGT has the largest predictive error (41%) as the ridge to groove width ratio falls from 1 to 0.5, but it provides accurate washout predictions (<15% error) for SGBs with equal groove and ridge widths and with groove depths below 400 μm.ConclusionsThe NGT gives accurate approximations of SGB washout in the creep flow realm. However, the NGT loses prediction accuracy as groove geometry favors inertial flow, and as centrifugal forces play a larger role. Empirically-derived models would prove more useful than NGT for designing conical SGBs that prioritize washout over load capacity.

102

P2A-6

Designing A Magnetically Suspended Blood Pump to Cope with Pump Tilting Movements in Patients Living An Active Life

1)Artificial Organ Technology Lab, Soochow University, Suzhou, China,2)CH Biomedical, Inc., Suzhou, China

Chen Chen1,2), Feng Lin2), Yunshan Ma2), Chengke Yin1), Xiao Ma2), Dexing Zhao2)

Purpose As technology advances, we require the magnetic suspension of an implantable blood pump not only to be miniaturized for less invasiveness, but also to provide adequate load capability that allows patients to return to an active life. Although the load capability pertaining to transverse shock and vibration of the pump has been adequately acknowledged in the field, fewer investiga-tions were publicly known regarding the load capability with respect to the tilting movement of the pump. However, a pump with fully magnetically suspended rotor is particularly susceptible to the tilting speed due to the gyroscopic effect. For example, such a pump may produce noise indicating rotor touch-down when it is twisted in a person’s hand at a moderate speed, which may raise con-cern with the effect of the rotor’s dynamic response to the tilting movement of a patient in daily life, on the blood flow and blood compatibility. Therefore, we performed a comprehensive investi-gation into the specification, design, and evaluation of the capability of withstanding tilting speed of the fully magnetically suspended pump CH-VAD.Methods Equations were developed for analysis of the dynamic response of a pump rotor to angular speed of tilting of the pump housing about a radial axis. These equations were successfully imple-mented in the design optimization process of CH-VAD pump. Eventually, the tilting capability of CH-VAD was evaluated with a purpose-made rotational stage that turns the pump reciprocatedly about the radial axes. The pump operated at 3800 rpm, the specified highest speed for continuous operation.Results No touch-down was detected for sinusoidal variation of tilting speed with a magnitude of 12 rad/s. This amplitude corresponds to the peak angular speed of the upper torso of highly skilled golf players, according to a literature. Therefore, the CH-VAD magnetic suspension allows patients to undertake high strength physical activities.

103

P2A-7

Hemolysis reduction for axial-flow blood pumps

1)School of Engineering, Kobe University, Japan,2)Yasojima Proceed, Co., Ltd., Japan, 3)School of Medicine, Kobe University, Japan, 4)National Institute of Advanced Industrial Science and Technology, Japan

Takashi Yamane1,4), Eiru Akao1), Takahiro Nishimura1), Risako Makita1), Toshinori Kashiwazaki2), Yojiro Koda3), Hidekazu Nakai3), Hiroshi Tanaka3)

Background/PurposeWe are developing portable axial-flow blood pumps for circulatory assist. The impellers are 15 mm in diameter and are made of polycarbonate. The casing has a screw-nut structure for easy disassem-bly. The pump weight is 186 g and the priming volume is 12 mL. MethodsHemolysis tests were conducted at a flow rate of 2 L/min and the rotational speed was changed every 30 min. The quantification of plasma free hemoglobin concentration was performed with the TMB method. ResultsFirst, two double-pivot axial-flow pumps were compared, whose impeller shapes were simple solid cylinders with spiral flow channels. The hemolysis rate increased with rotational speed. The hemol-ysis rate at 9000 rpm was NIH(g/20min)=0.091 for a pump with a tip clearance of 50 mm (KAP8) and NIH=0.024 for a pump with a tip clearance of 100 mm (KAP7). Hemolysis rate was improved for a larger clearance maybe because the highest shear became less than 100,000 /s. Second, two kinds of step hydrodynamic bearing pumps were compared, whose impeller shapes were similarly solid cylinders with spiral flow channels. The hemolysis rate at 9000 rpm was NI-H(g/20min)=0.048 for a pump (KHAP1) with a tip clearance of 50 mm and NIH=0.094 for a pump with a tip clearance of 100 mm (KHAP4). In this case hemolysis did not improved maybe because oscillation due to cavitation was generated. ConclusionsHemolysis reduction was achieved by expanding tip clearance corresponding to the highest shear is less than 100,000 /s for double pivot pumps. However, the hemolysis rate was not decreased when an oscillation due to cavitation is generated.

104

P2A-8

Preclinical assessment of the miniaturized ventricular assist device for bridge to decision: chronic study in a bovine model

1)Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Japan,2)Department of Cardiothoracic Surgery, Graduate School of Medicine, University of Tokyo, Japan

Junichi Shimamura1,2), Toshihide Mizuno1), Tomonori Tsukiya1), Yoshiaki Takewa1), Minoru Ono2), Eisuke Tatsumi1)

Background: We developed a novel ultra small centrifugal pump “BIOFLOAT NCVC” for ven-tricular assist device (VAD) and performed a preclinical study which is a process for approval by the pharmaceuticals and medical device agency as a bridge to decision use. The aim of this study is to assess the postoperative performance, hemocompatibility and anticoagulative status of this ven-tricular assist system in the chronic phase.Methods: Nipro VAD system, consists of the pump, inflow and outflow cannulas, the extracorporeal circuit, and connectors, was used. We implanted this assist system for adult bovine as LVAD in 6 and RVAD in 3 bovines for 30 days or longer periods. Hemodynamic, hematologic, and blood chemistry measurements were investigated as well as end-organ effect on necropsy. Results: All bovines survived for over 30 days in good general condition. Wedge thrombus forma-tion was observed in 1 case. Other major adverse events including neurological complication, bleeding or thrombosis events and infection was not observed.Conclusions: This ultra small VAD enables long term support in the chronic animal model. The 30-days performance, hemocompatibility and anticoagulative status of this VAD system were re-viewed.

105

P2B-1

Considerations from initial experiences of Impella in Japan

1)Second Department of Internal Medicine, University of Toyama, Japan,2)Department of General Thoracic and Cardiovascular Surgery, University of Toyama, Japan

Makiko Nakamura1), Shigeki Yokoyama2), Toshio Doi2), Kazuaki Fukahara2), Koichiro Kinugawa1)

Background/Purpose: Impella 2.5 and 5.0 have been available in Japan for cardiogenic shock since November 2017. The nature of cardiac unloading should be remarkable but so far there has been no established benefit over other mechanical circulatory devices. Methods and Results: We used Im-pella 2.5 in 3 cases and 5.0 in 3 cases since March 2018. Etiologies of cardiogenic shock were AMI (2), ICM (3), and VF of unknown reason (1). In 3 cases necessitating cardiopulmonary resuscita-tion, we first inserted VA-ECMO and then Impella was used in combination (ECPELLA). We could not control bleeding from traumatic wound in 2 ECPELLA cases and died with hypovolemic shock. However, 1 case with stable hemodynamics after ECPELLA, cardiac recovery was phenom-enal. We used Impella 5.0 in 2 cases as bridge to decision, and we successfully converted it to par-acorporeal LVAD aiming for recovery or transplant candidacy. Hemodynamic stabilization by Im-pella could buy time before LVAD implantation. Supporting flow was variable dependent on BSA, LV size, and pump speed, but Impella 2.5 could maintain ~2.0 L/m2 in 1 case. Conclusion: There are still many unsolved problems on device size selection, pump speed optimization, and ECPEL-LA indication. We will try to discuss in this session based on our initial experiences.

106

P2B-2

Our Experience with conversion of the extracorporeal VAD to the implantable LVAD

Department of Cardiovascular Surgery, Chiba University Hospital, Japan

Michiko Watanabe, Hiroki Kohno, Kaoru Matsuura, Yoshinori Enomoto, Daisuke Hiraoka, Tomohiko Inui, Yasunori Yakita, Yutaka Wakabayashi, Hideki Ueda, Goro Matsumiya

Background:Acute decompensated heart failure patients have to receive extracorporeal-type-de-vice(eVAD) as a primary treatment and switched to an implantable-device(iVAD) after officially approved as heart transplant candidates in Japan. These patients have worse outcomes in compared to those who received iVAD as a primary treatment. We have applied prophylactic omentopexy to prevent infectious complications, which is one of the significant risk factor in these patients.Objective:To investigate the results of conversion cases from eVAD to iVAD in our institution and elucidate the validity of our strategy.Methods:Ten patients who underwent eVAD as a primary treatment and converted to iVAD between 2012/6–2018/3 were retrospectively analyzed. Mean age was 42.0±16.0y.o, 8 were male. Etiology of heart failure was DCM in 3, AMI in 3, ICM in 3, and drug induced cardiomyopathy in 1. Preop-erative INTERMACS profile was 1 in 4, 2 in 6. Mean duration of eVAD support before conversion was 223(64-1225)days. One patient required drainage of abscess around the apical cuff. iVAD de-vice was Jarvik2000(JK) in 7, HeartMate-II(HM) in 2, Duraheart(DH) in 1. One patient with DH underwent the operation through intercostal-thoracotomy and laparotomy. Others underwent the operation through median sternotomy. Concomitant surgery was omentopexy in all, AVR in 1, RVAD explant in 1, TAP in 1. Mean operation time was 566min(HM: 610min, DH:478min, JK:566min), mean ECC time was 134min(HM:155min, DH:92min, JK:136min), Ao clamp time was 75min in AVR case of JK.Results:All the patients were discharged home. Mean follow-up after eVAD surgery was 951.9±628.8days. Re-admission for driveline infection were required in two patients(644,848 post-operative day), but no patients developed mediastinitis or cerebral complications. Three patients underwent successful heart transplant, 7 patients are still on waiting list with iVAD.Conclusion:Our surgical results of converting eVAD to iVAD were satisfactory. Omentopexy may be useful to prevent infectious complications in conversion cases.

107

P2B-3

The impact of implantable left ventricular assist devices (iVAD) therapy in Fukushima

Department of Cardiovascular Surgery, Fukushima Medical University, Japan

Akihiro Yamamoto, Hirono Satokawa, Shinya Takase, Hiroki Wakamatsu, Yuki Seto, Hiroyuki Kurosawa, Tsuyoshi Fujimiya, Keichi Ishida, Hitoshi Yokoyama

Implantable left ventricular assist devices (iVAD) are effective therapy for severe heart failure pa-tients. But limited facilities can implant these devices because of restrict certification system in Ja-pan. We have made a team of severe heart failure treatment at Fukushima medical university in 2015. At the beginning, the outcomes were poor because heart failure therapy was delayed. All pa-tient’s survival rates, include extracorporeal VAD, were 90% at 1 month, 75% at 6 months, and 50% at 1 year after implantation. Subsequently, we successfully performed to implant iVAD for 4 cases (3 cases in 2017, and 1 case in 2018). As a result, the numbers of referred patients from near-by hospitals are increasing, and the patient’s survival rates are improved because of shortening of pre-operative ECMO supporting time. Now, 6 patients visit to our hospital, severe adversed events, for example severe right heart failure, driveline infection, are not observed so far. iVAD have a big impact on the heart failure treatment in Fukushima.

108

P2B-4

Long-term outcome of patients with durable ventricular assist device as bridge to transplantation

Division of Cardiothoracic Srugery, Tohoku University Hospital, Japan

Masatoshi Akiyama, Masanori Naganuma, Ichiro Yoshioka, Hiroki Takaya, Kouyu Watanabe, Yusuke Suzuki, Goro Takahashi, Kiichiro Kumagai, Osamu Adachi, Yoshikatsu Saiki

Background & PurposeDurable ventricular assist device (dVAD) program was commenced in 2011 at our institute. 55pa-tients underwent dVAD implantation as bridge to transplantation (BTT) and 3 patients as destina-tion therapy. Patient selection and management are changing over time. We comprehensively re-viewed our seven-year experiences of BTT patients for improving our outcome.MethodsThis study was a retrospective analysis of patients implanted with dVAD. 55 patients were enrolled in this study. Clinical data was obtained from J-MACS database.Major adverse events including bleeding, hemorrhagic and ischemic stroke, pump thrombus, pump pocket infection, and device malfunction were tracked.ResultsBasic characteristics; The average age was 44.2±13.5 years. 23% were women. Before surgery, 23% were supported on extracorporeal VAD. The major etiologies of heart failure were dilated car-diomyopathy and dilated phase hypertrophic cardiomyopathy. Intermacs profile was two or three in most cases.Used device; The devices primary used were 27 HeartMate II, 11 Jarvik 2000, 8 DuraHeart, 8 EVA-HEART, and 1 HVAD.Survival and adverse events; Survival rate at 1, 2, and 3 years were 88.7%, 81.6%, and 71.2%, re-spectively. 14 patients underwent heart transplantation, 27 patients are supported on dLVAD, and 14 patients died. The causes of death were MOF in sepsis (n=5), stroke (n=2), pump pocket infection (n=2), and other causes (SMA thrombus, GI perforation, NOMI, device malfunction, and ARDS) (n=5). Several patients were complicated with major adverse events (Major bleeding (n=13), Cere-bral infarction (n=8), Pump pocket infection (n=6), Pump thrombus (n=3), Device malfunction (n=3), Cerebral bleeding (n=2)). DiscussionSeptic MOF and pump pocket infection were the main cause of death. The results of emergent re-exploration for debridement in case with pump pocket infection and emergent pump exchange in case with device malfunction were not so poor. We should improve our strategy infection control, especially sepsis.

109

P2B-5

The Heartmate II implantation for the patient with congenitally corrected transposition of the great arteries and situs inversus: a case report

Department of Cardiovascular and Thoracic Surgery, Hokkaido University Graduate School of Medicine, Japan

Tomonori Ooka, Tatsuya Seki, Yasushige Shingu, Hiroki Kato, Suguru Kubota, Yoshiro Matsui

[Background]The combination of congenitally corrected transposition of the great arteries(ccTGA) and situs inversus totalis(SI) is extremely rare. With advancing age, systemic right ventricle (sRV) failure would become refractory for optimal medical therapy including cardiac resynchronization therapy (CRT) and life-threatening problem, sometime requiring heart transplantation. [Case Pres-entation]A man in fifties with a diagnosis of ccTGA and SI developed severe congestive heart fail-ure refractory to intensive including beta-blockers, angiotensin-converting enzyme and CRT. Final-ly, he became catecholamine-dependent status and we decided to perform the implantation of the continuous flow left ventricular assist device (CFLVAD) as the bridge to transplantation. He under-went ventricular septal defect closure at the age of two years old and anatomical tricuspid valve re-placement with mechanical valve at age 32. The anatomical characteristics were as follows: the po-sitional relation of the great arteries, the distance between the sternum and the main pulmonary artery (mPA), the position of the apex of the sRV. Cardiovascular morphology was compatible with [I,D,D] segmental anatomy. The ascending aorta (Ao) connecting to the sRV located right to the mPA. The outflow graft must be anastomosed to the right aspect of the Ao because the sub-sternum space was too narrow to pass the outflow graft over the mPA. Considering these technical problems, we planned the implantation of a Heartmate II with up-side-down inverted outflow elbow. The op-eration was performed successfully and the postoperative course was uneventful without CFL-VAD-related problems including hemolysis. [Discussion]A few published reports of the implanta-tion of CFLVAD in ccTGA with or without SI were found. If the Ao would locate left to the mPA, Heartmate II could be placed in a mirror-image manner. [Conclusion]We have reported the success-ful implantation with some technical modifications of a Heartmate II in patient with ccTGA and SI.

110

P2B-6

Pneumopericardium can be a sign of the occurrence of a serious infection

1)Department of Cardiovascular Surgery, Kyushu University Hospital, Japan,2)Department of Cardiovascular Medicine, Kyushu University Hospital, Japan

Tomoki Ushijima1), Kazuto Hirayama1), Yoshihisa Tanoue1), Takeo Fujino2), Taiki Higo2), Hiroyuki Tsutsui2), Akira Shiose1)

Purpose:The purpose of this case report is to show that the existence of unusual air in pericardium (pneu-mopericardium) may indicate the occurrence of serious infection in patients on ventricular assist device. Case Report:The patient is a 69-year-old man, who underwent implantation of a HeartMate II (HM2) due to re-fractory heart failure associated with ischemic cardiomyopathy 1 year ago. After HM2 implantation, he suffered from the pump pocket infection and had been treated with antibiotics and surgical drain-age, but completely overcoming the infection was difficult. Nine months after the implantation, the follow-up computed tomography images revealed the existence of unusual air localized around the apical HM2 cuff. Some anaerobes species were found by local cultures. We guessed that the infec-tion would spread to peritoneum and peritoneal cavity. One year the after implantation, he had a sudden melena with fresh blood, for which he underwent a colon fiberscope, revealing that the HM2 strain relief of drainage conduit was found from the inside of transverse colon. He underwent an emergent laparoscopy assisted partial resection of the transverse-descending co-lon. The peritoneum was deficit beneath the HM2 pump, which penetrated to the transverse colon through hollowed-out peritoneum. Subsequently, the HM2 system was removed and hemodynamic support by IMPELLA 5.0 started aiming to getting over serious infection. Summary:Pneumopericardium can be a sign of a suspicious infection, and any infection should be considered as the differential diagnosis.

111

P2B-7

The transition of driveline and exit site management in patients with left ventricular assist device

1)Department of Cardiovascular Surgery, Satiama Medical Center, Jichi Medical University, Japan, 2)exMedio Inc., Tokyo, Japan,3)Department of Cardiology, Satiama Medical Center, Jichi Medical University, Japan

Mamoru Arakawa1), Sho Kusadokoro1), Tatsuro Ibe3), Shinichiro Monobe2), Masatoshi Takemura2), Hiroshi Wada3), Atsushi Yamaguchi1)

BackgroundDriveline exit site infection (DLI) has been a serious and common complication in long-term left ventricular assist device (LVAD) support. It has reported that the several methods might reduce mortality due to DLI. However, the incidence of DLI remains high. The purpose of this study was to review the transition of management of DLI.Methods We reviewed the medical record of the 11 patients who received LVAD in our institute from Ja-nuraly, 2008 to Januraly, 2018. Individual patients’ characteristics including, pump type and pur-pose of implantation were reviewed. In addition, outcomes including, incidence of DLI, causative bacteria for DLI and management for DLI were summarized in each patient. Then, the transition of driveline management was post prospectively reviewed. ResultsWe had implanted 13 pumps for 11 patients, including two bridge to bridge patients. Five pumps were heartmate II, one was EVAHEART and others were extracorporeal NIPRO LVAD. In the pa-tients with extracorporeal LVAD, three out of seven patients(43%) had DLI and, three patients out of six(50%) had DLI in the patients with implantable LVAD. Types of the causative bacteria were Methicillin-resistant Staphylococcus aureus in 3 patients(50%), Pseudomonas aeruginosa in 2 pa-tients(33%). In the patients with Heartmate II, the driveline was lead to left side frank based on double tunnel technique to increase the distance under skin. In two patients, repeated debridement with negative pressure wound therapy (NPWT) made new drive line exit site to make time for heart transplantation. Recently, we introduced the novel mobile application for DLI management to check patient driveline exit site frequently. Although a patient with extracorporeal LVAD died due to me-diastinitis, no patient died due to DLI in the patients with implantable LVAD.ConclusionsEven if incidence of DLI was not decreased, early intervention and repeated debridement with NPWT makes time for transplantation.

112

O7-Keynote

Dynamic movement of the magnetically levitated impeller during pulsatile operation

1) Ibaraki University, 2) Tokyo Metropolitan Geriatric Medical Center, 3) National Cerebral and Cardiovascular Center

Toru Masuzawa1), Shuya Shida1), Masahiro Osa1), Takashi Nishimura2), Eisuke Tatsumi3)

The blood compatibility of the blood pump is not still perfect even several types of the rotary blood pumps are available clinically. The magnetic bearing is a key technology to enhance the blood compatibility of devices. We have developed a magnetically levitated blood pump that is used ex-tracorporeally for acute heart disease patients to recover natural heart with several month’s support. The stability of the levitated impeller of the blood pump that is important for the safety driving of the device was investigated. The maglev centrifugal blood pump consists of an axial magnetic bearing, a synchronous motor and a levitated impeller set between the magnetic bearing and a motor stator in the axial direction. The axial position and inclination of the levitated impeller are regulated actively with the magnetic bear-ing, and the radial movement of the impeller is restricted by the passive stability. The levitated im-peller receives the fluid force during pumping and the radial position of the impeller moves dynam-ically. The radial position is determined by the balance between the radial fluid force and the restoring force produced by the magnet system.The radial movement of the levitated impeller during pulsatile operation in the mock circulation was observed by using laser displacement sensors and the effect of the spring constant of the mag-netic system was studied. The rotating speed was changed from 1200 rpm to 2400 rpm with a pul-satile rate of 60 beats/min. The magnitude of the fluid force and the impeller displacement from the pump center increase with increasing the rotating speed even the double volute mechanism is em-ployed. The displacement of the impeller decreases by increasing the spring constant of the magnet-ic system. It is useful information to confirm the maglev safety for not only our device but also other devices with the levitated impeller.

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O7-RF2

Tissue integration of a novel ventricular assist device cannula using advanced manufacturing

1)The Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Chermside, Qld, Australia,2)School of Chemistry, Physics and Mechanical Engineering, Queensland University of Technology, Brisbane, Australia,3)The University of Queensland, School of Dentistry, Herston, Qld, Australia,4)The University of Queensland, School of Medicine, St Lucia, Qld, Australia,5)Department of Mechanical and Aerospace Engineering, Monash University, Clayton, Vic, Australia

Nicole Bartnikowski1,2), Taryn Smith1), Michal Bartnikowski3), Eleonore Bolle1,2), Sam Liao1,2), John Fraser1,4), Shaun Gregory1,4,5)

BackgroundImplantation of ventricular assist devices requires an inflow cannula connected between the heart and the pump. Currently the standard method is to attach the inflow cannula via sutures, however a rapidly implantable suture-less inflow cannula (SLC) that can significantly reduce postoperative bleeding and surgery time has recently been developed. There is drive towards developing new technologies that promote permanent integration of the SLC with the endocardial tissue. This study aims to promote rapid tissue integration around the SLC cannula by covering the SLC with poly(ε-caprolactone) (PCL) scaffolds produced using melt-electrospinning writing (MEW). We also performed a range of surface modifications and tested their effects on cellular attachment and pro-liferation.

MethodsWe initially optimised the scaffold surface treatments by screening a wide range of exposures to two catalysts of PCL degradation, sodium hydroxide (NaOH) and hydrochloric acid (HCl). We as-sessed the effect of the treatments on surface charge, surface morphology, and mechanical proper-ties. We then evaluated the growth of human umbilical vein endothelial cells (HUVECs) on the scaffolds and analysed cell seeding efficiency and proliferation, cellular attachment, intercellular junction formation and cellular morphology.

ResultsWe found that HCl treatment did not increase surface charge, with limited surface morphological changes, while NaOH exposure resulted in dramatic increases in surface charge and morphology. Increased cellular attachment and proliferation was observed for scaffolds treated with NaOH, even after short treatment times (1h) when compared with HCl (4h) and untreated controls. Staining of intercellular junction markers demonstrated improved cellular morphology and cell-cell interactions for the NaOH groups.

ConclusionsWe overall demonstrated the feasibility of using MEW PCL scaffolds to aid tissue integration of the SLC. Furthermore, we demonstrated that the surface modification of PCL scaffolds using NaOH may be optimised to maximise cellular adhesion and proliferation, whilst maintaining the mechani-cal integrity of the scaffold.

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O7-RF3

Electrical Fields Modulate Endothelialization of Mechanical Circulatory Support Interfaces– An Electroceutical Strategy for Enhanced Hemocompatibility

1)Department of Biomedical Engineering, University of Arizona, Tucson, AZ, USA, 2)Department of Medicine, University of Arizona, Tucson, AZ, USA

Kaitlyn Rose Ammann1), Marvin J Slepian1,2)

Background/Purpose: Thrombosis of mechanical circulatory support (MCS) remains a major lim-itation leading to thromboembolic events including device malfunction, stroke and potential death. Current clinical strategies to limit thrombosis have been only partially effective, with recent phar-macologic mechanistic studies revealing the predominance of anti-thrombotic drugs in clinical use today have limited ability to limit shear-mediated platelet activation and thrombosis. Here, we uti-lize a new drug-free approach in an attempt to enhance thromboresistance via facilitated endothelial cell coverage of foreign biomaterial surfaces. We hypothesized that local application of DC electric fields (DCEF) – i.e. galvanotaxis, will direct and enhance endothelial cell (ECs) migration and sur-face coverage. In this study, we aim to define parameters of DCEFs as they relate to the directed growth of vascular ECs.Methods: A galvanotaxis chamber was specifically designed for exposing ECs to DCEFs. Saline solution and agar salt bridges mediated DCEF exposure to cell media and ECs. Prior to DCEF ap-plication, human umbilical vein endothelial cells (HUVECs) were seeded at 3 x 104 cells/ml for 4 hours in the chamber. DCEFs were then applied to the saline solution over a range of electric poten-tials (0 – 150 mV/cm). Time-lapse imaging was utilized to track cell movement over time (4 hours).Results: Vascular ECs were found to be responsive to galvanotaxis, with both migration direction-ality (i.e. alignment to the DCEFs) and cell displacement. Notably, an increase in DCEF magnitude led to a significant increase in EC displacement and increased directionality towards the cathode.Conclusion: Our findings suggest galvanotaxis may serve as an electroceutical alternative to drugs, facilitating and enhancing cell-based anti-thrombotic protection of MCS surfaces. Follow-on stud-ies are underway aimed at further translation of this approach to practically re-endothelialize blood-contacting surfaces of MCS and other implanted cardiovascular devices.

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O7-4

Development of a Micro Optical Thrombus Sensor for Multi-Point and Real-Time Monitoring in Mechanical Circulatory Support Devices

1)Advanced Manufacturing Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Tosu, Japan,2)Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Tsukuba, Japan

Nobutomo Morita1), Daisuke Sakota2), Kazuki Kondo2), Ryo Kosaka2), Masahiro Nishida2), Osamu Maruyama2), Wataru Iwasaki1)

Background/Purpose: In further development of mechanical circulatory support (MCS) devices, a micro-electro-mechanical system (MEMS) technology that can fabricate various small and high-sensitive sensors has a potential to achieve longer-term and safer management for patient safe-ty. The aim of this research is to develop a few-millimeter-sized micro optical thrombus sensor by applying MEMS technology for monitoring the thrombus formation in mechanical circulatory sup-port devices.Methods: We developed a 3 x 3 x 1.2 mm-sized micro optical thrombus sensor which equipped three different color LEDs (wavelength: 525 nm, 660 nm, and 855 nm), a photodiode (PD) and a signal amplification circuit. Oxygenated porcine blood which was anticoagulated by adding sodium citrate was circulated in a closed-loop heparin-coated extracorporeal circulation circuit by a rotary blood pump at 2880 rpm. We performed thrombus formation testing by gradually adding calcium chloride to reduce the activated clotting time (ACT) of the blood. The optical thrombus sensor at-tached to the pump continuously measured optical property of blood in the pump by sequentially il-luminating each LED in turn every 1 second, and detecting scattered light intensity for each light wavelength by its PD. Blood flow rate was monitored by ultrasonic flow meter. The testing was continued until the blood flow rate decreased over 20% due to suspected thrombus formation.Results: Decrease in blood flow rate associated with thrombus formation was observed 92 minutes after the start of the experiment, while the detected scattered light intensity for 855 nm was gradual-ly increased about 60 minutes after the start. No significant change was observed for both 525 nm and 660 nm light. After the experiment, thrombus formation in the blood pump was confirmed. Conclusions: We suggest that thrombus formation in the blood pump could be detected earlier than blood flow monitoring by the developed micro optical thrombus sensor.

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O7-5

Novel flow rate estimation method of a centrifugal blood pump using passive stabilization dynamics of magnetically levitated impeller

1)Graduate School of Science and Engineering, Ibaraki University, Japan,2)Department of Mechanical Engineering, Ibaraki University, Japan

Shuya Shida1), Toru Masuzawa2), Masahiro Osa2)

Background/PurposeFlow rate measurement in mechanical circulatory support devices (MCSDs) without additional flow sensors improve the quality of life of patient by controlling the circulation flow rate according to physiological demand. In this study, a flow estimation method using passively stabilized displace-ment of a magnetically levitated (Maglev) impeller was proposed, aiming to increase the resolution of flow estimation and to develop a reliable MCSD system for safer clinical use.Methods A Maglev impeller which was focused on in this study was axially suspended by magnetic bearing. A radial displacement of the Maglev impeller was restricted by passive stability and determined by the equilibrium of the radial magnetic restoring force and the radial hydraulic force exerted on the impeller. The radial hydraulic force varies according to a flow rate. Therefore, a radial displacement of the impeller can be correlated with a flow rate. To obtain the correlation, the relationships be-tween radial displacements of the Maglev impeller and pressure-flow characteristics of the pump were measured using laser displacement meters in a mock circulation loop. Effects of blood viscos-ity change on the proposed estimation method were investigated by using aqueous solutions of glycerol with various viscosities (2.31–4.21 mPa・s) as blood analogs.Results The displacements of the Maglev impeller corresponded uniquely to flow rate of the pump, and the relationships were formulated as linear equations with high determination coefficients of approxi-mately 0.99. An estimation resolution of 8.80 (L/min) / mm was obtained at a rotational speed of 2000 rpm. The resolution of the flow estimation varied by 4.1% with change in blood analog vis-cosity.Conclusions High correlation and resolution of flow rate estimation were achieved with the proposed method. The change of the resolution caused by a variation in viscosity was small compared with conven-tional methods.

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O7-6

The Effect of Transient Flow in Mechanical Circulatory Support

1)The University of Utah, USA, 2)INTEGRIS Health Medical Center, USA, 3)VADovations, Inc, USA

Ryan Stanfield1,3), Trevor Snyder2,3), Tony Vladovich3), James W. Long2,3)

The hydraulic performance of a rotary pump is graphically represented as a characteristic curve, also known as “H-Q” curve. “H” represents head pressure, and “Q” represents flow capacity. The shape or slope of a characteristic curve is heavily influenced by the pump design. The slope of an axial flow pump is typically steeper than that of a centrifugal pump. Typical “H-Q” curves reported in texts and academic literature is limited to steady-state pressure-flow conditions.

In this study, we explore the relationship between static and dynamic “H-Q” curves, or those that depict steady-state and transient (or cyclic) hydraulic performance. Three rotary blood pumps (RBPs) commonly used in clinical mechanical circulatory support (MCS) are examined under tran-sient conditions on an in vitro mock circulation loop. Pressure and flow data is recorded real-time at various pump speeds representing conditions of similar output under steady-state conditions.

Characteristic curves under transient conditions result in loops rather than lines for each device. Each device yields a unique set of hysteresis loops that graphically represent hydrodynamic perfor-mance. The loops from transient conditions typically only intersect the curves from steady-state conditions at two points. The operating conditions of RPBs analogous to the clinical environment have a much wider range than that predicted by steady-state settings.

Detailed examination of hydraulic performance of RBPs in dynamic conditions often shows fea-tures corresponding to the dicrotic notch, pulsatility index, and pressure sensitivity of pump de-signs. Thus, it is an incorrect assumption that as the head pressure of a rotary pump varies dynami-cally, the output flow will vary along the static “H-Q” curve. Design of RBPs for MCS require an understanding of hydrodynamic performance under transient conditions similar to those inherent to the native circulation. This is especially true when developing algorithms for computational analy-sis, physiologic control, flow estimation, or adverse event prediction.

118

O8-Keynote

Bridging to lung transplantation: Current status and challenges

1) Department of Thoracic Surgery, The University of Tokyo Hospital, Japan, 2) Department of Therapeutic Strategy for Heart Failure, The University of Tokyo Hospital, Japan, 3) Department of Surgical Intensive Care Medicine, Nippon Medical School Hospital, Japan, 4) Department of Cardiac Surgery, The University of Tokyo Hospital, Japan

Masaki Anraku1), Masaru Hatano2), Shingo Ichiba3), Minoru Ono4), Jun Nakajima1)

There has been an increasing demand of organs for lung transplantation to save those who are suf-fered from end-stage lung disease However, the number of organ donations have never matched that of candidate recipients. Many efforts have been made to solve this urgent problem; including the utilization of the so-called “marginal lungs” for transplantation, accepting organs donated after cardiac death, and ex-vivo lung perfusion after the retrieval of the lungs for functional recovery. Besides, these donor-side attempts, one potential approach is to develop an artificial gas-exchange device that can replace the impaired lung function of the recipients until the time of transplantation. To date, some experienced transplant centers have tried using membrane lungs for bridging to lung transplantation on a case-by-case basis. However, extracorporeal lung support therapy using cur-rently available membrane lungs and cannulas have challenges yet to be overcome, including mem-brane durability, the bleeding from anticoagulation, blood clotting, and so on.To this end, we’ve started to develop a gas-exchange system that consists of silicone-based mem-brane lungs with a new anti-thrombotic polymer coating and tubing system that can safely support patients for a longer period of time.Our goal is to offer more opportunities and safer surgical interventions to those who are waiting for lung transplantation. We have built a multi-disciplinary team for this project including medical en-gineers, lung and heart transplant surgeons, a cardiologist, an intensivist, and medical companies to achieve our goal.

119

O8-RF2

Physiological responses of the circulation during ECLS A training simulator.

Department of Biomedical Engineering, TU Eindhoven, The Netherlands

Marcel CM Rutten, Maaike van Oorschot, Tilai T Rosalina, Ken MM Peeters, Frans N van de Vosse

Veno-arterial extracorporeal life support (ECLS) has become an important therapy in acute and re-fractory cardiogenic shock. ECLS implantation is straightforward, allowing instantaneous and com-plete circulatory and respiratory support. This makes ECLS an attractive and versatile ‘bridging’ device to cardiac recovery, long-term support, or transplantation. Tuning of an ECLS device is te-dious, because of the large number of possibly inconclusive patient-specific monitoring data in-volved. Models can give a physiology-based interpretation of this complex information instantane-ously. To help clinicians develop the skills required for optimizing the treatment of these patients, a simulator was built, capable of mimicking the physiological responses (blood pressure, heart rate, oxygenation levels) to ECLS and administration of intravenous fluid.

The simulator consists of a mock circulatory system comprising the complete human circulation, and is built in such a way that venous and arterial cannulae can be inserted at will, thus mimicking ECLS with a real support device. Besides the standard Frank-Starling mechanism, models for blood volume control, heart rate, salt balance and oxygenation levels of various organs including the brain have been implemented in the driving software, so as to mimic a patient's vital functions as closely as possible. Long-term control mechanisms such as venous volume control have been accelerated to enable a quick response to changes in support level.

The simulator has been tested with a Maquet Cardiohelp ECLS system in a standard VA-ECMO configuration. The responses are reported in real time and are in good agreement with clinical ob-servations. The system is capable of mimicking a variety of patients under ECLS support, and gives nearly instantaneous feedback to the operator, leading to a better understanding of the effects of changing various support parameters, in a safe environment, without any patient risk.

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O8-RF3

Evaluation of Microcirculation in Patients on Extracorporeal Membrane Oxygenation (proECMO Study): Pilot Study in 5 Patients

1)Cleveland Clinic, Cleveland, OH, USA,2)New York University Langone Health, New York, NY, USA,3)Massachusetts General Hospital, Boston, MA, USA,4)Oslo University Hospital, Oslo, Norway

Takuma Miyamoto1), Jamshid H Karimov1), Balaram Anandamurthy1), Mariya Geube1), Michael Z Tong1), Nader Moazami2), David A D'Alessandro3), Sumner Eaton Kilmax3), Knut Kvernebo4), Van Tran4), Kiyotaka Fukamachi1)

Propose: Maintaining microvascular perfusion may be key to successful weaning from extracor-poreal membrane oxygenation (ECMO). In this study, we evaluated the microcirculation in patients on venoarterial ECMO. Methods: Skin microvascular examinations were done on the dorsum of the hand via computer-assisted video microscopy (CAVM) in 5 male patients (ages 52-80, mean 65). De-identified data files were sent for blind analysis to the core laboratory (Circulation lab, Oslo University Hospital). Functional capillary density (FCD) was assessed visually and expressed as number of microvascular loops/mm2. Capillary flow velocities (CFV) in 6 categories (0: No flow, 1: Sluggish, 2: Slow, 3: Continuous, 4: Rapid, 5: Brisk) were assessed in terms of heterogeneity (nor-mal microvascular circulation shows 90% in category 3). Results: Indications for ECMO were postcardiotomy shock (2), cardiac arrest (1), myocarditis (1), and complication during percutaneous coronary intervention (type A acute aortic dissection) (1). Mean ECMO support duration was 6.8 ± 4.7 days. During support, 1 patient had an ascending aorta replacement. Overall, 3 patients (60%) were weaned from ECMO, 1 received a heart transplant, and 1 died while on ECMO. By CAVM analysis, the two who could not be weaned off ECMO showed dysregulation of microcirculation (flow mainly in categories 0 and 5), with FCD of 37.3 ± 15.0 loops/mm2. Two patients were weaned off ECMO, showing preserved microcirculation (flow mainly in categories 2, 3, and 4) and dysreg-ulation of microcirculation in 1 patient; FCD was 65.8 ± 28.3 loops/mm2. Conclusion: Maintaining regulation of microvascular perfusion could be key to successful weaning from ECMO in patients in acute heart failure. As this pilot study included only 5 subjects, this hypothesis will need to be confirmed in a much larger number of patients.

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O8-4

Long-term in vivo testing of extracorporeal membrane oxygenation via the pulmonary artery to the left atrium as a bridge to lung transplantation

1)Department of Thoracic Surgery, The University of Tokyo, Japan, 2)Department of Healthcare Safety Management, The University of Tokyo, Japan, 3)Department of Biomedical Engineering, The University of Tokyo, Japan, 4)Niigata University of Health and Welfare, Japan, 5)Department of Cardiac Surgery, The University of Tokyo, Japan

Kento J. Fukumoto1), Masaki Anraku1,2), Shintaro Hara2), Takashi Isoyama3), Toshiya Ono3), Yutaka Fujii1,4), Keita Nakao1), Minoru Ono5), Jun Nakajima1)

Background/Purpose:Extracorporeal membrane oxygenation (ECMO) has been reported as a bridge to lung transplanta-tion for a few days to weeks but is not sufficient to support patients with end-stage lung disease in the long term, unlike ventricular assist device in heart failure and renal replacement therapy in chronic kidney disease. In addition, the waiting time is long (2.5 years on average) for lung trans-plantation in Japan. Taking these issues into account, a durable bridging ECMO that can be used for months to years is needed. This study evaluated the safety and validity of the surgical technique and configuration of bridging ECMO in a long-term animal model.

Methods:The ECMO system (CAPIOX®EBS®“EMERSAVE®”; TERUMO, Tokyo, Japan) was attached be-tween the pulmonary artery (PA) and the left atrium (LA) in five goats. An ECMO flow rate of 2 L/min was maintained while the centrifugal pump was kept at 1,000 to 1,500 rpm. In one goat, intra-venous heparin was administered continuously to maintain an activated clotting time (ACT) of 150-200 seconds. Arterial pressure (AP), PA pressure (PAP), LA pressure, and PA flow rate were contin-uously monitored.

Results:In two goats, surgery and long-term postoperative monitoring were performed without significant problems. One goat survived for 16 days. On necropsy inspection, no visual clot was found around the site where ECMO conduits were connected. One goat survived for 40 days and has been in a stable condition (mean AP, 112 ± 18.5 mm Hg; mean PAP, 13 ± 5.9 mm Hg). The PA flow rate was 4.8 L/min on average.

Conclusions:Directly anastomosed PA-to-LA ECMO is considered a safe and feasible configuration as a long-term bridge to lung transplantation. In the future, we will test the durability and antithrombogenici-ty of our currently developed novel artificial lung in this animal model.

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O8-5

A model of the pathological circulation under ECLS support

Department of Biomedical Engineering, TU Eindhoven, The Netherlands

Marcel CM Rutten, Arjet HM Nievergeld, Frans N van de Vosse

Extra-corporeal life support (ECLS) is quickly gaining popularity among cardiologists/intensivists. Its major purpose, maintaining the circulation, is well established. The complexity of some patient cases, however, is such that sometimes it is hard to predict efficacy and development of the patients' condition over even relatively short periods of time. In these cases, a predictive model, describing the patient's pathophysiology in combination with ECLS may be useful.

In this study, we present a lumped parameter model of the full circulation (systemic and pulmo-nary), supported with an ECLS system, and the main circulatory autoregulation mechanisms in-volved. As a pump/oxygenator, we determined the pressure/flow characteristics of the Maquet Car-diohelp, and implemented this device as being a steady flow pump. The model further comprises both the left and right heart including the Frank-Starling mechanism, the lungs and their oxygena-tion function, and oxygen and/or carbon dioxide saturation-driven flow control through various or-gans, especially the brain and the heart. As a first case, the model implemented a typical VA-ECMO configuration, with the pump having an averaged output of 4L/min. The patient was modelled as having a cardiogenic shock, in combination with poor lung function.

The results indicate a decrease in end-diastolic left-ventricular volume when ECLS is applied, due to the lowered filling pressure. Poor lung function leads to increased cerebral perfusion, which is normalized with ECLS. A combination of poor functioning of both heart and lungs leads to dimin-ished peripheral perfusion, preserving vital organs such as heart and brain. Similarly, flow condi-tions are normalized with ECLS, at the cost of poor ventricular filling.

The model has been shown to describe typical clinical observations well. For clinical use, it will be extended with a continuous paramter estimation algorithm, to assess patient characteristics in paral-lel with the monitoring of vital data in the ICU.

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O8-6

Development Of A Compact ECMO System Consisting Of A Centrifugal Pump With Hydrodynamic Bearings And Long-term Evaluation In Animal Experiments

Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Japan

Nobumasa Katagiri, Yoshiaki Takewa, Tomonori Tsukiya, Toshihide Mizuno, Eisuke Tatsumi

BACKGROUND/PURPOSE: ECMO system has been used for over days to weeks to treat pa-tients with severe respiratory/circulatory failure, while its poor durability and thrombo-resistant property are still risks in long-term use. In addition, lack of portability and operability due to com-plicated apparatus are also problematic issues. We have been developing a compact durable ECMO system which can solve these problems. In this study, we developed a prototype of a compact ECMO system with disposable tiny centrifugal pump using hydrodynamic bearings and evaluated its durability and biocompatibility in a series of chronic animal experiments.METHODS: A circuit unit of this ECMO system consists of a novel disposable centrifugal blood pump (BIOFLOAT-NCVC) with hydrodynamically levitated impeller, a compact oxygenator (BIO-CUBE6000) with polymethylpentene membrane and built-in sensor connectors. The entire blood-contacting surface of the circuit was treated with potent heparin bonding material (T-NCVC). A pump motor and measurement instruments were integrated into a driver unit with extremely com-pact size (W290 x D205 x H260 mm) and lightweight (6.6 kg). Veno-arterial bypass ECMO was conducted for over 4 weeks using adult goats (48.0, 49.5, 49.0 kg). Heparin was continuously ad-ministrated to control ACT between 150-200 sec.RESULTS: In all cases, the ECMO could run for 28 days without any device exchange and moni-tored stably. Pressure drops of the oxygenator were 20.1 ± 1.8, 16.5 ± 1.6 and 16.0 ± 1.5 mmHg, and showed no tendency of increase. Average pump rotational speed to achieve at 2.5 L/min of by-pass flow rate were 4496 ± 159, 4592 ± 253 and 5041 ± 356 rpm, respectively. After the experi-ments, thrombus formation was hardly observed in the each blood circuits including the built-in sensor connectors.CONCLUSIONS: The ultra compact ECMO system was developed and demonstrated long-term durability, stability of monitor function and thrombo-resistant property for 4 weeks.

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O9-Keynote

Pedatric Ventricular Assist Device

Pediatric Hospital Bambino Gesù, Rome, Italy

Antonio Amodeo

End-stage hheart failure is a complex pathophysiological syndrome that can occur in children from a variety of diseases. While heart transplantation continues to be the mainstay for treatment of end-stage heart failure, this mode of therapy is severely limited by pediatric donor organ availability. Ventricular assist devices (VADs) have taken an increasingly important role in the management of advanced heart failure in children. Berlin Heart (BH) EXCOR Pediatric ventricular assist device is the only available VAD for infants and small children. This has been a frustrating reality, particular-ly given the fact that the Berlin Heart device was developed over 20 years ago. The current genera-tion of continuous- flow (CF) devices for adult has become popular in children in the last years with an overall outcome of pediatric patients supported on these devices is excellent with 92% favorable outcome at 6 months. In case of biventricular dysfunction, the only option is Bi Vad Berlin Heart for infants and small children. The Total artificial heart (Syncardia) has now developed a 50 cc pump which can be utilized for children (10-18 years). In the near future, the Infant Jarvik 2015 probably will be adopted for infants from 8 to 20 kg with the clinical trial starting in Usa and Eu-rope in 2018. There are also several other devices on the horizon, although it will be several more years before clinical trials are underway to evaluate the safety and efficacy of these devices

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O9-2

Current status of temporally ventricular assist device support for acute fulminant myocarditis in pediatric patients

Department of Cardiaovascular Surgery, Osaka University Graduated School of Medicine, Japan

Tomomitsu Kanaya, Takayoshi Uno, Mask Taira, Takashi Kids, Naomi Okuda, Kanta Araki, Takuji Watanabe, Chichi Toda, Toru Kuratani, Yoshiko Sawa

Introduction: Acute fulminant myocarditis (AFM) is a life-threatening and rapidly progressive dis-ease with cardiogenic shock. Although the emergent introduction of peripheral extracorporeal mem-brane oxygenation (p-ECMO) for the treatment of AFM should be needed in severe circulating fail-ure, there are some complications such as lower limbs ischemia, pulmonary congestion, and low cerebral perfusion especially in pediatric patients. It should be needed to consult a specialized center where temporal ventricular assist device (tVAD) can be used as soon as possible. We re-vealed the clinical outcomes of AFM in pediatric patients in our institution.Patients: Eight patients with diagnosed of AFM in the past 5 years were found and analyzed. Medi-an age was 11 (range: 2-16) years; Median body surface area was 1.26 (range: 0.6-1.51) m2. Five patients were transported from a previous hospital to our hospital.Results: p-ECMO was used with 7 of 8 patients at first but these all converted to tVAD. For the reasons of converting to tVAD, there were 7 cases of progressive pulmonary congestion and 2 cases of severe lower limbs ischemia. The median duration to convert from p-ECMO to tVAD was 8 (range: 3-60) hours. All patients needed left ventricular venting from the apex and 5 patients needed right-sided circulation support. Three patients (38 %) including two of the brain dead in acute phase died and all deaths were secondary to neurologic complications. Two patients were removed tVAD, 1 patient successfully underwent heart transplantation, and 2 patients have been on the implantable VAD. Conclusion: Using p-ECMO for pediatric patients had possibility of severe complications such as severe lower limbs ischemia and pulmonary congestion. When sudden cardiogenic shock occurs and AFM is suspected, the prompt transportation to a specialized center where tVAD can be used is important for life saving and reducing complications of AFM in pediatric patients.

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O9-3

von Willebrand Factor activity:antigen ratio is a poor surrogate for multimer analysis in the detection of acquired VWS among children on ECLS devices

1)Department of Pathology & Immunology,2)Department of Pediatrics,3)Baylor College of Medicine,4)Department of Medicine,5)Texas Children's Hospital, USA

Shiu-Ki Rocky Hui1,2,3,5), Lisa Hensch1,3,5), Karen Bruzdoski1,5), Vadim Kostousov1,3,5), Teruya Jun1,2,3,4,5)

Background/Purpose: The association of acquired von Willebrand syndrome (AVWS) in the set-ting of extracorporeal circulatory life support (ECLS) devices [TJ1] is well established. The gold standard for diagnosis of AVWS is von Willebrand factor (vWF) multimer analysis (MA) which is not readily available in most institutions. The aim of our study was to determine the utility of vWF activity:antigen ratio (ratio: ref. range 0.7-1.1) as a surrogate marker for AVWS in patients on ECLS devices.Methods: A retrospective review of ECLS patients with vWF testing between 2015-18 was per-formed. vWF results with concurrent MA were obtained from the electronic medical record. Statis-tical analysis was performed using MS Excel 2010.Results: Sixty-four ECLS (30 LVAD; 34 ECMO) patients (25 females) ranging in age from 0 days to 26 years were identified with 118 instances of vWF testing and concurrent MA. AVWS was iden-tified in 95.8% via MA versus only 64.4% identified as consistent with AVWS using a ratio cutoff of < 0.7. This ratio cutoff for AVWS diagnosis has a positive predictive value of 98.7% but negative predictive value of only 12.1%. In addition, for LVAD patients, ratio shows poor correlation with high molecular weight multimer loss (R=0.29) versus ECMO patients who showed a better correla-tion (R=0.66).Conclusions: MA remains the gold standard for diagnosis of AVWS among ECLS patients as the commonly used Ratio cut-off of < 0.7 for diagnosis of type 2 von Willebrand disease will miss a large number of AVWS. In addition, for LVAD patients, ratio is an especially poor predictor of the degree of vWF multimer loss. As the prevalence of AVWS among ECLS patients is high, AVWS should be considered even when ratio is within normal reference range.

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O9-4

Total Artificial Heart for Pediatric Population: Cleveland Clinic Device Update


Jamshid Karimov1), David Horvath2), Barry Kuban1), Nicole Byram1), Shengqiang Gao1), Takuma Miyamoto1), Hani Najm1), Kiyotaka Fukamachi1)

BACKGROUND/PURPOSE: Heart transplantation in small patients (infants and children) is cur-rently an accepted clinical therapy for congenital heart disease (CHD), but donor organ availability will continue to remain limited. Mechanical circulatory support is another standard option, but is limited due to implantable device size and functional range. At Cleveland Clinic, we are developing pediatric continuous-flow total artificial heart (P-CFTAH) in attempt to provide the population of pediatric patients with mechanical circulatory alternative to transplantation.

METHOD: The Cleveland Clinic P-CFTAH is a miniaturized double-ended centrifugal pump that is designed to passively self-balance left and right circulations without electronic intervention. The nominal external dimensions of the P-CFTAH (pediatric configuration) tested in vivo were 70 mm (length), 43 mm (diameter), 58 cc (volume displacement) (Fig. 1). Device undergoing optimizations and design changes that will be presented.

RESULTS: Device implantation showed good anatomical fit and easy implantation (n=4). The dif-ference between the left and right atrial pressures was maintained within ± 5 mm Hg with a wide range of SVR/PVR ratio. Speed-modulation allowed creating arterial pulsation with this device.

CONCLUSION: Our early experience with P-CFTAH met the proposed requirements for self-reg-ulation, performance and pulse modulation. Additional research into the physiological mechanisms of this pediatric device and related pump design improvements is part of our current long-term strategy.


1

For symposium presentation: “MCS for pediatric patients” Total Artificial Heart for Pediatric Population: Cleveland Clinic Device Update Jamshid H. Karimov1, David Horvath2, Barry Kuban1, Nicole Byram1, Shengqiang Gao1, Takuma Miyamoto1, Hani Najm,1 Kiyotaka Fukamachi1

1Cleveland Clinic, Cleveland, Ohio, USA. 2R1 Engineering, LLC, Euclid, Ohio, USA BACKGROUND/PURPOSE: Heart transplantation in small patients (infants and children) is currently an accepted clinical therapy for congenital heart disease (CHD), but donor organ availability will continue to remain limited. Mechanical circulatory support is another standard option, but is limited due to implantable device size and functional range. At Cleveland Clinic, we are developing pediatric continuous-flow total artificial heart (P-CFTAH) in attempt to provide the population of pediatric patients with mechanical circulatory alternative to transplantation. METHOD: The Cleveland Clinic P-CFTAH is a miniaturized double-ended centrifugal pump that is designed to passively self-balance left and right circulations without electronic intervention. The nominal external dimensions of the P-CFTAH (pediatric configuration) tested in vivo were 70 mm (length), 43 mm (diameter), 58 cc (volume displacement) (Fig. 1). Device undergoing optimizations and design changes that will be presented. RESULTS: Device implantation showed good anatomical fit and easy implantation (n=4). The difference between the left and right atrial pressures was maintained within ± 5 mm Hg with a wide range of SVR/PVR ratio. Speed-modulation allowed creating arterial pulsation with this device. CONCLUSION: Our early experience with P-CFTAH met the proposed requirements for self-regulation, performance and pulse modulation. Additional research into the physiological mechanisms of this pediatric device and related pump design improvements is part of our current long-term strategy. Fig.1. The Cleveland Clinic P-CFTAH (driveline concealed).

128

O9-5

Implantable ventricular assist device for patients younger than 18 years

1)Department of Cardiac Surgery, The University of Tokyo, Japan,2)Department of Cardiovascular Medicine, The University of Tokyo, Japan

Kan Nawata1), Osamu Kinoshita1), Mitsutoshi Kimura1), Haruo Yamauchi1), Shogo Shimada1), Sachito Minegishi1), Hyoe Komae1), Yasuhiro Hoshino1), Masaru Hatano2), Eisuke Amiya2), Minoru Ono1)

BACKGROUNDIn Japan, ventricular assist device (VAD) is of great importance as a treatment of severe heart fail-ure patients, because of extreme shortage of organ donors. On the other hand, Japan has a rule for heart from brain dead donor younger than 18 years old are preferentially offered to recipient candi-date younger than 18 years old, which means the support time of patients younger than 18 years old by VADs tends to be shorter in those patients. METHODSHere we examined 6 cases at the age younger than 18 years who had an implantable VAD installed between 2012 and 2017 at the University of Tokyo Hospital.RESULTSThe average age was 15.2 years (11-17), the average body weight was 55 kg (32-72) and the aver-age body height was 167 cm (148-182) with the average body surface area of 1.61 (1.17-1.93). Five out of six were male, and their background diseases of heart failure were dilated cardiomyopathy in 5 and dilated phase hypertrophic cardiomyopathy in a patient. Three patients were in the heart fail-ure status of INTERMACS Profile 2, and the other three were in INTERMACS Profile 3. Two pa-tients had EVAHEART, two had HeartMate II, and the other two had Jarvik 2000. All of them reached heart transplantation after the VAD support of average 989 days (271-1399). CONCLUSIONEven smaller patients younger than eighteen years with small body surface area can have a suitable implantable VAD in their body and enjoy being supported until heart transplantation.

129

O10-1

Successful Heart Transplant after Sixteen-hour ex-vivo donor heart perfusion during long distance transportation


Zhuldyz Nurmykhametova, Rymbay Kaliyev, Serik Bekbossynov, Yuriy Pya

Background We report a case of successful heart transplantation following an ex-vivo allograft perfusion time of 955 minutes into a recipient with dilated cardiomyopathy and previously implant-ed left ventricular assist device implant.Patient The patient was on LVAD support as a bridge to transplantation. Patient’s clinical status was complicated by drive line infection influenced his necessitating urgent heart transplantation.Results The patient underwent successful heart transplantation, requiring central veno-arterial ECMO support for the first 44 hours. The recipient is over 6 months post-transplant with no evi-dence of rejection or cardiac dysfunction.Conclusion We report the longest ex-vivo allograft perfusion time for a successful human cardiac transplant to be added to a global learning curve of long runs using OCS.

130

O10-2

Sarcopenia as a predictor of mortality in Japanese patients undergoing left ventricular assist device implantation

1)Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Japan,2)Department of Therapeutic Strategy for Heart Failure, The University of Tokyo, Japan, 3)Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Japan

Masaki Tsuji1), Eisuke Amiya1), Masaru Hatano1,2), Mitsutoshi Kimura3), Osamu Kinoshita3), Kan Nawata3), Hiroyuki Morita1), Minoru Ono3), Issei Komuro1)

Background: We assessed preoperative sarcopenia in patients undergoing left ventricle assist de-vice (LVAD) implantations using abdominal skeletal muscle images on computed tomography (CT) and explored the associations between the preoperative sarcopenia and clinical outcomes after LVAD implantation.

Methods and Results: We retrospectively examined the records of 111 patients who underwent continuous-flow LVAD implantations as bridge-to-transplant therapy from January 2010 to Decem-ber 2016 at our institution. After excluding 33 patients, the study cohort consisted of 78 individuals. CT images used to calculate the skeletal muscle index (SMI) at the third lumbar vertebra level were obtained before the LVAD implantation procedures. Patients were classified as having sarcopenia if their SMI fell into the lowest gender-based tertile. The median SMI for the study patients was 37.6 cm2/m2. The SMI cutoff values for the lowest tertiles were 36.7 cm2/m2 for men and 28.2 cm2/m2 for women, resulting in 26 patients (33.3%) with sarcopenia in this study. During the mean follow-up of 738 ± 379 days, there were 10 deaths (12.8% mortality). Seven of the 26 patients with sarcopenia (26.9%) died, and 3 of the 52 patients without sarcopenia (5.8%) died. The times to all-cause mor-tality were significantly different between patients with and without sarcopenia (p = 0.0094). Sarco-penia was found to be associated with mortality in univariate and multivariate Cox analyses.

Conclusions: Preoperative sarcopenia was associated with a higher mortality in patients with LVAD. Assessment of the abdominal skeletal muscle area on CT prior to LVAD implantation can help predict mortality.

131

O10-3

Long-term outcome of HVAD left ventricular assist device – single center experience in Japan

Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Japan

Yuji Sakashita, Koichi Toda, Shigeru Miyagawa, Yasushi Yoshikawa, Daisuke Yoshioka, Satoshi Kainuma, Shohei Yoshida, Yoshiki Sawa

Background/Purpose We report the clinical experiences of long-term HVADR support in Japan.Methods 17 patients (11 males, 6 females; including 5 pediatric patients, in which body surface area (BSA) ranged from 0.76 to 1.92 m2) underwent the HVAD implantation as a bridge to transplantation be-tween 2011 to 2017. Ten had dilated cardiomyopathy, four secondary cardiomyopathy, two dilated phase hypertrophic cardiomyopathy and one restrictive cardiomyopathy. All patients underwent HVAD implantation via median sternotomy. Results Two patients required a right ventricular assist device (RVAD), and one was weaned from RVAD on postoperative day 20, but another required permanent RVAD implantation using HVAD. One pa-tient required pump exchange due to foreign tissue in the inflow cannula immediately after surgery. Mean support duration was 750 ± 428 days and the longest support duration was 1359 days. Nine patients successfully bridged to heart transplantation, and two patients died during support and 3 years survival on VAD was 86%. Four patients suffered from driveline infection and 2 required conversion to other devices including paracorporeal LVAD and Jarvik 2000 before transplant. Four patients suffered from a cerebral hemorrhage and one died. There was no mechanical failure in the pump.Conclusions Our single center experiences demonstrated that HVAD could be used in the variety of patients for long period of time and suggested that HVAD could be an important option for small Japanese pa-tients who require long-term circulatory support.

132

O10-4

Is it possible to insert the cannula into the left ventricle from outside of the human body for the VAD implant?

Tohoku University, Japan

Tomoyuki Yambe, Yasuyuki Shiraishi, Yusuke Inoue, Akihiro Yamada

The consiousness will be lost within 10-15 seconds after cardiac arrest, and brain tissue will not be able to be recovered after 3-4 minites after the stop of the systemic circulation. Early recovery of the circulation as soon as possible will be needed in the emergency cases. However, implantation of the Ventricular assist device needed a lot of time for the procedure. If the implantion witin 3 minites will be embodied, this device will be useful for the emergency room.New left ventricular assist device, which will be able to start the assist within three minites, by the direct puncture of the leftventricle and direct puncture of the femoral artery was invented in this study.During cardiac massage, echocardiography will be smoothly attached to the chest wall, and check the position of the both ventricle. And direct puncture of the left ventricle form outside of the body will be tried, and the other doctor will try the puncture of the femoral artery during the prodcedure.Experienced cardiologist will be able to be insert the both cannulae within 3 minutes, which was the limitation of the brain damage.By the use of the healthy adult goats, direct puncture of the left ventricule with sheeth catheter and dilator was tried in this invention.As the results, smooth approache to the left ventricule with less bleeding was observed and left pump flow was observed using magnetic driven newly developed pump.This pump system is so small so that it will be able to be inserted under the skin after tha start of the LVAD, and the pump sill be driven from outside of the body by magnetic power.This system will be useful for the emergency room.

133

O10-5

Aorta - VAD Outflow Graft Anastomosis Angle Significantly Impacts MCS Prothrombosis – in vitro Validation of in silico DTE Predictions

1)Department of Biomedical Engineering, The University of Arizona, Tucson, AZ, USA, 2)Department of Medicine Sarver Heart Center, The University of Arizona, Tucson, AZ, USA, 3)Department of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA

Ryan Walk1), Daniel Palomares1), Yana Roka Moiia1,2), Jawaad Sheriff3), Danny Bluestein3), Marvin J. Slepian1,2,3)

Background: New ventricular assist device (VAD) designs have resulted in reductions in VAD thrombosis. Despite this, thromboembolic events remain significant adverse events of mechanical circulatory support (MCS) therapy. Therefore, it is important to consider MCS as a “system thera-py,” involving multiple components which may contribute to overall pro-thrombotic potential. In prior work we demonstrated, using Device Thrombogenicity Emulation (DTE), that the angle of the aorta-VAD outflow graft anastomosis may significantly contribute to pathologic flow and shear leading to shear-mediated platelet activation (SMPA). Here we sought to confirm our in-silico pre-dictions utilizing an in vitro flow loop system.

Methods: An in-vitro flow loop system was assembled (HeartAssist V and ½” diameter Tygon non-thrombogenic tubing). Aorta-VAD outflow graft anastomosis angles of 60 and 90 degrees were created through tubing heat-molding. Human platelets were circulated for 60 minutes, samples were collected at 2, 5, 10, 30, and 60 minutes. Platelet procoagulant activity, an indicator of SMPA and system thrombogenicity, was assessed by chromogenic platelet activation state (PAS) assay. Flow cytometry was performed to detect FITC-conjugated annexin V binding, which is proportional to phosphatidylserine externalization levels.

Results: Platelet annexin V binding and procoagulant activity exponentially increased with the time of platelet circulation. The PAS assay after 60 minutes circulation showed platelet activation in-creased 6.4x in a 90 degree set-up, as compared to only 3.7x with 60 degrees (n = 5, ANOVA, p < 0.05). Annexin V binding showed similar results: the annexin V positive platelet population was el-evated 19x in a 90 degree system, but only 11.5x in a 60 degree set-up.

Conclusion: Our results confirm, validate, and reinforce the utility of the DTE predictive approach. Further our results emphasize the importance of the “system concept” for MCS, in which each com-ponent must be considered critically as to its overall contribution to thrombogenicity.

134

O11-Keynote

Development of a clinically-relevant thrombogenicity testing method of an inflow cannula at the interface with left ventricle: Contribution to the approval of titanium-mesh in flow cannula of EVAHEART without clinical trial

1) Cooperative Major in Advanced Biomedical Sciences, Tokyo Women’s Medical University Waseda University Joint Graduate School, Waseda University, 2) Department of Bioscience and Biomedical Engineering, Waseda University, 3) Department of Cardiovascular Surgery, Hokkaido Cardiovascular Hospital

Kiyotaka Iwasaki1,2), Kenji Yamazaki3), Yuki Matsuhashi1,2), Azuma Takahashi2), Mayuki Hirata2), Mitsuho Umezu1,2)

Background: Thrombus formation at the interface between the inflow cannula of LVAD and left ventricular wall is an unsolved issue inducing adverse events. We have developed a novel clinically-relevant pulsatile blood flow and pressure circulation system for thrombogenicity testing of LVAD. We here show the thrombogenicity study of the titanium-meshed exterior surface of the in-flow cannula (M-cannula) of EVAHEART LVAD to assess potential safety and efficacy in compari-son with the smooth surface cannula (S-cannula) in terms of thrombus detachment in acute phase.Method: The test circuit consisted of a left ventricular model, two valves, elastic atrial and aortic tubes, a resistance, and an EVAHEART® LVAD (Sun Medical Technology Research Co., Japan). In each thrombogenicity test, two identical circuits except for the cannula were prepared for compara-tive study. A heparinized single porcine blood with activated clotting time of 250-270 sec was cir-culated for 4.5 hours. The tests were performed under the combinations of the total flow rate of 4 L/min and 5 L/min, and the pump rotational speed of 1800 rpm, 1850-1900 rpm, 1950-2000 rpm, re-spectively, in totally 6 conditions. Result: Pressure and flow waveforms in severe heart failure patients incorporating a LVAD were successfully reproduced. Quantitative assessment of thrombus volume detached from the cannula into the circuit revealed that the M-cannula exhibited significantly lower amount of thrombus de-tachment compared with the S-cannula (P<0.01, n=6, Student’s T test). Conclusion: A novel thrombogenicity testing method to investigate the risk of thrombus formation and its detachment from the inflow cannula of LVAD in the acute phase was successfully devel-oped. The data contributed to the approval of the titanium-mesh inflow cannula for EVAHEART without additional clinical trial in Japan and the novel thrombogenicity testing method was pub-lished as the pre-approval testing method to promote device development from MHLW.

135

O11-2

CONTINUOUS-FLOW LVAD SUPPORT ALTERS MULTIPLE ANGIOGENIC SIGNALING PEPTIDES

Division of Cardiovascular Surgery, Hospital of The University of Pennsylvania, USA

Samson Hennessy-Strahs, Pavan Atluri, Christian A Bermudez, Michael A Acker, Carlo R Bartoli

BACKGROUND: Emerging data suggests that continuous-flow left ventricular assist device (LVAD) support alters systemic angiogenic signaling and contributes to mucosal angiodysplasia in LVAD patients. In a preliminary study, we investigated plasma levels of angiogenic signaling pep-tides in patients with a continuous-flow LVAD.

METHODS: Paired whole blood samples were obtained from continuous-flow LVAD patients (n=12) prior to LVAD implantation and after three months of support. Angiogenic signaling pep-tides (n=60) were quantified via fluorescent, sandwich-based protein microarray prior to LVAD im-plantation and during LVAD support.

RESULTS: Compared to pre-LVAD baseline, LVAD support increased pro-angiogenic peptides an-giopoietin-like 4 (9.4±2.3 vs. 16.5±4.0 ng/ml, p=0.03), CCL5 (1.7±0.1 vs. 2.0±0.1 ng/ml, p=0.03), CXCL16 (959±133 vs. 1042±133 pg/ml, p=0.06), VEGF (356±79 vs. 1031±343 pg/ml, p=0.05), and VEGF-D (264±48 vs. 766±243 pg/ml, p=0.08), and decreased anti-angiogenic peptide leukemia inhibitory factor (86±10 vs. 67±10 pg/ml, p=0.08).

CONCLUSIONS: Continuous-flow LVAD support altered multiple plasma angiogenic signaling peptides. These data suggest signaling pathways that may contribute to abnormal angiogenesis in LVAD patients.

136

O11-3

Optimal Hemodynamics during Left Ventricular Assist Device Support are Associated with Reduced Hemocompatibility-Related Adverse Events

1)University of Chicago Medicine, USA, 2)Brigham and Women's Hospital, USA, 3)Advocate Heart Institute, USA, 4)Montefiore Medical Center, Albert Einstein College of Medicine, USA, 5)Columbia University Medical Center, USA

Teruhiko Imamura1), Valluvan Jeevanandam1), Daniel Rodgers1), Gene Kim1), Mandeep Mehra2), Maria Rosa Costanzo3), Ulrich P Jorde4), Daniel Burkhoff5), Gabriel Sayer1), Nir Uriel1)

Background:Left ventricular assist device (LVAD) therapy improves the hemodynamics of advanced heart fail-ure patients. However, it is unknown whether the hemodynamic optimization improves hemocom-patibility-related clinical adverse events (HRAEs). This study aimed to assess HRAEs in patients with optimized hemodynamics or not. Methods:LVAD patients undergoing an invasive hemodynamic ramp test were prospectively enrolled and followed for one year. LVAD speed was optimized using a ramp test with the following goals: cen-tral venous pressure <12 mmHg, pulmonary artery wedge pressure < 18 mmHg, and cardiac index >2.2 L/min/m2. The survival free of any HRAEs (nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) and the net burden of HRAEs, which was calculated by using a hemocompatibility score (uses 4 escalating tiers of hierarchal severity to derive a total score for events), were compared between patients with/without optimized hemodynamics. Results:Eighty-three outpatients (58.8 ± 13.9 years old, 50 male) underwent ramp test 480 ± 547 days after LVAD implantation, and 51 (61%) had optimized hemodynamics following LVAD speed adjust-ment. Survival free of any HRAEs was achieved in 75% of the optimized group and only in 44% of the non-optimized group (hazard ratio, 0.36; p = 0.003). Using the hemocompatibility score, the op-timized group had numerically less medically managed pump thrombosis (0 vs. 4 points, p = 0.010), less multiple gastrointestinal bleedings (4 vs. 8 points, p = 0.14), and less non-disabling stroke (8 vs. 12 points, p = 0.14) than the non-optimized group. The net hemocompatibility score in the opti-mized group compared with the non-optimized group was 52 (1.02 ± 2.08 points/patient) versus 84 (2.00 ± 2.85 points/patient) (p = 0.075). Conclusion:LVAD patients in whom hemodynamics can be optimized had greater freedom from HRAEs com-pared with the non-optimized group.

137

O11-4

The effect of synchronous rotary LVAD support: from the perspective of flow induced intraventricular thrombosis

1)Innovative Cardiovascular Engineering and Technology Lab (ICETLAB), The Prince Charles Hospital, Chermside, Australia,2)Institute of Health and Biomedical Innovation (IHBI), Queensland University of Technology (QUT), Kelvin Grove, Australia,3)Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen University, Aachen, Germany,4)School of Medicine, The University of Queensland, St. Lucia, Australia,5)Department of Engineering, Nottingham Trent University, Clifton Lane, Nottingham, United Kingdom,6)Department of Mechanical and Aerospace Engineering, Monash University, Clayton, Australia

Sam Liao1,2,3), Eric L Wu1,4), Michael Neidlin3), Zhiyong Li2), Benjamin Simpson5), Shaun D Gregory1,4,6)

Background: Adverse events due to thrombosis with left ventricular assist devices (LVADs) is problematic. Speed modulation of rotary blood pumps have been developed to address pump and aortic valve thrombosis. However, the effects of localised intraventricular flow dynamics, and thus potential for intraventricular thrombosis, have not been well characterised. Nevertheless, there have been contentious debates on the importance of speed modulating strategies for LVADs. The aim of this study was to evaluate the risk of intraventricular thrombosis with synchronous speed modulated rotary LVAD support.Methods: A severely dilated patient-specific left ventricle was supported by a HeartWare HVAD in a 3D multiscale computational fluid dynamics model. Three rotary LVAD operating strategies were evaluated: constant speed, sinusoidal co- and counter-pulsation in relation to maximum left ven-tricular pressure. The mean pump speed was set to restore a cardiac output of 5.0 l/min. The sinu-soidal speed profile amplitude was 750 rpm. There was no aortic valve opening in all cases. Ten cardiac cycles were simulated to assess the risk of intraventricular thrombosis, based on: blood resi-dence time, ventricular washout, kinetic energy densities and a pulsatility index map.Results: Constant speed and counter-pulsation modes had respective 1.8% and 3.7% longer blood residence times in the left ventricle compared to co-pulsation. By displacing pre-existing blood in the left ventricle for 10 cardiac cycles, counter-pulsation retained 1.5% more old blood than co-pul-sation. The maximum apical energy density for co-pulsation was 84% and 27% higher in compari-son to counter-pulsation and constant speed mode, respectively. Pulsatility indices were higher around the left ventricular outflow tract and mid-cavity with co-pulsation. Conclusions: For the studied condition, co-pulsation appeared to minimise blood stasis due to com-paratively higher E-wave velocities. Co-pulsation has the potential to reduce incidences of throm-boembolic events, attributed to superior left ventricular washout.

138

O11-5

Endothelial Cell Inflammatory Activation Enhances the Prothrombotic State of Shear-Activated Platelets: Mechanistic Implications for VAD Thrombosis?

1)Anesthesia and Cardiothoracic Intensive Care - Advanced Heart Failure and Mechanical Circulatory Support Program, San Raffaele Scientific Institute, Milan, Italy,2)Universita Vita Salute San Raffaele, Milano, Italy,3)Departments of Medicine and Biomedical Engineering, Sarver Heart Center, University of Arizona, Tucson, AZ, USA,4)Politecnico di Milano Research Unit, National Interuniversity Consortium of Materials Science and Technology – INSTM, Milano, Italy,5)Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milano, Italy,6)Department of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA,7)Biocompatibility and Cell culture Laboratory “BioCell”, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Milano, Italy

Filippo Consolo1,2), Kaitlyn R Ammann3), Yana Roka Moiia3), Nina Bono4), Gianfranco B Fiore5), Federico Pappalardo1,2), Danny Bluestein6), Gabriele Candiani7), Alberto Redaelli5), Marvin J Slepian3)

Background/Purpose: Pre-clinical and clinical studies have identified a range of contributing ele-ments driving thrombosis in Ventricular Assist Devices (VADs). However, a full understanding of the mechanisms initiating and propagating thrombosis, particularly endoventricular thrombosis, have only been partially elucidated. Here we hypothesized that endoventricular endothelial inflammatory activation combines with shear-mediated platelet activation (SMPA) to drive endoventricular pro-thrombosis. We systemati-cally analyzed in vitro synergies of i) cytokine-activation of endothelial cells (ECs) and ii) SMPA to gain insight as to their potential contribution to endoventricular thrombosis and subsequent throm-boembolic events associated with thrombus ingestion into the pump.Methods: Intact and shear-activated human platelets were exposed to nonactivated and cy-tokine-activated ECs. To modulate the level of SMPA, platelets were exposed to shear stress pat-terns of varying magnitude (30, 50, 70 dynes/cm2, 10min) via a hemodynamic shearing device. ECs were activated via exposure to Tumor Necrosis Factor-α (TNF-α, 10 and 100 ng/mL, 24h). EC-platelet adhesion was evaluated through i) Scanning Electron Microscopy and ii) flow cytome-try analysis of EC αvβ3 integrin surface expression. Platelet prothrombinase activity was quantified via i) the Platelet Activity State (PAS) assay, and analysis of ii) surface expression of P-selectin and iii) phosphatidylserine externalization (annexin V binding). The soluble and surface expression of EC prothrombotic markers (ICAM-1, VCAM-1 and E-selectin) was quantified via i) ELISA and ii) flow cytometry.Results: Cytokine-activated ECs were completely adhesive for platelets, regardless of their initial SMPA level. Moreover, activated ECs further enhanced thrombin generation of shear-activated platelets.Conclusions: Cytokine-mediated inflammatory activation of ECs creates a prothrombotic surface enhancing platelet adhesivity. This milieu synergizes with SMPA to further increase platelet pro-thrombotic function. Our findings highlight that the endothelial surface of the VAD-implanted ventricle acts a pro-thrombotic nidus and suggest that this may be a valuable target to reduce plate-let prothrombotic activity and VAD-related thromboembolic complications.

139

O12-Keynote

Anticoagulation Quality and Frequency of INR Testing in LVAD Patients: A Correlation to Hemocompatibility Related Adverse Events and Outcomes

1)Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria, 2)Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, Austria,3)Department of Cardiac Surgery, Medical University of Vienna, Austria

Thomas Schlöglhofer1,2,3), Lydia Zapusek1,2), Dominik Wiedemann3), Julia Riebandt3), Kamen Dimitrov3), Guenther Laufer3), Francesco Moscato1,2), Daniel Zimpfer3), Heinrich Schima1,2,3)

Background: Anticoagulation therapy in LVAD patients is essential to reduce hemocompatibility related adverse events (HRAE). Phenprocoumon dose must be adapted and monitored by INR point-of-care-testing (POCT) in outpatients. The study aims to determine if the frequency of INR POCT in LVAD outpatients has an influence on the quality of anticoagulation therapy, HRAE and clinical outcomes.

Methods: This retrospective, pseudo-randomized study included n=48 patients who received an LVAD implantation (HMII, HM3 and HVAD) between Jan. 2012 and Oct. 2016. Based on the fre-quency of weekly INR POCT, we compared a daily (n=36) and a 3x/week (n=12) group, specifical-ly the 1-year anticoagulation quality (% of INR Tests in Range) as well as clinical outcomes, read-missions and HRAE using Kaplan-Meier curves. Readmission profiles and outcomes in three groups, based on the achieved quality of anticoagulation (% of INR Tests in Range) ranging from 0-60% (poor), 60-70% (acceptable), 70-100% (well controlled) were compared.

Results: Daily and 3x/week groups were similar in demographic and pre-operative risk factors, INR target (2.0-3.0, p=0.27) and Aspirin daily doses (p=0.29). Freedom from any HRAE (38.9% vs. 25.0%, p=0.44), any readmission (72.2% vs. 75.0%, p=0.97) and 1-year survival (91.7% vs. 91.7%, p=0.98) were comparable in both groups. The % of INR Tests in Range was significantly higher with the daily self-assessments (73.5% vs. 68.4%, p=0.006). Freedom from any neurological event (91.7% vs. 75.0%, p=0.14) was n.s. higher in the daily POCT group. Well vs. poor controlled INR POCT patients had a significant higher freedom from any neurological event (96.0 vs 69.2%, p=0.024) as well as hemorrhagic strokes (100% vs. 76.9%, p=0.011).

Conclusion: Well controlled anticoagulation of LVAD outpatients results in less neurological events including hemorrhagic stroke. Daily INR POCT and subsequent dose adjustment of vita-min-K antagonists result in a better quality of anticoagulation than 3x/week checks.

140

O12-RF2

Multidisciplinary approach for right heart failure after left ventricular assist device implantation in a patient with restrictive cardiomyopathy

Department of Thoracic and Cardiovascular Surgery, University of the Ryukyus, Japan

Hitoshi Inafuku, Yukio Kuniyoshi

Background: Left ventricular assist device (LVAD) therapy is considered to be difficult in patients with restrictive cardiomyopathy (RCM), especially those with small left ventricles (LVs). Right heart failure (RHF) is one of the most important problems in these patients. Purpose: We aimed to present a multidisciplinary approach for managing RHF after LVAD implan-tation in a RCM patient with a small LV. Methods: A 43-year-old woman with RCM and a history of multiple congestive heart failure epi-sodes was registered for heart transplantation. Inotropic support could not be discontinued, and thus, she was referred for implantation of Jarvik 2000 (Jarvik Heart, Inc., New York, NY) as a bridge to transplantation. Before LVAD implantation, her LV end-diastolic diameter (LVDd) was 3.8 cm, with an ejection fraction (EF) of 23%. Her mean pulmonary artery pressure (mPAP) and right atrial pressure (RAP) were 31 and 11 mmHg, respectively. Additionally, the cardiac index (CI) was 1.4 L/min/m2. After LVAD implantation, her RHF gradually deteriorated. Her LVDd was 2.8 cm. Moreover, 1 month after implantation, her mPAP and RAP were 31 and 23 mmHg, respectively. We administered a phosphodiesterase-5 inhibitor and endothelin receptor inhibitor. To prevent RHF oc-currence owing to over-activity, we provided guidance to the patient on rehabilitation and lifestyle according to the results of cardiopulmonary exercise tests and activity assessments with an acceler-ometer-based activity monitor. Moreover, nutritional guidance was provided by a nutritionist, and her weight was adjusted with diet modification, as well as diuretic administration. Results: Our multidisciplinary approach for RHF resulted in the amelioration of her symptoms, in-cluding dyspnea and foot edema. Her mPAP and RAP decreased to 18 and 16 mmHg, respectively, and CI increased to 2.5 L/min/m2. Conclusion: We presented a multidisciplinary approach for managing RHF after LVAD implanta-tion with good early results in our RCM patient with a small LV.

141

O12-RF3

MAIN PREDICTORS OF RIGHT VENTRICULAR FAILURE IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE : SINGLE CENTER EXPERIENCE

National Research Cardiac Surgery Center, Astana, Kazakhstan

Saltanat Andossova, Yuriy Pya, Makhabbat Bekbossynova, Saltanat Dzhetybayeva, Serik Bekbossynov, Muradym Murzagaliyev, Svetlana Novikova, Assel Medressova, Ainur Tauekelova, Timur Kapyshev, Arnur Zhambylov

Objective: Right ventricular failure (RVF) is a major cause of morbidity and mortality after ven-tricular assist device (LVAD) implantation. Severe RVF is associated with increased peri-operative mortality, length of stay (LOS) and poor prognosis. Prediction of RV failure after LVAD placement would lead to more precise patient selection and optimal management. This study evaluated the predictors of RVF which impact to develop it after LVAD implantation.Methods: We reviewed 252 consecutive patients undergoing LVAD surgery: Heart Mate II (n=99), Heart Ware (n=59) and Heart Mate 3 (n=95) between November 2011 and March 2018. Of them 144 cases (52.7%) before LVAD implantation had RV dysfunction. After surgery RVF was defined as the need for a subsequent right ventricular assist device (RVAD), ≥ 14 days of intravenous ino-tropes/pulmonary vasodilators, or both, high total bilirubin (>2.0 mg/dl), CVP ≥ 16 according to INTERMACS definition. 93 (38%) RVF patients were identified. By logistic regression method age, sex, laboratory, ECHO and cathetherization dates, duration of cardio pulmonary bypass. Results: Of 144 in 93 patients (38%) developed RVF after LVAD implantation, 9 (9.6%) patients died during 1 month due to multiple organ failure, 6 (6.4%) required RVAD support. RVF patients had low level of albumin b=0.230±0.091 (p=0.017), high level of bilirubin b=0.273±0.151 (p=0.09), high preoperative ratio of central venous pressure to pulmonary capillary wedge pressure (CVP/PCWP ) b=2.442±1.195 (p=0.07), INTERMACS I-III level b=10.946±0.486 (p=0.05), low PAPi b=0.349±0.139 (p=0.034), low TAPSE b0.152±0.095 (p=0.11), hemoglobin b=0.023±0.11 (p=0.04), INR b=1.526±0.789 (p=0.05).Conclusion: Poor nutrition status, higher level of INR, lower hemoglobin, INTERMACS I-III and low PAPi were preoperative significant predictors to develop of RVF in short term period after LVAD implantation.

142

O12-4

Microfluidic Technology for the Development of a Point-Of-Care Diagnostic Device of Prothrombotic Platelet Function

1)Anesthesia and Cardiothoracic Intensive Care - Advanced Heart Failure and Mechanical Circulatory Program, San Raffaele Scientific Institute, Milano, Italy,2)Universita Vita Salute San Raffaele, Milano, Italy,3)Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milano, Italy,4)Coagulation Service and Thrombosis Research Unit, San Raffaele Scientific Institute, Milano, Italy,5)Departments of Medicine and Biomedical Engineering, Sarver Heart Center, University of Arizona, Tucson, AZ, USA,6)School of Medicine, Nanyang Technological University, Singapore, Singapore

Filippo Consolo1,2), Silvia Bozzi3), Giovanni S Ugolini3), Loris Pozzi4), Marco Rasponi3), Federico Pappalardo1,2), Marvin J Slepian5), Han W Hou6), Alberto Redaelli3)

Background/Purpose: Systematic, serial monitoring of platelet prothrombosis is crucial to prevent thrombotic complications during mechanical circulatory support (MCS). To date limited methods exist for convenient routine monitoring of MCS patients. We recently demonstrated the clinical util-ity of the Platelet Activity State (PAS) assay for identification of high-risk patients with an activated platelet prothrombotic profile. Here we present further advancements towards the development of a microfluidic PAS-based Point-of-Care (PoC) diagnostic device allowing single-step, automated, and rapid platelet separation from whole blood to facilitate sample extraction and downstream on-chip PAS analysis.Methods: A microfluidic device was fabricated, where high resolution Dean Flow Fractionation allows different blood components - red and white blood cells, platelets, and plasmatic coagulation factors - to exit from separate outlet channels. Chip-filtered platelets (CFPs) were obtained from human whole blood (WB) collected in 1:10 citrate anticoagulant and diluted i) 1:5 (WB1:5) and ii) 1:3 (WB1:3) in Ca2+ free saline buffer. Following sample extraction, device efficiency was charac-terized as to platelet recovery and depletion of plasmatic coagulation factors. The CFP activation level was measured via the PAS assay.Results: The microfluidic device enhanced rapid (10μl/min) and efficient platelet separation (WB1:3=43% recovery), and effective plasma depletion, consistent with measured values of Pro-thrombin Time, activated Partial Thromboplastin Time, and Thrombin Time >250s (Option2 Coag-ulometer; bioMerieux). PAS analysis showed low but non-negligible CFP activation (PAS=3.0%±0.4%), which, however, might be compensated via pre-processing WB incubation with prostaglandin I2 (PGI2), to avoid systematic bias of the platelet activation level.Conclusions: Integrating microfluidic platelet separation with downstream on-chip PAS analysis is essential to advance the development of a clinically relevant PoC diagnostic device for routine anal-ysis of platelet function. Such a system will enhance serial monitoring of MCS implanted patients as well as development of patient-specific antithrombotic strategies to limit the burden of MCS thrombosis.

143

O12-5

Driveline fracture in patients supported with HeartMate II left ventricular assist device

Department of Cardiac Surgery, The University of Tokyo, Japan

Shogo Shimada, Kan Nawata, Osamu Kinoshita, Haruo Yamauchi, Sachito Minegishi, Hyoe Komae, Yasuhiro Hoshino, Mitsutoshi Kimura, Minoru Ono

Background/Purpose: HeartMate II driveline fracture has been reportedly diminished since the last lead improvements in Dec 2010 although longer-term outcomes are lacking. In this study we sought to evaluate outcomes on HeartMate II driveline fracture in our institution.Methods: 40 consecutive patients who underwent HeartMate II implantation between May 2013 and March 2017 in our institution and were supported for more than a year were analyzed by retro-spective review of the medical records. In all patients the driveline route was created in a tunnel method for a longer subcutaneous distance from the blood pump to the driveline exit site. Driveline fracture was confirmed by sending the explanted HeartMate II devices to the manufacturer.Results: Patient characteristics were as follows: average age: 37 years old (16-59); male: 33 (83%); dilated cardiomyopathy: 31 (78%); bridge to transplant: 40 (100%); Preoperative INTERMACS profile 2, 11 (28%); profile 3, 27 (68%); profile 4, 2 (5%); average support period: 31 months (13-53). Driveline fracture occurred in 7 patients (17.5%). All had internal lead damage and successful pump exchange was performed. Pump end was the most susceptible area to damage and wear on the leads probably due to repetitive motion was a common finding. According to Kaplan-Meier analysis, the actuarial freedom rates from HeartMate II driveline fracture were 97.5% at 1 year and 74% at 2 years.Conclusions: HeartMate II driveline fracture is still an unresolved issue with high prevalence even after the implementation of the lead improvements. Considering that most of the fracture developed at the pump end, making a driveline loop immediately after the blood pump may help relieve the mechanical force/stress applied to the driveline and extend the durability.

144

O13-1

The utility of thromboelastometry to monitor bivalirudin anticoagulation in children on extracorporeal circulatory support devices

Division of Transfusion Medicine & Coagulation, Texas Children's Hospital, Baylor College of Medicine, USA

Jun Teruya, Lisa Hensch, Karen Bruzdoski, Shiu-Ki Hui, Vadim Kostousov

Background/Purpose: Bivalirudin, a direct thrombin inhibitor, is a useful alternative to unfraction-ated heparin for providing anticoagulation in infants and children in the settings of extracorporeal life support. While activated thromboplastin time (aPTT) is commonly used to monitor bivalirudin therapy, the utility of thromboelastometry (ROTEM) as a means to monitor anticoagulation with bi-valirudin is unknown. The purpose of this study is to compare ROTEM with routine plasma-based coagulation assays used to monitor hemostasis and bivalirudin effect in children on ECMO/LVAD.Methods: A retrospective study (2017-18) was performed in a tertiary care pediatric hospital. RO-TEM variables and concomitant routine coagulation test results from patients receiving bivalirudin as an anticoagulant for ECMO/LVAD were obtained from electronic medical record hospital data-base. Statistical analysis was performed using MS Excel 2010, data are presented as mean±SD, and significance was set at p<0.05.Results: Eighteen children (9 females) ages 3 weeks to 22 years old (12 LVAD, 6 ECMO) who re-ceived bivalirudin infusion at maintenance dose of 0.33±0.21 mg/kg/hour were reviewed and 106 data points showing daily hemostatic changes over 6±1 days of treatment were collected. aPTT was 68.0±14.8 sec (reference range 25-36 sec) and CT-INTEM was 276±61 sec (reference range 122-208 sec) that showed moderate correlation (r=0.54, p<0.001), while aPTT-Hepzyme 61.5±10.8 sec correlated strongly with CT-HEPTEM 260±50 sec (r=0.68, p<0.001). Maintenance dose of bivali-rudin showed no or weak correlation with laboratory data, but was age-dependent; patients 9±7 months old (n=10) required a twice higher rate than older (13±5 years; n=8) 0.42±0.2 vs 0.2±0.16 mg/kg/hour, p<0.001. Very strong correlation was found between MCF-FIBTEM and fibrinogen (r=0.83, p<0.001); however, MCF overestimated fibrinogen when platelet count >300 × 103/mm3. Conclusions: ROTEM variables showed moderate to very strong correlations with routine plas-ma-based coagulation testing. Therefore, ROTEM is a suitable method to monitor the anticoagulant effect of bivalirudin for ECMO/LVAD patients.

145

O13-2

Evaluation of Hemodynamics of Aortic Insufficiency under LVAD Support

1)Department of Cardiovascular Surgery, Tokyo Women's Medical University, Japan,2)Department of Artificial Organs, Cerebral and Cardiovascular Center Research Institute, Japan

Kei Iizuka1), Tomohiro Nishinaka1), Hiroshi Niinami1), Daichi Akiyama2), Noritsugu Naito2), Toshihide Mizuno2), Tomonori Tsukiya2), Yoshiaki Takewa2), Eisuke Tatsumi2)

Aortic insufficiency (AI) is a worrisome problem under left ventricular assist device (LVAD) sup-port. The factors causing AI were still controversial. We evaluated some clinical questions from ba-sic side.Progressive AI can lead to LVAD-LV recirculation, resulting low-output syndrome. Increasing of rotational speed to solve the low-output was controversial because it could also increase the LVAD-LV recirculation. We established an animal model of AI with LVAD, and evaluated the hemody-namics with changing rotational speed. It was suggested from experiments with five goats that the increasing of rotational speed did not contribute to improve the output in AI with Sellers classifica-tion 3 or more.Progressive AI can need surgical intervention, but the influence of AI progression on hemodynam-ics was not clarified enough. We evaluated the hemodynamics of AI progression with cardiac dys-function model of five LVAD-AI goats. Left atrial and ventricular pressures showed marked in-crease when the recirculation rate surpassed 40%. It was demonstrated that the changes of left heart pressures can be the key sign to know the limitation of LVAD support against AI progression, and to consider the surgical intervention.Anatomical factors could be also one of factors causing AI. It was reported that the group of pa-tients who have obtuse angle between outflow graft and the aorta (O-A angle) can progress AI earli-er. We established LVAD-AI model with seven calves, and evaluated the influence of the O-A an-gle. It was suggested that the obtuse O-A angle could cause increase of recirculation without pressure changes.We performed those animal experiments to give some feedback for some clinical problems. The bi-directional approach from clinical and basic research is important.

146

O13-3

Imaging the contraction of mechanically supported ex vivo beating hearts

Department of Biomedical Engineering, Eindhoven University of Technology, The Netherlands

Louis Fixsen, Niels Petterson, Frans N van de Vosse, Richard Lopata, Marcel Rutten

In MCS patients, clinicians lack tools to monitor the condition of the heart due to metals in the body. Factors such as LV dP/dtmax and contraction pattern are valuable in assessing cardiac function, but have yet to be quantified in MCS patients. Ultrasound (US) strain imaging could enable the study of these parameters. However, due to a high level of illness it is difficult to validate new methods in MCS patients. Therefore, in this study, 2-D US strain imaging was used to investigate changes in heart mechanics in LVAD-supported hearts, with an isolated beating porcine heart plat-form.

Ex vivo porcine hearts were implanted with Thoratec HeartMate II (n=2) and MicroMed DeBakey (n=2) LVADs. The hearts were attached to a mock-loop, re-perfused with oxygenated blood, resus-citated and paced at 120 bpm (PhysioHeart, LifeTec). Measurements were performed whilst the LVAD-supported hearts deteriorated from baseline condition (based on cardiac output). Radio-fre-quency US data were acquired (MyLab70, Esaote) at pump speeds from 0 (no outflow) to 10.5 krpm. Data were manually segmented and local radial (erad) and circumferential strains (ecir) were estimated over each heart cycle. The unloaded 0 krpm initial geometry was used as an initial condi-tion for further pump speeds per heart condition.

In each heart, as the pump speed was increased and the hearts degraded, measured dP/dtmax reduced. An increase was seen in ecir magnitude relative to the reduction in pressure, showing that ecir esti-mated using US strain imaging can be related to dP/dtmax. Time-to-peak strain around the left ventri-cle was measured. As the pump speed was increased and the heart condition degraded, regions of early and late contraction grew in size and magnitude. This is a first step in unravelling the interplay between pump-action and remaining cardiac function.

This work was funded by the EU-MSCA. GA No 642612 (www.vph-case.eu).

147

O13-4

Mid-term Evaluation of Hemodynamics and Exercise Tolerance after Jarvik 2000 Left Ventricular Assist Device Implantation.

1)Department of Cardiovascular Medicine, Chiba University Hospital, Japan,2)Department of Cardiovascular Surgery, Chiba University Hospital, Japan

Togo Iwahana1), Sho Okada1), Hiroki Kohno2), Michiko Watanabe2), Goro Matsumiya2), Yoshio Kobayashi1)

Background. The Jarvik 2000 left ventricular assist device (LVAD), featuring small size and inter-mittent low speed (ILS) function, tend to be selected for patients with small body size and relatively preserved cardiac output, due to concerns of dizziness during ILS and shortage of total pump flow. On the other hand, we usually select the Jarvik 2000 regardless of patients’ body size. This study aimed to investigate whether the Jarvik 2000 could support left ventricular adquately regardless of patients’ body size.Method. Nineteen patients were implanted the Jarvik 2000 LVADs in Chiba Uni-versity Hospital; all of them were bridge to transplantation. Patients were examined echocardio-gram and cardiopulmonary exercise test every six months, and pump flow adjustment as ‘ramp test’ using Swan-Ganz catheter at 1 year after implantation. Correlation between hemodynamic status, exercise tolerance and body surface area (BSA) was evaluated.Results. After excluding 5 patients within 1 year after implantation, 2 patients due to physical dysfunction, and 1 patient due to death, 11 patients (BSA was 1.67±0.18 m2) were analyzed. Before LVAD implantation, pulmonary capil-lary wedge pressure (PCWP) was 28±13 mmHg, and cardiac index (CI) was 1.98±0.66 L/min/m2. With the adjusted pump speed after the ramp test, peak VO2, PCWP and CI were improved to 13.1±2.5 ml/min/kg, 10±6 mmHg and 2.50±0.25 L/min/m2, respectively, without dizziness during ILS. Peak VO2, PCWP and CI were not correlated with BSA (r =-0.17, 0.02, and -0.01, respective-ly), however, there was a strong negative correlation between peak VO2 and PCWP (r = -0.77, p=0.01).Conclusion. In this study, exercise tolerance after Jarvik 2000 implantation depended on hemodynamics, not body size. It is suggested that Jarvik 2000 is able to support left ventricular ad-equately, and applicable widely regardless of body size.

148

O13-5

In Vitro Validation of Flowestimators for the HVAD and the HMIII

1)Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria, 2)Department of Cardiac Surgery, Medical University of Vienna, Austria ,3)Ludwig-Boltzmann-Cluster for Cardiovascular Research, Vienna, Austria

Martin Maw1,2,3), Thomas Schlöglhofer1,2,3), Christoph Gross1,3), Heinrich Schima1,2,3), Francesco Moscato1,3)

Background: Clinically used flowestimators (FE) and their derived hemodynamic parameters pro-vide clinicians with important information about patient status. However the accuracy and exact performance of these FEs has not yet been fully described in the literature. Purpose: This work aims at validating clinically used FEs for the HVAD and the HMIII. Methods: The validation was performed in a single ventricle in-vitro mock-loop for 3 different vis-cosities and across the clinical operating range of pump-speeds. Mean estimate pump flow was compared for both devices to measured mean pump flow. For the HMIII, the Pulsatility Index (PI) was compared to measured flow-pulsatility quantified by the amplitude of the flow waveform (Qp2p) and to Qp2p divided by the mean flow(Qmean). To evaluate the HMIII PI, ventricular func-tion was simulated using a pneumatic actuator.Results: The HVAD FE was able to estimate flowrate with an offset of 0.11 L/min and 95% CI of 0.85 L/min. Within a single viscosity test, the absolute offset component of the error was dominant (0.4 L/min) with 95%CI of 0.4L/min. For the HMIII the estimated flow showed an offset of -0.37 L/min and a 95% CI of 1.7 L/min in the non-pulsatile condition. Estimations at low head-pressures underestimated with an average offset of -1.6L/min and a 95%CI of 1.3L/min compared to 0.1L/min offset and 0.6L/min 95% CI in higher head-pressure scenarios. The PI was found to correlate with Qp2p via the equation: PI=0.78*Qp2p+1.57 (r2=0.96) and with Qp2p/Qmean via: PI= 3.19*Qp2p/Qmean+2.76 (r2=0.95) for physiological resistances. The addition of data from a high resistance setting changed the equations as well as the coefficient of determination to PI=1.18*Qp2p+1.168 (r2=0.76) and PI=2.94*Qp2p/Qmean+2.50. (r2=0.84) respectively.Conclusions: Clinically available FEs can be a valuable tool in the arsenal of the VAD specialist, with reasonable accuracy.

149

O14-Keynote

An Update on the OpenHeart Project - Towards the development of an Open-Source Online Research Platform to Improve Research Outcomes within the International Society for Mechanical Circulatory Support

1)School of Medicine, The University of Queensland, Australia, 2)Innovative Cardiovascular Engineering and Technology Laboratory (ICETLAB), Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia, 3)School of Engineering and Built Environment, Griffith University, Queensland, Australia, 4)Department of Mechanical and Aerospace Engineering, Monash University, Melbourne, Australia

Jo P. Pauls1,2), Andrew Stephens3,2), Shaun D Gregory4), Geoff Tansley3,2)

Background: Currently an estimated 85% of all global research resources are wasted due to false and non-reproducible results or slow and inefficient translation of knowledge into useful applica-tions. Whereas adoption of large-scale collaborative research with a strong replication culture has been shown to be successful in several biomedical fields. The OpenHeart Project is an open-source research project which aims to improve research practices and outcomes within ISMCS through im-plementation of an online research platform, to ultimately improve outcomes and quality of life for heart failure patients. Key objectives of OpenHeart are to:

•Promote improved collaboration and standardisation within ISMCS;• Leverage the existing resources, data and expertise within ISMCS and other societies through open data sharing; and

•Improve education and training of students and emerging researchers.

Methods: To promote improved collaboration within ISMCS team collaboration tools have been embedded into OpenHeart. An easy-to-use platform to share and reuse existing data (e.g. from PhD projects that would have otherwise languished in university archives) was implemented. To improve education an MCS Wiki has been implemented and a free massive open online course (MOOC) is under development.

Results: Team collaboration tools, MCS Wiki and data repositories have been implemented using the software solutions Stride, Confluence and Bitbucket (Atlassian, Sydney, Australia). The plat-form can be found online under www.openheartproject.org and is fully functional and growing dai-ly. Currently over 40 students and researchers from 19 universities and laboratories in 10 countries signed up for the OpenHeart Project. First data repositories (e.g. anatomical models and physiologi-cal control systems) have been created and the MCS Wiki is being populated.

Conclusions: Successful implementation of the OpenHeart Project will improve collaboration and standardization within ISMCS. Development of free education tools will improve training and edu-cation of emerging researchers and subsequently improve research outcomes. We invite everyone to visit, join and contribute to the OpenHeart Project.

150

O14-2

Development of a percutaneously deployable axial flow blood pump placed at aortic valve position: early prototype and its performance

1)Sapporo Liberal Arts Center, Tokai University, Japan,2)Graduate School of Science and Engineering, Hirosaki University, Japan, 3)Institute of Development Aging and Cancer, Tohoku University, Japan, 4)Hokkaido University, Japan

Eiji Okamoto1), Tetsuya Yano2), Yusuke Inoue3), Yasuyuki Shiraishi3), Tomoyuki Yambe3), Yoshinori Mitamura4)

Purpose We have been developing a new axial flow blood pump that can be percutaneously installed at aor-tic valve position for the short term and midterm cardiac support. We have been developing the pro-totype model and we demonstrate its feasibility in in vitro experiments. MethodsThe prototype of the percutaneous axial flow blood pump consists of a blushless dc motor and an impeller. The impeller is placed at the rear of the motor, and the percutaneous axial flow blood pump gets blood from blood intake placed at the rear of the motor and ejects blood in a direction of backward like a torpedo. The rotation of the impeller is sustained by a pivot bearing using polyeth-ylene. The impeller is designed using the angular momentum theory and the air foil theory, and the outer diameter of the impeller is 10 mm and the hub ratio 0.6 with three or four impeller vanes. The motor for the percutaneous axial flow blood pump was designed by using the motor analysis soft-ware (Jmag express, JSOL Co.) to satisfy its requirement. The percutaneous axial flow blood pump has a diameter of 12 mm and a length of 50 mm.ResultsThe pump performance of the percutaneous axial flow blood was investigated by in in-vitro experi-ments using 33 glycerin solution. The maximum pump output of 3.6 L/min against a pump differen-tial pressure of 100 mmHg at a rotational speed of 26400 rpm.ConclusionIn this study, we are developing a new axial flow blood pump that is intended to percutaneously in-stalled at aortic valve position. The percutaneous axial flow blood pump has enough pump perfor-mance for partial cardiac assistance, and we are redesigning the impeller to improve pump perfor-mance by theoretical calculation and in vitro experiments.

151

O14-3

Evaluation of a Novel Short-Term Intraventricular Balloon Pump to Support Heart Failure Patients - an In Vitro Study

1)School of Engineering and Built Environment, Griffith University, Queensland, Australia, 2)Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia,3)School of Medicine, The University of Queensland, Brisbane, Australia,4)Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia,5)Department of Epidemiology and Preventative Medicine, Monash University, Australia, 6)Intensive Care Unit, Alfred Hospital, Melbourne, Australia,7)Department of Mechanical and Aerospace Engineering, Monash University, Melbourne, Australia

Alice Catherine Boone1,2), Shaun D. Gregory 1,2,3,7), Eric L. Wu2,3), Andrew Stephens1,2), Sam Liao2,4), Jo P. Pauls2,3), Robert Salamonsen5,6), Geoff D. Tansley 1,2)

BackgroundVentricular assist devices commonly used for supporting decompensated heart failure are designed for long-term support. However, the poor cost-effectiveness of these devices in acute situations ne-cessitates short-term bridging alternatives. This study aimed to develop a novel intraventricular bal-loon pump (IVBP) for short-term support of severe heart failure (SHF) patients. MethodsA silicone IVBP (balloon volume 60 mL), was designed and manufactured to avoid contact with in-ternal left ventricular features (e.g. papillary muscles, aortic and mitral valves) based on left ven-tricular CT data of SHF patients (N=10). The haemodynamic effects of the balloon inflation and de-flation parameters (inflation duty (D) and phase from commencement of systole (phi) as percentages of the cardiac cycle) were varied and evaluated in a custom-built systemic mock circu-latory loop. A SHF condition was simulated, and the resulting effect of the IVBP assistance on the haemodynamics was assessed. ResultsDepending on the balloon actuation timing (D and phi), the IVBP was able to improve haemody-namics. IVBP co-pulsation (D=20% and phi=5%) increased the aortic flow (AoF) from 3.5 L/min to 5.2 L/min, mean arterial pressure (MAP) increased from 70 mmHg to 95 mmHg and ejection fraction (EF) increased from 14% to 21% when compared to the SHF baseline condition. The bal-loon end-inflation time (D+phi) appeared to be a determinant factor in the degree of support; (D+phi) of 25% maximised AoF, MAP and EF. Unfavourably, IVBP counter-pulsation (i.e. (D+phi)>40%) induced a decrease in AoF to as low as 3.1 L/min and a decrease in MAP to as low as 63.5 mmHg. ConclusionIn vitro data revealed that a novel population-specific IVBP may be suitable to provide short-term mechanical circulatory support for SHF patients. In vivo evaluation is required for validating the proposed IVBP design and identifying potential limitations (e.g. mitral regurgitation).

152

O14-4

Effect of atrial inflow conditions on ventricular flow pattern during mechanical circulatory support

1)Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria, 2)Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, Austria, 3)Institute of Fluid Dynamics and Heat Transfer, Technical University of Vienna, Austria, 4)Department for Cardiac Surgery, Medical University of Vienna, Austria

Mojgan Ghodrati1), Francesco Zonta3), Francesco Moscato1,2), Philipp Aigner1,2), Heinrich Schima1,2,4)

Usually simulation of the ventricular flow patterns is based on straight inflow conditions from the atrium without considering asymmetries arising from the contribution of pulmonary veins. In this study, the influences of the atrial flow conditions – including rotation and asymmetric flow profiles – on the intraventricular flow patterns were investigated via Computational Fluid Dynamics (CFD) simulations. A left ventricular model with a mechanical support device was used for three different simulations with laminar methods. At first was performed with normal velocity at the inflow as a validation study against PIV (pump speed: 2800 rpm, flow rate: 3.5 lit/min), secondly added a rotational com-ponent to the velocity field at the inflow (30 rpm) and third with an asymmetric inflow combining (60%/40% left/right flow ratio to replicate physiologic uneven flow distribution of the pulmonary veins’). Deviation of the velocity angle with respect to normal velocity at the inflow, as well as stagnation areas (velocity<0.01m/s) and instability of the vortical structures from the standard devi-ation (STD) of Q-value were calculated. The measured and calculated velocity angles at the ventricular inflow in the symmetric condition were comparable (PIV: 0.6°, CFD: 1.2°). By adding rotation or radial asymmetry these angles changed (CFDrot: 3.8°, CFDasym: -4.2°). With the rotational velocity at the inflow, less stagnation areas were detected (CFDrot: 3.4cm2,CFD: 4.9cm2, CFDasym: 4.6cm2). Unstable vortex structures occurred when comparing inflow rotation and asymmetry with straight profile (STD of Q-value, CFD: 0.07 vs. CFDrot: 0.1, CFDasym: 0.09).Neglecting the atrial flow conditions could lead to inaccurate simulation of the ventricular flow pat-tern. Hence, reliable prediction of ventricular stagnation areas and recirculation zones requires also the consideration of the atrial inflow conditions.

153

O14-5

A study on optimal pump design of a catheter-based intravascular rotary blood pump for assisting selective renal blood circulation

1)Division of Electronic Engineering, Department of Science and Engineering, School of Science and Engineering, Tokyo Denki University, Saitama, Japan,2)Department of Medical Technology, Faculty of Biomedical Engineering, Toin University of Yokohama, Kanagawa, Japan,3)Taisei Clinic, Osaka, Japan,4)Departments of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan

Hirohito Sumikura1), Kei Aoyagi1), Kentaro Ohnuma2), Shigeru Hanada3), Tomonori Tsukiya4), Toshihide Mizuno4), Akihiko Homma4), Yoshiaki Takewa4), Eisuke Tatsumi4)

Background/Purpose We are developing a minimally invasive catheter-based intravascular rotary blood pump (Re-nal-RBP) which can perform renal selective blood perfusion on renal ischemic dysfunction in acute cardiorenal syndrome. The target performance of Renal-RBP is pressure head (PH) of 30 mmHg at flow rate of 1.0 L/min. The purpose of this study is to improve the performance of Renal-RBP using an automatic optimization system that employs a CFD analysis and optimization algorithm.

MethodsThe automatic optimization system consisted of 3DCAD, CFD software and the optimization tool. The objectives were to maximize the PH for high pump performance (ObjPH), and to minimize the maximum value of the wall shear stress (WSS) to ensure a low hemolysis (ObjWSS). The inlet and outlet angle (3 variables) and shaft diameter (2 variables) of the impeller and pump outlet height (1 variable) were used as the design variables in the original design. The diameter and total length of impeller were 3.0 and 13.8 mm, respectively. The PH and WSS were calculated in CFD analysis. SHERPA was used as optimization algorithm and the number of calculations was 500. The optimi-zation algorithm efficiently searches for the maximum (or minimum) value of objectives by chang-ing the geometry of the original design with the design variables, conducting CFD analysis and re-peating these changes until the number of calculations.

ResultsNumerous superior designs which have high PH and low WSS were generated in comparison with the original design. The tendency to increase in the inlet angle and shaft diameter of the impeller was confirmed in the Pareto designs. The optimal design (PH: 29 mmHg, WSS: 321 Pa) resulted in a 30% improvement in ObjPH and a 49% improvement in ObjWSS compared with the original de-sign.

Conclusions The optimization of the pump designs is useful for improving the performance in the Renal-RBP.

154

Acknowledgements

Tokyo Memorial Lecture

Abbott Medical Japan Co., Ltd.

Luncheon Seminar

Sun Medical Technology Research Corp.

Century Medical, Inc.

Exhibition

Berlin Heart GmbH USCI Japan Ltd.

Medtronic Japan CO., Ltd. ABIOMED

Century Medical, Inc.

Advertisement

SENKO MEDICAL INSTRUMENT Mfg. CO., LTD. Sun Medical Technology Research Corp.

Mallinckrodt Pharma K.K. Roche Diagnostics K.K.

Berlin Heart GmbH TERUMO CORPORATION

Otsuka Pharmaceutical Co., Ltd. CSL Behring K.K.

Medtronic Japan CO., Ltd.

155

Authors Index

AAburatani, H. ……………… O6-6Acker, M. A. ……… PS-3, O11-2Adachi, O. ……………… P2B-4Adams, J. …………………… O1-3Aigner, P. … YIA-5, PS-10, O14-4Akao, E. ………………… P2A-7Akiyama, D. …… YIA-2, O13-2Akiyama, M. ……… PS-1, P2B-4Amiya, E. … PS-9, O9-5, O10-2Ammann, K. R. O7-RF3, O11-5Amodeo, A. …………O9-KeynoteAnai, H. ………………… P1B-2Anandamurthy, B. ………O8-RF3Andossova, S. … YIA-3, O12-RF3Anraku, M. … O8-Keynote, O8-4Aoyagi, K. ……………… O14-5Arai, H. ………… O3-RF2, O5-5Arai, S. ………………… P1B-5Arakawa, M. …………… P2B-7Araki, K. …………………… O9-2Ashyrov, Z. ………… PS-8, P1B-1Atluri, P. …………… PS-3, O11-2

BBanayosy, A. E. ……O3-KeynoteBarth, E. J. ………… PS-6, O5-4Bartnikowski, M. ………O7-RF2Bartnikowski, N. … O6-3, O7-RF2Bartoli, C. R. ……… PS-3, O11-2Bekbossynov, S. … YIA-3, PS-8,

O10-1, O12-RF3Bekbossynova, M. ……… YIA-3,

PS-8, O12-RF3Bermudez, C. A. …… PS-3, O11-2Bierewirtz, T. ……………… O5-3Bieritz, S. A. …………… P2A-5Biocina, B. …………………O1-1Bluestein, D. … YIA-1, O10-5, O11-5Bolle, E. …………………O7-RF2Bono, N. ………………… O11-5Boone, A. C. …………… O14-3Bozzi, S. ………………… O12-4Bruzdoski, K. ………O9-3, O13-1Burkhoff, D. …………… O11-3

Byram, N. … O1-3, O2-Keynote, O2-RF3, O4-4, O9-4, P1A-3, P1A-4

CCandiani, G. …………… O11-5Cesarovic, N. …………… YIA-5Chan, C. H. H. …………… P1A-2Chen, C. ………………… P2A-6Chen, T. ………… P1A-1, P2A-1Cikes, M. …………………… O1-1Cohn, W. E. ……………… P2A-5Consolo, F. ……… O11-5, O12-4Costanzo, M. R. ………… O11-3

DD’Alessandro, D. A. ……O8-RF3Darlak, M. ……………… P2A-4Dessoffy, R. ………………… O1-3Dimitrov, K. …… O12-KeynoteDoguchi, T. ……………… P1B-5Doi, T. …………………… P2B-1Doman, T. ……………… P1A-7Dunn, J. L. ……… P1B-6, P2A-2Dzhetybayeva, S. YIA-3, O12-RF3

EEnomoto, Y. ……………… P2B-2Esumi, R. ………………… P1B-4

FFaizov, L. ………… PS-8, P1B-1Fan, Q. …………………… P2A-1Fetanat, M. …………………O4-2Fiore, G. B. ……………… O11-5Fixsen, L. ……………… O13-3Frankman, Z. D. ……………O4-6Fraser, J. …………………O7-RF2Fraser, J. F. ………… PS-2, O4-5,

O6-3, P1A-2Fraser, K. ………………… YIA-5Fraser, K. H. ……………… O2-5Frazier, O. H. …………… P2A-5Fresiello, L. ……O2-4, O4-3, O4-5Fujii, Y. …………………… O8-4Fujimaki, S. ……………… P1A-7

Fujimiya, T. ……………… P2B-3Fujimoto, K. ……………… PS-7Fujino, T. ………………… P2B-6Fujioka, M. ……………… P1B-4Fujita, K. …………………… PS-9Fujita, T. …………………… O6-6Fujiwara, T. ……… O3-RF2, O5-5Fukahara, K. …………… P2B-1Fukamachi, K. …O1-3, O2-Keynote, O2-RF3, O4-4, O8-RF3, O9-4, P1A-3,

P1A-4Fukumoto, K. J. ……………O8-4

GGao, S. …………… O2-RF3, O9-4Garrick, K. M. ………………O6-3Gasparovic, H. …………… O1-1Gawlikowski, M. … P2A-3, P2A-4Geube, M. ………………O8-RF3Ghodrati, M. …… PS-10, O14-4Gomibuchi, T. ……………… PS-5Gonsior, M. ……… P2A-3, P2A-4Goto, D. …………………… O5-2Graefe, R. ………………… O4-3Grande-Allen, J. ………… P2A-5Granegger, M. …………… YIA-5Gregory, S. …… O7-RF2, P1B-6,

P2A-2Gregory, S. D. ……… O4-5, O6-3,

O11-4, O14-Keynote, O14-3Gross, C. …… O4-Keynote, O13-5

HHagiwara, N. ……………… O6-6Hanada, S. ……………… O14-5Hara, S. …………………… O8-4Hartner Z. ………… O5-KeynoteHata, H. ………O1-2, O3-5, O6-4Hatano, M. ………… PS-9, O6-6,

O8-Keynote, O9-5, O10-2Hatori, K. ……………… P1B-2Hellers, G. ………………O2-RF2Hennessy-Strahs, S. … PS-3, O11-2Hensch, L. …………O9-3, O13-1Higo, T. ………………… P2B-6

156

Hijikata, W. ……… YIA-4, PS-1, PS-4, O5-5

Hiraoka, D. ……………… P2B-2Hirata, M. ……… O11-KeynoteHirayama, K. …………… P2B-6Homma, A. ……………… O14-5Horio, N. ………………… P1B-5Horiuchi, H. ……… PS-1, P1A-7Horvath, D. ………O2-RF3, O4-4,

O9-4, P1A-3, P1A-4Hoshino, Y. … O6-2, O9-5, O12-5Hosoya, Y. ………………… PS-9Hou, H. W. ……………… O12-4Hübler, M. ……………… YIA-5Hui, S. …………………… O13-1Hui, S. R. ……………………O9-3Hyakutake, T. ……………… O5-2

IIbe, T. …………………… P2B-7Ichiba, S. …………… O8-KeynoteIchimura, H. ……………… PS-5Iizuka, K. ………… YIA-2, O13-2Ikejiri, K. ………………… P1B-4Imai, H. ………………… P1B-4Imamura, T. ……………… O11-3Inafuku, H. …………… O12-RF2Inoue, Y. ………… O10-4, O14-2Inui, T. …………………… P2B-2Ishida, K. ………………… P2B-3Isoyama, T. ………………… O8-4Ito, A. …………………… P1B-4Ito, H. ……………… PS-7, P1B-4Iwahana, T. ……………… O13-4Iwasaki, K. ……… O11-KeynoteIwasaki, W. ………………… O7-4Iwashita, Y. ……………… P1B-4

JJacobs, S. …………………… O6-5Jeevanandam, V. ………… O11-3Jiang, M. ………………… YIA-4Jorde, U. P. ……………… O11-3Jun, T. ……………………… O9-3

KKainuma, S. … O1-2, O3-5, O6-4,

O10-3Kakuta, Y. ………………… O3-4Kaliyev, R. … PS-8, O10-1, P1B-1Kanaya, T. …………………O9-2Kapis, A. ………………… P2A-3Kapyshev, T. …PS-8, O12-RF3, P1B-1Karimov, J. …… O2-RF3, O9-4,

O4-4, P1A-3, P1A-4Karimov, J. H. ………O2-Keynote,

O8-RF3Kasahara, S. …………… P1B-5Kashiwazaki, T. ………… P2A-7Katagiri, N. ………… O3-4, O8-6Kato, H. ………………… P2B-5Kawada, S. ……………… P1B-5Kawamura, A. ……………… O6-4Kawamura, T. ……………… O6-4Kawano, M. ……………… P1B-2Khalpey, Z. ………………… O4-6Khienwad, T. …………… PS-10Ki, K. K. ………………… P1A-2Kids, T. …………………… O9-2Kilmax, S. E. ……………O8-RF3Kim, G. ………………… O11-3Kimura, K. ………………O3-RF3Kimura, M. … O6-2, O9-5, O10-2,

O12-5Kinoshita, O. ……… O6-2, O9-5,

O10-2, O12-5Kinugawa, K. …………… P2B-1Ko, K. H. K. …… P1B-6, P2A-2Ko, T. ……………………… PS-9Kobayashi, Y. …… O13-4, P1B-5Koda, Y. ………………… P2A-7Kohno, H. ……… O13-4, P2B-2Kokame, K. ……………… P1A-7Komae, H. … O6-2, O9-5, O12-5Komatsu, M. ……………… PS-5Komatus, M. ……………O3-RF3Komuro, I. … PS-9, O6-6, O10-2Kondo, K. ………………… O7-4Kosaka, R. ………… O5-2, O5-6,

O7-4, P1A-6

Kostousov, V. ………O9-3, O13-1Kotani, Y. ……………… P1B-5Kozaki, S. ……………… P1B-2Kroll, H. ……………………O5-3Kuban, B. …………O2-Keynote,

O2-RF3, O9-4, P1A-3, P1A-4Kuban, B. D. ………………O4-4Kubota, S. ……………… P2B-5Kumagai, K. …………… P2B-4Kuniyoshi, Y. ………… O12-RF2Kuratani, T. ……O1-2, O3-5, O9-2Kuroki, H. ………………O3-RF2Kuroko, Y. ……………… P1B-5Kurosawa, H. …………… P2B-3Kurtyka, P. ……… P2A-3, P2A-4Kusadokoro, S. ………… P2B-7Kustosz, R. ……… P2A-3, P2A-4Kuwabara, K. ……………O3-RF3Kuwana, K. ………………… O5-2Kvernebo, K. ……………O8-RF3

LLaufer, G. ……… O12-KeynoteLemme, F. ……………… YIA-5Lesbekov, T. ……… PS-8, P1B-1Li, M. ……………… PS-6, O5-4Li, Z. …………………… O11-4Liao, S. ………… PS-2, O7-RF2,

O11-4, O14-3Lin, F. …………………… P2A-6Long, J. W. ………………… O7-6Lopata, R. ……………… O13-3Lovell, N. ………………… O4-2

MMa, X. …………………… P2A-6Ma, Y. …………………… P2A-6Machida, K. ………………… PS-5Maki, H. …………………… PS-9Makita, R. ……………… P2A-7Malojcic, B. ………………… O1-1Maruyama, O. ……… PS-1, O5-2,

O5-6, O7-4, P1A-6Maruyama, T. ……………… O5-5Masuzawa, T. …………… YIA-6,

O7-Keynote, O7-5, P1A-6

157

Matsuhashi, Y. …… O11-KeynoteMatsui, Y. ……………… P2B-5Matsumiya, G. …… O13-4, P2B-2Matsumoto, M. ………… P1A-7Matsuura, K. …………… P2B-2Maurer, A. ……………… PS-10Maw, M. …… O4-Keynote, O4-5,

O13-5McCree, D. ………………… O2-5Medart, D. ………………… O5-3Medressova, A. … YIA-3, O12-RF3Mehra, M. ……………… O11-3Meyns, B. ………… O2-4, O4-3,

O4-5, O6-5Mikoshiba, T. ……………… PS-5Milicic, D. ………………… O1-1Minegishi, S. ……… O6-2, O9-5,

O12-5Mitamura, Y. …………… O14-2Miyagawa, S. ……… O1-2, O3-5,

O6-4, O10-3Miyamoto, S. …………… P1B-2Miyamoto, T. O1-3, O2-Keynote,

O2-RF3, O4-4, O8-RF3, O9-4, P1A-3, P1A-4

Mizuno, T. …… YIA-2, O3-RF2, O3-4, O8-6, O13-2, O14-5,

P1A-5, P2A-8Moazami, N. ……………O8-RF3Moiia, Y. R. ……… O10-5, O11-5Mondee, K. ………………… O1-5Monobe, S. ……………… P2B-7Mori, K. ………………… P1B-2Morita, H. …………O6-6, O10-2Morita, N. …………………O7-4Moscato, F. …PS-10, O4-Keynote,

O4-5, O5-Keynote, O12-Keynote, O13-5, O14-4

Motoki, H. ………………O3-RF3Munoz, F. ………………… PS-2Murashige, T. …… YIA-4, PS-4,

O5-5Murphy, M. ………………… O1-3Murzagaliyev, M. …… O12-RF3Mutsuga, M. ……………… PS-7

NNaber, J. …………………… O1-3Naganuma, M. …………… P2B-4Naito, N. ………………… O13-2Naiyanetr, P. ………………O1-5Najar, A. … O2-RF2, O2-4, O2-5Najm, H. …………………… O9-4Nakai, H. ………………… P2A-7Nakajima, J. … O8-Keynote, O8-4Nakamura, M. …………… P2B-1Nakao, K. ………………… O8-4Narita, Y. …………………… PS-7Nawata, K. … O6-2, O9-5, O10-2,

O12-5Necid G. …………… O5-KeynoteNeidlin, M. ……………… O11-4Nievergeld, A. H. ………… O8-5Niinami, H. ……………… O13-2Nishida, M. ………… O5-2, O5-6,

O7-4, P1A-6Nishimura, T. …………… YIA-2,

O7-Keynote, P2A-7Nishinaka, T. …………… O13-2Nomura, S. ………… PS-9, O6-6Novikova, S. ……PS-8, O12-RF3Nurmykhametova, Z. ………PS-8,

O10-1, P1B-1Nusem, E. ……… P1B-6, P2A-2

OObonyo, N. G. ……………… O6-3Ogata, A. …………………… O5-5Ohashi, N. ………………… PS-5Ohnuma, K. ……………… O14-5Ohuchi, K. ……… O3-RF2, O5-5Oi, K. ……………………O3-RF2Oishi, K. …………………O3-RF2Okada, K. ……… PS-5, O3-RF3Okada, S. ………………… O13-4Okamoto, E. …………… O14-2Okuda, N. ………………… O9-2Ono, M. …… YIA-2, O6-2, O6-6,

O8-Keynote, O8-4, O9-5, O10-2, O12-5, P2A-8

Ono, T. ……………………… O8-4

Ooka, T. ………………… P2B-5Oorschot, M. v. …………O8-RF2Oota-Ishigaki, A. ………… P1A-6Oqda, V. ………………… P1A-2Orihara, R. ……………… YIA-6Osa, M. …YIA-6, O7-Keynote, O7-5

PPahlm, F. ……O2-RF2, O2-4, O2-5Palomares, D. …………… O10-5Palomares, D. E. ………… YIA-1Pappalardo, F. …… O11-5, O12-4Passmore, M. R. ………… P1A-2Pauls, J. P. ……………… O6-3,

O14-Keynote, O14-3Pederson, S. ………………… O6-3Peeters, K. M. ……………O8-RF2Petricevic, M. ……………… O1-1Petterson, N. …………… O13-3Pieper, I. L. ………O2-RF2, O2-4,

O2-5Pozzi, L. ………………… O12-4Puyvelde, J. V. ……………… O6-5Pya, Y. …… YIA-3, PS-8, O10-1,

O12-RF3, P1B-1Pydzinski, P. …………… P2A-4

RRasponi, M. ……………… O12-4Redaelli, A. ……… O11-5, O12-4Rega, F. …………………… O6-5Riebandt, J. ……… O12-KeynoteRodgers, D. ……………… O11-3Roka-Moiia, Y. ………… YIA-1Rosalina, T. T. ……………O8-RF2Rungsirikunnan, C. ………… O1-5Rutten, M. ……………… O13-3Rutten, M. C. ……O8-RF2, O8-5

SSaiki, Y. …… PS-1, P1A-7, P2B-4Sakashita, Y. …………… O10-3Sakata, Y. …………………… O3-5Sakatsume, K. ……………… PS-1Sakota, D. ……PS-1, O5-2, O5-6,

O7-4, P1A-6

158

Salamonsen, R. ………… O14-3Sampaio, L. C. ………… P2A-5Samura, T. …………………O1-2Sasaki, K. ……………… P1B-4Satokawa, H. …………… P2B-3Sawa, Y. ……… SL2, O1-2, O3-5,

O6-4, O9-2, O10-3Sayer, G. ………………… O11-3Schima, H. ……… YIA-5, PS-10,

O4-Keynote, O4-5, O5-Keynote, O12-Keynote, O13-5, O14-4

Schlöglhofer, T. ……O4-Keynote, O5-Keynote, O12-Keynote,

O13-5 Schweiger, M. …………… YIA-5Seki, T. ………………… P2B-5Seto, T. ………… PS-5, O3-RF3Seto, Y. ………………… P2B-3Shaimerden, K. ………… YIA-3Sheriff, J. ………… YIA-1, O10-5Shida, S. ……………O5-Keynote,

O7-Keynote, O7-5Shimada, S. … O6-2, O9-5, O12-5Shimamura, J. …………… P2A-8Shimamura, S. ……………… O3-4Shingu, Y. ……………… P2B-5Shinpo, H. ……………… P1B-4Shiose, A. ……………… P2B-6Shiraishi, Y. ……… O10-4, O14-2Shoji, K. …………………… PS-4Shuto, T. ………………… P1B-2Simpson, B. ……………… O11-4Slepian, M. J. ……… SL4, YIA-1, PS-6, O4-6, O5-4, O7-RF3, O10-5,

O11-5, O12-4Smagulov, N. …………… P1B-1Smith, P. A. ……………… P2A-5Smith, T. …………………O7-RF2Snyder, T. ………………… O7-6Someya, T. ………………… SL1Song, Y. ………… P1A-1, P2A-1Stanfield, R. ………………O7-6Stephens, A. …O14-Keynote, O14-3Stevens, M. ………………… O4-2Stevens, M. C. ……………… O4-5Straker, K. ……… P1B-6, P2A-2

Suen, J. Y. ……………… P1A-2Sugawara, S. …………… P1A-7Sumikura, H. …………… O14-5Suzuki, K. ……………… P1B-4Suzuki, Y. ……………… P2B-4Sweedo, A. ……………… YIA-1

TTaira, M. …………………… O9-2Tajima, T. ……………… P1B-2Taka, H. ………………… P1B-5Takahashi, A. …… O11-KeynoteTakahashi, G. …………… P2B-4Takase, S. ……………… P2B-3Takaya, H. ……………… P2B-4Takemura, M. …………… P2B-7Takeshita, M. ……………O3-RF2Takewa, Y. … YIA-2, O3-4, O8-6,

O13-2, O14-5, P1A-5, P2A-8Tanaka, H. … PS-5, P1B-2, P2A-7Tanoue, Y. ……………… P2B-6Tansley, G. ………… PS-2, O4-5,

O6-3, O14-Keynote, P1A-2Tansley, G. D. …………… O14-3Tatsumi, E. ……… YIA-2, YIA-6,

O3-4, O7-Keynote, O8-6, O13-2, O14-5, P1A-5, P2A-8

Tauekelova, A. ……… O12-RF3Terazawa, S. ……………… PS-7Teruya, J. ………………… O13-1Thomson, B. ……………… O6-3Tobita, T. …………………… O6-6Toda, C. …………………… O9-2Toda, K. …… O1-2, O3-5, O6-4,

O10-3Tokuda, Y. ………………… PS-7Tong, M. Z. ………………O8-RF3Tran, V. …………………O8-RF3Tsuji, M. ………………… O10-2Tsukiya, T. … YIA-2, O3-4, O8-6,

O13-2, O14-5, P1A-5, P2A-8Tsutsui, H. ……………… P2B-6

UUchida, W. ………………… PS-7

Ueda, H. ………………… P2B-2Uemura, Y. ………………… PS-9Ueno, T. …………… O1-2, O3-5Ugolini, G. S. …………… O12-4Umezu, M. ……… O11-KeynoteUno, T. ……………………… O9-2Uriel, N. ………………… O11-3Ushijima, T. ……………… P2B-6Usui, A. …………………… PS-7

VVerbeken, E. ……………… O6-5Vincent, D. ………………… O1-3Vladovich, T. ……………… O7-6Vosse, F. N. v. d. ……… O8-RF2,

O8-5, O13-3

WWada, H. ………………… P2B-7Wada, T. ………………… P1B-2Wada, Y. ………… PS-5, O3-RF3Wakabayashi, Y. ………… P2B-2Wakamatsu, H. ………… P2B-3Walk, R. ……………O5-4, O10-5Wang, Y. ………………… P2A-5Watanabe, K. …………… P2B-4Watanabe, M. …… O13-4, P2B-2Watanabe, T. ……………… O9-2Wi, J. …………………… P1B-3Wiedemann, D. … O12-KeynoteWieselthaler, G. ……O6-KeynoteWrigley, C. ……… P1B-6, P2A-2Wu, E. L. ……O4-5, O11-4, O14-3Wu, P. ………………………O1-4

XXu, J. …………… P1A-1, P2A-1

YYakita, Y. ………………… P2B-2Yamada, A. ……………… O10-4Yamaguchi, A. …………… P2B-7Yamamoto, A. …………… P2B-3Yamamoto, T. ……………… PS-5Yamamoto, Y. ……………… O5-2

159

Yamane, T. ………… SL3, O5-2, O5-6, P2A-7

Yamauchi, H. ……… O6-2, O9-5, O12-5, P1B-2

Yamazaki, K. …… O11-KeynoteYambe, T. ……… O10-4, O14-2Yano, T. ………………… O14-2Yashima, M. ……………O3-RF2Yin, C. …………………… P2A-6Yokoyama, H. …………… P2B-3Yokoyama, S. …………… P2B-1Yoshida, S. ………… O1-2, O3-5,

O6-4, O10-3Yoshikawa, Y. ……… O1-2, O3-5,

O6-4, O10-3Yoshioka, D. ……… O1-2, O3-5,

O6-4, O10-3Yoshioka, I. ……………… P2B-4

ZZalewski, J. ……… P2A-3, P2A-4Zapusek, L. ……… O12-KeynoteZhambylov, A. ………… O12-RF3Zhang, X. ……………… P1A-1Zhao, D. ………………… P2A-6Zhao, T. ………………… P2A-1Zhu, C. ………………… P1A-1Zieliński, K. ……………… O2-4Zimpfer, D. …………O4-Keynote,

O5-Keynote, O12-KeynoteZonta, F. ………… PS-10, O14-4Zuo, Y. ……………………… PS-1

160

－－161

MEMO

－－162

－－163

－－164

▪ Only VAD approved for pediatric patients▪ Uni- and biventricular support▪ Suitable for all ages, from newborns to

teenagers

EXCOR® PediatricThe Ventricular Assist Device for Children

*Ono, M., et al. (2018). Long-term Results of Berlin Heart EXCOR Pediatric Implantation in Japan. The Journal of Heart and Lung Transplantation, 37(4), S409-S410.

Excellent long-term results in Japan*

„The positive results support our satisfying experiences with the EXCOR

®

Pediatric system.“Minoru Ono MD, Congress Chair ISMCS 2018

Methods:▪ n= 29 patients▪ Age= 54d - 13y (Ø 26m)

Results:▪ Support duration: Ø 308d▪ 16 of 29 transplanted▪ 3 of 29 weaned▪ No disabeling strokes▪ No deaths on device

－－165

▪ Only VAD approved for pediatric patients▪ Uni- and biventricular support▪ Suitable for all ages, from newborns to

teenagers

EXCOR® PediatricThe Ventricular Assist Device for Children

*Ono, M., et al. (2018). Long-term Results of Berlin Heart EXCOR Pediatric Implantation in Japan. The Journal of Heart and Lung Transplantation, 37(4), S409-S410.

Excellent long-term results in Japan*

„The positive results support our satisfying experiences with the EXCOR

®

Pediatric system.“Minoru Ono MD, Congress Chair ISMCS 2018

Methods:▪ n= 29 patients▪ Age= 54d - 13y (Ø 26m)

Results:▪ Support duration: Ø 308d▪ 16 of 29 transplanted▪ 3 of 29 weaned▪ No disabeling strokes▪ No deaths on device

－－166

－－167

EVAHEART 2 & Double Cuff Tip-Less Cannula

Sun Medical Technology Research Corp.

2990 Shiga, Suwa-shi, Nagano 392-0012 Tel: 0266-54-1900 / Fax: 0266-58-6443 http://www.evaheart.co.jp/

－－168

ABSTRACTBOOK

MEANINGFULINNOVATION

© Medtronic Japan Co., Ltd. 2018. All Rights Reserved.

medtronic.co.jp

販売名 / 医療機器承認・認証番号C315 デリバリーカテーテル / 22400BZX00372000　メドトロニック Reveal LINQ / 22800BZX00111000　Arctic Front Advance冷凍アブレーションカテーテル/22600BZX00062000 　メドトロニックペイシェントコネクタ/22800BZX00306000　Micra 経カテーテルペーシングシステム/22900BZX00047000　Claria MRI CRT－Dシリーズ / 22900BZX00362000　Visia AF MRI ICDシリーズ / 22800BZX00304000　Medtronic Azure MRIシリーズ / 23000BZX00027000　Serena MRI CRT-Pシリーズ / 23000BZX00139000　Freezor 冷凍アブレーションカテーテルシリーズ /22700BZX00252000　メドトロニックケアリンクエクスプレスモバイルアプリケーション/228ADBZX00094000

日本メドトロニック株式会社CRHF事業部 108-0075 東京都港区港南1-2-70

26th Annual Meeting of the International Society for M

echanical Circulatory Support (ISMCS2018) ABSTRACT BO

OK

HILTON

TOKYO

OD

AIBA, Japan

表紙.indd 1 2018/10/24 16:00:11

abstract book - jcs / 日本コンベンション ...€¦ · c/o japan convention services, inc....

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