late mitraclip failure: removal technique for leaflet-sparing mitral valve repair

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c 2012 Wiley Periodicals, Inc. 1 SURGICAL TECHNIQUE Late MitraClip Failure: Removal Technique for Leaflet-Sparing Mitral Valve Repair David Rose, M.D., Riccardo D’Ascoli, M.D., Ilaria Chirichilli, M.D., Antonino GM Marullo, M.D., Ph.D.,Michele Toscano, M.D., and Fabio Miraldi, M.D. Department of Cardiocirculatory Pathophysiology, Anesthesiology, and General Surgery, “Sapienza” University of Rome, Rome, Italy; and Department of Biotechnology and Medical-Surgical Sciences, “Sapienza” University of Rome, Latina, Italy ABSTRACT MitraClip system has been recently introduced in clinical practice for percutaneous mitral valve repair in selected patients. In the case of early or late detachment of the device dedicated tools, either with percutaneous or surgical approach, have been developed. We describe a novel technique to atraumatically remove the MitraClip. doi: 10.1111/j.1540-8191.2012.01483.x (J Card Surg 2012;**:1-3) INTRODUCTION We describe a case of a 74-year-old female who was admitted with a diagnosis of severe mitral regurgitation (MR) due to a late partial detachment of a percuta- neous MitraClip device. In June 2010 MitraClip device implantation was successfully performed with a post- procedure mild residual MR. In November 2010 for a severe MR due to partial detachment of the device from the anterior leaflet of the valve, the patient was referred for surgical treatment. The MitraClip removal using standard instrument was unsuccessful and de- tachment was achieved with a technique that spares the posterior leaflet. This approach allowed a success- ful mitral valve re-repair avoiding the necessity of mitral valve replacement. CASE REPORT A 74-year-old female was admitted with a diagnosis of severe MR due to partial detachment of a percuta- neous MitraClip device (Abbott Vascular, Santa Clara, CA, USA). Patient’s medical history began in 2007 with the diagnosis of severe mitral valve regurgitation and persistent atrial fibrillation. In June 2010 MitraClip de- vice implantation was successfully performed with a postprocedure mild residual MR. 1 In November 2010 the patient was symptomatic with dyspnea (NYHA We certify that there is no conflict of interest with any financial orga- nization regarding the material discussed in this article. Address for correspondence: David Rose, M.D., Department of Cardiocirculatory Pathophysiology, Anesthesiology, and General Surgery, “Sapienza” University of Rome, 00161 Rome, Italy. Fax: 00390649972599; e-mail: [email protected] functional class III/IV) and an echocardiogram showed severe MR due to MitraClip detachment from the an- terior leaflet of the valve (Figs. 1 and 2). A second MitraClip implantation was scheduled but the manufac- turer recalled the device and the patient was referred for surgery. Following a median sternotomy, access to the left atrium was obtained via Sondergaard’s groove (Fig. 3). Once the mitral valve was exposed, we tried to open the clip using the technique recommended by Abbott (Fig. 4). Despite using a 8 Fr Frazier suction tube, the re-opening was unsuccessful, therefore we decided to remove the clip separating the gripper by the arm creating as little trauma as possible through a cleavage using a blunt instrument (Fig. 5). When the clip does not open with the device, we recommend de- taching the four pairs of gripper teeth from the side of the atrial leaflets using a spatula, thus avoiding tearing. On the ventricular side we recommend separating the arms of the clip using a right-angled instrument. With this method we spared the posterior leaflet (Fig. 6). The intraoperative aspect of the mitral valve confirmed the tethering mechanism of regurgitation and showed re- dundant fibrotic tissue on the free edge of the anterior leaflet at the level of the MitraClip anchoring site. 2 Af- ter removal of the device and of the fibrotic tissue we identified the insufficiency mechanism as a type I as- sociated with partial tethering of P2 and P3 segments and successfully repaired the mitral valve with isolated annuloplasty through implantation of a complete rigid ring—St. Jude Saddle n 28 (Figs. 7 and 8). At 8 months follow-up the transthoracic echocar- diography confirmed the successful repair of the mitral valve with a residual trivial MR, with in- creased systolic function that correlated to the clinical

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Page 1: Late MitraClip Failure: Removal Technique for Leaflet-Sparing Mitral Valve Repair

c© 2012 Wiley Periodicals, Inc. 1

SURGICAL TECHNIQUE

Late MitraClip Failure: RemovalTechnique for Leaflet-Sparing MitralValve RepairDavid Rose, M.D.,∗ Riccardo D’Ascoli, M.D.,∗ Ilaria Chirichilli, M.D.,∗Antonino GM Marullo, M.D., Ph.D.,† Michele Toscano, M.D.,∗ and Fabio Miraldi, M.D.∗

∗Department of Cardiocirculatory Pathophysiology, Anesthesiology, and General Surgery,“Sapienza” University of Rome, Rome, Italy; and †Department of Biotechnology andMedical-Surgical Sciences, “Sapienza” University of Rome, Latina, Italy

ABSTRACT MitraClip system has been recently introduced in clinical practice for percutaneous mitral valve

repair in selected patients. In the case of early or late detachment of the device dedicated tools, either with

percutaneous or surgical approach, have been developed. We describe a novel technique to atraumatically

remove the MitraClip. doi: 10.1111/j.1540-8191.2012.01483.x (J Card Surg 2012;**:1-3)

INTRODUCTION

We describe a case of a 74-year-old female who wasadmitted with a diagnosis of severe mitral regurgitation(MR) due to a late partial detachment of a percuta-neous MitraClip device. In June 2010 MitraClip deviceimplantation was successfully performed with a post-procedure mild residual MR. In November 2010 for asevere MR due to partial detachment of the devicefrom the anterior leaflet of the valve, the patient wasreferred for surgical treatment. The MitraClip removalusing standard instrument was unsuccessful and de-tachment was achieved with a technique that sparesthe posterior leaflet. This approach allowed a success-ful mitral valve re-repair avoiding the necessity of mitralvalve replacement.

CASE REPORT

A 74-year-old female was admitted with a diagnosisof severe MR due to partial detachment of a percuta-neous MitraClip device (Abbott Vascular, Santa Clara,CA, USA). Patient’s medical history began in 2007 withthe diagnosis of severe mitral valve regurgitation andpersistent atrial fibrillation. In June 2010 MitraClip de-vice implantation was successfully performed with apostprocedure mild residual MR.1 In November 2010the patient was symptomatic with dyspnea (NYHA

We certify that there is no conflict of interest with any financial orga-nization regarding the material discussed in this article.

Address for correspondence: David Rose, M.D., Departmentof Cardiocirculatory Pathophysiology, Anesthesiology, and GeneralSurgery, “Sapienza” University of Rome, 00161 Rome, Italy. Fax:00390649972599; e-mail: [email protected]

functional class III/IV) and an echocardiogram showedsevere MR due to MitraClip detachment from the an-terior leaflet of the valve (Figs. 1 and 2). A secondMitraClip implantation was scheduled but the manufac-turer recalled the device and the patient was referredfor surgery. Following a median sternotomy, access tothe left atrium was obtained via Sondergaard’s groove(Fig. 3). Once the mitral valve was exposed, we triedto open the clip using the technique recommended byAbbott (Fig. 4). Despite using a 8 Fr Frazier suctiontube, the re-opening was unsuccessful, therefore wedecided to remove the clip separating the gripper bythe arm creating as little trauma as possible througha cleavage using a blunt instrument (Fig. 5). When theclip does not open with the device, we recommend de-taching the four pairs of gripper teeth from the side ofthe atrial leaflets using a spatula, thus avoiding tearing.On the ventricular side we recommend separating thearms of the clip using a right-angled instrument. Withthis method we spared the posterior leaflet (Fig. 6). Theintraoperative aspect of the mitral valve confirmed thetethering mechanism of regurgitation and showed re-dundant fibrotic tissue on the free edge of the anteriorleaflet at the level of the MitraClip anchoring site.2 Af-ter removal of the device and of the fibrotic tissue weidentified the insufficiency mechanism as a type I as-sociated with partial tethering of P2 and P3 segmentsand successfully repaired the mitral valve with isolatedannuloplasty through implantation of a complete rigidring—St. Jude Saddle n◦28 (Figs. 7 and 8).

At 8 months follow-up the transthoracic echocar-diography confirmed the successful repair of themitral valve with a residual trivial MR, with in-creased systolic function that correlated to the clinical

Page 2: Late MitraClip Failure: Removal Technique for Leaflet-Sparing Mitral Valve Repair

2 ROSE, ET AL.LATE MITRACLIP FAILURE

J CARD SURG2012;**:1-3

Figure 1. Four chamber apical view (LV, left ventricle; LA,left atrium; RA, right atrium; white arrow, MitraClip on theposterior leaflet).

Figure 2. Echo color-Doppler evaluation showing severe re-gurgitation (LA, left atrium; LV, left ventricle; AA, ascendingaorta; white arrow, MitraClip on the posterior leaflet).

Figure 3. Intraoperative view showing the MitraClip detach-ment from the anterior leaflet of the valve (AL, anterior leaflet;PL, posterior leaflet; white arrow, MitraClip device; head of ar-row, fibrosis tissue on the free edge of the anterior leaflet atthe level of MitraClip anchoring site).

Figure 4. Intraoperative view (White arrow, the instrumentsupplied by the manufacturer for the removal).

Figure 5. Intraoperative view (White arrow, blunt instrumentused for the removal; head of arrow, MitraClip gripper teeth).

Figure 6. Intraoperative view (White arrow, the MitraClip re-moval).

improvement with reduction of NYHA functional classfrom class III/IV to class II.

DISCUSSION

MitraClip has been recently introduced in the treat-ment of MR as an alternative to the standard surgicalapproach. Early and late failures have been describedin the literature mainly related to a partial detachment

Page 3: Late MitraClip Failure: Removal Technique for Leaflet-Sparing Mitral Valve Repair

J CARD SURG2012;**:1-3

ROSE, ET AL.LATE MITRACLIP FAILURE

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Figure 7. Intraoperative view showing the mitral valve repair .

Figure 8. Postoperative echo color-Doppler evaluation show-ing a successful mitral valve repair .

of the device. Patients are recommended for surgeryafter percutaneous MitraClip implantation in the follow-ing situations: (1) inability to successfully reduce MRwith one or two clips; (2) inability to achieve acute pro-cedural success, with residual MR equal to or greaterthan moderate grade; (3) recurrent MR despite an initialacute procedural success; (4) development of anotherindication for cardiac surgery. The first three cases canbe explained by MitraClip displacement, which mightbe due to a combination of progressive left ventricu-lar enlargement with subsequent increased tethering,lack of annuloplasty, incorrect clip positioning, and con-sequent slipping.

Preliminary results from the EVEREST report that30% of patients treated with MitraClip device implan-

tation underwent subsequent MV surgery with a suc-cessful surgical MV repair in 67% of cases.3

A proper clip removal technique is essential to min-imize the risk of damaging the leaflets. Several tech-niques of atraumatic MitraClip removal have been de-scribed. In case of clip removal failure using the well-known technique recommended by Abbott with theFrazier suction tube, one arm of the MitraClip might besteadied with one forceps with careful release of theunderlying leaflet by using a second pair of forceps.Otherwise, a 3/0 polypropylene suture can be gentlyinserted into the two small loops of the lock assemblypositioned at the fulcrum of the clip; the tension be-tween the suture line and the loops should allow theclip opening and therefore the access to the arms andgrippers for a careful separation of the leaflets from themitral device.4

In conclusion, if late MitraClip detachment occursand the supplied device fails to function, we suggestremoving the MitraClip with our technique to avoidcutting the leaflet in order to allow a mitral valvere-repair.

REFERENCES

1. Mauri L, Garg P, Massaro J, et al: The EVEREST II Trial:Design and rationale for a randomized study of the valveMitraClip system compared with mitral valve surgery formitral regurgitation. Am Heart J 2010;160:23-29.

2. Ladich E, Michaels MB, Jones RM, et al: EndovascularValve Edge-to-Edge Repair Study (EVEREST) Investiga-tors. Pathological healing response of explanted MitraClipdevices. Circulation 2011;123:1418-1427.

3. Rogers JH, Yeo KK, Carroll JD, et al: Late surgical mi-tral valve repair after percutaneous repair with MitraClipSystem. J Card Surg 2009;24:677-681.

4. Dang NC, Aboodi MS, Sakaguchi T, et al: Surgical revisionafter percutaneous mitral valve repair with a clip: Initialmulticenter experience. Ann Thorac Surg 2005;80:2338-2342.

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