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The use of the Bantam α 0.014” PTA Catheter in the pedal plantar loop revascularization of a patient with Critical Limb Ischemia. Dr. Ian Kelly, Consultant Interventional Radiologist, Waterford Regional Hospital, Ireland Highlighted Products. •Bantam α 2 x 120 mm • Nimbus Pico Miu 1.5 x 20 mm •ReeKross 3 x 120 mm • EmboCath Microcatheter (ev3) • V 18 0.018” 300 cm Guidewire (Boston Scientific) • Pilot 0.014” Guidewire Introduction. Angioplasty is now the established first choice treatment in patients with typical patterns diabetic vasculopathy and critical limb ischaemia. They typically have patent proximal vasculature and occlusive crural and distal small vessel disease. 1 Pedal plantar loop technique is an innovative new angioplasty method to revascularise foot vasculature in critical limb ischaemia due to diabetic vasculopathy. 2 It also allows a retrograde approach to subintimal angioplasty of the crural vasculature when an antegrade approach fails or is technically impossible. These techniques often involve time consuming long segment angioplasty. The Bantam α, a tough, long, trackable balloon is a technical advance and invaluable adjunct in performing this procedure. Case Report. A 66 year old male was referred with a six month history of a severe non- healing ulcer on his left heel. He had a 10 year history of type 2 diabetes complicated by retinopathy, neuropathy and nephropathy. He was on haemodialysis. Originally presenting with a grade 2 pressure ulcer, his course was exacerbated by a traumatic subarachnoid haemorrhage and subdural haematoma which made him bedbound. Pressure elements compounded the neuropathic and vasculopathic aetiologic factors and the condition of the ulcer deteriorated markedly. It became entirely resistant to conservative strategies and the patient was facing limb loss. Angiography showed a proximal stenosis of the left anterior tibial artery and a complete occlusion of the posterior tibial. Intervention was intended to restore vascularisation to the calcaneal region by either an antegrade SIA recanalisation of the posterior tibial or a retrograde approach to restore the full plantar arch. After antegrade puncture and introduction of a 5 Fr sheath to the left common femoral artery, it was not possible to recanalate the occluded posterior artery from a conventional antegrade approach. The proximal anterior tibial stenosis was angioplastied to 3 mm and a retrograde approach to the vessel taken after negotiating the plantar arcade with a microcatheter (Embocath EV3) and V-18 wire 300 cm (Boston Scientific). A retrograde route through the occluded lateral plantar and posterior tibial arteries was taken. At the origin of the posterior tibial the wire was exchanged via the microcatheter for a Pilot 014 300 cm wire (Abbott). An attempt to track a Bantam α 2.0 mm x 120 mm balloon was made but two hold up points at the lateral plantar and distal posterior tibial were identified. A rapid exchange Nimbus Pico 1.5 mm x 20 mm predilated these to assist tracking of the Bantam α. The plantar arch, lateral plantar artery and posterior tibial were angioplastied to 2mm. After successfully recanalising the posterior tibial from a retrograde approach it was then possible to further angioplasty its proximal segment with a 3 mm balloon ReeKross 3 mm x 120 mm. The full plantar arch, lateral plantar and posterior tibial artery were restored with good flow. The puncture site was closed with a standard closure device. Fig 1. Lateral and AP views of the left foot. The ulcer was on the posterior lateral aspect of his heel. This territory is near completely devascularised by completely occluded posterior tibial and plantar arteries.

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Page 1: Bantam

The use of the Bantam™ α 0.014” PTA Catheter in the pedal plantar loop revascularization of a patient with Critical Limb Ischemia.

Dr. Ian Kelly, Consultant Interventional Radiologist, Waterford Regional Hospital, Ireland

Highlighted Products. •Bantam™ α 2 x 120 mm•NimbusPicoMiu1.5x20mm•ReeKross™ 3 x 120 mm•EmboCathMicrocatheter(ev3)•V180.018”300cmGuidewire(BostonScientific)•Pilot0.014”Guidewire

Introduction.Angioplastyisnowtheestablishedfirstchoicetreatmentinpatientswithtypicalpatternsdiabeticvasculopathyandcriticallimbischaemia.Theytypicallyhavepatentproximalvasculatureandocclusivecruralanddistalsmallvesseldisease.1Pedalplantarlooptechniqueisaninnovativenewangioplastymethodtorevascularisefootvasculatureincriticallimbischaemiaduetodiabeticvasculopathy.2Italsoallowsaretrogradeapproachtosubintimalangioplastyofthecruralvasculaturewhenanantegradeapproachfailsoristechnicallyimpossible.Thesetechniquesofteninvolvetimeconsuminglongsegmentangioplasty.TheBantam™ α,atough,long,trackableballoonisatechnicaladvanceandinvaluableadjunctinperformingthisprocedure.

Case Report.A66yearoldmalewasreferredwithasixmonthhistoryofaseverenon-healingulceronhisleftheel.Hehada10yearhistoryoftype2diabetescomplicatedbyretinopathy,neuropathyandnephropathy.Hewasonhaemodialysis.Originallypresentingwithagrade2pressureulcer,hiscoursewasexacerbatedbyatraumaticsubarachnoidhaemorrhageandsubduralhaematomawhichmadehimbedbound.Pressureelementscompoundedtheneuropathicandvasculopathicaetiologicfactorsandtheconditionoftheulcerdeterioratedmarkedly.Itbecameentirelyresistanttoconservativestrategiesandthepatientwasfacinglimbloss.Angiographyshowedaproximalstenosisoftheleftanteriortibialarteryandacompleteocclusionoftheposteriortibial.

Interventionwasintendedtorestorevascularisationtothe calcanealregionbyeitheranantegradeSIArecanalisationoftheposteriortibialoraretrogradeapproachtorestorethefullplantararch.Afterantegradepunctureandintroductionofa5Frsheathtotheleftcommonfemoralartery,itwasnotpossibletorecanalatetheoccludedposteriorarteryfromaconventionalantegradeapproach.

Theproximalanteriortibialstenosiswasangioplastiedto3mmandaretrogradeapproachtothevesseltakenafternegotiatingtheplantararcadewithamicrocatheter(EmbocathEV3)andV-18wire300cm(BostonScientific).Aretrograderoutethroughtheoccludedlateralplantarandposteriortibialarterieswastaken.

AttheoriginoftheposteriortibialthewirewasexchangedviathemicrocatheterforaPilot014300cmwire(Abbott).AnattempttotrackaBantam™ α2.0mmx120mmballoonwasmadebuttwoholduppointsatthelateralplantaranddistalposteriortibialwereidentified.ArapidexchangeNimbusPico1.5mmx20mmpredilatedthesetoassisttrackingoftheBantam™ α.Theplantararch,lateralplantararteryandposteriortibialwereangioplastiedto2mm.Aftersuccessfullyrecanalisingtheposteriortibialfromaretrogradeapproachitwasthenpossibletofurtherangioplastyitsproximalsegmentwitha3mmballoonReeKross™3mmx120mm.Thefullplantararch,lateralplantarandposteriortibialarterywererestoredwithgoodflow.Thepuncturesitewasclosedwithastandardclosuredevice.

Fig 1. Lateral and AP views of the left foot. The ulcer was on the posterior lateral aspect of his heel. This territory is near completely devascularised by completely occluded posterior tibial and plantar arteries.

Page 2: Bantam

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use.

Bard, Bantam and ReeKross are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners.Copyright © 2011, C. R. Bard, Inc. All Rights Reserved. 1011/3139

Discussion.CriticallimbischaemiainDiabetesisaformofvasculopathywhichparticularlyafflictstheinfrapoplitealvasculatureinasevereocclusivemanneranddistribution.Itcanbeverydifficulttotreateffectivelyasitischaracterisedbylongcalcifiedoccludedsegmentaldisease.Angioplastyisthefirstchoicelineoftreatmentandhasproventobeeffectiveinminimisingtissuelossandlimbsalvage.1Thepedalplantarlooptechniqueisanewapproachtorevascularisethefootinpatientswithcriticallimbischaemia.2Itisproventoimprovetissueoxygentensionessentialtothehealingprocessinthisverydifficultpatientgroup.3Thenovelrestorationofanativevasculararcadeoffersbimodalinflowperfusioninadditiontooutflowrunoff.Restoringadequatebloodflowtothefootparticularlytoaffectedterritoriesisessentialtopromotehealing.4Thisisoftennotpossiblewithconventionaltechniquesandtheplantarloopoffersanewapproachtorevascularisation.

Theretrograderecanalisationinthiscaseallowedcalcanealreperfusionwithoutaspecificsecondarypercutaneouspuncture.HavingadditionvesselpatencyistothebenefitofpatientswithCLIasthegreaterthenumberofinflowvesselsthatcanberevascularisedthegreaterthechancesoflimbsalvage.Inthiscasetheextentofterritoryneedingangioplastywaslonganddifficulttogetto.Thefacilityofbeingabletotrackaballoonofthisconsiderablelengthinthismannerwasamajoradjunctinmakingittechnicallyfeasible.Italsoshortenedtheproceduretimeconsiderably.

AUSTRIA Bard Medica SA, Thaliastrasse 125A/1/5, 1160 Wien, Austria. Tel: +43 14 949130. Fax: +43 14 94913030.BENELUX Bard Benelux n.v., Hagelberg 2, 2250 Olen, Belgium. Tel: +32 14 286950. Fax: +32 14 286955.CZECH REPUBLIC Bard Czech Republic s.r.o., Taborska 619, 140 00 Prague, Czech Republic. Tel: +420 242 408620. Fax: +420 242 408621.FRANCE Bard France SAS, Av. Joseph Kessel 164-166, Parkile P14, 78960 Voisins-le-Bretonneux, France. Tel: +33 1 39305858. Fax: +33 1 39305859.GERMANY C. R. Bard GmbH, Wachhausstrasse 6, 76227 Karlsruhe, Germany. Tel: +49 721 94450. Fax: +49 721 9445111.GREECE Bard Hellas SA, 22, Alkiviadou St & 72, Vouliagmenis Av, 16675 Glyfada, Greece. Tel: +30 210 9690770. Fax: +30 210 9628810.ITALY Bard S.p.A., Via Cina 444, 00144 Roma, Italy. Tel: +39 06 524931. Fax: +39 06 5295852.NORDIC Bard Norden AB, Karbingatan 22, 254 67 Helsingborg, Sweden. Tel: +46 42 386000. Fax: +46 42 386010.POLAND Bard Poland sp. z o.o., ul. Cybernetyki 7b, 02-677 Warszawa, Poland, Tel: +48 22 3210930, Fax: +48 22 3210938PORTUGAL C. R. Bard Portugal, LDA, Rua Castilho 13D-2A, 1250-066 Lisboa, Portugal. Tel: +351 21 3190330. Fax: +351 21 3190339.SPAIN Bard de Espana S.A., Avda. Diagonal 652-656, Edificio A, 4a planta, 08034 Barcelona, Spain. Tel: +34 93 2537800. Fax: +34 93 2537834.SWITZERLAND Bard Medica SA, Seestrasse 64, 8942 Oberrieden/Zürich, Switzerland. Tel: +41 44 7225360. Fax: +41 44 7225370.UK Bard Limited, Forest House, Tilgate Forest Business Park, Brighton Road, Crawley, West Sussex RH11 9BP, UK. Tel: +44 1293 527888. Fax: +44 1293 552428.

References

1. Faglia E et al.PeripheralAngioplastyastheFirst-choiceRevascularizationProcedureinDiabeticPatientswithCriticalLimbIschemia:EurJVascEndovascSurg2005;29:620-627.

2. Manzi M.Pedal-PlantarLoopTechnique.Anewtechniqueforrevascularisationoffootvessels.EndovascularTo-dayMarch2009.

3. Manzi M et al.ClinicalResultsofBelowtheKneeInterventionUsingPedal-PlantarLoopTechniquefortheRevascularizationofFootArteries; ManziMetalJCardiovascSurg2007;48.

4. Norgren L et al.Inter-societyconsensusforthemanagementofperipheralarterialdisease(TASC2).J.VascSurg2007;45(Suppl):S5-67.

Fig 2. Retrograde transplantar arch approach to posterior tibial SIA recanalisation.

Fig 3. Pedal Plantar loop angioplasty with the Bantam™ α 2 mm x 120 balloon.

Fig 4. Lateral and AP views of the restored pedal plantar loop and posterior tibial artery.