經(jīng)股動脈vs經(jīng)心尖部主動脈瓣置換術(shù)-那種創(chuàng)傷更小

EricE.Roselli,MD聲明Medtronic 顧問Edwards 研究者DirectFlowMedical 顧問EdwardsSapienUS試驗,CE標志22-24Fr鞘管CorevalveCE標志18Fr鞘管其他尚未投入使用主動脈狹窄和PVD患者的一般情況與胸主動脈瘤疾病類似鞘管20–25Fr髂動脈導(dǎo)管 7–15%JACC,2007Corevalve鞘管18Fr使用21Fr鞘管并發(fā)癥的發(fā)生率為9.6%，使用18Fr鞘管后發(fā)生率下降至1.9%EdwardsTHV

臨床研究EdwardsSAPIENexperienceaddresseseachClinicalresearchstage可行性合理，安全且有效隨機對照

和對照組相比有效l(AVR&藥物治療)上市后

評估商業(yè)利用情況長期隨訪

RECAST

I-REVIVETRAVERCE*

REVIVEIIREVIVALIITRAVERCEPARTNEREU#

PARTNERIDE

PARTNEREUSOURCE*=AmendedfromFIMtoFeasibility

#=AmendedfromFeasibilitytoPost-MarketREVIVEandREVIVALII

可行性研究REVIVALII包括

備選入路:經(jīng)心尖1/3rd

患者篩查后發(fā)現(xiàn)股動脈入路條件較差經(jīng)股動脈AVR匯總分析

REVIVE&REVIVALII(n=161)年齡(y) 83.5±5.9(66-96) ≥90y 14.3%(23) ≥80y 75.2%(121)平均EuroSCORE對數(shù) 30.7%±15.2平均STSScore(只有REVIVAL) 13.1%±7.2

經(jīng)心尖部AVR

REVIVALII(n=40)年齡(y) 83.7±5.2(69–93)

≥90y 10% ≥80y 70%平均EuroSCORE對數(shù) 35.5±15.3平均STS評分(只有REVIVAL) 13.4±7.0更多CVDz,PVDz,COPD盡管風險評分類似，但患者群體并不相同*OnepatientonCVVHDpriortovalveimplantation血管并發(fā)癥25(15.5%)腎功能衰竭需要透析治療2(1.2%)*永久起博8(4.9%)經(jīng)股動脈AVR匯總分析

REVIVE&REVIVALII(n=161)經(jīng)心尖入路在CCF并沒有心室出血

4.8%transverse血管并發(fā)癥VascularComplications(n=25)Perforations(n=12)AorticDissection(n=3)FlowLimitingIliacDissection(n=4)AvulsedIliacArtery(n=3)下肢缺血

(n=4)涂層支架-3SurgicalBypass-3藥物

-2藥物

-23例死亡2例死亡2例死亡2例死亡VascularComplications(n=25)Perforations(n=12)主動脈夾層

(n=3)髂動脈夾層，血流受限(n=4)髂動脈撕脫y(n=3)血管并發(fā)癥(n=25)穿孔(n=12)死亡率36%vs10%w/o血管并發(fā)癥numberatrisk13129622Yes120968860139No91.4%[86.7,96.0]82.9%[76.6,89.3]78.2%[71.0,85.4]72.7%[54.1,91.3]63.3%[43.0,83.6]46.0%[23.8,68.3]LogRankP=0.0004絕對不能發(fā)生血管入路的并發(fā)癥使入路更簡便:

髂動脈導(dǎo)管基本假設(shè)創(chuàng)傷更小

急性風險更少

死亡率

并發(fā)癥無法穿過-3納入161例患者釋放不成功

n=19無法進入-9換瓣成功率

88.2%23mmValve(55)心臟穿孔-326mm瓣膜(87)61.3%38.7%位置錯誤/血栓形成-2麻醉并發(fā)癥-2SuccessfulDeployment

n=14223mm

瓣膜(55)釋放成功

n=142SlidecourtesyofSusheelKodaliRetroFlexII輸送系統(tǒng)

AddressesCrossing冠狀動脈堵塞

移植瓣膜返流由于瓣葉懸吊所致i.e.瓣膜太低體外模擬和災(zāi)難性事件的預(yù)案危急情況的搶救方案瓣膜血栓形成冠狀動脈開口堵塞瓣膜功能障礙BAV后出現(xiàn)重度AI導(dǎo)致失代償循環(huán)支持SlidecourtesyofJohnWebbVancouver的經(jīng)驗SlidecourtesyofJohnWebbTRAVERCE:換瓣成功率:93%168例患者換瓣成功

N=156換瓣不成功N=1223mm

n=43

26mmn=113TRAVERCE:

中轉(zhuǎn):7%

位置錯誤

過低

過高

422

瓣膜返流

遠端

心室321

主動脈關(guān)閉不全

中央返流

>3+

瓣周漏

>2+由于瓣環(huán)撕裂所致

瓣周加中央返流6222

升主動脈夾層1

二尖瓣腱鎖糾結(jié)112例患者15起事件SlidemodifiedfromThomasWaltherTA學(xué)習曲線

(n=175)

TRAVERCE98±2%

88±3%

71±4%

73±4%

Pat.1-120,2Pts(CPR)excludedES29%,STS14%Pat.121-177ES37%,STS13%30days6months1yearSlidecourtesyofThomasWalther無中風*置換成功

=設(shè)備成功輸送并釋放

書后AVA>0.9cm2，AI<2+PARTNEREU經(jīng)股動脈心室血栓形成(n=1)主動脈血栓形成

(n=1)23mmSAPIEN瓣膜N=2526mmSAPIEN瓣膜N=27置換失敗n=2換瓣的患者數(shù)n=54置換成功*n=52計劃納入患者數(shù)n=60血管入口(n=3)BAV失敗

(n=2)活動性心內(nèi)膜炎(n=1)96.3%SlidecourtesyofT.LefèvrePARTNEREUTF

并發(fā)癥并發(fā)癥(n)手術(shù)當中<30天>30天心肌梗死102中風021腎功能衰竭(透析)021心律失常需要治療600新的起博器010心源性休克100充血性心力衰竭001血管事件872瓣膜血栓形成200NonHierachicalRankingSlidecourtesyofT.LefèvreSAPIEN?THV商業(yè)經(jīng)驗

&SOURCE注冊

治療的患者人數(shù):7232007.11-2008.12SlidecourtesyofT.Lefèvre34心臟介入中心598植入15%的患者簽署代理協(xié)議TheSOURCERegistry

SlidecourtesyofT.LefèvreTHV學(xué)習曲線

植入成功的百分數(shù)%SlidecourtesyofT.Lefèvre比較經(jīng)股動脈經(jīng)心尖切口腹股溝/經(jīng)皮胸部微型切口優(yōu)點LOS更短到瓣膜的途徑Retrograde順行性優(yōu)點可穿過性主動脈弓部的操作較多較少優(yōu)點中風發(fā)生率更低輸送長度長短優(yōu)點移位更少TA是否優(yōu)于TF?不是!腋動脈導(dǎo)管

避免跨越主動脈弓ConduitAxillarya.下一代設(shè)備結(jié)構(gòu)更簡單-創(chuàng)傷更小可以重新定位/可退出瓣周主動脈瓣返流更少而且，患者的選擇也會不斷的變化結(jié)論June3-52009InterContinentalHotel&

BankofAmericaConferenceCenterCleveland,OhioSessionswillinclude:?AorticDisease?CoronaryArteryDisease?ValvularDisease?Electrophysiology?HeartFailure?Prevention?Imaging?Heart-BrainMedicine?VascularDisease?TransplantationThisactivityhasbeenapprovedforAMAPRACategory1Credit.?TransfemoralVsTransapicalValves–WhichisLessInvasive?EricE.Roselli,MDDisclosureMedtronic ConsultantEdwards InvestigatorDirectFlowMedical ConsultantPercutaneousAorticValvesEdwardsSapienUSTrial,CEMark22-24FrSheathsCorevalveCEMark18FrSheathOthersonthewayAorticStenosisandPVDPtprofilesimilartothoracic aneurysmaldiseaseSheaths20–25FrIliacConduit 7–15%JACC,2007CorevalveSheath18FrAccesscomplicationsdownto1.9%from9.6%with21FrEdwardsTHV

ClinicalInvestigationsEdwardsSAPIENexperienceaddresseseachClinicalresearchstageFirst-in-ManProceduralsuccessinhumansFeasibility

Demonstrate“reasonable”safety&effectivenessRandomizedControl

Effectivenessvs.control(AVR&medicaltherapy)Post-MarketEvaluate

transitionto

commercialuseLong-term

follow-up

RECAST

I-REVIVETRAVERCE*

REVIVEIIREVIVALIITRAVERCEPARTNEREU#

PARTNERIDE

PARTNEREUSOURCE*=AmendedfromFIMtoFeasibility

#=AmendedfromFeasibilitytoPost-MarketREVIVEandREVIVALII

FeasibilityStudies4NorthAmericanand6EuropeanCentersInclusion:>70yearsold severesymptomaticAS EuroSCORE>20 ornon-operableSafetyandEfficacyendpointsFollow-upto24monthsforREVIVALIIREVIVALIIincluded

AlternateAccess:Transapical1/3rdscreenedpoorfemoralaccess12/2006-2/2008Inclusioncriteria:PVDprecludingTFapproachSTS≥15%,orinoperableAoVarea≤0.7cm2>70yrsofageNYHA≥IIPooledTransfemoralAVR

REVIVE&REVIVALII(n=161)

Age(yrs) 83.5±5.9(66-96) ≥90years 14.3%(23) ≥80years 75.2%(121)MeanLogisticEuroSCORE 30.7%±15.2MeanSTSScore(REVIVALOnly) 13.1%±7.2

TransapicalAVR

REVIVALII(n=40)

Age(yrs) 83.7±5.2(69–93)

≥90years 10% ≥80years 70%MeanLogisticEuroSCORE 35.5±15.3MeanSTSScore(REVIVALOnly) 13.4±7.0MoreCVDz,PVDz,COPDPopulationsaredifferentdespitesimilarriskscores*OnepatientonCVVHDpriortovalveimplantationVascularComplications25(15.5%)RenalFailurereq.Dialysis2(1.2%)*PermanentPacemaker8(4.9%)PooledTransfemoralAVR

REVIVE&REVIVALII(n=161)TransapicalAccessVentricularbleeding 0@CCF 4.8%TRAVERSEVascularComplicationsVascularComplications(n=25)Perforations(n=12)AorticDissection(n=3)FlowLimitingIliacDissection(n=4)AvulsedIliacArtery(n=3)LowerExtremityIschemia(n=4)CoveredStent-3SurgicalBypass-9SurgicalRepair-4SurgicalBypass-3Surgery-1Medical-2Surgery-2Medical-23Deaths2Deaths2Deaths2DeathsVascularComplications(n=25)Perforations(n=12)AorticDissection(n=3)FlowLimitingIliacDissection(n=4)AvulsedIliacArtery(n=3)VascularComplications(n=25)Perforations(n=12)Mortality36%vs10%w/oVascularComplicationsnumberatrisk13129622Yes120968860139No91.4%[86.7,96.0]82.9%[76.6,89.3]78.2%[71.0,85.4]72.7%[54.1,91.3]63.3%[43.0,83.6]46.0%[23.8,68.3]LogRankP=0.0004ZeroToleranceforVascularAccessComplicationsPre-proceduralPlanningCriticalAngiographyIntraluminalunderestimatesPoorresolutionofcalciumburdenCTMoreaccuratewithcontrast(toxic)CandelineatecalciumHighresolutionstudyIVUSFacilitatedAccess:

IliacconduitFundamentalAssumptionLessInvasive

LessAcuteRisk Mortality MorbidityUnabletocross-3161PatientsEnrolledUnsuccessfulDeployment

n=19Failedaccess-9ImplantSuccess88.2%23mmValve(55)CardiacPerforation*-326mmValve(87)61.3%38.7%Malplaced/Embolized-2AnesthesiaComplication-2TransfemoralAVR

ProceduralResultsSuccessfulDeployment

n=14223mmValve(55)SuccessfulDeployment

n=142SlidecourtesyofSusheelKodaliRetroFlexIIDeliverySystem

AddressesCrossingREVIVALIITransapical

TechnicalSuccess

87.5%Migration/Embolization 12.5%Failuretocross 0Meandeploymenttime 11.7minMeanproceduretime 87.1minOtherIntra-ProceduralEventsRelatedtoPositioningCoronaryOcclusionProstheticvalveinsufficiencyDuetoleafletoverhangi.e.ValvetoolowIntra-operativeManagementHemodynamicoptimizationpriortostartingJudiciousrapidventricularpacingTEEandfluoroscopyfacilitatepositioningRecognitionoffactorsaffectingplacement:HypertrophiedventricularseptumCalcifiedrootnon-distensiblerootNarrowsino-tubularjunctionBulkycalciumonleafletsIntra-operativeManagementDryrunsanddisasterplanningRescueplansforemergenciesValveembolizationCoronaryostialocclusionProsthesismalfunctionSevereAIafterBAVleadingtodecompensationCirculatorySupportSlidecourtesyofJohnWebbVancouverExperienceTransapicalProceduralsuccess(n=58)SlidecourtesyofJohnWebbTRAVERCE:ImplantSuccess:93%168PatientsSuccessfulImplants

N=156UnsuccessfulImplantswithconversionN=1223mm

n=43

26mmn=113TRAVERCE:

Conversion:7%

Malposition

LowHigh

422

Valve

migration

Distal

Ventricular321

Aortic

InsufficiencyCentralregurgitation

>3+

Paravavlular

leak

>2+duetoannular

tear

Paravalvular¢ral

regurgitation6222

Ascending

aorta

dissection1

Mitral

chordae

entanglement115eventsin12patientsSlidemodifiedfromThomasWaltherTALearningCurve(n=175)

TRAVERCE98±2%

88±3%

71±4%

73±4%

Pat.1-120,2Pts(CPR)excludedES29%,STS14%Pat.121-177ES37%,STS13%30days6months1yearSlidecourtesyofThomasWaltherNoStrokes*Implantsuccess=SuccessfuldevicedeliveryanddeploymentresultinginanAVA>0.9cm2withAI<2+PARTNEREUTF

Ventricularembolization(n=1)Aorticembolization(n=1)23mmSAPIENvalveN=2526mmSAPIENvalveN=27Implantfailuresn=2PatientsImplantedn=54SuccessfulImplants*n=52PatientsPlannedn=60Implantabortedn=6Vascularaccess(n=3)UnsucessfullBAV(n=2)Activeendocarditis(n=1)96.3%SlidecourtesyofT.LefèvrePARTNEREUTF

ComplicationsComplication(n)Intraprocedural<30days>30DaysMyocardialInfarction102Stroke021RenalFailure(Dialysis)021Arrhythmiasrequiringintervention600NewPacemaker010CardiogenicShock100CongestiveHeartFailure001VascularEvents872ValveEmbolization200NonHierachicalRankingSlidecourtesyofT.LefèvreSAPIEN?THVCommercialExperience

&TheSOURCERegistry

Numberofpatientstreated:723November2007-September2008SlidecourtesyofT.Lefèvre34cardiacinterventioncenters598implants15%ofcasesproctoredTheSOURCERegistry

SiteInformation

SlidecourtesyofT.LefèvreTHVLearningCurve

PercentSuccessfulImplant%SlidecourtesyofT.LefèvreComparisonTransfemoralTransapical