经股动脉vs经心尖部主动脉瓣置换术-那种创伤更小

EricE.Roselli,MD声明Medtronic 顾问Edwards 研究者DirectFlowMedical 顾问EdwardsSapienUS试验,CE标志22-24Fr鞘管CorevalveCE标志18Fr鞘管其他尚未投入使用主动脉狭窄和PVD患者的一般情况与胸主动脉瘤疾病类似鞘管20–25Fr髂动脉导管 7–15%JACC,2007Corevalve鞘管18Fr使用21Fr鞘管并发症的发生率为9.6%，使用18Fr鞘管后发生率下降至1.9%EdwardsTHV

临床研究EdwardsSAPIENexperienceaddresseseachClinicalresearchstage可行性合理，安全且有效随机对照

和对照组相比有效l(AVR&药物治疗)上市后

评估商业利用情况长期随访

RECAST

I-REVIVETRAVERCE*

REVIVEIIREVIVALIITRAVERCEPARTNEREU#

PARTNERIDE

PARTNEREUSOURCE*=AmendedfromFIMtoFeasibility

#=AmendedfromFeasibilitytoPost-MarketREVIVEandREVIVALII

可行性研究REVIVALII包括

备选入路:经心尖1/3rd

患者筛查后发现股动脉入路条件较差经股动脉AVR汇总分析

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

经心尖部AVR

REVIVALII(n=40)年龄(y) 83.7±5.2(69–93)

≥90y 10% ≥80y 70%平均EuroSCORE对数 35.5±15.3平均STS评分(只有REVIVAL) 13.4±7.0更多CVDz,PVDz,COPD尽管风险评分类似，但患者群体并不相同*OnepatientonCVVHDpriortovalveimplantation血管并发症25(15.5%)肾功能衰竭需要透析治疗2(1.2%)*永久起博8(4.9%)经股动脉AVR汇总分析

REVIVE&REVIVALII(n=161)经心尖入路在CCF并没有心室出血

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

(n=4)涂层支架-3SurgicalBypass-3药物

-2药物

-23例死亡2例死亡2例死亡2例死亡VascularComplications(n=25)Perforations(n=12)主动脉夹层

(n=3)髂动脉夹层，血流受限(n=4)髂动脉撕脱y(n=3)血管并发症(n=25)穿孔(n=12)死亡率36%vs10%w/o血管并发症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绝对不能发生血管入路的并发症使入路更简便:

髂动脉导管基本假设创伤更小

急性风险更少

死亡率

并发症无法穿过-3纳入161例患者释放不成功

n=19无法进入-9换瓣成功率

88.2%23mmValve(55)心脏穿孔-326mm瓣膜(87)61.3%38.7%位置错误/血栓形成-2麻醉并发症-2SuccessfulDeployment

n=14223mm

瓣膜(55)释放成功

n=142SlidecourtesyofSusheelKodaliRetroFlexII输送系统

AddressesCrossing冠状动脉堵塞

移植瓣膜返流由于瓣叶悬吊所致i.e.瓣膜太低体外模拟和灾难性事件的预案危急情况的抢救方案瓣膜血栓形成冠状动脉开口堵塞瓣膜功能障碍BAV后出现重度AI导致失代偿循环支持SlidecourtesyofJohnWebbVancouver的经验SlidecourtesyofJohnWebbTRAVERCE:换瓣成功率:93%168例患者换瓣成功

N=156换瓣不成功N=1223mm

n=43

26mmn=113TRAVERCE:

中转:7%

位置错误

过低

过高

422

瓣膜返流

远端

心室321

主动脉关闭不全

中央返流

>3+

瓣周漏

>2+由于瓣环撕裂所致

瓣周加中央返流6222

升主动脉夹层1

二尖瓣腱锁纠结112例患者15起事件SlidemodifiedfromThomasWaltherTA学习曲线

(n=175)

TRAVERCE98±2%

88±3%

71±4%

73±4%

Pat.1-120,2Pts(CPR)excludedES29%,STS14%Pat.121-177ES37%,STS13%30days6months1yearSlidecourtesyofThomasWalther无中风*置换成功

=设备成功输送并释放

书后AVA>0.9cm²，AI<2+PARTNEREU经股动脉心室血栓形成(n=1)主动脉血栓形成

(n=1)23mmSAPIEN瓣膜N=2526mmSAPIEN瓣膜N=27置换失败n=2换瓣的患者数n=54置换成功*n=52计划纳入患者数n=60血管入口(n=3)BAV失败

(n=2)活动性心内膜炎(n=1)96.3%SlidecourtesyofT.LefèvrePARTNEREUTF

并发症并发症(n)手术当中<30天>30天心肌梗死102中风021肾功能衰竭(透析)021心律失常需要治疗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商业经验

&SOURCE注册

治疗的患者人数:7232007.11-2008.12SlidecourtesyofT.Lefèvre34心脏介入中心598植入15%的患者签署代理协议TheSOURCERegistry

SlidecourtesyofT.LefèvreTHV学习曲线

植入成功的百分数%SlidecourtesyofT.Lefèvre比较经股动脉经心尖切口腹股沟/经皮胸部微型切口优点LOS更短到瓣膜的途径Retrograde顺行性优点可穿过性主动脉弓部的操作较多较少优点中风发生率更低输送长度长短优点移位更少TA是否优于TF?不是!腋动脉导管

避免跨越主动脉弓ConduitAxillarya.下一代设备结构更简单-创伤更小可以重新定位/可退出瓣周主动脉瓣返流更少而且，患者的选择也会不断的变化结论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