最新心脏辅助器械发展-中英文课件PPT课件 126页

'心脏辅助器械发展-中英文课件 DEBAKEYROLLERPUMP1954 心脏支持辅助装置的发展历史心脏移植前类脉动式装置完全人工或永久性支持设计DeBakeyVAD–1966LiottaTAH–1969AkutsuTAH–1981Jarvik7TAH-1982 AKUTSUTAH的临床植入1981DentonCooley 1982首例永久性TAH植入 里程碑式的转变:FDA通过了（LVAD）作为最终移植前的过渡治疗1984 心脏大小差异带来的技术限制 TCI-THORATECLVADVictorPoirier1984,1986 NOVACOR-WORLDHEARTPeerPortner1984 持续流动装置的出现SarnsBiomedicus LinearisedRateofRightVentricularFailure0.000.100.200.300.400.500.600-77-1414-30>30DaysafterLVASImplantEvents/Recipient.month REMATCH试验RandomizedEvaluationofMechanicalAssistancefortheTreatmentofCongestiveHeartFailure充血性心力衰竭机械辅助治疗的随机化评估研究 植入到装置失效时间总体平均时间332天(15-632)流入瓣衰竭408天(240-632)动力装置失效285天(15-439)NumberofDays 通过轴流改进装置的小型化/微型化1998GeorgeNoon HeartMateII >2800PatientsImplanted53先期研究488移植前过渡治疗商业性植入Europe:PostCEMarkUS:PostFDAApproval648最终治疗HeartMateII全球临床研究1136主要研究AsofMarch2009n=281(18mofollow-up)Durations413>1year241>1.5year188>2yr42>3yr3>4yr1>5yrDT主要人群随访2年May2009Cohorts:RandomizedvsXVEXVEExchangeSmallptsFDAApprovalApr2008 HeartMateII临床研究有效支持时间(n=281)中位数:155天(最长：5年)平均持续时间:237天181患者年累积支持87%患者出院78%带着支持装置10%在心脏移植后(priortoindexdischarge)77%的使用时间(140例年)为院外使用时间 HeartMateII实际存活曲线Primary(n=133)andCAP(n=146)Cohorts12mo:71±5%6mo:77±4%RemainingatriskPrimary:1334832CAP:1468410PRIMARYCAPAsofSep14,20076mo:87±3%12mo:75±6%PaganietalAHA2007 HeartMateII临床试验移植后存活率移植后30天存活率150/157(96%)移植后一年存活率117/128(91%) HeartMateII临床研究致死因素(56/281) HeartMateII临床研究不良事件 HeartMateII临床研究不良事件UseofRVADorextendedinotropeuse>14days,orstartingafter14days 不良事件发生率比较HMII(n=281)vsHMVEBTT(n=280)11Frazier,Rose,OzetalJTCVS2001 HeartMateII无主要装置失效或置换事件率(BTT,n=281)6mo:96±1%12mo:93±2%18mo:92±3%Remainingatrisk2811317252Paganietal(submitted2008) VentrAssist VentrAssist HeartWare DuraHeart Matthews-Michigan35%LVAD患者出现右室衰竭共197例患者1996–200668例RV衰竭患者中,58例为植入第一代VAD患者,3例为非脉动式LVAD患者。RV衰竭使LVAD患者的死亡几率增加了6倍 Dang-Columbia39%例出现RV衰竭108patients1996–2004CVP的升高是唯一的独立预测因素 Potapov-Berlin17%RV衰竭54patients1998-2006 Potapov–BerlinRV衰竭的危险因素三尖瓣关闭不全右室的解剖形状RV的后负荷脉动式和持续血流装置间无差异 Fitzpatrick-UPenn37%RV衰竭266patients1995-2007 RVFRSRisk(RV衰竭危险评分)需血管加压素-4分AST>80-2分胆红素>2.0-2.5分肌酐>2.3-3分 AbioCorImplantableComponentsThoracicUnitImplantedControllerImplantedTETCoilImplantedBattery 14例患者入选4个中心12例获得成功心脏支持2例出院支持作用时间:53-512days(17个月)累积支持：5.2例年2例围术期死亡出血—79岁,二次手术,泵工作5小时余肺动脉血栓形成—弥漫的凝血病理改变,应用血液制品 CardioWestTotalArtificialHeart 首例完全人工心脏移植--Dr.BarneyClark 前景如何??完全人工心脏左室辅助装置左室辅助并短期右室辅助装置(Hybrids)双室辅助装置 结论完全人工心脏：从整体生理控制角度考虑，具有一定优势心室辅助装置更容易接受两个泵会2倍增加机械失效几率无论结果怎样，期望辅助装置能更小,能效更高,可靠,植入易行,性价比更高,而且最好能完全植入(患者满意). 英文原版 TheU.S.ExperiencewithTotalArtificialHeartsvs.LeftVentricularAssistDevicesLyleD.Joyce,M.D.,PhD.DivisionofCardiovascularSurgeryTheMayoClinic,Rochester,MN,USA DEBAKEYROLLERPUMP1954 “Experimentally,itispossibletoreplacetheheartwithanartificialheart,andanimalshavebeenknowntosurviveaslongas36hours.Thisidea,Iamsure,couldreachfullfruitionifwehadmorefundstosupportmorework,particularlyinthebioengineeringarea.”M.DeBakey1963 NATIONALHEARTANDLUNGINSTITUTEESTABLISHEDTHEU.S.ARTIFICIALHEARTPROGRAM1964 WILLEMJ.KOLFF FIRSTSUCCESSFULLVADBRIDGETORECOVERY1966 HistoryofCardiacSupportDevicesPre-datesCardiacTransplantationPulsatileDevicesDesignedforWeaningorPermanentSupportDeBakeyVAD–1966LiottaTAH–1969AkutsuTAH–1981Jarvik7TAH-1982 CLINICALIMPLANTATIONOFAKUTSUTAH1981DentonCooley 1982FIRSTPERMANENTTAHIMPLANT ParadigmShift:FDAApprovalForBridgetoTransplantationPriortoUseasDestinationTherapy1984 TECHNICALLIMITATIONSDUETOSIZE TCI-THORATECLVADVictorPoirier1984,1986 NOVACOR-WORLDHEARTPeerPortner1984 EMERGENCEOFCONTINUOUSFLOWDEVICESSarnsBiomedicus LinearisedRateofRightVentricularFailure0.000.100.200.300.400.500.600-77-1414-30>30DaysafterLVASImplantEvents/Recipient.month REMATCHTrialRandomizedEvaluationofMechanicalAssistancefortheTreatmentofCongestiveHeartFailure ImplanttoFailureTimeOverallMeanTime332days(15-632)Inflowvalvefailure408days(240-632)MotorMalfunction285days(15-439)NumberofDays MINIATURIZATIONTHROUGHAXIALFLOW1998GeorgeNoon HeartMateII >2800PatientsImplanted53PilotStudy488BridgetoTransplantCommercialImplantsEurope:PostCEMarkandUS:PostFDAApproval648DestinationTherapyHeartMateIIWorldwideClinicalExperience1136PivotalStudyAsofMarch2009n=281(18mofollow-up)Durations413>1year241>1.5year188>2yr42>3yr3>4yr1>5yrDTprimarycohortwith2yearfollow-upMay2009Cohorts:RandomizedvsXVEXVEExchangeSmallptsFDAApprovalApr2008 HeartMateIIClinicalStudySupportDuration(n=281)Medianduration:155days(longest:5.0yr)Averageduration:237days181pt-yearscumulativesupport87%patientsdischarged78%ondevicesupport10%followingtransplant(priortoindexdischarge)77%oftime(140pt-years)spentoutofhospital HeartMateIIActuarialSurvivalPrimary(n=133)andCAP(n=146)Cohorts12mo:71±5%6mo:77±4%RemainingatriskPrimary:1334832CAP:1468410PRIMARYCAPAsofSep14,20076mo:87±3%12mo:75±6%PaganietalAHA2007 HeartMateIIClinicalTrialPost-transplantSurvival30DaysPost-Transplant150/157(96%)Oneyearpost-transplant117/128(91%) HeartMateIIClinicalStudyCausesofDeath(56/281) HeartMateIIClinicalStudyAdverseEvents HeartMateIIClinicalStudyAdverseEventsUseofRVADorextendedinotropeuse>14days,orstartingafter14days AdverseEventRateComparisonsHMII(n=281)vsHMVEBTT(n=280)11Frazier,Rose,OzetalJTCVS2001 HeartMateIIFreedomfromMajorDeviceFailureorReplacement(BTT,n=281)6mo:96±1%12mo:93±2%18mo:92±3%Remainingatrisk2811317252Paganietal(submitted2008) VentrAssist VentrAssist HeartWare DuraHeart Matthews-Michigan35%RVfailureafterLVAD197Patients1996–2006Of68casesofRVfailure,58occurredinfirstgenerationVAD,3innon-pulsatileLVADPresenceofRVfailureadds6foldincreaseinoddsofpost-opLVADdeath Dang-Columbia39%RVfailureafterLVAD108patients1996–2004ElevatedCVPwasonlyindependentpredictor Potapov-Berlin17%RVFailure54patients1998-2006 Potapov–BerlinRVFailureRiskFactorsTricuspidincompetenceGeometryofRVRVafter-loadNodifferencebetweenpulsatileandcontinuousflowdevices Fitzpatrick-UPenn37%RVFailure266patients1995-2007 RVFRSRisk(RVfailureriskscore)Vasopressorrequirement-4pointsAST>80-2pointsBilirubin>2.0-2.5pointsCreat>2.3-3points AbioCorImplantableComponentsThoracicUnitImplantedControllerImplantedTETCoilImplantedBattery FourteenPatientsEnrolledatFourCenters12successfullysupported2dischargedSupportedduration:53-512days(17months)Cumulativesupport:5.2patientyears2perioperativedeathsBleeding—79yr.,reop,5+hr.pumprunPulmonaryarterythrombosis—profoundcoagulopahy,givenfactorconcentrates CardioWestTotalArtificialHeart FirstPermanentTotalArtificialHeartImplant--Dr.BarneyClark WhatWillTheFutureBe??TotalArtificialHeartsLeftVentricularAssistsLeftVentricularAssistwithshorttermRightVentricularAssist(Hybrids)BiventricularAssists CONCLUSIONTotalArtificialHeartshavetheadvantagewhenconsideringthevalueoffullphysiologicalcontrolVentricularAssistDeviceshavemoreemotionalappeal.Twopumpscoulddoublethechanceofmechanicalfailure.Whatevertheoutcome,thedevice(s)willhavetobesmall,energyefficient,reliable,easytoimplant,cost-effective,andhopefullytotallyimplantable(patientsatisfaction). 结束语谢谢大家聆听！！！126'