心脏辅助器械发展中英文课件

TheU S ExperiencewithTotalArtificialHeartsvs LeftVentricularAssistDevices LyleD Joyce M D PhD DivisionofCardiovascularSurgeryTheMayoClinic Rochester MN USA DEBAKEYROLLERPUMP 1954 从实验角度来说 用人工装置代替心脏是可能的 这一点在动物身上已得到证实 实验动物可以存活长达36小时 而且我敢肯定 如果有足够的资金支持 尤其是在生物工程领域 那么人造心脏就能成为现实 M DeBakey 1963 美国国家心肺研究所开始实施美国人造心脏计划 THEU S ARTIFICIALHEARTPROGRAM 1964 WILLEMJ KOLFF 首个左室辅助装置治疗下康复病例 1966 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 1966 LiottaTAH 1969 AkutsuTAH 1981 Jarvik7TAH 1982 AKUTSUTAH的临床植入 1981 DentonCooley 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 THORATECLVAD VictorPoirier 1984 1986 NOVACOR WORLDHEART PeerPortner 1984 持续流动装置的出现 Sarns Biomedicus LinearisedRateofRightVentricularFailure 0 00 0 10 0 20 0 30 0 40 0 50 0 60 0 7 7 14 14 30 30 DaysafterLVASImplant Events 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 1998 GeorgeNoon HeartMateII 2800PatientsImplanted 53先期研究 488移植前过渡治疗 商业性植入Europe PostCEMarkUS PostFDAApproval 648最终治疗 HeartMateII全球临床研究 1136主要研究 AsofMarch2009 n 281 18mofollow up Durations413 1year241 1 5year188 2yr42 3yr3 4yr1 5yr DT主要人群随访2年May2009 Cohorts RandomizedvsXVEXVEExchangeSmallpts FDAApprovalApr2008 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 Cohorts 12mo 71 5 6mo 77 4 RemainingatriskPrimary 1334832CAP 1468410 PRIMARYCAP AsofSep14 2007 6mo 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 1 1Frazier 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 Remainingatrisk2811317252 Paganietal submitted2008 VentrAssist VentrAssist HeartWare DuraHeart Matthews Michigan 35 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 Columbia 39 例出现RV衰竭108patients1996 2004CVP的升高是唯一的独立预测因素 Potapov Berlin 17 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 UPenn 37 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 AbioCorImplantableComponents ThoracicUnit ImplantedController ImplantedTETCoil ImplantedBattery 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 LeftVentricularAssistDevices LyleD Joyce M D PhD DivisionofCardiovascularSurgeryTheMayoClinic Rochester MN USA DEBAKEYROLLERPUMP 1954 Experimentally itispossibletoreplacetheheartwithanartificialheart andanimalshavebeenknowntosurviveaslongas36hours Thisidea Iamsure couldreachfullfruitionifwehadmorefundstosupportmorework particularlyinthebioengineeringarea M DeBakey 1963 NATIONALHEARTANDLUNGINSTITUTEESTABLISHEDTHEU S ARTIFICIALHEARTPROGRAM 1964 WILLEMJ KOLFF FIRSTSUCCESSFULLVADBRIDGETORECOVERY 1966 HistoryofCardiacSupportDevices Pre datesCardiacTransplantationPulsatileDevicesDesignedforWeaningorPermanentSupport DeBakeyVAD 1966 LiottaTAH 1969 AkutsuTAH 1981 Jarvik7TAH 1982 CLINICALIMPLANTATIONOFAKUTSUTAH 1981 DentonCooley 1982 FIRSTPERMANENTTAHIMPLANT ParadigmShift FDAApprovalForBridgetoTransplantationPriortoUseasDestinationTherapy 1984 TECHNICALLIMITATIONSDUETOSIZE TCI THORATECLVAD VictorPoirier 1984 1986 NOVACOR WORLDHEART PeerPortner 1984 EMERGENCEOFCONTINUOUSFLOWDEVICES Sarns Biomedicus LinearisedRateofRightVentricularFailure 0 00 0 10 0 20 0 30 0 40 0 50 0 60 0 7 7 14 14 30 30 DaysafterLVASImplant Events Recipient month REMATCHTrial RandomizedEvaluationofMechanicalAssistancefortheTreatmentofCongestiveHeartFailure ImplanttoFailureTime OverallMeanTime332days 15 632 Inflowvalvefailure408days 240 632 MotorMalfunction285days 15 439 NumberofDays MINIATURIZATIONTHROUGHAXIALFLOW 1998 GeorgeNoon HeartMateII 2800PatientsImplanted 53PilotStudy 488BridgetoTransplant CommercialImplantsEurope PostCEMarkandUS PostFDAApproval 648DestinationTherapy HeartMateIIWorldwideClinicalExperience 1136PivotalStudy AsofMarch2009 n 281 18mofollow up Durations413 1year241 1 5year188 2yr42 3yr3 4yr1 5yr DTprimarycohortwith2yearfollow upMay2009 Cohorts RandomizedvsXVEXVEExchangeSmallpts FDAApprovalApr2008 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 Cohorts 12mo 71 5 6mo 77 4 RemainingatriskPrimary 1334832CAP 1468410 PRIMARYCAP AsofSep14 2007 6mo 87 3 12mo 75 6 PaganietalAHA2007 HeartMateIIClinicalTrialPost transplantSurvival 30DaysPost Transplant150 157 96 Oneyearpost transplant117 128 91 HeartMateIIClinicalStudyCausesofDeath 56 281 HeartMateIIClinicalStudyAdverseEvents HeartMateIIClinicalStudyAdverseEvents UseofRVADorextendedinotropeuse 14days orstartingafter14days AdverseEventRateComparisonsHMII n 281 vsHMVEBTT n 280 1 1Frazier Rose OzetalJTCVS2001 HeartMateIIFreedomfromMajorDeviceFailureorReplacement BTT n 281 6mo 96 1 12mo 93 2 18mo 92 3 Remainingatrisk2811317252 Paganietal submitted2008 VentrAssist VentrAssist HeartWare DuraHeart Matthews Michigan 35 RVfailureafterLVAD197Patients1996 2006Of68casesofRVfailure 58occurredinfirstgenerationVAD 3innon pulsatileLVADPresenceofRVfailureadds6foldincreaseinoddsofpost opLVADdeath Dang Columbia 39 RVfailureafterLVAD108patients1996 2004ElevatedCVPwasonlyindependentpredictor Potapov Berlin 17 RVFailure54patients1998 2006 Potapov BerlinRVFailureRiskFactors TricuspidincompetenceGeometryofRVRVafter loadNodifferencebetweenpulsatileandcontinuousflowdevices Fitzpatrick UPenn 37 RVFailure266patients1995 2007 RVFRSRisk RVfailureriskscore Vasopressorrequirement 4pointsAST 80 2pointsBilirubin 2 0 2 5pointsCreat 2 3 3points AbioCorImplantableComponents ThoracicUnit ImplantedController ImplantedTETCoil ImplantedBattery FourteenPatientsEnrolledatFourCenters 12successfullysupported2dischargedSupportedduration 53 512days 17months Cumulati