心脏辅助器械发展-中英文课件-精品文档126页

TheU.S.ExperiencewithTotalArtificialHeartsvs.LeftVentricularAssistDevicesLyleD.Joyce,M.D.,PhD.DivisionofCardiovascularSurgeryTheMayoClinic,Rochester,MN,USADEBAKEYROLLERPUMP1954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.DeBakey1963美国国家心肺研究所开始实施美国人造心脏计划（THEU.S.ARTIFICIALHEARTPROGRAM)1964WILLEMJ.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–1966LiottaTAH–1969AkutsuTAH–1981Jarvik7TAH-1982AKUTSUTAH的临床植入1981DentonCooley1982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-THORATECLVADVictorPoirier1984,1986NOVACOR-WORLDHEARTPeerPortner1984持续流动装置的出现SarnsBiomedicusIncidenceofRVADuse0%5%10%15%20%25%1984-901991-931993-951996-971997-2000YearofImplantIncidenceLinearisedRateofRightVentricularFailure0.000.100.200.300.400.500.600-77-1414-3030DaysafterLVASImplantEvents/Recipient.monthREMATCH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)3324082850100200300400500OverallInflowvalvedysfunctionMotormalfunctionNumberofDays通过轴流改进装置的小型化/微型化2019GeorgeNoonHeartMateII2800PatientsImplanted53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)Durations•4131year•2411.5year•1882yr•423yr•34yr•15yrDT主要人群随访2年May2009Cohorts:•RandomizedvsXVE•XVEExchange•SmallptsFDAApprovalApr2019HeartMateII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)CohortsMonths0123456789101112PercentSurvival010203040506070809010012mo:71±5%6mo:77±4%RemainingatriskPrimary:1334832CAP:1468410PRIMARYCAPAsofSep14,20196mo:87±3%12mo:75±6%PaganietalAHA2019HeartMateII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•UseofRVADorextendedinotropeuse14days,orstartingafter14days不良事件发生率比较HMII(n=281)vsHMVEBTT(n=280)11Frazier,Rose,OzetalJTCVS2019HeartMateII无主要装置失效或置换事件率(BTT,n=281)Months061218Freedomfrommajormalfunction(%)01020304050607080901006mo:96±1%12mo:93±2%18mo:92±3%Remainingatrisk2811317252Paganietal(submitted2019)VentrAssistVentrAssistHeartWareDuraHeartMatthews-Michigan35%LVAD患者出现右室衰竭共197例患者2019–201968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108patients2019–2019CVP的升高是唯一的独立预测因素Potapov-Berlin17%RV衰竭54patients2019-2019Potapov–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266patients2019-2019RVFRSRisk(RV衰竭危险评分)需血管加压素-4分AST80-2分胆红素2.0-2.5分肌酐2.3-3分AbioCorImplantableComponentsThoracicUnitImplantedControllerImplantedTETCoilImplantedBattery14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,USADEBAKEYROLLERPUMP1954“Experimentally,itispossibletoreplacetheheartwithanartificialheart,andanimalshavebeenknowntosurviveaslongas36hours.Thisidea,Iamsure,couldreachfullfruitionifwehadmorefundstosupportmorework,particularlyinthebioengineeringarea.”M.DeBakey1963NATIONALHEARTANDLUNGINSTITUTEESTABLISHEDTHEU.S.ARTIFICIALHEARTPROGRAM1964WILLEMJ.KOLFFFIRSTSUCCESSFULLVADBRIDGETORECOVERY1966HistoryofCardiacSupportDevicesPre-datesCardiacTransplantationPulsatileDevicesDesignedforWeaningorPermanentSupportDeBakeyVAD–1966LiottaTAH–1969AkutsuTAH–1981Jarvik7TAH-1982CLINICALIMPLANTATIONOFAKUTSUTAH1981DentonCooley1982FIRSTPERMANENTTAHIMPLANTParadigmShift:FDAApprovalForBridgetoTransplantationPriortoUseasDestinationTherapy1984TECHNICALLIMITATIONSDUETOSIZETCI-THORATECLVADVictorPoirier1984,1986NOVACOR-WORLDHEARTPeerPortner1984EMERGENCEOFCONTINUOUSFLOWDEVICESSarnsBiomedicusIncidenceofRVADuse0%5%10%15%20%25%1984-901991-931993-951996-971997-2000YearofImplantIncidenceLinearisedRateofRightVentricularFailure0.000.100.200.300.400.500.600-77-1414-3030DaysafterLVASImplantEvents/Recipient.monthREMATCHTrialRandomizedEvaluationofMechanicalAssistancefortheTreatmentofCongestiveHeartFailureImplanttoFailureTimeOverallMeanTime332days(15-632)Inflowvalvefailure408days(240-632)MotorMalfunction285days(15-439)3324082850100200300400500OverallInflowvalvedysfunctionMotormalfunctionNumberofDaysMINIATURIZATIONTHROUGHAXIALFLOW2019GeorgeNoonHeartMateII2800PatientsImplanted53PilotStudy488BridgetoTransplantCommercialImplantsEurope:PostCEMarkandUS:PostFDAApproval648DestinationTherapyHeartMateIIWorldwideClinicalExperience1136PivotalStudyAsofMarch2009n=281(18mofollow-up)Durations•4131year•2411.5year•1882yr•423yr•34yr•15yrDTprimarycohortwith2y