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1、心脏辅助器械发展-中英文课件DEBAKEY ROLLER PUMPDEBAKEY ROLLER PUMP1954心脏支持辅助装置的发展历史心脏支持辅助装置的发展历史心脏支持辅助装置的发展历史心脏支持辅助装置的发展历史 心脏移植前心脏移植前心脏移植前心脏移植前 类脉动式装置类脉动式装置类脉动式装置类脉动式装置 完全人工或永久性支持设计完全人工或永久性支持设计完全人工或永久性支持设计完全人工或永久性支持设计DeBakeyVAD1966DeBakeyVAD1966LiottaTAH1969LiottaTAH1969AkutsuTAH1981AkutsuTAH1981Jarvik7TAH-1982Ja
2、rvik7TAH-1982AKUTSU TAH AKUTSU TAH 的临床植入的临床植入的临床植入的临床植入1981DentonCooleyDentonCooley1982首例永久性首例永久性首例永久性首例永久性TAHTAH植入植入植入植入里程碑式的转变里程碑式的转变里程碑式的转变里程碑式的转变: FDA: FDA通过了通过了通过了通过了（LVADLVAD）作为最终移植前的过渡治疗）作为最终移植前的过渡治疗）作为最终移植前的过渡治疗）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心脏大小差异带来的技术限制心脏大小差异带来的技术限制心脏大小差异带来的技术限制TCI-THORATEC
3、 LVADTCI-THORATEC LVADVictorPoirierVictorPoirier1984, 1986NOVACOR-WORLD HEARTNOVACOR-WORLD HEARTPeerPortnerPeerPortner1984持续流动装置的出现持续流动装置的出现 SarnsBiomedicusBiomedicusLinearisedRateofRightVentricularFailure0.000.100.200.300.400.500.600-77-1414-3030Days after LVAS ImplantEvents/Recipient.monthREMATCH
4、试验 Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure充血性心力衰竭机械辅助治疗的随机化评估研究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植入到装置失效时间总体平均时间总体平均时间332 天天 (15-632)流入瓣衰竭流入瓣衰竭408 天天 (240-632)动力装置失效动力装置失效285 天天 (15-439)NumberofDays通过轴流改进装置的小型化通过轴流改进装置的小型化/微型化微型化1998GeorgeNoonGeorgeNo
5、onHeartMate IIHeartMate II2800 Patients Implanted 53 先期研究先期研究 488 移植前过渡治疗移植前过渡治疗商业性植入商业性植入Europe: Post CE Mark US: Post FDA Approval648 最终治疗最终治疗HeartMate II 全球临床研究全球临床研究 1136 主要研究主要研究 As of March 2009n=281 (18 mo follow-up)Durations4131year2411.5year1882yr423yr34yr15yrDT 主要人群随访主要人群随访2年年 May 2009Coho
6、rts: Randomized vs XVE XVE Exchange Small ptsFDA Approval Apr 2008 HeartMate II 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% 78% 带着支持装置带着支持装置 10% 10% 在心脏移植后在心脏移植后 (prior to (prior to index discharge)index discharge)77% 的使用时间(140例年)为院外使用时间HeartMate II 实际存活曲线 Primary (n=13
7、3) and CAP (n=146) Cohorts12 mo: 715%6 mo: 774%Remaining at riskPrimary: 133 48 32CAP: 146 84 10 PRIMARYCAPAs of Sep 14, 20076 mo: 873%12 mo: 756%PaganietalAHA2007HeartMate II 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%)HeartMate II 临床研究致死因素 (56/281)HeartMate II 临床研究不良事件HeartMate II 临床研究不良事
8、件 Use of RVAD or extended inotrope use Use of RVAD or extended inotrope use 14 days, or starting after 14 days 14 days, or starting after 14 days不良事件发生率比较HMII (n=281) vs HM VE BTT (n=280)11Frazier, Rose, Oz et al JTCVS 2001HeartMate II 无主要装置失效或置换事件率 (BTT, n=281)6 mo:961%12 mo:932%18 mo: 923%Remainin
9、g at risk281 131 72 52Paganietal(submitted2008)VentrAssistVentrAssistVentrAssistVentrAssistHeartWare DuraHeartMatthews - Michigan 35% LVAD35% LVAD患者出现右室衰竭患者出现右室衰竭患者出现右室衰竭患者出现右室衰竭 共共共共197 197 例患者例患者例患者例患者 1996 20061996 2006 6868例例例例RVRV衰竭患者中衰竭患者中衰竭患者中衰竭患者中, 58, 58例为植入第一代例为植入第一代例为植入第一代例为植入第一代VADVAD患者患
10、者患者患者, 3 , 3 例为非脉动式例为非脉动式例为非脉动式例为非脉动式LVADLVAD患者。患者。患者。患者。 RVRV衰竭使衰竭使衰竭使衰竭使 LVADLVAD患者的死亡几率增加了患者的死亡几率增加了患者的死亡几率增加了患者的死亡几率增加了6 6倍倍倍倍Dang - Columbia 39%39%例出现例出现例出现例出现RVRV衰竭衰竭衰竭衰竭 108 patients108 patients 1996 20041996 2004 CVPCVP的升高是唯一的独立预测因素的升高是唯一的独立预测因素的升高是唯一的独立预测因素的升高是唯一的独立预测因素Potapov - Berlin 17%
11、RV17% RV衰竭衰竭衰竭衰竭 54 patients54 patients 1998-20061998-2006Potapov Berlin RV衰竭的危险因素衰竭的危险因素 三尖瓣关闭不全三尖瓣关闭不全三尖瓣关闭不全三尖瓣关闭不全 右室的解剖形状右室的解剖形状右室的解剖形状右室的解剖形状 RV RV 的后负荷的后负荷的后负荷的后负荷 脉动式和持续血流装置间无差异脉动式和持续血流装置间无差异脉动式和持续血流装置间无差异脉动式和持续血流装置间无差异Fitzpatrick - U Penn 37% RV37% RV衰竭衰竭衰竭衰竭 266 patients266 patients 1995 -
12、 20071995 - 2007RVFRS Risk (RV衰竭危险评分衰竭危险评分) 需血管加压素需血管加压素需血管加压素需血管加压素 - 4 - 4 分分分分 AST 80 -2 AST 80 -2 分分分分 胆红素胆红素胆红素胆红素 2.0 - 2.5 2.0 - 2.5 分分分分 肌酐肌酐肌酐肌酐 2.3 - 3 2.3 - 3 分分分分AbioCor Implantable ComponentsThoracicUnitThoracicUnitImplantedImplantedControllerControllerImplantedImplantedTETCoilTETCoilIm
13、plantedImplantedBatteryBattery1414例患者入选例患者入选例患者入选例患者入选4 4个中心个中心个中心个中心 1212例获得成功心脏支持例获得成功心脏支持例获得成功心脏支持例获得成功心脏支持 2 2 例出院例出院例出院例出院 支持作用时间支持作用时间支持作用时间支持作用时间: 53-512 days (17 : 53-512 days (17 个月个月个月个月) ) 累积支持：累积支持：累积支持：累积支持： 5.2 5.2 例年例年例年例年 2 2例围术期死亡例围术期死亡例围术期死亡例围术期死亡 出血出血出血出血79 79 岁岁岁岁, , 二次手术二次手术二次手术
14、二次手术, , 泵工作泵工作泵工作泵工作5 5小时余小时余小时余小时余 肺动脉血栓形成肺动脉血栓形成肺动脉血栓形成肺动脉血栓形成弥漫的凝血病理改变弥漫的凝血病理改变弥漫的凝血病理改变弥漫的凝血病理改变, , 应应应应用血液制品用血液制品用血液制品用血液制品CardioWest Total Artificial Heart首例完全人工心脏移植首例完全人工心脏移植 - Dr. Barney Clark前景如何前景如何? 完全人工心脏完全人工心脏完全人工心脏完全人工心脏 左室辅助装置左室辅助装置左室辅助装置左室辅助装置 左室辅助并短期右室辅助装置左室辅助并短期右室辅助装置左室辅助并短期右室辅助装置左
15、室辅助并短期右室辅助装置(Hybrids)(Hybrids) 双室辅助装置双室辅助装置双室辅助装置双室辅助装置结论结论 完全人工心脏：从整体生理控制角度考虑，完全人工心脏：从整体生理控制角度考虑，完全人工心脏：从整体生理控制角度考虑，完全人工心脏：从整体生理控制角度考虑，具有一定优势具有一定优势具有一定优势具有一定优势 心室辅助装置更容易接受心室辅助装置更容易接受心室辅助装置更容易接受心室辅助装置更容易接受 两个泵会两个泵会两个泵会两个泵会2 2倍增加机械失效几率倍增加机械失效几率倍增加机械失效几率倍增加机械失效几率 无论结果怎样，期望辅助装置能更小无论结果怎样，期望辅助装置能更小无论结果怎样
16、，期望辅助装置能更小无论结果怎样，期望辅助装置能更小, , 能效能效能效能效更高更高更高更高, , 可靠可靠可靠可靠, , 植入易行植入易行植入易行植入易行, , 性价比更高性价比更高性价比更高性价比更高, , 而且最好而且最好而且最好而且最好能完全植入能完全植入能完全植入能完全植入 ( (患者满意患者满意患者满意患者满意). ).英文原版The U.S. Experience with The U.S. Experience with Total Artificial Hearts vs. Total Artificial Hearts vs. Left Ventricular Assist
17、 DevicesLeft Ventricular Assist DevicesLyle D. Joyce, M.D., PhD.Lyle D. Joyce, M.D., PhD.Division of Cardiovascular SurgeryDivision of Cardiovascular SurgeryThe Mayo Clinic, Rochester, MN,USAThe Mayo Clinic, Rochester, MN,USADEBAKEY ROLLER PUMPDEBAKEY ROLLER PUMP1954“ “Experimentally, it is possible
18、 to Experimentally, it is possible to replace the heart with an artificial replace the heart with an artificial heart, and animals have been known to heart, and animals have been known to survive as long as 36 hours. This survive as long as 36 hours. This idea, I am sure, could reach full idea, I am
19、 sure, could reach full fruition if we had more funds to fruition if we had more funds to support more work, particularly in support more work, particularly in the bioengineering area.” the bioengineering area.” M. DeBakeyM. DeBakey1963NATIONAL HEART AND LUNG INSTITUTE ESTABLISHED THE U.S. ARTIFICIA
20、L HEART PROGRAM1964WILLEM J. KOLFFWILLEM J. KOLFFFIRST SUCCESSFUL LVAD FIRST SUCCESSFUL LVAD BRIDGE TO RECOVERY BRIDGE TO RECOVERY 1966History of Cardiac Support DevicesHistory of Cardiac Support Devices Pre-dates Cardiac TransplantationPre-dates Cardiac Transplantation Pulsatile DevicesPulsatile De
21、vices Designed for Weaning or Permanent SupportDesigned for Weaning or Permanent SupportDeBakeyVAD1966DeBakeyVAD1966LiottaTAH1969LiottaTAH1969AkutsuTAH1981AkutsuTAH1981Jarvik7TAH-1982Jarvik7TAH-1982CLINICAL IMPLANTATION CLINICAL IMPLANTATION OF AKUTSU TAH OF AKUTSU TAH 1981DentonCooleyDentonCooley19
22、82FIRST PERMANENT TAH IMPLANT FIRST PERMANENT TAH IMPLANT Paradigm Shift: FDA Paradigm Shift: FDA Approval For Bridge to Approval For Bridge to Transplantation Prior to Transplantation Prior to Use as Destination TherapyUse as Destination Therapy1984TECHNICAL LIMITATIONS TECHNICAL LIMITATIONS DUE TO
23、 SIZEDUE TO SIZETCI-THORATEC LVADTCI-THORATEC LVADVictorPoirierVictorPoirier1984, 1986NOVACOR-WORLD HEARTNOVACOR-WORLD HEARTPeerPortnerPeerPortner1984EMERGENCE OF CONTINUOUS FLOW DEVICES SarnsBiomedicusBiomedicusLinearisedRateofRightVentricularFailure0.000.100.200.300.400.500.600-77-1414-3030Days af
24、ter LVAS ImplantEvents/Recipient.monthREMATCH Trial Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart FailureImplant to Failure TimeOverall Mean Time332 days (15-632)Inflow valve failure408 days (240-632)Motor Malfunction285 days (15-439)NumberofDaysMINIATURIZATION
25、 THROUGH AXIAL FLOW1998GeorgeNoonGeorgeNoonHeartMate IIHeartMate II2800 Patients Implanted 53 Pilot Study 488 Bridge to TransplantCommercial ImplantsEurope: Post CE Mark and US: Post FDA Approval648 Destination TherapyHeartMate II Worldwide Clinical Experience 1136 Pivotal Study As of March 2009n=28
26、1 (18 mo follow-up)Durations4131year2411.5year1882yr423yr34yr15yrDT primary cohort with 2 year follow-up May 2009Cohorts: Randomized vs XVE XVE Exchange Small ptsFDA Approval Apr 2008 HeartMate II Clinical Study Support Duration (n=281)Median duration: 155 days (longest: 5.0 yr)Average duration: 237
27、 days181 pt-years cumulative support87% patients discharged78% on device support10% following transplant (prior to index discharge)77% of time (140 pt-years) spent out of hospitalHeartMate II Actuarial Survival Primary (n=133) and CAP (n=146) Cohorts12 mo: 715%6 mo: 774%Remaining at riskPrimary: 133
28、 48 32CAP: 146 84 10 PRIMARYCAPAs of Sep 14, 20076 mo: 873%12 mo: 756%PaganietalAHA2007HeartMate II Clinical TrialPost-transplant Survival30 Days Post-Transplant150/157 (96%)One year post-transplant117/128 (91%)HeartMate II Clinical StudyCauses of Death (56/281)HeartMate II Clinical StudyAdverse Eve
29、ntsHeartMate II Clinical StudyAdverse Events Use of RVAD or extended inotrope use Use of RVAD or extended inotrope use 14 days, or starting after 14 days 14 days, or starting after 14 daysAdverse Event Rate ComparisonsHMII (n=281) vs HM VE BTT (n=280)11Frazier, Rose, Oz et al JTCVS 2001HeartMate II
30、Freedom from Major Device Failure or Replacement (BTT, n=281)6 mo:961%12 mo:932%18 mo: 923%Remaining at risk281 131 72 52Paganietal(submitted2008)VentrAssistVentrAssistVentrAssistVentrAssistHeartWare DuraHeartMatthews - Michigan 35% RV failure after LVAD35% RV failure after LVAD 197 Patients197 Pati
31、ents 1996 20061996 2006 Of 68 cases of RV failure, 58 occurred in first Of 68 cases of RV failure, 58 occurred in first generation VAD, 3 in non-pulsatile LVADgeneration VAD, 3 in non-pulsatile LVAD Presence of RV failure adds 6 fold increase Presence of RV failure adds 6 fold increase in odds of po
32、st-op LVAD deathin odds of post-op LVAD deathDang - Columbia 39% RV failure after LVAD39% RV failure after LVAD 108 patients108 patients 1996 20041996 2004 Elevated CVP was only independent predictorElevated CVP was only independent predictorPotapov - Berlin 17% RV Failure17% RV Failure 54 patients5
33、4 patients 1998-20061998-2006Potapov Berlin RV Failure Risk Factors Tricuspid incompetenceTricuspid incompetence Geometry of RVGeometry of RV RV after-loadRV after-load No difference between pulsatile and No difference between pulsatile and continuous flow devicescontinuous flow devicesFitzpatrick -
34、 U Penn 37% RV Failure37% RV Failure 266 patients266 patients 1995 - 20071995 - 2007RVFRS Risk (RV failure risk score) Vasopressor requirement - 4 pointsVasopressor requirement - 4 points AST 80 -2 pointsAST 80 -2 points Bilirubin 2.0 - 2.5 pointsBilirubin 2.0 - 2.5 points Creat 2.3 - 3 pointsCreat
35、2.3 - 3 pointsAbioCor Implantable ComponentsThoracicUnitThoracicUnitImplantedImplantedControllerControllerImplantedImplantedTETCoilTETCoilImplantedImplantedBatteryBatteryFourteen Patients Enrolled Fourteen Patients Enrolled at Four Centersat Four Centers 12 successfully supported12 successfully supp
36、orted 2 discharged2 discharged Supported duration: 53-512 days Supported duration: 53-512 days (17 months) (17 months) Cumulative support: 5.2 patient yearsCumulative support: 5.2 patient years 2 perioperative deaths2 perioperative deaths Bleeding79 yr., Bleeding79 yr., reopreop, 5+ hr. pump run, 5+
37、 hr. pump run Pulmonary artery thrombosisprofound Pulmonary artery thrombosisprofound coagulopahycoagulopahy, given factor concentrates, given factor concentratesCardioWest Total Artificial HeartFirst Permanent Total Artificial Heart Implant- Dr. Barney ClarkWhat Will The Future Be? Total Artificial
38、 HeartsTotal Artificial Hearts Left Ventricular AssistsLeft Ventricular Assists Left Ventricular Assist with short term Left Ventricular Assist with short term Right Ventricular Assist (Hybrids)Right Ventricular Assist (Hybrids) Biventricular AssistsBiventricular AssistsCONCLUSION Total Artificial H
39、earts have the advantage Total Artificial Hearts have the advantage when considering the value of full when considering the value of full physiological controlphysiological control Ventricular Assist Devices have more Ventricular Assist Devices have more emotional appeal.emotional appeal. Two pumps
40、could double the chance of Two pumps could double the chance of mechanical failure.mechanical failure. Whatever the outcome, the Whatever the outcome, the device(sdevice(s) will ) will have to be small, energy efficient, reliable, have to be small, energy efficient, reliable, easy to implant, cost-effective, and easy to implant, cost-effective, and hopefully totally implantable (patient hopefully totally implantable (patient satisfaction).satisfaction).结束语结束语谢谢大家聆听！谢谢大家聆听！126
