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1、The U.S. Experience with Total Artificial Hearts vs. Left Ventricular Assist Devices,Lyle D. Joyce, M.D., PhD. Division of Cardiovascular Surgery The Mayo Clinic, Rochester, MN,USA,DEBAKEY ROLLER PUMP,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。
2、M. DeBakey,1963,美国国家心肺研究所开始实施 美国人造心脏计划（ THE U.S. ARTIFICIAL HEART PROGRAM),1964,WILLEM J. 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,DeBakey VAD1966,Liotta TAH1969,Akutsu TAH 1981,Jarvik 7 TAH-1982,AKUTSU TAH 的临床植入,1981,Denton Cooley,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
3、植前的过渡治疗,1984,心脏大小差异带来的技术限制,TCI-THORATEC LVAD,Victor Poirier,1984, 1986,NOVACOR-WORLD HEART,Peer Portner,1984,持续流动装置的出现,Sarns,Biomedicus,Linearised Rate of Right Ventricular Failure,0.00,0.10,0.20,0.30,0.40,0.50,0.60,0-7,7-14,14-30,30,Days after LVAS Implant,Events/Recipient.month,REMATCH 试验,Randomiz
4、ed 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,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),Number of Days,通过轴流改进装置的小型化/微型化,1998,George Noon,HeartMate II,2800 Patients Implanted,53 先期研究,488 移植前过渡治疗,商业性植入 Europ
5、e: Post CE Mark US: Post FDA Approval,648 最终治疗,HeartMate II 全球临床研究,1136 主要研究,As of March 2009,n=281 (18 mo follow-up),Durations 413 1 year 241 1.5 year 188 2 yr 42 3 yr 3 4 yr 1 5yr,DT 主要人群随访2年 May 2009,Cohorts: Randomized vs XVE XVE Exchange Small pts,FDA Approval Apr 2008,HeartMate II 临床研究 有效支持时间
6、(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 (prior to 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=133) and CAP (n=146) Cohorts,12 mo: 715%,6 mo: 774%,Remaining at risk Primary: 133 48 32 CAP: 146 84 10,PRIMARY CAP,As of Sep 14, 2007
7、,6 mo: 873%,12 mo: 756%,Pagani et al AHA 2007,HeartMate 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 不良事件,Use of RVAD or extended inotrope use 14 days, or starting after 14 days,不良事件发生率比较 HMII (n=281) vs HM VE
8、BTT (n=280)1,1Frazier, Rose, Oz et al JTCVS 2001,HeartMate 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%,Remaining at risk 281 131 72 52,Pagani et al (submitted 2008),VentrAssist,VentrAssist,HeartWare,DuraHeart,Matthews - Michigan,35% LVAD患者出现右室衰竭 共197 例患者 1996 2006 68例RV衰竭患者中, 58
9、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 108 patients 1996 2004 CVP的升高是唯一的独立预测因素,Potapov - Berlin,17% RV衰竭 54 patients 1998-2006,Potapov Berlin RV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 - U Penn,37% RV衰竭 266 patients 1995 - 2007,RVFRS Risk (R
10、V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,AbioCor Implantable Components,Thoracic Unit,Implanted Controller,Implanted TET Coil,Implanted Battery,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: 53-512 days (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,CardioWe
11、st Total Artificial Heart,首例完全人工心脏移植 - Dr. Barney Clark,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,The U.S. Experience with Total Artificial Hearts vs. Left Ventricular Assi
12、st Devices,Lyle D. Joyce, M.D., PhD. Division of Cardiovascular Surgery The Mayo Clinic, Rochester, MN,USA,DEBAKEY ROLLER PUMP,1954,“Experimentally, it is possible to replace the heart with an artificial heart, and animals have been known to survive as long as 36 hours. This idea, I am sure, could r
13、each full fruition if we had more funds to support more work, particularly in the bioengineering area.” M. DeBakey,1963,NATIONAL HEART AND LUNG INSTITUTE ESTABLISHED THE U.S. ARTIFICIAL HEART PROGRAM,1964,WILLEM J. KOLFF,FIRST SUCCESSFUL LVAD BRIDGE TO RECOVERY,1966,History of Cardiac Support Device
14、s,Pre-dates Cardiac Transplantation Pulsatile Devices Designed for Weaning or Permanent Support,DeBakey VAD1966,Liotta TAH1969,Akutsu TAH 1981,Jarvik 7 TAH-1982,CLINICAL IMPLANTATION OF AKUTSU TAH,1981,Denton Cooley,1982,FIRST PERMANENT TAH IMPLANT,Paradigm Shift: FDA Approval For Bridge to Transpla
15、ntation Prior to Use as Destination Therapy,1984,TECHNICAL LIMITATIONS DUE TO SIZE,TCI-THORATEC LVAD,Victor Poirier,1984, 1986,NOVACOR-WORLD HEART,Peer Portner,1984,EMERGENCE OF CONTINUOUS FLOW DEVICES,Sarns,Biomedicus,Linearised Rate of Right Ventricular Failure,0.00,0.10,0.20,0.30,0.40,0.50,0.60,0
16、-7,7-14,14-30,30,Days after LVAS Implant,Events/Recipient.month,REMATCH Trial,Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure,Implant to Failure Time,Overall Mean Time 332 days (15-632) Inflow valve failure 408 days (240-632) Motor Malfunction 285 days (1
17、5-439),Number of Days,MINIATURIZATION THROUGH AXIAL FLOW,1998,George Noon,HeartMate II,2800 Patients Implanted,53 Pilot Study,488 Bridge to Transplant,Commercial Implants Europe: Post CE Mark and US: Post FDA Approval,648 Destination Therapy,HeartMate II Worldwide Clinical Experience,1136 Pivotal St
18、udy,As of March 2009,n=281 (18 mo follow-up),Durations 413 1 year 241 1.5 year 188 2 yr 42 3 yr 3 4 yr 1 5yr,DT primary cohort with 2 year follow-up May 2009,Cohorts: Randomized vs XVE XVE Exchange Small pts,FDA Approval Apr 2008,HeartMate II Clinical Study Support Duration (n=281),Median duration:
19、155 days (longest: 5.0 yr) Average duration: 237 days 181 pt-years cumulative support 87% patients discharged 78% on device support 10% following transplant (prior to index discharge) 77% of time (140 pt-years) spent out of hospital,HeartMate II Actuarial Survival Primary (n=133) and CAP (n=146) Coh
20、orts,12 mo: 715%,6 mo: 774%,Remaining at risk Primary: 133 48 32 CAP: 146 84 10,PRIMARY CAP,As of Sep 14, 2007,6 mo: 873%,12 mo: 756%,Pagani et al AHA 2007,HeartMate II Clinical Trial Post-transplant Survival,30 Days Post-Transplant 150/157 (96%) One year post-transplant 117/128 (91%),HeartMate II C
21、linical Study Causes of Death (56/281),HeartMate II Clinical Study Adverse Events,HeartMate II Clinical Study Adverse Events,Use of RVAD or extended inotrope use 14 days, or starting after 14 days,Adverse Event Rate Comparisons HMII (n=281) vs HM VE BTT (n=280)1,1Frazier, Rose, Oz et al JTCVS 2001,H
22、eartMate II Freedom from Major Device Failure or Replacement (BTT, n=281),6 mo: 961%,12 mo: 932%,18 mo: 923%,Remaining at risk 281 131 72 52,Pagani et al (submitted 2008),VentrAssist,VentrAssist,HeartWare,DuraHeart,Matthews - Michigan,35% RV failure after LVAD 197 Patients 1996 2006 Of 68 cases of R
23、V failure, 58 occurred in first generation VAD, 3 in non-pulsatile LVAD Presence of RV failure adds 6 fold increase in odds of post-op LVAD death,Dang - Columbia,39% RV failure after LVAD 108 patients 1996 2004 Elevated CVP was only independent predictor,Potapov - Berlin,17% RV Failure 54 patients 1
24、998-2006,Potapov Berlin RV Failure Risk Factors,Tricuspid incompetence Geometry of RV RV after-load No difference between pulsatile and continuous flow devices,Fitzpatrick - U Penn,37% RV Failure 266 patients 1995 - 2007,RVFRS Risk (RV failure risk score),Vasopressor requirement - 4 points AST 80 -2
25、 points Bilirubin 2.0 - 2.5 points Creat 2.3 - 3 points,AbioCor Implantable Components,Thoracic Unit,Implanted Controller,Implanted TET Coil,Implanted Battery,Fourteen Patients Enrolled at Four Centers,12 successfully supported 2 discharged Supported duration: 53-512 days (17 months) Cumulative supp
26、ort: 5.2 patient years 2 perioperative deaths Bleeding79 yr., reop, 5+ hr. pump run Pulmonary artery thrombosisprofound coagulopahy, given factor concentrates,CardioWest Total Artificial Heart,First Permanent Total Artificial Heart Implant- Dr. Barney Clark,What Will The Future Be?,Total Artificial
27、Hearts Left Ventricular Assists Left Ventricular Assist with short term Right Ventricular Assist (Hybrids) Biventricular Assists,CONCLUSION,Total Artificial Hearts have the advantage when considering the value of full physiological control Ventricular Assist Devices have more emotional appeal. Two pumps could double the chance of mechanical failure. Whatever the outcome, the device(s) will have to be small, energy efficient, reliable, easy to implant, cost-effective, and hopefully totally implantable (patient satisfaction).,