心脏辅助器械发展-中英文课件PPT.ppt

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 (15-439) 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 Study 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: 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) Cohorts 12 mo: 71±5% 6 mo: 77±4% Remaining at risk Primary: 133 48 32 CAP: 146 84 10 PRIMARY CAP As of Sep 14, 2007 6 mo: 87±3% 12 mo: 75±6% Pagani et al AHA 2007 HeartMate II Clinical TrialPost-transplant Survival 30 Days Post-Transplant 150/157 (96%) One year post-transplant 117/128 (91%) HeartMate II Clinical StudyCauses of Death (56/281) HeartMate II Clinical StudyAdverse Events HeartMate II Clinical StudyAdverse Events Use of RVAD or extended inotrope use 14 days, or starting after 14 days Adverse Event Rate ComparisonsHMII (n=281) vs HM VE BTT (n=280)1 1Frazier, Rose, Oz et al JTCVS 2001 Hear