title: Lessons learned from experience with over 100 consecutive HeartMate II left ventricular assist devices.
abstract: BACKGROUND
  Continuous-flow left ventricular assist devices (LVADs) such as the HeartMate II have become the therapy of choice in patients with end-stage heart failure. The aim of this study is to report the outcomes in patients receiving the HeartMate II LVAD at a single center and review the lessons learned from this experience.
  
  
  METHODS
  From June 2005 to June 2010, 130 consecutive patients received the HeartMate II LVAD. Of these, 102 were bridge-to-transplant (BTT), 17 destination therapy, and 11 exchanges for failed HeartMate XVE. This study focuses on the 102 BTT patients. The HeartMate II was approved by the US Food and Drug Administration (FDA) as BTT in April 2008 and 64 patients received this device as BTT since that date. We review our experience with the device as BTT and report on patient survival and adverse events as well as the impact of FDA approval on outcomes.
  
  
  RESULTS
  Overall, mean age was 52.6 ± 12.8 years; 26 (25.5%) were female. Disease etiology was ischemic in 58, nonischemic in 36, and other in 8. Overall, 30-day, 6-month, and 1-year survival for the BTT patients was 95.1%, 83.5%, and 78.8%, respectively. The 6-month survival in 38 patients in the clinical trial (pre-FDA) was 88.8% and was not statistically significant compared with the 76.2% 6-month survival in the 64 patients in the post-FDA approval period (p value = 0.1). Major adverse events among the 102 BTT patients included right ventricular failure in 5 (4.9%), LVAD driveline infections in 25 (24.5%), neurologic events in 10 (9.8%), and gastrointestinal bleeding in 18 (17.6%) patients. In addition, 1 patient (0.98%) had pump thrombus requiring device replacement.
  
  
  CONCLUSIONS
  Despite significant morbidity, use of the HeartMate II LVAD as BTT provides excellent hemodynamic support and is associated with excellent survival and low mortality. In addition, there needs to be improvement and focused strategies in the areas of gastrointestinal bleeding, driveline infections, and adverse neurologic events for these devices to be able to provide a real long-term alternative to heart transplantation.
authors: Division of Cardiothoracic Surgery, University of Minnesota, 420 Delaware St SE, MMC 207, Minneapolis, MN 55455, USA. johnx008@umn.edu
authors: Ranjit
authors: R
authors: John
authors: Forum
authors: F
authors: Kamdar
authors: Peter
authors: P
authors: Eckman
authors: Monica
authors: M
authors: Colvin-Adams
authors: Andrew
authors: A
authors: Boyle
authors: Sara
authors: S
authors: Shumway
authors: Lyle
authors: L
authors: Joyce
authors: Kenneth
authors: K
authors: Liao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000601:surgery; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult