title: Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial.
abstract: BACKGROUND
  A multicenter clinical trial conducted from 2005 to 2008 of a continuous flow left ventricular assist device (LVAD) resulted in Food and Drug Administration approval for bridge to transplantation. The purpose of this analysis was to determine changes in posttrial outcomes in widespread commercial use since the clinical trial.
  
  
  METHODS
  We compared outcomes of 486 patients who received a continuous flow LVAD as a bridge to transplantation at 36 centers during the clinical trial (March 2005 to April 2008) with outcomes of 1,496 posttrial patients who received a continuous flow LVAD at 83 centers (April 2008 to September 2010 as reported to the Interagency Registry for Mechanically Assisted Circulatory Support).
  
  
  RESULTS
  Baseline data were comparable between groups. Cumulative follow-up was 511 and 1,082 patient-years for trial and posttrial patients, respectively, and average support duration was 12.6 ± 14.0 and 8.7 ± 7.1 months. Kaplan-Meier survival improved at 1 year from 76% (trial) to 85% (posttrial). The percentage of patients undergoing transplantation in the first year decreased from 48% in the trial period to 39% in the posttrial period. Quality of life metrics improved by 3 months in both groups.
  
  
  CONCLUSIONS
  The survival rate of a large group of continuous flow LVAD patients in a real-world setting after Food and Drug Administration market approval for bridge to transplantation has improved since the clinical trial. These data show that excellent outcomes have been maintained with dissemination of new LVAD technology from a clinical trial phase to more broad based use in the period after market approval.
authors.affiliation: University of Minnesota, Minneapolis, MN, USA. johnx008@umn.edu
authors.forename: Ranjit
authors.initials: R
authors.lastname: John
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.forename: Nicholas G
authors.initials: NG
authors.lastname: Smedira
authors.forename: Randall
authors.initials: R
authors.lastname: Starling
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jorde
authors.forename: Peter
authors.initials: P
authors.lastname: Eckman
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016277:Ventricular Function, Left / Q000502:physiology*