Use of the HeartMate II Left Ventricular Assist Device as destination therapy was associated with improved survival and reduced incidence of adverse events over 2 years in patients with advanced HF, according to results from a post-approval study.
The HeartMate II device (Thoratec) was approved by the FDA in 2010 for the destination therapy indication.
The new study compared commercial results with results from the multicenter clinical trial conducted from 2005 to 2010. The data were presented at the International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions.
The post-approval study included the first 247 HeartMate II users (83% men) identified preoperatively as destination therapy in the national Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Patients were enrolled at 61 American centers from January 2010 through September 2010 and were followed for 2 years. One hundred thirty three patients at 34 American centers enrolled in the primary data cohort in the destination therapy pivotal trial served as a historical comparison group.
Post-approval results reveal a trend toward improved survival. At 2 years, Kaplan Meier survival was 62% in the post-approval group vs. 58% in the comparison group. Among patients with INTERMACS profiles 4-7 (n=63), survival at 1 year was 82% and 2 years 69%. Among patients with INTERMACS profiles 1-3 (n=184), survival at 1 year was 72% and 2 years was 60%.
Adverse event rates were similar or lower than in the comparison group. Post-approval mean length of stay was reduced by 6 days in the post-approval group.
“The positive results from this study further validate use of the HeartMate II for the treatment of advanced HF,” Ulrich Jorde, MD, medical director of the mechanical circulatory support program, New York-Presbyterian Hospital/Columbia, said in a press release. “Particularly for patients who do not have the option of heart transplantation, we are seeing results in the broader commercial setting that confirm the clinical trial results with continued excellent outcomes and good quality of life.”
For more information:
Jorde UP. Abstract #2. Presented at: International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions; April 24-27, 2013; Montreal.
Disclosure: Jorde reports consulting for Thoratec.