HeartWare’s HVAD left ventricular assist device won pre-market approval from the FDA in November 2012 as a bridge to heart transplantation. Last week at the International Society for Heart & Lung Transplantation’s annual conference in San Diego, HeartWare for the 1st time released data from its post-approval study of commercial HVAD patients.
The study tracked 600 bridge-to-transplant patients until device explant, transplantation or death. Compared with the patients in HeartWare’s Advance clinical trial, the post-approval cohort had a higher rate of prior cardiac surgery and were sicker, according to lead investigator Dr. Simon Maltais of the Vanderbilt University Medical Center.
Survival rates for the post-approval study were 88.0% after 6 months and 85.4% after a year, compared with 90.2% at 6 months and 84.1% after a year for the Advance group. The rate of stroke in patients implanted with the HVAD device between Nov. 20, 2012, and March 31, 2013 was 12.1% but just 7.0% in patients implanted between April 1, 2013, and June 30, 2013.
There was a similar division in survival rates for the 2 periods, with patients implanted between approval and the end of March 2013 coming in at 86.7% and patients implanted after that showing a 90.9% survival rate.
"Data are preliminary, but the commercial experience with HVAD is growing. Survival is similar with that observed in prior studies, despite sicker patients," according to Maltais et al. "The adverse event profile is consistent with those observed in the clinical trials."
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