Background: The HeartWare left ventricular assist device (HVAD; HeartWare Inc, Framingham, MA) was first implanted in Canada in 2010. We performed a multicentre analysis of the real world outcomes associated with its use.
Methods: Between May 2010 and January 2013, 4 Canadian centres inserted a total of 72 HVADs in 71 patients. Data were collected prospectively and analyzed retrospectively for the 1-year estimate of the principal outcome of transplant, explant for recovery, or death in patients who had a bridge to transplantation indication. Adverse event rates were estimated as events per patient-year (PPY).
Results: In the 67 patients who received the HVAD with the indication of bridge to transplant, 26 (38.8%) received a successful transplant, 2 (3%) received an explant for recovery, and 10 (14.9%) patients died during support. Median follow-up time with the HVAD was 6.9 months (range, 2 days to 30.4 months). Despite having 74% of the patients with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scores of level 1 and 2 at the time of implantation, the rate estimate for survival at 1 year was 86.3% (95% confidence interval, 76.7-93.3). With 48.2 total patient years of support, the rates of ischemic and hemorrhagic strokes were 0.21 and 0.19 events PPY, respectively. Women made up 40% of the cohort and an adverse neurologic event occurred with an event rate of 0.38 PPY in women.
Conclusions: The HVAD adequately supports acutely ill heart failure patients until the time of transplant or recovery. A high incidence of adverse neurologic outcomes might be related to the large percentage of female patients, the high INTERMACS levels, or unknown factors; further surveillance is required.
Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.