Abstract 19611: An Examination of Survival by Sex in the HVAD BTT and CAP Trials
Background: The HeartWare® Ventricular Assist System (HVAD) is a novel design, continuous flow, centrifugal pump. The ADVANCE Bridge to Transplant Trial (BTT) was a multi-center, prospective trial that used an external contemporaneous control group from the Inter-Agency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to compare the HVAD Pump with commercially available left ventricular assist devices (LVAD).
Methods: Baseline characteristics, adverse events and subsequent survival were compared for men and women in the combined BTT and Continued Access Protocol trials (CAP). Survival was evaluated by Kaplan-Meier and proportional-hazards methodologies.
Results: In the combined BTT and CAP study (N=332), 236 men and 96 women received an HVAD pump. At baseline, men had larger BSA (2.13+0.26 versus 1.80+0.25, P<0.001), more frequent history of hypertension (61.9% versus 49.5%, P=0.048) and more ischemic cardiomyopathy (45.3% versus 15.6%, P<0.001). Kaplan-Meier analysis revealed no significant difference in survival at 180 days (91.5%, men; 89.6%, women) and 1-year (84.1%, men; 84.3%, women). Furthermore, a Cox proportional hazards model indicated no statistically significant gender effect on survival when controlling baseline BSA. A review of adverse events revealed similar rates between men and women who received an HVAD.
Conclusion: As expected, heart failure etiology differed between men and women in this BTT cohort. However, these data suggest that gender was not a factor for survival in men and women receiving the HeartWare System, and the survival data in women compares very favorably to data reported using contemporary LVADs.
- © 2012 by American Heart Association, Inc.