An examination of survival by sex and race in the HeartWare Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) and continued access protocol trials

BACKGROUND: The Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) trial was a multicenter, prospective trial of the HeartWare Ventricular Assist Device (HVAD). The performance of the HVAD in various demographic sub-groups was evaluated. METHODS: Baseline characteristics, adverse events, and survival were compared for men vs women and whites vs non-whites in the combined ADVANCE BIT and continued access protocol trial. Of 332 patients enrolled in these trials, 236 were men and 96 women, with 228 whites and 104 non-whites. RESULTS: At baseline, women had a smaller body surface area (1.8 +/- 0.2 vs 2.1 +/- 0.3 m(2), p < 0.0001), less hypertension (50.0% vs 61.9%, p = 0.05), and less ischemic cardiomyopathy (15.6% vs 45.3%, p < 0.0001). Differences in Kaplan-Meier survival were not significant at 180 days (men, 91.8%; women, 91.7%) and 1 year (men, 85.3%; women, 85.1%) despite adjustment for baseline differences. Men had a lower incidence of early right heart failure and renal and respiratory dysfunction, and a 'shorter length of stay. In the analysis by race, non-whites were younger than whites and had less ischernic heart failure, more hypertension, and lower creatinine levels at baseline. Non-whites had lower rates of arrhythmia, bleeding requiring rehospitalization, and device malfunctions than whites. Survival was high in non-whites and whites, at 94.1% vs 90.4% at 180 days and 89.2% vs 82.8% at 1 year, respectively, despite adjustment for baseline differences. CONCLUSIONS: Although heart failure etiology differed between men and women and between whites and non-whites, sex and race were not factors that affected survival in patients receiving the HVAD as BIT, which was high in all sub-groups. J Heart Lung Transplant 2015;34:815-824 (C) 2015 Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation. All rights reserved.