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.
- 2015
Available online from MWHC library: 1999 - present, Available in print through MWHC library:1999-2007
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. 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 BTT, which was high in all sub-groups.Copyright © 2015. Published by Elsevier Inc. METHODS: Baseline characteristics, adverse events, and survival were compared for men vs. women and whites vs. non-whites in the combined ADVANCE BTT 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 m2, 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 ischemic 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.
English
ISSN: 1053-2498
Subjects--Topical Terms: *Continental Population Groups *Heart Failure/mo [Mortality] *Heart Failure/th [Therapy] *Heart Transplantation *Heart-Assist Devices *Sex Factors Adult Creatinine/bl [Blood] Female Follow-Up Studies Heart Failure/eh [Ethnology] Humans Hypertension/ep [Epidemiology] Incidence Kaplan-Meier Estimate Length of Stay Male Middle Aged Prospective Studies Retrospective Studies Survival Rate Treatment Outcome
Subjects--Geographic Terms: MedStar Washington Hospital Center
Index Terms--Occupation: MedStar Heart Institute
Index Terms--Function: Comparative Study Journal Article Multicenter Study