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

1053-2498


*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


MedStar Washington Hospital Center


MedStar Heart Institute


Comparative Study
Journal Article
Multicenter Study