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.

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Citation: Journal of Heart & Lung Transplantation. 34(6):815-24, 2015 Jun.PMID: 25813372Institution: MedStar Washington Hospital CenterDepartment: MedStar Heart InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter StudySubject headings: *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 OutcomeYear: 2015Local holdings: Available online from MWHC library: 1999 - present, Available in print through MWHC library:1999-2007ISSN:
  • 1053-2498
Name of journal: The Journal of heart and lung transplantation : the official publication of the International Society for Heart TransplantationAbstract: 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.All authors: Aaronson KD, ADVANCE Trial Investigators, Birks EJ, Boyce S, Cotts WG, Hathaway DR, Jacoski MV, McGee EC Jr, Najarian K, Najjar SS, Pagani FD, Slaughter MSFiscal year: FY2015Digital Object Identifier: Date added to catalog: 2016-05-24
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 25813372 Available 25813372

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.

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