title: 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.
abstract: 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 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.
  
  
  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.
authors: Department of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky. Electronic address: emma.birks@louisville.edu.
authors: Emma J
authors: EJ
authors: Birks
authors: Departments of Cardiovascular Surgery and Cardiovascular Medicine, Northwestern University, Chicago, Illinois.
authors: Edwin C
authors: EC
authors: McGee
authors: Departments of Cardiovascular Surgery and Cardiovascular Medicine, University of Michigan, Ann Arbor, Ann Arbor, Michigan.
authors: Keith D
authors: KD
authors: Aaronson
authors: Department of Cardiovascular Medicine, Washington Hospital Center, Washington, DC.
authors: Steven
authors: S
authors: Boyce
authors: Departments of Cardiovascular Surgery and Cardiovascular Medicine, Northwestern University, Chicago, Illinois.
authors: William G
authors: WG
authors: Cotts
authors: Department of Cardiovascular Medicine, Washington Hospital Center, Washington, DC.
authors: Samer S
authors: SS
authors: Najjar
authors: Departments of Cardiovascular Surgery and Cardiovascular Medicine, University of Michigan, Ann Arbor, Ann Arbor, Michigan.
authors: Francis D
authors: FD
authors: Pagani
authors: HeartWare, Inc., Framingham, Massachusetts.
authors: David R
authors: DR
authors: Hathaway
authors: HeartWare, Inc., Framingham, Massachusetts.
authors: Kevin
authors: K
authors: Najarian
authors: HeartWare, Inc., Framingham, Massachusetts.
authors: Mary V
authors: MV
authors: Jacoski
authors: Department of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky.
authors: Mark S
authors: MS
authors: Slaughter
mesh_terms: D000328:Adult; D003404:Creatinine / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000208:ethnology / Q000401:mortality* / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D015994:Incidence; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D044469:Racial Groups; D012189:Retrospective Studies; D012737:Sex Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003404:Creatinine
keywords: heart failure; race; survival; ventricular assist device.; women