title: Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.
abstract: BACKGROUND
  Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail.
  
  
  RESULTS
  Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, P<0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024).
  
  
  CONCLUSIONS
  Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00751972.
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.). milan002@mc.duke.edu.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Milano
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: Duc Thinh
authors.initials: DT
authors.lastname: Pham
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: David R
authors.initials: DR
authors.lastname: Hathaway
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: Mary V
authors.initials: MV
authors.lastname: Jacoski
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Najarian
authors.affiliation: From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
mesh_terms: D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000601:surgery; D006333:Heart Failure / Q000209:etiology / Q000517:prevention & control*; D006343:Heart Septal Defects / Q000601:surgery; D016027:Heart Transplantation; D006349:Heart Valve Diseases / Q000150:complications / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D010496:Pericardium / Q000601:surgery; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D012189:Retrospective Studies; D016896:Treatment Outcome; D014262:Tricuspid Valve Insufficiency / Q000150:complications / Q000601:surgery
keywords: heart failure; heart-assist devices; thoracic surgery