title: Initial clinical experience with the HeartWare left ventricular assist system: a single-center report.
abstract: BACKGROUND
  The HeartWare ventricular assist device (HVAD) system (HeartWare International Inc, Framingham, MA) is a new centrifugal continuous-flow ventricular assist device. The aim of the present study is to review our institutional experience with this novel device.
  
  
  METHODS
  We reviewed the files of 50 patients (39 men, 11 women) with a mean age of 50.6 ± 11.8 years (range, 19 to 70 years) who underwent HVAD implantation between July 2009 and November 2011. Two patients underwent HeartWare BIVAD implantation. The underlying heart diseases were end-stage ischemic heart disease (n = 12), acute myocardial infarction (n = 9), dilated cardiomyopathy (n = 27) and acute myocarditis (n = 2). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles were level 1 (n = 11), 2 (n = 5), 3 (n = 10), and 4 (n = 24).
  
  
  RESULTS
  After a cumulative support duration of 11,086 days, Kaplan-Meier analysis revealed a survival of 82.0%, 77.9%, 75.5%, at 1, 12, and 24 months, respectively. Causes of early death were right heart failure (n = 4), multiorgan failure (n = 2), septic shock (n = 2), and major neurologic complications (n = 4). One late death occurred due to a right heart failure. Comparison between patients operated on in cardiogenic shock (INTERMACS 1 and 2) and patients who underwent elective HVAD implantation (INTERMACS 3 and 4) revealed a survival of 61.5% and 44.1% for the INTERMACS 1 and 2 group and 90.3% and 87.1% for the INTERMACS 3 and 4 group at 1 and 12 months, respectively (odds ratio, 4.67; p = 0.003). One patient was weaned from the system after 2 years. Eleven patients (22%) were successfully bridged to transplantation. Mean time to transplantation was 209 days (range, 72 to 427 days). Posttransplant survival at the 1-year follow-up was 90.9% (11 patients).
  
  
  CONCLUSIONS
  Our experience with HVAD shows satisfying results with an excellent posttransplantation survival. Moreover, the stratified survival based on the level of preoperative stability shows better outcomes in patients undergoing elective HVAD implantation.
authors.affiliation: Department of Cardiothoracic Surgery, University of Münster, Münster, Germany. am.dellaquila@gmail.com
authors.forename: Angelo Maria
authors.initials: AM
authors.lastname: Dell'Aquila
authors.forename: Stefan Rudolf Bertram
authors.initials: SR
authors.lastname: Schneider
authors.forename: Dominik
authors.initials: D
authors.lastname: Schlarb
authors.forename: Bassam
authors.initials: B
authors.lastname: Redwan
authors.forename: Jürgen R
authors.initials: JR
authors.lastname: Sindermann
authors.forename: Björn
authors.initials: B
authors.lastname: Ellger
authors.forename: Jörg
authors.initials: J
authors.lastname: Stypmann
authors.forename: Tony D T
authors.initials: TD
authors.lastname: Tjan
authors.forename: Hans H
authors.initials: HH
authors.lastname: Scheld
authors.forename: Andreas
authors.initials: A
authors.lastname: Hoffmeier
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006333:Heart Failure / Q000401:mortality / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012042:Registries; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D055815:Young Adult