title: Multicenter evaluation of an intrapericardial left ventricular assist system.
abstract: OBJECTIVE
  The aim of this study was to conduct an initial clinical evaluation of the new HeartWare Ventricular Assist System (HeartWare, Inc., Framingham, Massachusetts) in a multicenter, prospective, nonrandomized single-arm clinical trial.
  
  
  BACKGROUND
  Heart failure is a worldwide epidemic. The effectiveness of heart transplantation and medical therapy is limited, resulting in the emergence of mechanical circulatory support as a primary treatment for end-stage heart disease. Left ventricular assist devices that use rotary pumps are small and durable, which might reduce morbidity and mortality during support.
  
  
  METHODS
  Fifty heart transplant candidates with New York Heart Association functional class IV symptoms were supported at 5 international centers by the HeartWare System for 180 days, until heart transplant, myocardial recovery and device explant, or death. Patients who continue to be supported have been followed for a minimum of 2 years.
  
  
  RESULTS
  Of the 50 patients, 20 (40%) received transplants, 4 (8%) had the pump explanted after myocardial recovery, and 17 (34%) continue support at 2 years. Nine (18%) patients died during support from sepsis (n = 3), multiple organ failure (n = 3), or hemorrhagic stroke (n = 3). The actual survival at 6, 12, and 24 months was 90%, 84%, and 79%, respectively. In the survivors, measures of quality of life showed a significant improvement over baseline values. Significant improvements were found for recognition memory at 3 months after implant (p = 0.006). The most frequent adverse events were infection and bleeding.
  
  
  CONCLUSIONS
  Patients with end-stage heart failure can be safely and effectively supported by the HeartWare Ventricular Assist System with improved quality of life and neurocognitive function.
authors.affiliation: Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany. strueber.martin@mh-hannover.de
authors.forename: Martin
authors.initials: M
authors.lastname: Strueber
authors.forename: Gerry
authors.initials: G
authors.lastname: O'Driscoll
authors.forename: Paul
authors.initials: P
authors.lastname: Jansz
authors.forename: Asghar
authors.initials: A
authors.lastname: Khaghani
authors.forename: Wayne C
authors.initials: WC
authors.lastname: Levy
authors.forename: George M
authors.initials: GM
authors.lastname: Wieselthaler
mesh_terms: D000328:Adult; D000368:Aged; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008904:Miniaturization; D011788:Quality of Life; D012307:Risk Factors