title: Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation.
abstract: BACKGROUND
  Contemporary ventricular assist device therapy results in a high rate of successful heart transplantation but is associated with bleeding, infections, and other complications. Further reductions in pump size, centrifugal design, and intrapericardial positioning may reduce complications and improve outcomes.
  
  
  RESULTS
  We studied a small, intrapericardially positioned, continuous-flow centrifugal pump in patients requiring an implanted ventricular assist device as a bridge to heart transplantation. The course of investigational pump recipients was compared with that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days and was evaluated for both noninferiority and superiority. Secondary outcomes included a comparison of survival between groups and functional and quality-of-life outcomes and adverse events in the investigational device group. A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. Success occurred in 90.7% of investigational pump patients and 90.1% of controls, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin). At 6 months, median 6-minute walk distance improved by 128.5 m, and both disease-specific and global quality-of-life scores improved significantly.
  
  
  CONCLUSIONS
  A small, intrapericardially positioned, continuous-flow, centrifugal pump was noninferior to contemporaneously implanted, commercially available ventricular assist devices. Functional capacity and quality of life improved markedly, and the adverse event profile was favorable.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.
authors.affiliation: University of Michigan Medical Center, 1500 E Medical Center Dr, Cardiovascular Center, Room 2169, SPC 5853, Ann Arbor, MI 48109-5853, USA. keith@umich.edu
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.forename: Leslie W
authors.initials: LW
authors.lastname: Miller
authors.forename: Edwin C
authors.initials: EC
authors.lastname: McGee
authors.forename: William G
authors.initials: WG
authors.lastname: Cotts
authors.forename: Michael A
authors.initials: MA
authors.lastname: Acker
authors.forename: Mariell L
authors.initials: ML
authors.lastname: Jessup
authors.forename: Igor D
authors.initials: ID
authors.lastname: Gregoric
authors.forename: Pranav
authors.initials: P
authors.lastname: Loyalka
authors.forename: O H
authors.initials: OH
authors.lastname: Frazier
authors.forename: Valluvan
authors.initials: V
authors.lastname: Jeevanandam
authors.forename: Allen S
authors.initials: AS
authors.lastname: Anderson
authors.forename: Robert L
authors.initials: RL
authors.lastname: Kormos
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Teuteberg
authors.forename: Wayne C
authors.initials: WC
authors.lastname: Levy
authors.forename: David C
authors.initials: DC
authors.lastname: Naftel
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bittman
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.forename: David R
authors.initials: DR
authors.lastname: Hathaway
authors.forename: Steven W
authors.initials: SW
authors.lastname: Boyce
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery; D016027:Heart Transplantation / Q000401:mortality / Q000639:trends*; D006353:Heart-Assist Devices / Q000639:trends*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010496:Pericardium / Q000503:physiopathology; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000401:mortality / Q000503:physiopathology / Q000601:surgery; D014850:Waiting Lists / Q000401:mortality