Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation.

نویسندگان

  • Keith D Aaronson
  • Mark S Slaughter
  • Leslie W Miller
  • Edwin C McGee
  • William G Cotts
  • Michael A Acker
  • Mariell L Jessup
  • Igor D Gregoric
  • Pranav Loyalka
  • O H Frazier
  • Valluvan Jeevanandam
  • Allen S Anderson
  • Robert L Kormos
  • Jeffrey J Teuteberg
  • Wayne C Levy
  • David C Naftel
  • Richard M Bittman
  • Francis D Pagani
  • David R Hathaway
  • Steven W Boyce
چکیده

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. METHODS AND 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. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.

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عنوان ژورنال:
  • Circulation

دوره 125 25  شماره 

صفحات  -

تاریخ انتشار 2012