Use of an Intrapericardial, Continuous Flow, Centrifugal Pump in Patients Awaiting Heart Transplantation
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 to that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplant or explant for ventricular recovery at 180 days and was evaluated both for 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. 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 min walk distance improved 128.5 meters, 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 Information—clinicaltrials.gov; Identifier: NCT00751972.
- Received July 27, 2011.
- Accepted April 12, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited