TY  - BOOK
AU  - Boyce, Steven W
AU  - Miller, Leslie W
TI  - Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation
SN  - 0009-7322
KW  - *Heart Transplantation/td [Trends]
KW  - *Heart-Assist Devices/td [Trends]
KW  - *Pericardium
KW  - *Waiting Lists
KW  - Adult
KW  - Aged
KW  - Female
KW  - Follow-Up Studies
KW  - Heart Failure/mo [Mortality]
KW  - Heart Failure/pp [Physiopathology]
KW  - Heart Failure/su [Surgery]
KW  - Heart Transplantation/mo [Mortality]
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Pericardium/pp [Physiopathology]
KW  - Prospective Studies
KW  - Questionnaires
KW  - Survival Rate/td [Trends]
KW  - Treatment Outcome
KW  - Ventricular Dysfunction, Left/mo [Mortality]
KW  - Ventricular Dysfunction, Left/pp [Physiopathology]
KW  - Ventricular Dysfunction, Left/su [Surgery]
KW  - Waiting Lists/mo [Mortality]
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
KW  - Multicenter Study
KW  - Research Support, N.I.H., Extramural
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1950 - present, Available in print through MWHC library: 1999 - 2006
N2  - 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; CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972; 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; 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
UR  - http://dx.doi.org/10.1161/CIRCULATIONAHA.111.058412
ER  -