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

MedStar author(s):
Citation: Circulation. 125(25):3191-200, 2012 Jun 26.PMID: 22619284Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov'tSubject headings: *Heart Transplantation/td [Trends] | *Heart-Assist Devices/td [Trends] | *Pericardium | *Waiting Lists | Adult | Aged | Female | Follow-Up Studies | Heart Failure/mo [Mortality] | Heart Failure/pp [Physiopathology] | Heart Failure/su [Surgery] | Heart Transplantation/mo [Mortality] | Humans | Male | Middle Aged | Pericardium/pp [Physiopathology] | Prospective Studies | Questionnaires | Survival Rate/td [Trends] | Treatment Outcome | Ventricular Dysfunction, Left/mo [Mortality] | Ventricular Dysfunction, Left/pp [Physiopathology] | Ventricular Dysfunction, Left/su [Surgery] | Waiting Lists/mo [Mortality]Local holdings: Available online from MWHC library: 1950 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0009-7322
Name of journal: CirculationAbstract: 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.All authors: Aaronson KD, Acker MA, Anderson AS, Bittman RM, Boyce SW, Cotts WG, Frazier OH, Gregoric ID, Hathaway DR, HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators, Jeevanandam V, Jessup ML, Kormos RL, Levy WC, Loyalka P, McGee EC, Miller LW, Naftel DC, Pagani FD, Slaughter MS, Teuteberg JJDigital Object Identifier: Date added to catalog: 2013-09-17
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article Available 22619284

Available online from MWHC library: 1950 - present, Available in print through MWHC library: 1999 - 2006

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.

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