Normal view MARC view ISBD view

HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial.

MedStar author(s):

1053-2498

Name of journal: The Journal of heart and lung transplantation : the official publication of the International Society for Heart TransplantationAbstract: BACKGROUND: The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.CONCLUSIONS: The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates. Copyright 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.METHODS: The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.RESULTS: A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.All authors: Aaronson KD, Acker MA, Birks EJ, Boyce SW, Cotts WG, Gregoric I, Hathaway DR, HeartWare Bridge to Transplant ADVANCE Trial Investigators, Howard Frazier O, Icenogle T, John R, McGee EC, Najarian KB, Najjar SS, Pagani FD, Slaughter MSDigital Object Identifier:

http://dx.doi.org/10.1016/j.healun.2013.04.004

Date added to catalog: 2013-12-24

Holdings ( 1 )
Title notes ( 6 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article		Available		23796152

Available online from MWHC library: 1999 - present, Available in print through MWHC library:1999-2007

BACKGROUND: The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.

CONCLUSIONS: The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates. Copyright 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

METHODS: The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.

RESULTS: A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.

English