Heartware results of the advance bridge to transplant trial

Acker, Ranjit John , David R. Hathaway, Kevin B. Najarian, Keith D. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.

Methods: The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at days.

Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events. Results: A total of patients in the pivotal bridge to transplant and continued access protocols trial have completed their day primary end-point assessment. Quality of life scores improved significantly, and adverse event rates remain low. Conclusions: The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 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.

Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Epub May J Heart Lung Transplant. Epub Dec Epub Mar Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures. Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device. Epub Jun 4.

HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Chronic Heart Failure. Not Applicable. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :.

Actual Primary Completion Date :. Results: A total of patients in the pivotal bridge to transplant and continued access protocols trial have completed their day primary end-point assessment.

Quality of life scores improved significantly, and adverse event rates remain low. Of patients enrolled in these trials, were men and 96 women, with whites and non-whites. Results: At baseline, women had a smaller body surface area 1. Differences in Kaplan-Meier survival were not significant at days men,