The aim of this study was to conduct an initial clinical evaluation of the new HeartWare
Ventricular Assist System (HeartWare, Inc., Framingham, Massachusetts) in a multicenter,
prospective, nonrandomized single-arm clinical trial.
Heart failure is a worldwide epidemic. The effectiveness of heart transplantation
and medical therapy is limited, resulting in the emergence of mechanical circulatory
support as a primary treatment for end-stage heart disease. Left ventricular assist
devices that use rotary pumps are small and durable, which might reduce morbidity
and mortality during support.
Fifty heart transplant candidates with New York Heart Association functional class
IV symptoms were supported at 5 international centers by the HeartWare System for
180 days, until heart transplant, myocardial recovery and device explant, or death.
Patients who continue to be supported have been followed for a minimum of 2 years.
Of the 50 patients, 20 (40%) received transplants, 4 (8%) had the pump explanted after
myocardial recovery, and 17 (34%) continue support at 2 years. Nine (18%) patients
died during support from sepsis (n = 3), multiple organ failure (n = 3), or hemorrhagic
stroke (n = 3). The actual survival at 6, 12, and 24 months was 90%, 84%, and 79%,
respectively. In the survivors, measures of quality of life showed a significant improvement
over baseline values. Significant improvements were found for recognition memory at
3 months after implant (p = 0.006). The most frequent adverse events were infection
and bleeding.
Patients with end-stage heart failure can be safely and effectively supported by the
HeartWare Ventricular Assist System with improved quality of life and neurocognitive
function.
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier
Inc. All rights reserved.