Heart failure is defined as reduced ability of the heart to pump blood and maintain normal bodily
function. Heart transplantation is currently the preferred treatment for end-stage heart failure but
the supply of donor hearts is insufficient to meet the need and many patients are not eligible for
transplantation due to age or comorbid conditions.
Implantable mechanical pumps can assist the circulation of blood by the ventricles.
Left ventricular assist devices (LVADs) have been approved by the U.S. Food and Drug
Administration (FDA) for use in patients awaiting transplant (a bridge to transplant) and as
a last resort in patients with refractory heart failure who are not eligible for a heart transplant
(destination therapy). In January 2010, the first newer generation, rotary continuous flow
ventricular assist device (HeartMate II) was approved by the FDA for destination therapy.
Eligibility criteria are essentially the same as those used to select patients for the pivotal clinical
trial that included patients with shortness of breath and/or fatigue at rest or during minimal
exertion despite treatment with optimal therapy for heart failure associated with a low ejection
fraction (< 25%) who were not candidates for heart transplantation due to their age or co-morbid
conditions. The purpose of this report is to review the scientific evidence for use of the current
generation of left ventricular assist devices as destination therapy.