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Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure

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Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure (February 2012)

Principal Investigators: Thomas S. Rector, Ph.D, Brent C. Taylor, Ph.D., M.P.H.
Research Associates: Nancy Greer, Ph.D. Indulis Rutks, B.S.

Evidence-based Synthesis Program (ESP) Center
Minneapolis VA Medical Center

Minneapolis, MN; Department of Veterans Affairs; May 2012

Download PDF: Complete Report, Executive Summary, Report, Appendices

Background

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.

The key questions were:

Key Question #1. How does use of an FDA-approved, current generation LVAD as destination therapy (i.e., the HeartMate II left ventricular assist device) effect patient outcomes? Key Question #2. What patient or site characteristics have been associated with patient benefits or harms when the FDA-approved, current generation LVAD is used as destination therapy? Key Question #3. What is the range of cost-effectiveness estimates of using the FDA-approved, current generation LVAD as destination therapy in end-stage heart failure and what explains variation in these estimates?

See also

Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure (VA HSR&D Management e-Brief)