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|Issue 55||July 2012|
A Systematic Review: Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure
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 heart. Left ventricular assist devices (LVADs) have been approved by the FDA for use in patients awaiting 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.
Investigators with the VA Evidence-based Synthesis Program in Minneapolis, MN conducted a review of the literature from 1995 through October 2011, in order to assess the scientific evidence on the use of the current generation of left ventricular assist devices as destination therapy. After conducting in-depth reviews of 146 articles, 9 were determined to be appropriate for addressing the following key questions:
Clinical trials of other, newer-generation continuous flow ventricular assist devices for destination therapy are ongoing; however, results are not expected for several years.
A few studies have identified risk factors for mortality and complications -- and developed or applied mortality prediction models to this particular patient population. Further studies are needed to validate use of different criteria to improve patient outcomes. In the meantime, the approved FDA indication and CMS (Centers for Medicare and Medicaid Services) criteria for coverage are available to guide patient selection.
Even with favorable assumptions regarding the cost and effectiveness of treatment, destination therapy using the current generation, continuous flow ventricular assist device does not appear to have a very favorable cost-effectiveness ratio compared with traditional standards and other Medicare approved interventions. However, large improvements in cost-effectiveness have occurred in the past decade. If improvements continue to be made, destination therapy in end-stage heart disease with an LVAD may become cost-effective.
This report is a product of VA/HSR&D's Quality Enhancement Research Initiative's (QUERI) Evidence-Based Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers -- and to disseminate these reports throughout VA.
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This Management eBrief is a product of the HSR&D Evidence Synthesis Program (ESP). ESP is currently soliciting review topics from the broader VA community. Nominations will be accepted electronically using the online Topic Submission Form. If your topic is selected for a synthesis, you will be contacted by an ESP Center to refine the questions and determine a timeline for the report.
This Management e-Brief is provided to inform you about recent HSR&D findings that may be of interest. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. If you have any questions or comments about this Brief, please email CIDER. The Center for Information Dissemination and Education Resources (CIDER) is a VA HSR&D Resource Center charged with disseminating important HSR&D findings and information to policy makers, managers, clinicians, and researchers working to improve the health and care of Veterans.
This report is a product of the HSR&D Evidence-Based Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers - and to disseminate these reports throughout VA.
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