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Editorial

Innovation With Experience Using Implantable Left Ventricular Assist Devices

Deborah D. Ascheim, MD; Annetine C. Gelijns, PhD and Eric A. Rose, MD

From the Department of Health Policy (D.D.A., A.C.G., E.A.R.) and the Cardiovascular Institute (D.D.A., E.A.R.) of Mount Sinai School of Medicine, NY.

Correspondence to Deborah D. Ascheim, MD, Department of Health Policy, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1077, New York, NY 10029. E-mail deborah.ascheim@mssm.edu

Key Words: heart-assist device • heart failure • survival • health policy • outcomes

An extract of the first 250 words of the full text is provided, because this article has no abstract.

The National Institutes of Health’s artificial heart program, initiated in 1964, has generated sustained and coordinated efforts by industry and academic engineers and investigators to create and develop mechanical circulatory support devices to prolong and enhance the lives of patients with advanced heart failure. These efforts have been supported by a combination of federal, industry, and philanthropic funding. By the mid 1990s, left ventricular assist devices (LVADs), the direct offspring of the program, received Food and Drug Administration marketing approval to support patients awaiting cardiac transplantation. Favorable results in this bridge to transplant population encouraged the design of the multicenter REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart failure) trial to evaluate the efficacy and safety of long-term LVAD support in patients with chronic end-stage heart failure (stage D).¹ Compared with optimal medical management (n=61), LVAD implantation (n=68) doubled the 1-year survival (from 25% to 51%) in a terminally ill, transplant-ineligible population. Moreover, these patients had a significant improvement in quality of life and functional status compared with their medical counterparts. On the basis of these results, the Food and Drug Administration allowed initial commercialization of LVADs as a "destination therapy" (DT) in late 2002, and the Center for Medicare and Medicaid Services approved the therapy for coverage and reimbursement in 2003. In addition to proving the concept that LVADs could improve survival and quality of life of a defined severely ill population, REMATCH documented an array of limitations in device performance, durability, and clinical management. . . . [Full Text of this Article]

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