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Circulatory support with a left ventricular assist device (LVAD) as a bridge to transplantation or as destination therapy has progressed in recent years because of improvements in patient care and in technology. When compared with medical therapy, LVAD support provides both survival and quality-of-life benefits. The 1-year survival rate for bridge to transplantation is as high as 90%1; the 1-year survival rate for destination therapy is 68%, and the 2-year survival rate is 58%.2 Estimates of the number of patients in the United States who could benefit from LVAD support vary from 35,0003 to as many as 150,000.4 However, in 2010, fewer than 3,000 patients will have these devices implanted. Most heart-failure patients do not have access to this therapy; therefore, expanding access to more patients is essential.
The disparity between the overall number of LVAD candidates and the number who actually receive this therapy is a complex problem that may worsen in the future. At present, nearly 5.8 million Americans have heart failure, and 670,000 new cases are diagnosed annually.5 In patients older than 65 years, the incidence of heart failure increases from less than 2% to almost 10%, and heart failure is the leading hospital admission diagnosis for this age group. A large segment of the U.S. population, known as the “baby boom” generation, comprises 77.3 million people who now range from 46 to 64 years of age.6 As a result of our population's aging, the number of potential LVAD candidates will continue to increase for many years.
The bridge to heart transplantation with an LVAD is limited primarily by the inflexible and inadequate number of available donor hearts. Although destination therapy is not limited by the supply of LVADs, it too is available to only a small proportion of the heart-failure population. Left ventricular assist device testing and destination-therapy trials were undertaken by academic medical centers that had the resources to conduct the experimental programs. Consequently, the centers that offer destination therapy are typically in large metropolitan areas, which are not necessarily the areas with the highest incidence of heart-failure deaths (Fig. 1). Therefore, as the average age of residents in underserved areas increases, the lack of access to LVAD therapy will become even more severe.
Currently, only 79 medical centers in the U.S. have been certified for destination therapy by the Centers for Medicare and Medicaid; these centers are located predominantly in the northeastern quadrant of the country. The southern U.S., which has the largest regional population and the highest incidence of heart-failure deaths, has the fewest destination-therapy-certified centers. Nineteen U.S. states are currently without a destination-therapy center; 12 states have 1 center; another 12 states have 2 centers; and only 8 states have 3 or more. In the western U.S., large areas exist where the geographic distance to destination-therapy centers precludes any real access for heart-failure patients.
Although the recent commercial approval of the HeartMate® II LVAD (Thoratec Corporation; Pleasanton, Calif) for destination therapy has lessened the regulatory barriers for patient access, offering such therapy in the areas of greatest need might require community and other hospitals that provide advanced cardiac care—but do not provide heart transplantation services—to establish certified destination-therapy programs. At present, only 6 non-transplant centers are certified for destination therapy: 5 are in the Northeast and 1 in the Midwest. Many obstacles must be overcome before enough such centers can be established to make access equitable. Any new destination-therapy program must invest in the technology and in a highly trained heart-failure care team. At a minimum, a destination-therapy-certified program must have a surgeon who has performed at least 10 implants during a 36-month period, a dedicated heart-failure cardiologist, and a dedicated LVAD coordinator. To receive payment from Medicare, a destination-therapy center must be certified by the Joint Commission, which has set standards, clinical practice guidelines, and mandatory performance measures. The establishment of a new destination-therapy program is not a small task, and it may be cost-prohibitive for many community hospitals.
One option for providing nationwide access to destination therapy may be the formation of heart-failure networks with centers of excellence. The key to achieving good outcomes is clinician experience in patient selection and management.7 Centers of excellence for destination therapy are those that have a large experience with LVAD implants—LVADs not only for destination therapy, but also for bridge to transplantation and short-term treatment of acute heart failure. Such comprehensive heart-failure care centers can greatly expand the geographic areas for heart-failure patients by working in partnership with community hospitals that provide advanced cardiac care. A few communities have formed such networks8 and may serve as models for centers in the underserved regions of the country.
The use of LVAD technology has progressed sufficiently to become standard therapy in centers that provide comprehensive care for patients with heart failure. The time is right to extend destination therapy to more patients, especially in regions of the U.S. with a high incidence of deaths due to heart failure. However, all centers that provide destination therapy must use best-practice guidelines and maintain outcomes that are comparable to those of existing centers of excellence. As the field of destination therapy continues to evolve, consideration needs to be given to the aging of the U.S. population.
Address for reprints: Mark S. Slaughter, MD, Professor & Chief, Division of Thoracic & Cardiovascular Surgery, University of Louisville, 201 Abraham Flexner Way, Suite 1200, Louisville, KY 40202
Presented at the 18th Annual Texas Heart Institute Summit, “Heart Failure in the Next Decade: The Impact of Novel Therapies on Current Treatment Strategies,” 5–6 March 2010, Houston.
Program Director: Roberta C. Bogaev, MD, FACC