Release: Oct. 1, 1997
Contact:
Andrew Smith, (215) 707-8229 or [email protected]
New Trial Will Examine Effectiveness Of A Mechanical Device For People With End-Stage Heart Failure
PHILADELPHIA -- For patients in Class IV heart failure -- the most severe class -- getting off the couch and walking across the room can feel like climbing Mt. Everest. Without a heart transplant, approximately 75 percent of these patients will die within two years. Unfortunately, many of them will not be candidates for transplant.
A trial now underway at Temple University Hospital will examine the efficacy, safety and cost-effectiveness of using the Left Ventricular Assist Device (LVAD) as a permanent treatment of end-stage heart failure. The LVAD -- about the size of an outstretched hand -- is a two-pound mechanical device that pumps blood out of the heart to the body. In recent years, it has been used as a temporary "bridge" to heart transpla! nt, keeping the sickest transplant candidates alive until they receive a new heart. This trial will push the limits of the LVAD.
"Although the LVAD has been very effective in its role as a bridge to transplant, there is still only a limited amount of information about its ability to provide safe, long-term support of patients," says Dr. Valluvan Jeevanandam, surgical director of Temple's Heart Transplantation Program and chief investigator of the trial at Temple. Dr. Howard Eisen, medical director of the Heart Transplantation Program, is co-investigator.
The randomized trial will compare the functional status and health-related quality of life in the LVAD group -- before and after implantation -- with an optimal medical management group. Temple is one of only 11 medical centers in the U.S. participating in the trial.
People who want to learn more about participating in the study at Temple can call (215) 707-2685.
Additional Facts About the Trial:
-- The name of the trial is REMATCH -- randomized evaluation of mechanical assistance therapy for congestive heart failure.
-- The trial is randomized. Once patients are enrolled in the study, they have a 50/50 chance of receiving an LVAD. Randomization will occur from a pool of sequentially numbered envelopes.
-- Approximately 140 patients nationwide will be enrolled in the study -- half will receive an LVAD and half will receive optimal medical treatment. At the end of the trial, the two groups will be compared. About 20 patients will be enrolled at Temple.
-- The target population for this trial is patients with end-stage heart failure who have had symptoms of heart failure for at least four months in duration and are not candidates for heart transplantation.
-- Patients randomized to the LVAD will have the device implanted within 24 hours of being notified.
-- Patients randomized to the medical management arm of the study will receive the best possible treatment available.
-- The primary objective of the trial is to determine the effect of LVADs on all-cause mortality in patients with end-stage chronic heart failure versus patients receiving optimal medical managment.
The secondary objectives of the trial are as follows:
-- To determine patient preferences for balancing length of life with quality of life.
-- To compare the functional status and health-related quality of life in the LVAD group with the medical group.
-- To compare the incidence of adverse effects, such as infections, between the LVAD group and the medical group.
-- To compare the total length of hospital stay in the LVAD and medical group.
-- To document the costs of LVAD implantation and optimal medical management.
-- To measure LVAD performance. Additional Facts About Heart Failure:
-- Heart failure afflicts between three and four million Americans, with about 400,000 new cases being diagnosed each year.
-- The number of hospital admissions because of heart failure has increased tenfold since 1970.
-- Medicare alone paid $2.4 billion to hospital for about 613,000 heart failure cases in 1991, whereas total treatment costs for this condition were estimated to be more than $10 billion.
-- Mortality rates for heart failure remain high with five-year survival rates of approximately 30 to 40 percent in patients with mild to moderate symptoms, and zero to 20 percent in patients with severe symptoms.
-- Despite advances, existing drugs have met with only moderate success in Stage IV heart failure, and the one-year survival rate is only 40 to 50 percent.
-- It's been estimated that at least 16,500 people per year in this country would be suitable candidates to receive donor hearts. Unfortunately, the number of donor hearts harvested over the past few years has remained relatively constant at about 2,000 hearts annually.
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