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Release: Nov. 26, 2001

Photo caption for HeartMate VE LVAS: The HeartMate has been used as a temporary bridge to heart transplant in more than 3,000 implants in 22 countries. New results announced today suggest that the device, which is implanted alongside the natural heart to help it pump, may also someday serve as a permanent treatment for people who do not qualify for a heart transplant due to age or extenuating medical conditions.

UI Heart Care researchers participated in landmark REMATCH heart study

IOWA CITY, Iowa -- University of Iowa Heart Care researchers were among the first in the nation to evaluate a mechanical heart assist device that helped patients with end-stage heart failure live nearly three times longer than patients who received standard therapy.

The evaluation was conducted as part of a groundbreaking clinical trial, called REMATCH, the results of which were published in an early Web site edition of the current issue of the New England Journal of Medicine and presented at the American Heart Association's Scientific Sessions. The results conclude that the heart assist device resulted in statistically and clinically significant improved rates of survival and quality of life for end-stage heart failure patients ineligible for heart transplants.

"Not only did the patients survive longer, but they felt much better and could enjoy their lives more," said Wayne Richenbacher, M.D., professor and cardiac surgeon in the UI department of surgery. "Typically, these patients are the 'sickest of the sick' and are often so debilitated that they can't work, are frequently hospitalized and may become exhausted following even minimal exertion."

The REMATCH trial, which stands for "Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure," was a collaborative effort sponsored by the National Institutes of Health, Columbia University and Thoratec Corporation. Conducted at 22 sites nationwide, with 129 patients enrolled, the trial is the largest of its kind to compare the use of Thoratec's HeartMate VE implantable left ventricular assist device (LVAD) to optimal medical management, which consists of drug therapy, diet management and exercise.

Study outcomes showed that one-year survival for those with the HeartMate was nearly double – 52 percent versus 25 percent – compared to patients treated with drug therapy. This represents a 36 percent reduction in mortality among patients implanted with the device. These results suggest that a left ventricular assist device could prevent at least 270 deaths annually for every 1,000 end-stage heart failure patients – up to four times greater than the survival rate of patients being treated with today's drug therapies.

Median survival for the LVAD patients was nearly three times the control group (408 days and 105 days, respectively). The longest living HeartMate patient is still alive at 1,051 days of support and counting, while the longest living control patient died at 798 days.

While this is compelling data in and of itself, the one-year survivability rate for patients younger than 60 was even more dramatic – 74 percent versus 33 percent. This 74 percent survivability rate compares favorably with the 80 percent one-year survivability rate for heart transplant patients, suggesting that with continuous improvements in device technology and implantation techniques, LVAD survival rates may someday equal transplant rates in certain patient populations.

The study data also showed that LVAD patients reported statistically significant increases in quality of life at one year; patients felt better, were more mobile and had a more positive state of mind.

The REMATCH trial began in 1998 and concluded in June 2001. The goals of the trial were to evaluate survival rates, quality of life and cost effectiveness of heart assist devices as a permanent treatment therapy for end-stage heart failure patients who are ineligible for heart transplantation due to age, diabetes or other health issues that would make this type of surgery clinically unrealistic.

Heart disease is the number one cause of death in the United States. Congestive heart failure (CHF) afflicts 4.7 million Americans and is responsible for 285,000 deaths annually. A heart transplant is traditionally the only hope for these patients, but many CHF sufferers are ineligible for transplant. Of those who are eligible, cardiac transplantation is not guaranteed due to limitations of the number of donor hearts. Circulatory support devices, such as Thoratec's HeartMate VE LVAD, are used to take over the natural pumping function of a diseased heart that is no longer able to circulate a sufficient amount of blood on its own. Currently, the HeartMate is FDA-approved for use as a "bridge to transplant" to sustain life while a patient waits for a donor heart to become available.

Given the positive nature of the study findings, Thoratec has submitted a Pre-Market Approval supplement to the Food and Drug Administration requesting that this ventricular assist device be approved for use in this patient population for indication as a permanent support solution. This would help an estimated 100,000 Americans per year who have end-stage heart failure and do not qualify for a heart transplant. If approved by the FDA, this would mark the first time an LVAD has been approved for use in non-transplant candidates and would represent a dramatic change in the treatment of heart failure by expanding how ventricular assist devices are used as a treatment therapy. People seeking more information on the HeartMate heart assist device or the cardiac programs at UI Heart Care can visit a number of Web sites including www.rematch.net, www.thoratec.com, and www.uihealthcare.com, or by calling (319) 384-9212.

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.