CONTACT: TOM MOORE
Joint Office for Planning, Marketing and Communications
8788 John Pappajohn Pavilion
Iowa City IA 52242
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
UI Heart Care researchers participated in landmark REMATCH heart study
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
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
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,
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.