| [Embargoed for release
until 4 PM, May 27, 2003, to coincide with publication in the Journal of
the American Medical Association.]
COMBINED THERAPIES BENEFIT HEART FAILURE PATIENTS
COLUMBUS, Ohio – Devices implanted in the heart that combine the benefits of a pacemaker and defibrillator improve the quality of life and physical stamina capacity in patients with advanced congestive heart failure and life-threatening arrhythmias, according to a new national study.
Researchers found that at six months, patients with the devices had a greater improvement in their quality of life and physical functioning than did study participants in the control group who did not have the devices.
The study, published in the May 28 issue of The Journal of the American Medical Association, is an important step in understanding the potential benefits implanted devices offer in treating heart failure, a disease that even when treated with the latest pharmaceutical agents has a five-year mortality rate of 50 percent after diagnosis.
“The findings are significant in terms of how this relatively new combination of therapy can impact the quality of life for people with heart failure,” said William T. Abraham, a co-author of the study and director of cardiovascular medicine at The Ohio State University Medical Center and associate director of OSU’s Davis Heart and Lung Research Institute.
In addition, patients with the combined devices showed improvements in exercise capacity as measured on a treadmill, and improvements in heart structure.
The pacemaker-defibrillator devices combine cardiac resynchronization therapy with therapy provided by cardioverter defibrillators that provide an electrical shock to the heart to correct abnormal and dangerous heart rhythms.
In the study, nearly half (182) of the 369 patients were randomly assigned to receive implantable cardioverter defibrillators (ICD) and supporting medical treatment, while 187 were assigned to receive the combination cardioverter defibrillator and cardiac resynchronization therapy (CRT) devices in conjunction with supporting medical treatment.
At six months, patients with the CRT had a greater overall improvement in their quality of life than the other group, although there was no change in the distance they were able to walk in six minutes. The study was not designed to study mortality or morbidity differences between the two groups.
There are approximately 5 million people in the United States with congestive heart failure. It’s estimated about 5 percent of these patients could fit the medical profile of potentially benefiting from the combination device. Heart failure is the most common cause of hospitalization for older people. Because a failing heart can’t pump efficiently, blood circulation is impaired, causing shortness of breath, fluid in the lungs and swelling in the legs.
The principal investigator for the Ohio State arm of the study, Dr. Charles Love of cardiovascular medicine, said the study mirrors what he has observed in his own patient population.
“It’s clear this form of therapy can significantly improve patients’ quality of life,” said Love. The devices cost about $30,000 each, but Love said their use has been shown to reduce the number of costly hospital stays often required by patients with heart failure.
Medtronic Inc. provided funding for the study and is the manufacturer of the dual-chamber biventricular pacing ICD system used in the trial. Abraham is a recipient of grant support and speaker’s honoraria from Medtronic.
Contact: David Crawford, Medical Center Communications,
614-293-3737, or email@example.com