Strong Plays Role in Landmark Heart Failure Trial
Results: Up to 20% Reduction in Patient Death, Hospitalization Rates
May 20, 2004
A nationwide clinical trial of more than 1,600 heart failure patients showed that when medicines are combined with the use of a pacemaker-type device that resynchronizes both sides of the heart, hospital stays and death rates drop significantly. The University of Rochester Medical Center Cardiology Department was the only site in the Finger Lakes region, and was among 128 centers nationwide that took part in the research, which is published in the May 20 issue of New England Journal of Medicine.
The New England Journal devotes much of this week’s edition to several clinical studies of these devices, and raises the question of whether their use should be expanded to include a larger pool of patients.
“This research opens up a new avenue for heart failure patients,” says Chang-seng Liang, M.D., UR professor of Medicine and one of the lead investigators in Rochester. “The heart disease process is very complex, and treating patients is not a one-size-fits-all proposition. Being able to offer this gives us more options.” The co-investigator was David Huang, M.D., assistant professor of Medicine.
For Sharon DeCarlo of Rochester, participating in the study has brought benefits. DeCarlo, 38, a secretary at Strong Cardiology Associates, knew the warning signs of heart disease but had trouble believing her fatigue and shortness-of-breath could be attributed to something that serious. “Young, healthy women are like that – not in a million years did I think I had heart trouble,” she says. “You just shrug things off.”
But an escalation of symptoms and several tests showed she suffered from a dilated cardiomyopathy plus a left bundle branch block, an electrical malfunction that doesn’t allow both chambers of the heart to beat together. Doctors speculated that a virus had damaged her heart, perhaps months or years earlier.
DeCarlo enrolled in the clinical trial, called Comparison of Medical Therapy, Pacing and Defibrillation in Chronic Heart Failure or COMPANION, and surgeons implanted a cardiac resynchronization therapy (CRT) device in her chest. She also received heart medications, lost 25 pounds and began exercising again.
“I’m doing fine. It’s just the simple things like being able to run down to the laundry room and back upstairs without getting winded,” DeCarlo said. “I feel very lucky.”
The three-year randomized trial began in January 2000, and was the largest ever designed to measure death and hospitalization rates in congestive heart failure patients; other studies of cardiac resynchronization devices measured either patient clinical performance or quality of life. Volunteers were divided into three groups: those who received optimal heart failure medications only, those who received devices with a pacemaker component, and those who received devices with a pacemaker plus defibrillator component.
The patients who received devices had a 19 percent or 20 percent reduction in death rates and hospitalizations for any cause, compared to the medication group only, according to Guidant Corp., the Indianapolis-based manufacturer of the devices and sole sponsor of the trial.
Approximately five million Americans currently suffer from heart failure, a debilitating condition in which the heart weakens for any number of reasons and gradually loses its ability to pump blood. Nearly a half-million new cases are diagnosed annually.
Cardiac resynchronization therapy devices are about the size of a pager, with extension wires that connect to both chambers (ventricles) of the heart and use electrical stimulation to keep the contractions synchronized. Some devices also have a defibrillator function, which can restore a healthy rhythm by sending a shock to the heart if it suddenly starts beating irregularly.
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