WEDNESDAY, May 19, 2004 (HealthDayNews) -- Implanted devices that keep the heart beating properly can save the lives of people with serious cardiac problems, two studies find.
The studies utilized different devices and looked at people with different heart conditions. But both reported similar results: A marked reduction in deaths and hospitalizations in patients who got the implants in tandem with drug therapy, compared to those treated only with medications.
Both studies appear in the May 20 issue of the New England Journal of Medicine.
The first study used implanted pacemakers in some patients with weakened heart muscles that could not pump blood adequately. The patients also had irregular heartbeats. Other patients with the same combination of problems got a pacemaker and a defibrillator, which delivers electric shocks to keep the heart beating.
In the study of 1,520 people, the incidence of death or hospitalization was 34 percent lower for those who got a pacemaker, compared to those treated with drugs. The pacemaker-defibrillator combination produced an even greater reduction -- 40 percent.
Those results could help settle "a mild debate" about the value of implantable devices, said study author Dr. Michael R. Bristow, chairman of the division of cardiology at the University of Colorado Health Sciences Center.
The debate has been "mild" because a number of smaller studies of implanted heart devices have produced positive results. But they weren't definitive because they looked at less-decisive results, such as a reduction of symptoms, Bristow said.
"This is the first large-scale, controlled study measuring major clinical endpoints, mortality and hospitalization," he said.
The second study, done at Northwestern University School of Medicine, included 458 patients with a combination of moderate-to-severe heart failure and irregular heartbeats. Half got standard drug treatment, while the other half also received a device called a cardioverter-defibrillator.
The death rate two years after the study began was reduced by about one-third in patients with the implanted devices, compared to those who received standard drug treatment, said study leader Dr. Alan Kadish, a professor of medicine at Northwestern.
About 150,000 heart failure patients in the United States would be helped by an implanted cardioverter-defibrillator, Kadish estimated. That estimate is based not only on the results of the new study, but also another study that confirmed the device's benefits, he said.
"These devices clearly conferred additional benefits compared to the already favorable benefits conferred by aggressive pharmacological management," said Dr. Michael E. Cain, director of the cardiovascular division at Washington University School of Medicine in St. Louis. He wrote an editorial accompanying the reports in the journal.
The devices in both studies are expensive, costing tens of thousands of dollars, Cain acknowledged. But their benefits justify the expense, he added.
"When you look at the money spent for other issues and priorities that is required to save lives, this approach is worth it," Cain said. "It can save 150,000 American lives a year."
Nearly 5 million Americans are living with heart failure, and 550,000 new cases are diagnosed each year, according to the American Heart Association.
Bristow said the implanted devices are used regularly in his group's practice, although a formal cost-benefit analysis has not been completed.
"Because hospitalization rates were lowered by 30 to 40 percent, you are reducing the cost of caring for heart failure," Bristow said. A single hospitalization for heart failure can cost $10,000, Bristow said.
The devices used in his study are now covered by Medicare, but not for the conditions treated in the study. An application for such approval has just been filed with Medicare, Bristow said.