An implanted defibrillator, which automatically delivers shocks to keep the heart beating, reduced the death rate by 31 percent in people who had suffered heart attacks, says a report presented yesterday at a meeting of the American College of Cardiology in Atlanta and published tomorrow in the New England Journal of Medicine.
However, an ICD, as it is also called, costs $20,000. Add in the surgery required and one night in the hospital to recover, and the price could double.Money was not an issue for Vice President Dick Cheney, who had an ICD implanted last summer; the government paid for his operation. It is an issue for most other people and for the Medicare program, which has reduced its payments to doctors.
Dr. Arthur J. Moss, lead author and a professor of medicine at the University of Rochester Medical Center, estimates the device could be used by 2.4 million Americans right now, with an estimated 240,000 new cases every year. The potential price tag: tens of billions of dollars.
"I don't know if we have the money to do it," says Dr. David Faxon, chief of cardiology at the University of Chicago and president of the American Heart Association, who says cost is "a very serious issue."
"We have to say, 'Wait a minute, is it practical?'" Faxon says. "I think we have to look at the data, and find different groups of patients in the study who benefited and those who didn't."
The study enrolled 1,232 people. All had at least one heart attack and had very low ejection fraction, a measure of how well the heart pumps blood. A normal ejection fraction is 60 percent or more; people in the study had ejection fractions of 30 percent or less.
All were given the best available drug treatment. After two years, 20 percent of the patients without defibrillators had died, compared to 14.1 percent of those with an ICD -- a 31 percent reduction in mortality.
After making his report at the cardiology meeting, Moss appeared at an investor briefing for Guidant Corp., which supplied the ICDs and financed the study. Moss stresses Guidant played no role in carrying out the study, and he has no financial interest in the company.
"There is a huge population of patients who can benefit from an implanted defibrillator," Moss says. "Any time you get an effect above a 20 percent reduction in mortality, it affects the way medicine is practiced."
Moss adds the researchers are doing the kind of analysis recommended by Faxon, looking at data to determine characteristics that can single out patients who are most likely to benefit.
A cost-effectiveness study has already begun, and results are expected in May. It costs $40,000 to save one year of life by treating high blood pressure, Moss says, and $65,000 to save one year of life with artificial kidney treatment -- benchmarks against which the ICD can be measured.
Fred McCoy, president of Guidant's cardiac rhythm management group, calls the results of the study "straightforward, compelling and definitive."
The company is preparing a marketing plan in anticipation of approval by the U.S. Food and Drug Administration, which is processing the ICD application, he says.
"This is a story that physicians and patients at risk will be drawn to," McCoy says.
What To Do
Moss recommends people who have had a heart attack be aware of their ejection fraction as a measure of risk.
Faxon says everyone should know the signs and symptoms of a heart attack, and seek help immediately. Early treatment can limit heart damage, and avert the need for a defibrillator.
For a primer on defibrillators, consult the American Heart Association.
For more on how doctors treat irregular heartbeats, go to the National Heart, Lung, and Blood Institute.