Defibrillator home use OK'd

Heart: The FDA approves over-the-counter sale of the devices in the hope that they will prevent cardiac-arrest deaths.

Medicine & Science

October 18, 2004|By Erika Niedowski | Erika Niedowski,SUN STAFF

Partly on a whim, James W. Baum spent $2,000 apiece on three defibrillators - one for each of his homes - thinking he would someday need one to revive an elderly neighbor suffering from a cardiac arrest.

Little did he know the device would save his own life.

"I would be dead" without it, said the 65-year-old from Lodi, Calif., who owns several mobile-home parks and grows grapes for a winery. "Twenty-five of my friends have bought them. I really believe in them."

With stories like Baum's making converts, the Food and Drug Administration approved last month the over-the-counter sale of automated external defibrillators, or AEDs - which until now have been available to consumers only with a doctor's prescription.

Supporters say making the lunchbox-sized devices available to the public is a no-brainer. After all, they could help save some of the 350,000 to 450,000 people who die from sudden cardiac arrest in the United States each year.

"We hope ... that the FDA coming in and removing the prescriptive authority is truly going to make the defibrillator become as ubiquitous as a fire extinguisher in the home," said Dr. James A. D'Orta, a former paramedic, firefighter and emergency medicine physician who runs LifeLink MD, a Washington-based company that sells AEDs nationwide.

But critics say there's no scientific evidence to support the policy change and suggest the devices could provide families a false sense of security - at a steep price.

Though a heart attack - the death of heart tissue caused by a blockage - can lead to a so-called sudden cardiac arrest, they are not the same. In a sudden arrest, the heart might start beating too rapidly or in a chaotic rhythm.

Most people who suffer such an arrest are found to be in ventricular fibrillation, a condition in which the heart quivers or flutters rather than fully contracts. Blood, in turn, can't flow where it needs to - the brain and the rest of the body.

Unless the heart is jolted back into a normal rhythm, victims usually die within minutes. So time is of the essence. Every minute defibrillation is delayed, experts say, decreases the chance of survival 8 percent to 10 percent.

But even paramedics equipped with AEDs don't always get a chance to use them. In some cases, by the time they reach a patient, it's too late. That's why the devices have become fixtures in airports, shopping malls, sports stadiums and other public places in recent years.

The product the FDA approved for over-the-counter use, the HeartStart home defibrillator by Massachusetts-based Philips Medical Systems, is smaller than a laptop computer and weighs about 3 pounds.

Pulling a handle at the top activates voice instructions that guide users through each step. Once the patient is hooked up to the machine, it analyzes his or her heart rhythm to determine whether a shock is needed. FDA analysts found that the instructions made it easy to use the device properly.

"Anybody can do it," said John Gregoire, 44, of Plano, Texas, who suffered a sudden cardiac arrest two years ago while lifting free weights at his gym.

A surgeon who happened to be working out at the same time began cardiopulmonary resuscitation but realized Gregoire's heart needed a jump-start.

"You're basically dead, and the only way out is a shock from a defibrillator," said Gregoire, who runs a broadband software company.

Luckily, the gym had purchased one a few months earlier.

A study reported in the New England Journal of Medicine in August concluded that the number of people who survive cardiac arrest in public places could double if lay volunteers were trained to use defibrillators - along with CPR. But there's no such research on the effectiveness of defibrillators in the home.

The head of the American Heart Association's AED task force, Dr. Graham Nichol, testified before the FDA in July in favor of lifting the prescription requirement, but only because there's evidence that defibrillators are safe in the home. He said his organization would neither endorse nor oppose their use at home because there weren't enough data on how well they work.

"There's not evidence of effectiveness," said Nichol, an associate professor of medicine at the University of Washington in Seattle. "That's a subject of an ongoing trial."

The lack of scientific evidence worries doctors such as Arthur Kellermann, chairman of emergency medicine at Emory University School of Medicine in Atlanta. He doesn't dispute that AEDs can save lives, but he's not convinced that widespread home use will be entirely beneficial.

"While everybody understandably focuses on the big win - the save - there is the very real potential for unintended consequences," he said. "Deployment of the technology has raced ahead of science."

Kellermann fears, for instance, that victims' families might spend precious time searching for their AED rather than calling 911 or starting CPR.

"That could be a catastrophic mistake," he said.

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