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Health and medicine

Problems with heart device raise questions

How soon should doctors be notified when flaws are reported? That's what a group is debating.

By LISA GREENE
Published August 7, 2005

TAMPA - The number of Americans who rely on electrical devices to keep their hearts beating properly is soaring, with more than 250,000 people slated to get defibrillators implanted this year.

It's the job of Dr. Anne B. Curtis, who took over the cardiology division at the University of South Florida in April, to take care of them.

Yet Curtis believes most people don't even realize that her specialty - treating hearts that beat too fast or slow - is in fact a specialty. So when she became president in May of her national professional group, the Heart Rhythm Society, she thought her chief task would be to help change that.

Then something else did.

Two weeks after she took the president's post, one of the industry's biggest device makers, Guidant Corp., said more than 24,000 of its implanted defibrillators were flawed and could malfunction.

"The Guidant thing exploded, and it hasn't stopped since," said Curtis, 52.

More bad news kept coming. Guidant acknowledged the problem only when the New York Times broke a story about the safety concerns. The New York Times reported that Guidant knew about the problems for three years, but quietly kept selling the flawed devices. At least one patient had died. In June, the company said other models could be flawed. Last month, the company said nine models of its company pacemakers, 28,000 devices, might need to be replaced.

This summer, Curtis has been quoted as an expert in the New York Times, the Wall Street Journal, Forbes magazine and other publications. She's set up a task force. Next month, the society will sponsor a national conference in Washington, D.C., in cooperation with the Food and Drug Administration.

At first, Curtis said, the Guidant news didn't seem that unusual. Problems with devices are reported from time to time. This was just another one.

"But it's become more than that," she said. "Concerns were brought up about whether information was provided in a timely manner. . . . We realized there really aren't good policies out there" for telling doctors about problems.

As it stands now, companies report device problems to the FDA, which regulates drugs and medical devices. Too many doctors feel as if they're the last to know, and have no voice in their patients' care.

"We, as professionals, find out when the "dear doctor' letters come out," said Curtis, who also is director and CEO of cardiovascular services at USF.

The problem arose at a time when the device industry is booming. In 1995, 21,000 defibrillators were implanted in U.S. patients. Ten years later, that number is 250,000 to 300,000.

The defibrillator is a weapon against sudden cardiac arrest. The implanted devices monitor the heartbeat and deliver an electric shock if the heart beats abnormally.

When the first defibrillators were implanted, in 1982, they were given to only the sickest patients. People had to have survived two cardiac arrests to get one. The devices were too bulky to fit inside the chest and had to go in the abdomen.

Now, they're smaller than a human palm, small enough to fit in the chest. Doctors think of them as so reliable that they give them to patients as a preventive measure, in hopes of short-circuiting the first cardiac arrest.

The increased use has saved lives. It also means that many of those walking around with defibrillators inside their bodies will never suffer a sudden cardiac arrest.

And these days, when a company like Guidant has problems, far more people are affected.

"These devices are actually very reliable," said Dr. Mark Carlson, a professor of medicine at Case Western Reserve University who will chair the rhythm society's conference next month. "In fact, I think if they weren't so reliable, this story might not be nearly as interesting. Our expectations for perfection are based on the outstanding track record that many of these devices have had."

But now thousands of patients face a dilemma. Should they replace the defective device and face the risk of infection or other surgical problems? Or leave the device in place, knowing it might not work properly?

That's the decision that Palm Harbor resident Robert Haberle has to make. Haberle filed suit against Guidant last week, saying he received one of the flawed models. Haberle has reason to believe his defibrillator isn't working as it should: It shocked him late last year. His doctor said Haberle didn't have a heart attack.

"I wouldn't want to be walking around with one of those devices in my chest right now," said Tampa lawyer Dan Anderson, Haberle's attorney. Patients like Haberle, he said, "are already in a precarious health position, and now they're faced with additional surgery or the risk of leaving the device in."

For many patients, the best decision is to leave the device in place. Curtis isn't worried just about those patients, but about the reaction she's seeing from people whose heart problems are recently diagnosed.

"More of the problem I've had is people are reluctant to have a defibrillator implanted for the first time," she said.

Despite Guidant's recent problems, Curtis doesn't hesitate to recommend defibrillators to the same types of patients as she did before. She argues the odds: For every 100 patients who get defibrillators, three will suffer rhythm problems severe enough to get a lifesaving shock. For one faulty defibrillator model, Curtis said, the risk of failure is one in 10,000.

"The chance of a problem with a defibrillator is much less than the chance you'll need it," she said.

Curtis is among many doctors unhappy with Guidant's secrecy.

"They should have notified us earlier," she said.

But when? That's the question her group is debating. It's impractical to notify doctors every time a problem is reported with a device, she said.

"The problem is with the in-between stuff," Curtis said. "If it happens twice, what do you do? If it happens five times?"

At next month's conference, the group hopes to start developing guidelines for when and how doctors and patients should be told of problems with devices meant to save them. They'll also try to set clearer standards for when devices should be replaced.

Such guidelines would be "far more objective" than having companies decide such issues, Anderson said.

"The medical community itself needs to determine what defect rate is acceptable," he said. "My guess is it's going to be far lower than the rate at which Guidant ultimately notified people with these implants."

[Last modified August 7, 2005, 01:29:21]