Heart patients wonder whether to replace a wire that might fail

Heart patients wonder whether to replace a wire that might fail

For one heart patient, there will be no more agonizing over whether the implanted device meant to save his life might kill him instead.

On Tuesday, two months after Medtronic warned doctors and nearly a quarter-million patients that a wire, or lead, connecting their electronic defibrillators to their hearts might break, the 48-year-old patient had the lead and defibrillator removed and replaced. It required a painstaking 90-minute operation here at Morristown Memorial Hospital.

But thousands of other patients with failing hearts remain trapped in doubt. Their defibrillators are meant to deliver electric shocks to restore normal rhythms if their hearts start beating chaotically. Should they have the potentially faulty wire, or lead, removed — or leave it in place and hope it does not fail?

And if they do have it extracted, how will they pay for it? Medtronic is limiting its contribution to only a replacement lead and $800 toward each procedure, which can cost $12,500 or more. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured.

"This has been a nightmare," said the Morristown patient. He described his fears and agreed to let a reporter observe the procedure on the condition that his identity remained private.

The lead, called the Fidelis, is a spaghetti-thin plastic tube enclosing electrical wires and sensors. The risks of the patient's operation, besides the possibility for infection, included potential perforation of his heart and the veins in his chest. There was also a slight danger of damaging the heart valve through which the lead had been threaded in 2005, when doctors had screwed the tip into muscle in the bottom of the right ventricle of his heart. As it turned out, the procedure went relatively smoothly. Dr. Christopher Magovern, the surgeon who performed the procedure, said the patient would probably soon be back on the job as a supervisor for heating and air-conditioning projects.

Most Fidelis users will not end up needing such an operation, although all have been advised to check with their doctors. But the number of patients with the potentially faulty leads has made this the most widespread problem yet involving a heart device. And the episode has drawn renewed scrutiny to the way medical devices — particularly heart leads — are approved and regulated in this country. The episode has led to investigations in both houses of Congress.

"It seems like a good time to figure out where we are in regulating leads and what we can do better," said Daniel Schultz, director of the Food and Drug Administration's center for devices and radiological health.

Schultz will head an FDA delegation at a meeting in Boston on Thursday. The conference was arranged by Dr. William H. Maisel, the director of the Medical Device Safety Institute, a research arm of the Beth Israel Deaconess Medical Center in Boston. At the session, regulators, doctors and device companies plan to share information and proposals for changing the way heart devices are approved and then monitored after they reach the market.

The $5.6 billion global market for defibrillators stalled last year and has rebounded only slightly since then. The industry has been clouded by design defects and sometimes lax quality control, and by product recalls that included Guidant defibrillators in 2005 that were linked to seven deaths.

Sales in the United States, which accounted for more than $4 billion of last year's total, have also been damped by data indicating that as many as 80 percent of patients getting defibrillators never end up needing a life-saving jolt from them. The devices can cost $30,000 or more.

On Oct. 15 Medtronic reported that the Fidelis lead was fracturing at a higher rate than the Quattro, a thicker lead it had been rapidly displacing since being introduced in 2004. Data suggested that 2.3 percent of Fidelis implants fracture within 30 months, meaning more than 5,000 likely malfunctions among the estimated 235,000 patients with the leads.

Medtronic said that Fidelis fractures, which could prevent the defibrillator from firing when needed, had been linked in reports it received to five deaths. The fractures, which disrupted the lead's sensing mechanism, also caused numerous unnecessary shocks.

So far, the business impact has been less that Medtronic had originally forecast. Last month, the company — which gets close to 40 percent of its revenue from defibrillators, heart pacemakers and related products — said overall sales had risen 2 percent in the past year to $3.12 billion in its fiscal second quarter ending Oct. 26.

Medtronic said the 11 days of business in the quarter after the Fidelis warning had resulted in $130 million in lost sales. There was an additional $31 million in write-offs and other costs, like mailing notifications to patients and doctors. The company has directly contacted 175,000 patients about Fidelis and "virtually all of the rest" through their hospitals and doctors, according to Robert Clark, a spokesman.

The company moved so swiftly to shift customers back to the older Quattro lead that it now expects the total lost sales to end up below the $150 million to $250 million shortfall it had forecast.

"The data supplied by companies always underestimates failure rates, but if no other shoe drops, Fidelis won't be an issue," said Dr. Raymond Schaerf, a surgeon at Providence St. Joseph Medical Center in Burbank, California.

Such thinking has buoyed Medtronic's stock. The shares had fallen about 20 percent, to $45.25, on Nov. 19 from the $56.33 level at which they closed Oct. 12, the last trading day before the recall was announced. But more recently the stock has rebounded somewhat, closing Wednesday at $49.99, up 25 cents.

One reason for Wall Street's relief is the widespread agreement among doctors that most patients whose Fidelis leads have not already fractured are better off simply leaving them in place. The caveat is that the defibrillators need to be reprogrammed and monitored, to improve the odds of catching any developing fractures early.

Schaerf, who has been extracting device leads for various reasons since 1990, said he had removed the Fidelis from six patients in response to the warning in October. But he has also turned away 10 Fidelis patients who wanted replacement procedures that he thought did not justify the risk.

Others, like Dr. Robert Rea, the director of implantable devices at the Mayo Clinic in Rochester, Minnesota, said that many patients are reassured by wireless monitoring technology embedded in many Medtronic defibrillators. Devices with that technology can be remotely checked for signs of malfunctions via the Internet, through a free Medtronic service called CareLink.

But some patients and their families are seeking second opinions. A woman outside Detroit, who has been sharing her concerns with a reporter, said last week that her husband had his Fidelis lead reprogrammed to safer settings by a Medtronic representative during a recent visit to the doctor who had implanted the defibrillator. But she said she still planned to take her husband for a second checkup at the Cleveland Clinic by Dr. Bruce Wilkoff, one of the nation's busiest lead extractors.

"Maybe nothing will happen, but if it does I want him to be a patient of someone known to be a high-volume expert," the woman said. She requested anonymity for herself and her husband because she did not want to risk offending his local doctor.

Medtronic said in October that it would provide free replacement leads and up to $800 toward medical expenses. But that offer covered only patients with leads that had actually fractured.

Last month, the company extended that coverage to patients without fractures, in cases where doctors advise removing the leads because of the patient's specific medical condition. But in the end, Clark said, the group of patients without fractures who nonetheless need leads removed should be "very small."

One potentially vulnerable group includes patients with a congenital thickening of the heart muscle known as hypertrophic cardiomyopathy. Their condition can put more stress on the lead, which may increase the likelihood a lead fracture. And they are usually younger than the typical heart-failure patient, so they face higher odds of eventual fractures simply because they are likely to have the leads in place longer.

Dr. Robert Hauser, a Minneapolis cardiologist, is trying to organize a registry of major hospitals to track the performance of Fidelis and other leads in cardiomyopathy patients with defibrillators. He says he hopes to have preliminary data from at least eight hospitals in January.

Doctors are also concerned about patients who have dual-purpose implants that serve as both defibrillators and pacemakers and that rely on Fidelis leads for both functions. The patient Magovern treated on Tuesday had such a Medtronic device. Because of his cardiomyopathy, the patient had undergone previous heart operations that left him dependent on a pacemaker and later a dual-purpose implant to continuously stimulate his heart.

For such patients, a fracture that stops Fidelis from gently pacing the heart is an even more certain death sentence, Magovern said, than a fracture that stops it from delivering a defibrillating shock. Still, Magovern and the implant specialists he works with at Morristown Memorial, are advising most patients not to rush to have their leads removed.

And he, for one, is practicing what he preaches. Magovern's wife has a defibrillator with a Fidelis lead. For now, she is leaving it in place.