January 26, 1995 in Nation/World

The Panic Over Pacemakers Doctors Urge Checkups After Report Of Faulty Lead, But Some Patients Just Want Them Out

By The Spokesman-Review

A Spokane woman is recovering from surgery to remove a faulty pacemaker connection after the wire in her heart broke through its plastic coating.

Spokane doctors are urging dozens of their patients with the devices - known as the Accufix atrial “J” - to come in for checkups.

The federal Food and Drug Administration is recommending special X-rays for all 25,000 Americans who have the pacemaker connections, known as leads. Pacemakers deliver electrical impulses that keep hearts beating regularly.

Surgery isn’t recommended in most cases, however. Leaving the device in often may be safer than removing it, doctors say.

“It sort of has created a little bit of hysteria,” Dr. David Oakes, a Spokane pacemaker specialist said Wednesday. “My phones are ringing off the hook.

“Almost all the cardiologists in town have used this particular pacemaker wire.”

Oakes removed one of the leads from Doris Hale on Tuesday after X-rays showed a half-inch wire resembling a sewing pin exposed near her aorta and the wall of her heart.

“I was scared to death,” said Hale’s husband, Harold, a retired county appraiser. “You don’t know what it’s going to do.”

Another Spokane doctor recently removed a “J” lead from a man, although the wire hadn’t cut through its protective coating. A third doctor plans to remove one from a 71-year-old woman.

“She’s just afraid,” said the woman’s doctor, James Bonevallet. “She doesn’t want that breaking in her and she wants it out.”

The manufacturer of the pacemaker leads, Telectronics, recommends removing the leads only when the wire fractures and pops through the plastic surrounding it.

Terrence Judge, a Spokane cardiologist, agrees. “I have not advised anyone to have a lead removed that’s not fractured.”

Bonevallet, however, said he has no problems with taking them out, whether or not they’re obviously faulty.

Patients who don’t have the device removed may feel anxious and should still get X-rays every six months to check for problems, he said.

“My thinking is, why wait for a lead to protrude the insulation?” said Bonevallet.

Removing faulty leads is much more difficult than inserting them or removing them while they’re still intact, he said.

“Putting in a pacemaker is like shooting fish in a barrel. This is like walking a tightrope above a canyon.”

Oakes said experts on extracting pacemaker leads recommend open chest surgery whenever a wire is exposed. But he chose a process requiring a much smaller incision, and Hale may return home as early as today.

“I got it out. God was gracious. She’s doing great,” Oakes said.

A study of 525 patients shows 12 percent of have wire fractures that aren’t necessarily exposed.

The surgery to remove leads carries a significant risk as well, Oakes said. Removing leads causes significant injuries in about 2.5 percent of cases.

“One of every 150 people will die simply from taking out the lead,” he said.

“It’s a tough call.”

Telectronics has agreed to reimburse implanted patients for X-ray and removal costs not covered by insurance, according to a statement from the Englewood, Colo., company.

Spokane doctors, meanwhile, are gearing up to learn to deal with emotional patients who have potentially faulty pacemaker leads. Doctors estimate there are about 150 such patients here.

They’re trying to track down patients, although some who have moved may be difficult to find.

On Tuesday morning, several doctors crowded around a Deaconess Medical Center operating room to watch Hale’s surgery, which took nearly two hours, Oakes said. Hers was the first removal in the area involving an exposed wire.

“Right now, there’s a lot of people who are very anxious because they have that particular lead,” said Oakes.

Unless X-rays show exposed wires, he added, “I’m urging them to just sit tight.”

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