The 54-year-old Minneapolis woman has stared down a rare breed of late-stage cancer. And last year, she technically died after her heart stopped beating, but luckily her near-fatal attack occurred just outside Fairview Southdale Hospital in Edina.

She left the hospital with an implantable cardioverter defibrillator (ICD) made by Medtronic Inc. tucked inside her chest, a kind of medical-device insurance policy intended to shock her heart back into rhythm if she goes into sudden cardiac arrest.

“I have faced the darkest day,” she said recently.

But on Oct. 15, Lewis learned that Fridley-based Medtronic had pulled a key component of her defibrillator system, called a lead, off the market because it may fracture in the body. A lead is an insulated wire that connects the stopwatch-size portion of the device containing the battery to the heart.

“After all that I’ve been through, I just didn’t think it was going to be me,” she said.

Like many of the 235,000 patients worldwide implanted with Medtronic’s Sprint Fidelis lead, Lewis immediately called her doctor for an appointment.

She, and many others, have embarked on a series of phone calls to doctors and insurers that may prove confusing and frustrating.

All face similar options: Remove the leads — an often difficult surgery — and replace it with a new one. Leave the old lead in the body and snake a new one in the chest using a different vein. Or reprogram the defibrillator to new settings that may detect fractures.

That option would leave the leads in place, and they would have to be frequently tracked using sophisticated monitoring equipment.

Medtronic and the U.S. Food and Drug Administration (FDA) have advised patients to leave the leads intact. But for many patients, the choice isn’t so clear-cut. The potential rate of fracture is small, at 2.3 percent, but a risk nonetheless.

Lewis, a computer science graduate student at the University of Minnesota, didn’t like the odds of potential failure for her Medtronic lead. Plus, she already had experienced odd shocking sensations across her chest on several occasions before the lead recall, a possible indication that it may be defective.

When she asked her doctor at Fairview Southdale about having the lead removed, she was told that the Mayo Clinic was better equipped for the procedure, but that extracting it was considered an “elective” procedure, which meant she would have to pay for it.

Some major health plans in the state — including Medica, HealthPartners and Blue Cross Blue Shield of Minnesota — say they will cover the cost of replacing the Sprint Fidelis leads if that’s what the doctors order. Medtronic says that it will provide new leads free and cover as much as $800 in non-reimbursed medical expenses — but only if a lead is fractured. The device’s warranty doesn’t cover prophylactic removal, according to a company spokesman.

A few days after Lewis’ initial doctor’s visit, a scheduler from Mayo called to set up an appointment. “We’re not going to recommend that you replace it,” Lewis says she was told. Lewis couldn’t believe her ears — she hadn’t even seen the Mayo doctor yet.

The experience has left Lewis feeling whipsawed. “At this point, I just want them to turn this thing off,” she said.

The advocate

After the news broke on the Sprint Fidelis lead, Lisa Salberg sprang into action. As a defibrillator patient and founder of the Hypertrophic Cardiomyopathy (HCM) Association, Salberg is pressing for stepped-up surveillance of lead performance that is funded and conducted independently of the medical device industry. (Companies track the performances of their own devices.)

She presented her ideas this month to high-powered cardiologists at a major clinical meeting in Florida. She’s working with Dr. Robert Hauser of the Minneapolis Heart Institute Foundation — a whistleblower in the recall of Guidant Corp. defibrillators two years ago, and a diligent tracker of heart device performance — to set up a system that could spot potential problems in devices such as the Fidelis lead early on.

But Salberg, of Rockaway Township, N.J., is personally affected by the Sprint Fidelis news, too. Her 12-year-old daughter and 72-year-old father have HCM, a genetic heart condition — and both have implanted Sprint Fidelis leads.

“It was really hard to sit my 12-year-old down and tell her that she’s been recalled,” Salberg said. “But she took it really well.” If a lead is failing it will often make a beeping sound to alert the patient. This provided some angst for Salberg’s daughter, a middle-schooler.

“Will my ICD beep in the hallway at school?” she asked her mom.

For now, doctors will monitor Salberg’s daughter’s and father’s leads, but the watching and waiting is difficult, at best.

The fixer

Dr. Pierce Vatterott, a cardiac electrophysiologist with the St. Paul Heart Clinic, wasn’t terribly surprised to hear the Sprint Fidelis news.

In March, Medtronic sent a letter to doctors alerting them to the fracture problem, and reinforcing the proper way to use the devices. Vatterott and his colleagues had noticed a tendency of Sprint Fidelis leads to fracture well before the company stopped selling them.

The gregarious Vatterott is known in Minnesota — and beyond — as an expert in lead extraction. The most difficult and tricky cases often land on his and his colleagues’ desks.

Leads are sometimes hard to remove from the body because scar tissue tends to form over them. Doctors often use a special laser to take them out.

In a procedure that took nearly five hours at United Hospital in St. Paul last week, Vatterott extracted two (non-Fidelis) leads from a 59-year-old man and inserted two more, as well as a new pacemaker. Despite the difficulty and duration of the procedure, Vatterott was elated. “I’m pumped for this patient. He’s going to feel so much better,” he said.

“The Fidelis is relatively easy to take out,” Vatterott said. While the lead is thinner than most others on the market, it’s not as robust, he added. And, if it’s used on younger, more active, patients — which is often the case — more stress is put on the lead, occasionally causing it to fracture.

After the Medtronic news broke, patients and physicians began calling Vatterott’s office. So far, he’s extracted one Fidelis lead from a patient who requested that it be removed.

The recall news “scares patients,” he said. “It’s an unknown. They don’t know what it means.”

While a potentially faulty device is always alarming, Vatterott relishes the challenge of his unique specialty. “You have to be creative on the spot in these procedures,” he said. “You never know what will happen next.”

November 10th, 2007

SOURCE: Sprint Fidelis Lead Recall › A patient an advocate a fixer