The new pacemaker in Robert Kostoss’ chest was put there to help his heart beat, and the wire from the device to his heart was a lifeline. He knew all that. What he didn’t understand were the symptoms he was suddenly experiencing: shaking fits that lasted up to a minute, and a feeling that he was going to hyperventilate. Twelve weeks were about to drop out of his life. “Long story short, the wound (from the pacemaker) never really healed. It progressively got worse and worse and worse,” Kostoss said.
A 41-year-old chef and father of two, Kostoss had developed an ugly infection around the new pacemaker and the lead, or wire, that delivers energy from a pacemaker or implantable cardioverter defibrillator to the heart muscle.
Electrophysiologist Jude Clancy, M.D., picked up on the problem immediately. He directs the Lead Management Program at Yale—one of the highest-volume centers of its kind in the Northeast and a provider of laser-based device lead extraction. One of his biggest obstacles is lack of awareness about the potential dangers of cardiac device leads.
Dr. Clancy has seen critically ill patients battle infections that cleared up within days after old leads were removed. He’s seen patients with as many as eight old leads abandoned in their bodies when new devices were implanted. Often no one realizes that the leads could be a problem until the patient notices severe redness and swelling in the implantation area, or the device literally erodes through the skin.
Rise in implanted devices
Millions of people have implanted cardiac devices. New devices keep improving—with the promise of leadless devices on the horizon. But many of the leads on currently implanted devices will need to be removed at some point. There are a variety of reasons:
- A clot or scar tissue has blocked the vein.
- The lead is broken, damaged or worn out.
- The lead is malfunctioning, possibly because scar tissue has formed around the tip so that it needs more energy to function than the device can deliver.
- The device is infected.
- The patient has multiple leads.
“We try to take out leads to make room for new leads, and not have all these redundant leads, because the more leads you have the more they clog up the vascular space,” said Dr. Clancy. If a lead becomes infected, it can cause fevers, night sweats and other symptoms that may be ambiguous. “Most infections come in urgently, in the emergency room. When you look back, the patient has usually been to the emergency room multiple times before they’re admitted.”
‘Hell in a handbasket’
Kostoss had the first of multiple surgeries for a congenital heart problem when he was 36 hours old, and his first pacemaker implantation when he was 10. Everything always went smoothly until his third pacemaker was implanted last year. Five days later he began developing flu-like symptoms that grew progressively worse. “In a 36-hour-period, things went to hell in a hand basket,” he said. It was weeks before a blood test confirmed endocarditis, an infection of the inner tissue of the heart. He was referred to Dr. Clancy, who removed the new device and lead wire. Kostoss spent several more weeks recovering.
“Now my advice (to other patients) is—if it doesn’t feel good for a couple of weeks, ask for another opinion,” Kostoss said.
Dr. Clancy said the best scenario is when a patient visits the lead management clinic before a problem becomes serious for an evaluation and discussion, an echocardiogram, and other tests. If he recommends lead extraction, the surgery may be a simple two-hour procedure that essentially involves pulling out the lead. If scar tissue has formed, however, removal can be a painstaking, delicate task, with surgeons spending up to eight hours pulling the scar tissue apart, or using a laser or mechanical drill-like tip to break up the scar. A full cardiothoracic backup team stays on standby during a lead extraction procedure.
The patient is given general anesthesia. The surgeon may extract the lead through an incision in the upper chest, or through a small puncture in the groin. Patients stay overnight, or longer if they are fighting an infection.
Procedure is highly successful
Yale reports performing 100 lead extractions in the past year with no mortality and a success rate of about 98 percent—equal to the national average of high-volume centers. “I can count on one hand the leads we have not been able to get out in the past year,” said Ryan Donovan, PA-C, who works closely with Dr. Clancy. The success rate will only improve if research by Dr. Clancy, Donovan, and others provide answers to such questions as why some patients form scar tissue more quickly than others and which metals are most resistant to scar tissue formation.
In the meantime, many people who need a lead extraction evaluation may realize they have the option. “If you have a patient with a device, you almost have to take the time to rule it out every time,’ said Dr. Clancy. “The symptoms might look like something else, but it might be the device. You should always have that suspicion.”
For more information about Yale’s Lead Management Program, call 203-785-4126.