How New Technology Is Reshaping Pacemakers

Beverly Smith did not like how she felt. A former kindergarten teacher, she had retired in order to travel with her husband and see as much of the world as possible. However, while her spirit willed her to explore, Beverly’s heart was slowing her down. “My heart was beating way too slow, so I had no energy,” she says. “Even doing housework or going up and down the stairs would make me tired.”

Beverly was suffering from bradycardia, or a slow heart rate. This caused not only fatigue, but also lightheadedness and dizziness. “I actually fainted once and was taken to the hospital by ambulance, which frightened my husband,” she says.

Wanting to improve her energy level, and get back to her travels, Beverly sought help at University of Utah Health Care. She wasn’t surprised when her doctor, Roger A. Freedman, M.D., told her she would need a pacemaker. Several of her friends had pacemakers and Beverly felt she knew what to expect of the device, the surgery and the results.

She wasn’t prepared for what Freedman showed her, however. “He took out of his pocket this little, tiny capsule-looking device and said ‘this is the new technology, and this is what we would like to implant in your heart,’ ” she says.

The size of a vitamin pill

Freedman was holding a model of the first leadless pacemaker approved by the Food and Drug Administration (FDA). The agency approved the new pacemaker design in April, and Freedman is the only doctor in the Mountain West currently able to offer the technology to patients who need pacemakers with only one contact point on the heart. Beverly would be the first patient to receive the device in the Mountain West.

“This is a totally revolutionary design in pacemakers,” says Freedman. “Pacemakers were invented about 50 years ago, and for the entire 50 years that we’ve had pacemakers they have had the same basic design.“

That design is made up of a pocket-watch-sized generator containing a battery, electronics and small computer that is inserted under the skin near the collarbone. The generator is then attached to leads threaded through a vein into the heart. Electrodes on the ends of those leads allow electrical impulses to go to the heart.

In contrast, the new leadless pacemaker is self-contained and is completely implanted in the heart. The computer, battery and electronics sit in a small capsule, and four tines on the end of it attach to the heart so the pacemaker can deliver electronic impulses directly to the heart. The entire pacemaker is the size of a large vitamin pill. “It’s really a miracle of miniaturization that has allowed all of those components to fit into such a small size,” says Freedman.

Easier implantation

Due to its small size, the leadless pacemaker is much easier to implant. A traditional pacemaker is implanted by making an incision in the chest near the collarbone and creating a pocket under the skin. The incision is then sewn closed. The leadless pacemaker is inserted using a delivery system that threads the device through a vein in the leg that reaches the heart. After the device is implanted, the delivery system is removed and pressure is briefly placed on the leg to prevent bleeding. Then the patient is taken to recovery. There is no incision, no pocket, no suture.

Patients receiving the leadless pacemaker also have a nearly non-existent recovery time. “A lot of the restrictions that patients had after implantation of a standard pacemaker are avoided with this pacemaker,” says Freedman. “There’s no dressing to keep dry. There’s no restriction on arm motion for three or four weeks.”

Possible complications

Long-term complications of traditional pacemakers are almost all due to the pacemaker pocket under the skin or to the lead through the vein that connects the pacemaker to the heart. These complications occur in approximately 10 percent of patients, according to Freedman. “The lead has to flex with every heartbeat. You have about 100,000 heartbeats in a day,” he says. “Over a number of years, even the best-designed lead can fray or crack or malfunction. Then we often have to take the lead out, which is not a small procedure.”

Another important complication of pacemakers is an infection, either of the pocket or of the lead, which also requires extraction of the lead and generator. Because the new pacemaker design has no pocket and no lead, those complications will be avoided and it is likely that its long-term complication rate will be much lower than that of traditional pacemakers.

Talk to your doctor

While the leadless pacemaker is a breakthrough in medical technology, it is not suitable for many patients who may need a pacemaker. Because the leadless pacemaker can be attached to only one spot in the heart it is currently available for patients who require a single contact point. Traditional pacemakers can attach up to three leads to three contact points. “For patients who need a two-lead pacemaker or a three-lead pacemaker this would not be the best choice for them,” says Freedman. “Cardiologists are the best to decide which sort of pacemaker a patient will need.”

Beverly is glad Dr. Freedman decided the leadless pacemaker was the right choice for her. She has her energy back and her concerns about heart problems while in a foreign country or on a long airplane ride are all gone. “I have my life back,” she says. “I can travel and I can do all the things I love to do because I feel better.”