Wireless pacemaker using new technology found effective and safe in most patients

By American Heart Association News

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A wireless pacemaker inserted directly into the heart without surgery was effective and safe for most patients, according to a study recently presented at the European Society of Cardiology congress in London.

Ken Ellenbogen, M.D., electrophysiologist and chairman of the Division of Cardiology at the Virginia Commonwealth University School of Medicine in Richmond, hails the new pacemaker as a “totally revolutionary technology.” He was not involved in the study.

Conventional pacemakers are battery-operated devices that regulate the heartbeat in people with abnormal or slow rhythms. About the size of a wristwatch, they’re implanted under the skin through an incision in the chest.  Wires connect the device to the heart and deliver electrical pulses to the heart.

 

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Wireless pacemaker found safe and effective in a study; the device is not yet approved for use by the FDA.

The new wireless device studied is inserted through a catheter threaded from a leg vein to the right ventricle of the heart, according to researchers. At 6 millimeters by 42 millimeters, the new device is smaller than conventional pacemakers. All components are self-contained.

The wires used by conventional pacemakers can lead to infection, albeit in less than 1 percent of patients, Ellenbogen said.

Researchers analyzed the first 300 patients who had the wireless device for six months and found it effective in 90 percent and safe from serious complications in 93 percent.

However, there was a nearly 7 percent rate of major complications, including the device poking a hole in the heart and becoming dislodged. The rate of serious complications was lower after the cardiologists inserting the devices had performed the procedure more than 10 times, researchers said.

"With a little more fine-tuning, it's likely that the complications from implanting this new device will decrease," Ellenbogen said.

The wireless pacemaker is now primarily intended for a small portion of patients who have an abnormal heart rhythm known as long-lasting persistent atrial fibrillation, plus a slow heartbeat, he said. It may also be the only technology for kidney failure patients on dialysis or patients who have chronic blood vessel infections, Ellenbogen said.

Because the new technology uses a catheter and does not require surgery, "avoiding an incision that puts a scar on their chests will be appealing to many patients," he said.

Ellenbogen said he plans to insert wireless pacemakers as soon as they’re approved by the Food and Drug Administration. “Obviously, this is just the very beginning,”Ellenbogen said. “The whole concept is what’s really important.”

Ellenbogen is the chair of the safety monitoring board of another wireless pacemaker being studied by Medtronic.

Pacemaker photo provided by St. Jude Medical.


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