New Leadless Pacemakers Show Great Promise

Bleeding, infection and breakage minimized in study

Leadless Pacemaker

Pacemakers can vastly improve quality of life for individuals with irregular heart rhythms. However, there were always risks associated with the surgically implanted devices, including infection and breakage of the wires that connect the device to the heart.

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These complications may be significantly improved by a new leadless, self-contained version currently in clinical trials at Cleveland Clinic.

“We’re seeing a shift in the field,” says Cleveland Clinic electrophysiologist Daniel J. Cantillon, MD, with the Sydell and Arnold Miller Family Heart & Vascular Institute, who was a leading investigator in the multicenter trial. “The weakest link in traditional pacemaker systems is the lead wire and the surgical pocket. The leadless systems have neither, so in effect they break through that ceiling of limitations that have been in place for 60 years, and into a new era.”

Surgery-free insertion

The new self-contained design is about 10 percent of the size of a traditional pacemaker. Instead of inserting the new leadless pacemaker surgically, a flexible tube, or catheter, is snaked through a vein in the leg up to the heart and the leadless pacemaker is placed inside one chamber. A tiny corkscrew-like tip anchors it into the heart and controls the heart’s rhythm.“It gets around the long-standing limitations of the traditional pacemaker,” Dr. Cantillon says.

The device is still investigational, but the study is now complete and the results have been published in the New England Journal of Medicine which show that it is safe and effective.

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Fewer complications

While surgery-free insertion is less invasive, the main advantage to the leadless devices is the elimination of common complications, such as lead breakage, and bleeding and infection in the surgical pocket created to hold the device in the body, which occurs in about 2 to 3 percent of patients every time a traditional device’s generator needs to be replaced, typically every seven to 10 years. More serious complications also occur with traditional pacemakers, including, venous occlusive disease, which occurs when scar tissue builds up in the veins, blocking blood return to the heart.

Over time, pacemaker-related adverse events occur in about 10 percent of patients who receive traditional pacemakers. Occasionally, manufacturers have needed to recall the devices due to lead-related problems.

Success case

At 58-years-old, Norm Johnson loves being outdoors. And he can be, thanks to a positive experience with the new leadless pacemaker.

Before receiving the device through a clinical trial at Cleveland Clinic, Norm had a traditional pacemaker to help control the rhythm of his heart, but the wires were causing severe complications like extreme swelling and headaches.

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“Because the new pacemaker does not have wires, he could preserve the benefits of having a pacemaker while alleviating the problems that were created by the traditional pacemaker,” says Dr. Cantillon.

Good candidates for the current leadless pacemaker include those who require stimulation in only one chamber of their heart.

“Now,” says Dr. Cantillon, “it’s a matter of developing and showing that these systems can be effective and safe and extend the benefit long-term.”

 

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