Walter Reed Makes New Leadless Pacemaker Innovation Available to Military Patients

This is the start of an ongoing series highlighting the innovations and research happening at Walter Reed National Military Medical Center in Bethesda, Maryland.

Leadless Pacemaker surgery Surgeons at Walter Reed National Military Medical Center implant the leadless pacemaker. (Photo courtesy: WRNMMC)

By Yolanda R. Arrington
DoD News, Defense Media Activity

Heart surgeons at Walter Reed National Military Medical Center are giving patients a chance to live longer with a newly approved device that’s keeping their hearts beating.

Doctors there are implementing use of the leadless pacemaker, a device that was approved by the Food and Drug Administration in April 2016.

Leadless pacemakers don’t have the leads, or wires, found in traditional pacemakers. They’re significantly smaller than traditional pacemakers. Since there are no leads for the energy to pass through, the generator is able to make direct contact with heart tissue. This process takes less energy to pace the heart.

“The ‘Achilles heel’ of traditional pacemakers has always been the pacemaker leads, long metal wires coated with a silicon/plastic that are tunneled from the pacemaker under the left collarbone into the heart,” said Navy Cmdr. (Dr.) Matthew Needleman, a cardiologist at Walter Reed.

Navy Cmdr. (Dr.) Matthew Needleman, a cardiologist at Walter Reed National Military Medical Center, holds the leadless pacemaker. (Photo: Mark Oswell, WRNMMC Public Affairs)

Navy Cmdr. (Dr.) Matthew Needleman, a cardiologist at Walter Reed National Military Medical Center, holds the leadless pacemaker. (Photo: Mark Oswell, WRNMMC Public Affairs)

Needleman noted the new pacemakers solve a few big problems. The leads on traditional pacemakers can fracture, dislodge and get infected. That infection can travel to the entire heart, leading to the removal of the pacemaker, a procedure that can lead to deadly results for the patient.

“Leadless pacemakers are implanted directly into the right ventricle in the heart, solving a significant portion of pacemaker lead problems,” Needleman said. “Without leads, this pacemaker has no lead to break. In addition, there have been over 3,000 implants worldwide and no cases of the leadless pacemaker dislodging.”

The body tends to form a capsule over the new pacemaker, which reduces the infection rate. Needleman says the overall complication rate of the leadless pacemaker is about half that of a traditional pacemaker.

“There’s also no surgical scar,” Needleman added.

Patients who receive the new pacemakers take less time to recover after surgery. Traditional pacemakers require a six-week period of post-implant restrictions. Most patients who receive the leadless pacemakers get back to normal life just a week after surgery.

The leadless pacemaker. (Photo: Mark Oswell, WRNMMC Public Affairs)

The leadless pacemaker. (Photo: Mark Oswell, WRNMMC Public Affairs)

The device is also good for patients with dementia and memory issues who may not always remember to follow the post-surgical guidelines associated with typical pacemakers.

Since the leadless pacemaker is only approved for use in the right ventricle, they can currently only be used in patients who need single chamber ventricular pacemakers. That’s about ten to 20 percent of patients who need pacemakers.

“As the technology advances, we will likely be able to implant this device or future generations of this device in other chambers in the heart,” Needleman said.

Needleman believes the next generation of leadless pacemakers could service multiple chambers and he expects future leadless pacemaker to be able to work with defibrillators.

Surgeons at Walter Reed implanted the first leadless pacemaker in the Washington, D.C., area in November. In the few short months since, physicians there have since implanted more of the devices than any other single institution in the area.

“We are currently the only DoD hospital to implant the leadless pacemaker. With our experience, we are looking at strategies to expand implantation of these devices in patients with difficult vascular access,” Needleman said.

While the military did not invent the device, it is making a difference for the military community. Medicare has not finalized the reimbursement for the new innovation, so it has not been used in many patients across the country. However, the military does not have to wait for Medicare reimbursements, so Walter Reed’s doctors are able to use it.

“We can do what’s right for our patients now,” Needleman added.

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