Leadless Pacemaker Provides New Option

A tiny pacemaker is making huge waves in the electrophysiology community.

The one-inch Micra Transcatheter Pacing System is currently the world’s smallest pacemaker and is also the first one without wires, known as leads. VCU Pauley Heart Center is the first health system in central Virginia to implant the pacemaker, which was approved by the FDA in April 2016.

“This is a brand-new technology—the future of pacing,” said Kenneth Ellenbogen, M.D., chair of the Division of Cardiology and director of Clinical Cardiac Electrophysiology and Pacing. “It’s a new procedure, you can’t get it done at any other hospital in central Virginia. We’re excited to be offering this procedure and have been successful with it.”

Pacemakers generate electrical impulses to treat irregular heartbeats and are traditionally placed through an incision in the chest. Because of its small size, Micra can be implanted directly into the heart’s right ventricle by a deflectable catheter—entering the body through a vein in the groin. This provides a new option for patients who were previously not candidates for surgery, including some with a history of infections or who have had prior surgery on the chest, such as a mastectomy.

“It’s a new procedure, you can’t get it done at any other hospital in central Virginia. We’re excited to be offering this procedure and have been successful with it.” —Kenneth Ellenbogen, M.D.

Micra also differs from standard pacemakers because it is self-contained and does not contain leads—the wires that connect the device to the heart. Over time, leads can sometimes get scarred into nearby tissue or be secondarily infected when a patient has a bloodstream infection. This would necessitate major interventions and occasionally might require surgical removal.

The device is available to patients who require a single-chamber ventricular pacemaker to control arrhythmias, such as atrial fibrillation or bradycardia-tachycardia syndrome. While it can vary by patient, the estimated battery life is 12 years.

“At this moment, it is a niche device, helping patients who need pacing in only one chamber, but the future of this technology is truly promising. The current leadless pacemaker is a spectacular device with an outstanding safety profile,” said Jayanthi Koneru, M.D., who with fellow electrophysiologist Gautham Kalahasty, M.D., received special training in the device and began implanting it in Dec. 2016.

Koneru predicted that “leadless pacing will truly be a game changer.”