St. John's Offers World's Smallest Leadless Pacemaker

St. John's Regional Medical Center (SJRMC), a Dignity Health Hospital, is one of the first hospitals in California to offer the world's smallest leadless pacemaker for patients with bradycardia. The first procedure was successfully performed on September 30 at SJRMC by cardiac electrophysiologist, Ali Sovari, MD.

Micra® leadless pacemaker is implanted inside the heart using a transcatheter approach with no lead or pocket outside the heart. “The leadless pacemaker’s design results in fewer complications and minimizes the risk of infection associated with a conventional pacemaker,” said Dr. Sovari. “Patients also enjoy fewer restrictions on activities after the leadless device is implanted, improving their quality of life.” 

Recently approved by the U.S. Food and Drug Administration (FDA), the Micra® Transcatheter Pacing System (TPS) is a new type of heart device that provides patients with the most advanced pacing technology at one-tenth the size of a traditional pacemaker. Micra is the only leadless pacemaker approved for use in the U.S. 

Bradycardia is a condition characterized by a slow heart rhythm, usually fewer than 60 beats per minute. At this rate, the heart may not be able to pump enough oxygen-rich blood to the body during normal activity or exercise, causing dizziness, fatigue, shortness of breath or fainting spells. Pacemakers are the most common way to treat bradycardia to help restore the heart's normal rhythm and relieve symptoms by sending electrical impulses to the heart to increase the heart rate.

Comparable in size to a large vitamin, physicians at St. John’s Regional Medical Center have elected to use the Medtronic Micra TPS for certain patients because unlike traditional pacemakers, the device does not require cardiac wires (leads) or a surgical “pocket” under the skin to deliver a pacing therapy. Instead, the device is small enough to be delivered through a catheter and implanted directly into the heart with small tines, providing a safe alternative to conventional pacemakers without the complications associated with leads – all while being cosmetically invisible. The Micra® TPS is also designed to automatically adjust pacing therapy based on a patient’s activity levels, and it is compatible for obtaining MRI images. 

For patients who need more than one heart device, the miniaturized Micra TPS was designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction. 

Disclaimer: The Medtronic Micra® Transcatheter Pacing System (TPS) device received U.S. Food and Drug Administration (FDA) approval in April 2016. The Centers for Medicare and Medicaid Services (CMS) has initiated an analysis to establish a national coverage determination (NCD) for its coverage of leadless cardiac pacemakers and its determination is pending. If you have questions about whether a proposed therapy is covered, contact your insurance company.