St. Mary's Health Care System announced that it is the first hospital in Northeast Georgia to offer a leadless pacemaker for patients who have bradycardia with atrial fibrillation (a-fib).

The Micra Transcatheter Pacing System is a new type of heart device, approved for Medicare reimbursement, that provides patients with the most advanced pacing technology at one-tenth the size of a traditional pacemaker. The first procedure at St. Mary's was performed by Amit Shah, M.D., a cardiologist with Oconee Heart and Vascular Center, on Wednesday, June 13, in St. Mary's Cardiac Electrophysiology Laboratory.

Bradycardia is a condition characterized by a slow or irregular heart rhythm, usually fewer than 60 beats per minute. At low rates, the heart is unable 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.

The Micra is comparable in size to a large vitamin pill. Dr. Amit Shah elected to use Medtronic’s Micra TPS because, unlike traditional pacemakers, the device does not require cardiac wires (leads) or a surgical “pocket” under the skin to deliver pacing therapy. Instead, the leadless pacemaker is small enough to be delivered through a catheter and implanted directly into the heart with small tines. It provides 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, enabling patients to lead an active lifestyle.

"Pacemaking is a life-saving technology that has been around for decades, but leadless pacemakers represent a paradigm shift that will change the way we implant cardiac rhythm management devices," Dr. Shah said after the procedure. "Since these devices alleviate the need for a surgical pocket and leads, we avoid traditional complications such as pneumothorax (collapsed lung), infections, pocket hematoma, and lead fractures. These features will improve our patients' safety and quality of life while providing equal if not superior pacemaker function."

The Micra is implanted through a small incision in the groin. In the June 13 procedure, after creating the incision, Dr. Shah carefully threaded a catheter (a long, thin tube) through the patient's blood vessels to the inside of his heart. With guidance from the cardiac electrophysiology laboratory's advanced x-ray imaging system, he positioned the catheter at the right location in the patient's heart and attached the device to the heart wall. He then tested the device to make sure it was properly attached and functioning well before removing the catheter. The entire procedure took only a few minutes, and the patient was able to go home the next day.

The Micra TPS incorporates a feature to enable retrieval of the device when possible; however, the device is designed to be left in the body.  For patients who need more than one heart device over the course of their life, Medtronic designed the miniaturized Micra TPS  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.

The Micra TPS is the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla full-body magnetic resonance imaging scans. It is also designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network.

The Micra TPS was approved by the U.S. Food and Drug Administration in April 2016 and has been granted Medicare reimbursement, allowing broad patient access to the novel pacing technology. Other companies have their own proprietary technology, and their leadless pacemakers will be commercially available pending FDA approval.