STUDY CONDUCTED AT OU MEDICAL CENTER FINDS WORLD’S SMALLEST PACEMAKER MEETS INITIAL SAFETY AND PERFORMANCE MEASURES

Oklahoma City, OK— A year out from a first-of-its-kind pacemaker implant surgery, Oklahoma City pacemaker recipient Ray Haggard is excited to see the safety results of his innovative implant.

Ray Haggard, 66, was the third person in the U.S. to receive the new Micra® Transcatheter Pacing System (TPS) as part of a clinical trial conducted at OU Medical Center. He had the pacemaker placed after being diagnosed with a heart arrhythmia. When doctors told him about the new vitamin-sized pacemaker, Haggard decided it was the best option for him.

“Before, I was just feeling like I had no energy and had a hard time breathing. Then I was having episodes where I was blacking out,” said Haggard. “Today, I am doing great and have had zero complications from the pacemaker. If anything, it’s almost an afterthought, and it is easy to forget it is even there.”

“These initial findings are encouraging and we are pleased to be among the participating clinical trial sites evaluating this novel pacemaker,” said Dr. Dwight Reynolds, the OU Physicians cardiologist who implanted the device. Reynolds also is the chief of the Cardiovascular Section of the Department of Medicine at the OU Health Sciences Center. “We believe this study will prove that this pacemaker significantly reduces the risk of complications that are related to having the larger pacemaker in a pocket under the skin.”

Initial results from the study of the world’s smallest pacemaker were presented at the Heart Rhythm Society’s 36th annual Scientific Sessions last month. Results showed that the miniaturized Micra® Transcatheter Pacing System (TPS) has met its initial safety and performance measures: 100 percent of the first 140 patients who received the Micra TPS experienced a successful implant procedure.

Patients evaluated in the study ranged in ages from 21 – 94, weighed from 90 – 362 pounds and lived in a variety of places, including in Europe, the Asia-Pacific and the U.S. The study also included high-risk patients with lung diseases such as chronic obstructive pulmonary disease (COPD) and pulmonary hypertension. Of the 140 patients who were followed for an average of two months, only two patients (1.4 percent) experienced events resulting in prolonged hospitalization. This is in line with rates observed in studies of traditional pacemakers.

At less than one-tenth the size of traditional pacemakers, the Micra TPS provides the most advanced pacing technology available while being cosmetically invisible. It is small enough to be delivered through a tube, or catheter, which is inserted in the upper leg, threaded to the heart and then implanted directly inside the heart.

The Micra TPS does not require the use of wires, known as “leads,” to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Once positioned, the Micra TPS can be repositioned or retrieved, if needed. The device responds to patients’ activity levels by automatically adjusting therapy. Unlike traditional pacemakers, the Micra TPS does not require a surgical “pocket” under the skin, so potential sources of complications are eliminated—as are any visible signs of the device.

www.oumedicine.com

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