Cardiologist Charles Gornick, MD, of the Minneapolis Heart Institute® implanted a Medtronic Micra Transcatheter Pacing System (TPS) on May 1 at Abbott Northwestern Hospital.
The patient, Kathleen Buckholtz, 66, of Aitkin, Minn., became the first patient in the Midwest and one of the first in the United States to receive the device. Buckholtz went home from Abbott Northwestern today.
"She is also the first person in the world with artificial heart valves to have the device implanted," said Dr. Gornick. "The Micra TPS is the best option for her, because it doesn't require leads or wires which cause artificial heart valves to leak, which is exactly why people need artificial valves in the first place."
At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein.
Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned if needed. Instead of connecting to the heart with wires, known as leads, the miniature device attaches to the heart via small tines. The pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.
In contrast to current pacemaker implant procedures, the Micra TPS implant does not require a surgical incision in the chest and the creation of a "pocket" under the skin. This eliminates a potential source of device-related complications including infection, and any visible sign of the device.
"Because this device is small enough to be implanted with a transcatheter procedure, patients can benefit by potentially reducing pocket or lead complications and recovery times of traditional surgical pacemaker implants," Dr. Gornick said.
The Micra TPS is an investigational device worldwide. The Minneapolis Heart Institute Foundation is one of approximately 50 centers participating in a single-arm, multi-center global clinical trial that will enroll up to 780 patients. Initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.