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News Americas

The Nanostim leadless pacemaker is designed to be implanted directly into the heart during a non-surgical procedure. (Photo: St. Jude Medical)
Feb 11, 2014 | News Americas

Doctors place leadless pacemaker without surgery

by Surgical Tribune

NEW YORK, USA: Doctors at Mount Sinai Hospital in New York have implanted the U.S.'s first leadless cardiac pacemaker directly inside a patient's heart without surgery. The miniature pacemaker was implanted by a cardiac electrophysiologist directly inside the heart during a catheter-guided procedure through the groin via the femoral artery. The device, resembling a small metal silver tube, is only a few centimeters in length, making it less than 10 percent the size of a traditional pacemaker.

The Nanostim device, made by St. Jude Medical, is being tested for safety and efficacy in an international, multicenter clinical trial called LEADLESS II, which is to enroll 670 patients at 50 centers across the U.S., Canada, and Europe.

"This clinical research trial will be testing the latest innovative nonsurgical pacemaker option for patients experiencing a slowed heart beat," said Dr. Vivek Reddy, co-investigator and chairman of the steering committee of the study, and Director of Electrophysiology Services at Mount Sinai Hospital. "This new-age tiny pacemaker may ultimately be safer for patients because it doesn't have leads or have to be inserted under the skin of a patient's chest, like a traditional cardiac pacemaker."

Similar to other cardiac pacemakers, the Nanostim device treats a heart rate that is too slow, called bradycardia. It works by closely monitoring the heart's electrical rhythms and providing electrical stimulation therapy to regulate the heart beat if it is too slow. More than 4 million patients globally have a pacemaker, and 700,000 new patients receive one each year.

The possible advantages of the leadless pacemaker include the elimination of a surgical pocket, no visible pacemaker device under a patient's chest skin, no incision scar on the chest, no connector wires or leads, and no restrictions on a patient's activities. The device's benefits may also allow for reduced patient discomfort, as well as fewer infections, device complications and instances of device dysfunction. In addition, the freestanding battery-operated pacemaker device is designed to be fully retrievable from the heart.

"The same cardiac pacing results for patients may be available with this smaller lead-free device with the added benefits of a nonsurgical procedure and fewer complication risks," said Dr. Srinivas Dukkipati, Co-Director of Electrophysiology Services at Mount Sinai Hospital and the study's principal investigator at Mount Sinai Hospital. "The new pacemaker may also improve a patient's quality of life, allowing them to live a more active lifestyle, since the device is more safely hidden away deep inside their heart."

"I believe this pioneering, compact device, which is placed directly inside the heart, may be a true game-changing technology in cardiovascular medicine that may help revolutionize care for patients with arrhythmias," added Reddy. "I look forward to the results of the LEADLESS II clinical trial. Previous initial research testing of the device already showed that overall its performance is comparable to traditional pacemakers."

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