The Cleveland Clinic has successfully implanted the world’s first leadless pacemaker defibrillator system in two patients. The novel device combines state-of-the-art technology to help patients who have low or elevated heart rates sustain regular heart rhythms without wires that are vulnerable to damage over time.
The apparatus, which uses a leadless pacemaker combined with a subcutaneous implantable cardioverter defibrillator (ICD) will be tested globally in a clinical trial enrolling 300 patients across 50 centers in the U.S., Canada, and Europe.
Pacemakers help regulate a patient’s heartbeat while the ICD monitors the heart rhythm to protect against sudden cardiac arrest that affects more than 356,000 Americans each year. The advantage of the new device is that unlike conventional ICDs, this leadless system doesn’t require any wires threaded through blood vessels that can be damaged over time or lead to blood clots. In addition, the new system ensures proper monitoring of heart rhythms to prevent potentially lethal asystole, which occurs when the heart flatlines due to abnormally slow rhythms.
“Modular therapy curates implantable medical device therapy to the specific needs of the patients throughout their lifetime so that they receive only the device they need when they need it,” said Dr. Daniel Cantillon, research director and associate section head of the Cardiac Electrophysiology and Pacing in the Heart, Vascular & Thoracic Institute at Cleveland Clinic, and the principal investor of the worldwide study.
“Combined use of both types of devices in a leadless approach could benefit a much larger patient population,” he added. “Furthermore, while lifesaving, ICD shocks are both painful and psychologically traumatizing for patients. It’s our hope that the combination of a tiny leadless pacemaker implanted directly into the heart with the subcutaneous ICD in the soft tissue will allow the majority of lethal arrhythmias to be painlessly terminated without long-term risks.”
Shannon Kelley, of the Cleveland Clinic Corporate Communications center, tells Newsmax that the two successful implant procedures were performed this week at the Cleveland Clinic, and the patients were able to go home the next day.
“We expect that in the future, the procedure will be able to be performed in an outpatient basis,” she said. “But we wanted to be extra cautious the first time around. Dr. Cantillon expects this breakthrough modular therapy to help hundreds of thousands of patients in a safe, painless and sustainable way.”
“There are approximately 6 million patients with heart failure in the U.S alone, and 10,000 patients per month qualifying for and receiving ICDs. While not all of those will meet the criteria for this novel leadless defibrillator combination, it is expected to become a dominant platform over time,” Cantillon tells Newsmax.
The multicenter trial sponsored by Boston Scientific, manufacturer of the modular therapy system, will evaluate the safety, performance, and effectiveness of the system.