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Cleveland Clinic performs world's first implant of leadless pacemaker defibrillator system

This groundbreaking procedure is part of a global clinical trial aiming to enroll up to 300 patients in the U.S., Canada and Europe.

CLEVELAND — Editor's note: Video in the player at the top of this story was originally published in an unrelated medical article on Nov. 23, 2021.

The Cleveland Clinic announced their team successfully implanted the world's first leadless pacemaker defibrillator system in two patients. 

Pacemakers provide electrical stimulation to regulate a patient’s heartbeat, while subcutaneous implantable cardioverter defibrillators (ICD) are implanted to constantly monitor the patient’s heart rhythm and protect against sudden cardiac arrest.

Experts say the device uses wireless communication between leadless pacing and defibrillator therapy. Unlike conventional pacemaker-ICD’s, officials with the Cleveland Clinic say this leadless system does not require wires to be threaded through the blood vessels, which are vulnerable to fracture over time and are associated with blood clot risks. 

“Modular therapy curates implantable medical device therapy to the specific needs of patients throughout their lifetime so that they receive only the device they need when they need it,” said Daniel Cantillon, M.D., research director and associate-section head of Cardiac Electrophysiology and Pacing in the Heart, Vascular & Thoracic Institute at Cleveland Clinic and global principal investigator.

Health experts say that in the past, patients receiving subcutaneous-ICD alone, did not have the capability to receive back-up pacing support for abnormally slow heart rhythms, and did not have the capability for painless termination of sudden cardiac arrest due to ventricular tachycardia. 

“Combined use of both types of devices in a leadless approach could benefit a much larger patient population, said Dr. Cantillon. “Furthermore, while life-saving, 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.”

This groundbreaking procedure is part of a global clinical trial aiming to enroll up to 300 patients in the U.S., Canada and Europe. Clinic officials say patients who require a new ICD or who already have a subcutaneous-ICD system implanted are eligible to participate from the trial which will evaluate the safety, performance and effectiveness of the modular cardiac rhythm management system.


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