In August 2022, AdventHealth Heart, Lung and Vascular Institute’s (HLVI) Chandra Bomma, MD, implanted Central Florida’s first dual-chamber leadless pacemaker system as part of its participation in the Aveir DR i2i clinical trial, a prospective, multicenter, international, single-arm study designed to evaluate the clinical safety and efficacy of this new device. AdventHealth HLVI cardiologist and electrophysiologist Usman Siddiqui, MD, serves as Principal Investigator (PI) and has implanted three of the Aveir DR i2i leadless pacemakers.
While a traditional transvenous pacemaker delivers electrical impulses through thin, insulated wires, called cardiac leads, that connect to the heart muscle chambers, a leadless pacemaker is a self-contained generator and electrode system implanted directly into the right ventricle through a minimally invasive, catheter-based procedure and requires no subcutaneous generator pocket. This approach decreases the risk of complications like infection, erosion and pocket hematoma. It also allows for a less restrictive recovery period and aesthetically, the patient does not have to live with device protrusion.
“While nearly 80% of people who receive a pacemaker need a dual-chamber option to pace both chambers on the right side of the heart, leadless pacemakers have historically been limited to single-chamber devices because synchronization of two leadless pacemakers had been difficult to achieve,” explains Dr. Siddiqui. “However, the technology in the new, investigational Aveir DR i2i dual-chamber leadless pacemaker was designed to solve for this challenge, regulating the heart rate synchronously between two leadless pacemakers – one placed in the right ventricle and the other positioned in the right atrium.”
In addition, this new dual-chamber leadless pacemaker provides a real-time mapping capability so physicians can assess therapy delivery and reposition the device before implant during a patient’s procedure. It was also designed to be retrievable so the system can be replaced as therapy needs evolve.
“AdventHealth is excited to be part of this pivotal research,” shares Dr. Siddiqui. “It is a clinical milestone in the evolution of leadless pacing technology to enhance patient care.”
Recruitment for this study has closed, and it is expected to conclude by the end of 2022. The Aveir DR i2i leadless pacemaker is not yet commercially available.