SARASOTA, Fla. – (Nov. 3, 2022) – Sarasota Memorial Hospital is among a select group of world-class heart institutions participating in an international clinical trial of the world’s first true dual-chamber, leadless pacemaker for people with slow and irregular heart rhythms.
One of 80 research sites globally testing Abbott's Aveir DR dual-chamber leadless pacemaker, Sarasota Memorial's electrophysiology team -- led by cardiac electrophysiologists Dilip Mathew, MD, and Robert Eckhart, MD -- implanted the investigational device in patients at SMH in July and September. All of the patients are doing well and will be monitored by their physicians and the Sarasota Memorial Research Institute team at regular intervals until the study period ends next year.
Abbott's Aveir VR single-chamber, leadless pacemaker received FDA approval this spring after a pivotal, multi-center trial found it safe and effective for certain patients with abnormal heart rhythms. The Aveir VR leadless pacemaker, which is now commercially available at Sarasota Memorial, was designed for expandability and potential upgrade to a dual-chamber system with regulatory approval in the future.
"We are proud to be part of pioneering research that brings these leading-edge treatment options to people in our community," said Mathew, who is the principal investigator of the trial at SMH. "Abbott's VR leadless pacemaker addresses many of the complications we have seen with traditional pacemakers, but is currently approved for single-chamber pacing only, so the number of patients it benefits remains limited. Because nearly 80% of people who receive a pacemaker need a dual-chamber option to pace both chambers on the right side of the heart, the Aveir DR device we are studying could address a critical need for many more patients."
Like traditional pacemakers, Abbott's VR and DR leadless pacemakers use pulses of electricity to trigger the heart to beat. But instead of using lead wires to send electrical pulses through veins into the heart, doctors implant the leadless devices directly into the heart. The FDA-approved Aveir VR pacemaker is implanted in the right ventricle, while the DR dual-chamber device includes a second implant in the right atrium of participants enrolled in the current trial. The devices communicate wirelessly, providing beat by beat synchronization based on each patient's condition and unique needs.
The leadless pacemakers, inserted via a minimally invasive catheter-based procedure, offer a number of benefits over traditional pacemakers, including:
- Unique mapping capability that allows the physician to measure electrical signals within the heart and detect the correct placement of the device before final implantation.
- Retrievable device that can be removed or replaced if patient needs change.
- Increased battery life, up to 10 years and two times longer than others.
- Faster recovery and reduced risk of lead and pocket-related complications for patients who are immune-compromised or prone to infections, who have vascular access issues, or whose chest wall is not sufficient to support a pocket device.
For more information about Aveir’s leadless pacemaker study or other clinical trials, contact the Sarasota Memorial Research Institute at (941) 917-2225. For a physician referral or information about cardiac care at Sarasota Memorial, call (941) 917-7777 or visit smh.com/heart.
About Sarasota Memorial Health Care System
Founded in 1925, Sarasota Memorial Health Care System is a regional medical center offering Southwest Florida’s greatest breadth and depth of care, with more than 1,900 physicians and advanced practice providers and more than a million patient visits a year across its network of care. Sarasota County’s largest employer, the health system includes two full-service hospitals in Sarasota and Venice, a freestanding ER in North Port, and a comprehensive network of outpatient centers, urgent care clinics and physician practices that stretch from Manatee County to North Port. As the region's only public health system and not-for-profit health care provider, SMH serves as a critical safety net for the uninsured in Sarasota County. Visit smh.com for information.