Methodist Healthcare
April 28, 2022

As part of a clinical trial, Methodist Hospital | Texsan is the first hospital in Texas to implant the dual-chamber leadless pacemaker, a new and improved device to treat abnormally slow heart rhythms and heart block. The trial is designed to assess the safety and effectiveness of this device. The clinical trial with enroll up to 550 patients at up to 80 sites worldwide. Dr. Roman-Gonzalez, at South Texas Cardiovascular Consultants, PLLC, is the Principal Investigator.

“We are very fortunate to be a center that is at the forefront of this advancement in pacing technology,” commented Jacqueline Schwartz, MD. Dr. Schwartz implanted the first three dual-chamber leadless pacemakers in three patients last week. Patients had variations of heart blockages that caused symptoms such as fatigue, dizziness and syncope.

The first pacemaker implantation was performed in 1958, and since then, the technology has undergone many advancements. Traditional pacemakers require an incision to implant a power generator placed under the skin near the collarbone, which then connects to cables that are extended through veins and attached to the heart muscle. Unfortunately, studies have demonstrated that over a three year period up to one-in-six patients will have a lead or surgical pocket-related complication.

The leadless pacemakers are miniature battery-powered devices that are implanted directly into the heart via a minimally invasive catheter-based approach, and do not require an incision or cables. The dual-chamber leadless pacemaker is designed to provide synchronous, beat-by-beat pacing of the right atrium and right ventricle of the heart. An advantage of this device is that it is retrievable, meaning once the battery runs out, it can be taken out and replaced in the same minimally invasive procedure. Additionally, recovery and exercise restrictions are minimized with this approach compared to the traditional pacemaker.

The Abbott Aveir™ DR Leadless Pacemaker System - CAUTION: The Aveir™ DR dual-chamber leadless pacemaker is an investigational device limited by Federal (U.S.) local law and Medical Device Regulation for investigational use only.

Methodist Hospital | Texsan is well-known as an institute that excels in cardiac care by the community and surrounding areas “The medical team at Texsan is constantly looking for ways to perform less invasive procedures that result in outcomes that are more successful for the patients we serve,” says Scott Rausch, CEO for Methodist Hospital | Texsan. “We are honored to be a part of these clinical trials that advance healthcare for us all.” The hospital aims to ensure that every patient receives the highest level of care possible and this development will allow us to serve a broader patient population.

The leadless pacemaker in this trial is being clinically evaluated as part of a clinical trial – and is not yet commercially available. If you would like to learn more about this clinical trial sponsored by Abbott, visit clinicaltrial.gov. For more information about Methodist Hospital | Texsan’s cardiovascular program, visit https://sahealth.com/specialties/cardiology?location=methodist-hospital-texsan.