CHICAGO--(BUSINESS WIRE)--An oral presentation at the American Heart Association’s Scientific Sessions examined recent reporting rates of esophageal injury after left atrial ablation for the treatment of atrial fibrillation and found that the rates have not decreased in the last four years.
The presentation at AHA by Christopher Joseph, MD (University of Texas, Southwestern Medical Center, Dallas, TX, USA) during the session Rapid Fire: More Sessions on Atrial Fibrillation Ablation.. Get Ready!! reviewed data from the Manufacturer and User Facility Device Experience (MAUDE) database. Complications under the category of fistula that occurred over the last 4 years (2019 to 2022) were reviewed, finding that the annual rate of reported injuries has not decreased, and instead shows a generally increasing trend. Reported fatality rates remain high at 41 percent. This presentation comes on the heels of the release last month of the peer-reviewed study, “Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation.”
Co-author Jose Nazari, MD, FHRS, Associate Director, Cardiac Electrophysiology at NorthShore University Health System, Evanston, IL, USA, noted, "This study emphasizes that esophageal injury remains a concern. Our hospital has addressed this with the use of active esophageal cooling, which was recently granted marketing authorization from the FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and it has become our standard of care.” Dr Nazari added “Our group recently contributed data to the large multicenter study finding a significant reduction in the risk of esophageal injury, and we’ve shown significant improvements in long-term procedure outcomes in a study using this new technology that we published earlier this year.”
The ensoETM has been used to treat over 50,000 patients since first becoming available in 2015, and recently was granted De Novo marketing authorization from the US FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for proactive controlled temperature management.
About Attune Medical
Attune Medical’s novel technology platform pioneered the practice of using the esophageal space to proactively manage patient temperature and to reduce the likelihood of esophageal injury during cardiac ablation procedures.