LAAC with Watchman FLX reduces bleeding risks after AFib ablation
![Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S](/sites/default/files/styles/top_stories/public/2024-08/screenshot_2024-08-12_at_11.35.13_am.png.webp?itok=5FeQeMFj)
Left atrial appendage closure (LAAC) with Boston Scientific’s Watchman FLX device significantly reduces the risk of bleeding after cardiac ablation for atrial fibrillation (AFib) compared to oral anticoagulation (OAC) alone, according to new findings presented at the American Heart Association (AHA) 2024 Scientific Sessions and published in The New England Journal of Medicine. LAAC was also comparable to OAC in terms of stroke prevention.
The OPTION trial tracked 1,600 AFib patients who underwent catheter-based cardiac ablation in one of 10 different countries from 2019 to 2021. The mean age was nearly 70 years old, and 65.9% of patients were men. While 803 patients were treated with LAAC, the remaining 797 were treated with either a direct oral anticoagulant or warfarin. Approximately 60% of LAAC patients received their Watchman FLX device 90 to 180 days following the AFib ablation procedure. The remaining patients all underwent LAAC immediately after ablation.
Overall, the study’s primary safety endpoint—nonprocedure-related major bleeding events or clinically relevant nonmajor bleeding events after 36 months—was seen in 8.5% of LAAC patients and 18.1% of OAC patients. The study’s primary efficacy endpoint—a composite of all-cause mortality, stroke or systemic embolism after 36 months—occurred in 5.3% of LAAC patients and 5.8% of OAC patients.
“The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, LAAC with the Watchman FLX device is not only as safe, but superior to OAC therapy for reducing the risk of long-term bleeding events,” OPTION principal investigator Oussama Wazni, MD, vice chairman of cardiovascular medicine and section head of cardiac electrophysiology at Cleveland Clinic, said in a statement. “Notably, we found high rates of procedural success in patients who had a Watchman FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischemic and hemorrhagic stroke within the trial population.”
“These positive primary outcomes mean that patients receiving the Watchman FLX device were able to eliminate long-term medication use while maintaining stroke protection,” added Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific. “With this data, we see potential to both expand the indication for the Watchman FLX platform and ultimately elevate it to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce their risk of stroke."
Read the full analysis in The New England Journal of Medicine here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.