Key result
WATCHMAN FLX Pro with EXPRESS-LAAO protocol achieves ~99% procedural success without in-hospital complications.
Why the study?
What are the procedural outcomes and short-term safety of the WATCHMAN FLX Pro LAAO device using the EXPRESS-LAAO protocol in high-risk patients?
Observational (n=109)
No
What are the procedural outcomes and short-term safety of the WATCHMAN FLX Pro LAAO device using the EXPRESS-LAAO protocol in high-risk patients?
Answers are grounded in this paper and cite their sources.
The WATCHMAN FLX Pro LAAO device, implanted using a streamlined protocol, demonstrated high procedural success and short-term safety in a high-risk cohort.
This study evaluates the procedural outcomes and short-term follow-up of the WATCHMAN FLX Pro left atrial appendage occlusion (LAAO) device (Boston Scientific) using the EXPRESS-LAAO protocol at a high-volume center. The new device offers enhanced features, including a 40-mm size for large anatomies, additional radiopaque markers for improved positioning, and a hemocompatible coating for faster endothelization. The EXPRESS-LAAO protocol streamlines patient management with pre-procedure computed tomography or cardiac magnetic resonance imaging, intracardiac echocardiography guidance, conscious sedation, and same-day discharge for stable patients. Between June and September 2024, 109 patients (median age 78 years, 48.6% female) underwent LAAO with the WATCHMAN FLX Pro device. Key indications included recurrent falls (33%), gastrointestinal bleeding (29.4%), and very high bleeding risk (21.1%). Procedural success was high (99.1%), with 1 case of cardiac tamponade requiring pericardiocentesis and no in-hospital complications. The 40-mm device was used in 7.3% of cases, proving essential for larger anatomies. At an average follow-up of 49.7 days, there was 1 lacunar stroke without device-related complications and 1 minor bleeding event. The study demonstrates the safety and effectiveness of the WATCHMAN FLX Pro device using the EXPRESS-LAAO protocol. The TruSteer catheter (Boston Scientific) facilitated implantations in complex anatomies, reducing the number of maneuvers. While post-LAAO imaging surveillance was a limitation, this is the first study assessing peri-procedural outcomes with the new device. Findings support its clinical utility in high-risk patients requiring LAAO.
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Frazzetto et al. (2025) conducted an observational in High bleeding risk requiring left atrial appendage occlusion (n=109). WATCHMAN FLX Pro device using the EXPRESS-LAAO protocol was evaluated on Procedural success. Left atrial appendage occlusion using the WATCHMAN FLX Pro device and EXPRESS-LAAO protocol achieved a 99.1% procedural success rate with no in-hospital complications.
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