Abstract / Summary
Background: Left atrial appendage occlusion (LAAO) is an alternative approach to stroke prevention in selected patients with non-valvular atrial fibrillation. This single-centre retrospective study describes device implantation, peri-procedural complications and clinical outcomes during the first year after Watchman FLX implantation. Methods: We analysed 100 consecutive patients who underwent LAAO with the Watchman FLX device at Helios Frankenwaldklinik-Hospital, Kronach, Germany, between 2021 and 2024. The primary endpoint was device implantation success, defined as correct device deployment and implantation. The secondary safety endpoint was a composite of major peri-procedural complications within 72 h. Additional clinical outcomes were strokes and mortality at 30 days and one year. Results: The mean age was 70.7 ± 6.5 years, and 47% of patients were female. The mean CHA2DS2-VASc score was 4.9 ± 1.4, and the mean HAS-BLED score was 4.1 ± 1.0. Device implantation was successful in 100% (95% CI 96.4–100%). The reported peri-procedural complication rate was 7% (95% CI 2.9–13.9%), including major bleeding in 6% (95% CI 2.2–12.6%) and pericardial tamponade in 1% (95% CI 0.0–5.4%). Thirty-day mortality was 2% (95% CI 0.2–7.0%), with no reported strokes (0%; 95% CI 0.0–3.6%). One-year mortality was 11% (95% CI 5.6–18.8%), with one reported stroke (1%; 95% CI 0.0–5.4%). Conclusions: Watchman FLX implantation was achieved in all patients in this cohort. Bleeding was the most frequently reported peri-procedural complication. The low observed stroke proportion should be interpreted alongside the 11% one-year mortality and incomplete imaging surveillance. This uncontrolled descriptive study cannot establish comparative efficacy or comprehensive device safety.