Watchman FLX implantation was achieved in all 100 consecutive patients in this single-centre retrospective cohort, with bleeding the most frequent peri-procedural complication; the low stroke proportion must be read alongside 11% one-year mortality and incomplete imaging surveillance, and this uncontrolled descriptive study cannot establish comparative efficacy or comprehensive device safety.
Device implantation was successful in all 100 patients.
Patients in the cohort had high stroke and bleeding risk scores.
Major peri-procedural complications within 72 hours occurred in 7% of patients, with bleeding the most frequent.
Thirty-day outcomes showed 2% mortality and no strokes.
One-year outcomes showed 11% mortality and one reported stroke.
The authors caution that the low stroke proportion should be interpreted alongside substantial one-year mortality and incomplete imaging surveillance, and that the design limits inference.
This study looked back at 100 consecutive patients with non-valvular atrial fibrillation who had a Watchman FLX device implanted at one German hospital between 2021 and 2024. The device closes off the left atrial appendage, a small pouch in the heart where clots can form, as an alternative way to prevent stroke. Patients were typically around 70 years old and had high stroke and bleeding risk scores. The device was successfully implanted in all 100 patients. Serious complications within 72 hours occurred in 7%, mostly major bleeding (6%), and one patient (1%) had fluid build-up around the heart (pericardial tamponade). Within 30 days, 2% of patients died and none had a stroke. By one year, 11% had died and one patient (1%) had a stroke. This research suggests the procedure can be performed reliably in an experienced centre, with bleeding as the main early concern. However, the study had no comparison group, was done at a single hospital, and follow-up imaging was incomplete. The authors note that the low stroke rate has to be considered together with the 11% one-year mortality, and the study cannot show how the device compares with other treatments or fully establish its safety.
Allakkis W, Salem M, Salem M, Elabd M, Balakishiyev A, Aboud M, et al.. (2026). Left Atrial Appendage Occlusion with the Watchman FLX Device: A Single-Centre Retrospective Analysis of Procedural and One-Year Clinical Outcomes.. Medical sciences (Basel, Switzerland). https://doi.org/10.3390/medsci14060665