Arrhythmias & electrophysiologyCohort study
Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study
- Prospective registry study
- multicentre
- single-arm
Authors' conclusion
Exclusive fluoroscopy-guided sLAAO with the WATCHMAN FLX device is feasible, safe, and resource efficient, achieving high procedural success and low complication rates
Study context
- Population
- Non-valvular AF at high thromboembolic and bleeding risk
- Participants
- 400 participants
- Outcome
- Procedural safety, efficacy and short-term outcomes
Main finding
As reported in the abstract
Procedural success
Procedural success
100%
Observational data: associations, not effects.
Further findings
Follow-up outcomes · median follow-up 194.5 days [IQR 129.0-265.0]
- All-cause mortality
- 3 (0.8%)
- TIA
- 13 (3.3%)
- Device-related thrombosis
- 1 (0.3%)
Independent predictors of adverse events (multivariable Cox regression)
- Chronic obstructive pulmonary disease
- HR 2.86, 95% CI 1.98-4.11, P < 0.001
- Higher CHA2DS2-VASc scores
- HR 4.69, 95% CI 1.90-11.57, P < 0.001
Safety
Major complications
- Pericardial effusion
- 0.5%
- Access-site complications
- 1.3%
- Major bleeding
- 0.8%
Original publication
Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study. Europace. Published 29 May 2026. doi:10.1093/europace/euag045
Summarised from the published abstract; every number is checked against it