Arrhythmias & electrophysiologyCohort study
Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman
- Registry-based cohort study
- National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry
- secondary analysis with 2:1 propensity score matching
Authors' conclusion
Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device.
Study context
- Population
- Patients undergoing transcatheter LAAO in the National Cardiovascular Data Registry LAAO Registry
- Exposure
- Watchman FLX vs Watchman 2.5
- Outcome
- Ischemic stroke
- Follow-up
- 1 year
Main finding
As reported in the abstract
Adjusted hazard ratio
0.82
95% CI 0.68–0.98
P = 0.02
Watchman FLX vs Watchman 2.5
adjusted HR 0.82 (95% CI 0.68–0.98); P = 0.02
Observational data: associations, not effects.
Further findings
| Outcome | adjusted HR (95% CI) | P value | |
|---|---|---|---|
| Major adverse events · 1 year | 0.84 (0.80–0.88) | P < 0.0001 | |
| Ischemic stroke or systemic embolism · 1 year | 0.74 (0.62–0.87) | P = 0.0003 | |
| 0.512Adjusted hazard ratio (log scale) |
Any peridevice leak (TEE at 45 days)
P < 0.001
Safety
Device-related thrombus (TEE at 45 days)
P = 0.27
Original publication
Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman. JACC Cardiovasc Interv. Published 26 May 2025. doi:10.1016/j.jcin.2025.03.025
Summarised from the published abstract; every number is checked against it