Arrhythmias & electrophysiologyRandomised controlled trial
Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation
- Randomised controlled trial
- multicentre
- non-inferiority
- 34 US centres
- Enrolled December 2017 to November 2020
Authors' conclusion
Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF.
Study context
- Population
- Patients with atrial fibrillation (AF) and severe AS undergoing transcatheter aortic valve replacement (TAVR)
- Participants
- 349 patients
- Comparison
- TAVR + left atrial appendage occlusion (LAAO) vs TAVR + medical therapy
- TAVR + LAAOn = 177
- TAVR + medical therapyn = 172reference
- Primary endpoint
- All-cause mortality, stroke and major bleeding (non-inferiority)
- Follow-up
- 2 years
Primary result
As reported in the abstract
Hazard ratio
0.86
95% CI 0.60–1.22
P < 0.001 for non-inferiority
By group
TAVR + LAAO vs TAVR + medical therapy
HR 0.86 (95% CI 0.60–1.22); P for non-inferiority < 0.001
Further findings
Antiplatelet therapy use · 24 months
Anticoagulation use · 24 months
Procedure · contrast volume
Incremental LAAO procedure time TAVR + LAAO 38 minutes
Original publication
Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation. Circulation. Published 24 October 2023. doi:10.1161/circulationaha.123.067312
Summarised from the published abstract; every number is checked against it