Valvular & structural heart diseaseSecondary analysis
Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders
- Secondary analysis of the Amulet IDE randomised trial
- independent core lab
- propensity-score matched controls
Authors' conclusion
The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial.
Study context
- Population
- Patients randomised in the Amulet IDE trial undergoing left atrial appendage occlusion (LAAO)randomised
- Participants
- 1,878 patients
- Comparison
- Amulet vs Watchman 2.5 LAAO devices
- Primary endpoint
- Severe peri-device leak (>5 mm): incidence, mechanisms, predictors and evolution
- Follow-up
- Through 18 months
Primary result
As reported in the abstract
Severe peri-device leak (>5 mm)
45 days
P < 0.001
12 months
P < 0.001
Further findings
Evolution of Watchman severe leaks · through 18 months
- Most Watchman severe leaks did not resolve over time
Original publication
Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders. Europace. Published 16 August 2023. doi:10.1093/europace/euad237
Summarised from the published abstract; every number is checked against it