Valvular & structural heart disease
Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety
Authors' conclusion
Amulet occluder implantation was feasible, safe, and effective in patients with or without failed Watchman screening, providing a viable option for both anatomically simple and complex anatomies.
Study context
- Population
- Patients undergoing Amulet LAAO
- Participants
- 609 patients
- Comparison
- Screen Fail vs Device Eligible
- Screen Failn = 97
- Device Eligiblen = 512reference
Methodological detailsindependent core laboratory and clinical events committee adjudication
- Independent core laboratory and clinical events committee adjudication
Primary result
As reported in the abstract
Implant success
- Implant success high in both groups despite more complex anatomy in Screen Fail
- Screen Fail vs Device Eligible: P = 0.446
Further findings
Stroke · 1 year
P > 0.05
CV/unknown death · 1 year
P > 0.05
All-cause death · 1 year
P > 0.05
Clinically relevant closure on TOE (≤3 mm peri-device leak) · at implant and 1-3 months
- Achieved in both groups
- ≥97%
Safety
| Outcome | Screen Fail | Device Eligible | OR (CI) | P value | |
|---|---|---|---|---|---|
| Peri-procedural safety endpoint composite (all-cause death, ischaemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or major endovascular intervention) · within hospital discharge or 7 days post-implant | 3.1% | 2.7% | 1.14 (0.32–4.03) | P = 0.742 | |
| 0.20.5125Odds ratio (log scale) |
Major bleeding · 1 year
P > 0.05
Original publication
Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety. Europace. Published 26 August 2026. doi:10.
Summarised from the published abstract; every number is checked against it