Arrhythmias & electrophysiologyCohort study
1-Year Real-World Outcomes With the Amulet Occluder From the EMERGE LAA Postapproval Study
- Registry-based postapproval study
- single-arm
- NCDR LAAO Registry
Authors' conclusion
One-year outcomes from EMERGE LAA for the first 12,180 patients demonstrated the success, safety, and effectiveness of the Amulet occluder in the real-world setting.
Study context
- Population
- Patients with nonvalvular AF undergoing attempted Amulet LAAO, NCDR LAAO Registry, August 2021–December 2023median follow-up 1 year
- Participants
- 12,180 patients
- Outcome
- Safety endpoint composite:
- All-cause death
- Ischemic stroke
- Systemic embolism
- Device- or procedure-related events requiring open cardiac surgery or endovascular intervention
- Follow-up
- 7 days or hospital discharge (whichever was later)
Main finding
As reported in the abstract
Safety endpoint composite:
- All-cause death
- Ischemic stroke
- Systemic embolism
- Device- or procedure-related events requiring open cardiac surgery or endovascular intervention
Safety endpoint composite event
0.9% (112 of 12,180)
Observational data: associations, not effects.
Further findings
Implantation success
- Implantation success
- 96.0% (11,693 of 12,180)
- Implantation success, prior failed LAAO attempts
- 88.9% [353 of 397]
Clinically relevant closure (peridevice leak ≤3 mm) · 45 days postprocedure
- Clinically relevant closure
- 97.2% (4,293 of 4,418)
All stroke, CV-related death or death of unknown cause, all-cause death (Kaplan-Meier) · median 1 year
- All stroke
- 1.6% (n = 143)
- CV-related death or death of unknown cause
- 2.9% (n = 257)
- All-cause death
- 7.9% (n = 693)
Safety
Any major adverse event, by operator experience · 45 days
- Any major adverse event, by operator experience: decreased with increased operator experience, P < 0.001
Major bleeding (Kaplan-Meier) · median 1 year
- Major bleeding
- 6.3% (n = 610)
Original publication
1-Year Real-World Outcomes With the Amulet Occluder From the EMERGE LAA Postapproval Study. JACC Cardiovasc Interv. Published 11 May 2026. doi:10.1016/j.jcin.2026.02.016
Summarised from the published abstract; every number is checked against it