Valvular & structural heart disease
First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study
Authors' conclusion
The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting.
Study context
- Population
- US patients with a commercial Amulet occluder implant attempt between FDA approval (August 14, 2021) and December 31, 2022
- Participants
- 5,499 patients
- Outcome
- Safety composite:
- All-cause death
- Ischemic stroke
- Systemic embolism
- Device/procedure-related events requiring open cardiac surgery or endovascular intervention
- Follow-up
- Between device implantation and 7 days or hospital discharge (whichever is later)
Methodological detailsNCDR LAAO Registry, postapproval
- NCDR LAAO Registry
- Postapproval
Main finding
As reported in the abstract
Safety composite endpoint:
- All-cause death
- Ischaemic stroke
- Systemic embolism or device/procedure-related events requiring open cardiac surgery or endovascular intervention
Safety composite endpoint event occurred in patients
0.76%
Observational data: associations, not effects.
Further findings
Implant success
- Implant success
- 95.8%
Complete closure
- Complete closure post-LAAO
- 97.2%
- Complete closure at 45 days
- 87.1%
Safety
Pericardial effusion requiring surgery or percutaneous intervention, by operator experience · decreased significantly with increasing experience
In-hospital
P = 0.006
45 days
P = 0.012
Any major adverse event (driven by major bleeding and pericardial effusion requiring intervention)
- Any major adverse event in-hospital
- 2.9%
- Any major adverse event through 45 days
- 5.7%
Original publication
First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study. JACC Cardiovasc Interv. Published 19 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →