Arrhythmias & electrophysiology
Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial
Authors' conclusion
Incidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device.
Study context
- Population
- Patients with successful left atrial appendage occlusion (LAAO) implant in the Amulet IDE trialsuccessful implants
- Participants
- 903 vs 885
- Comparison
- Amulet vs Watchman LAAO device
- Amuletn = 903
- Watchmann = 885reference
- Primary endpoint
- Incidence of DRT (by transesophageal echocardiography)
- Follow-up
- 18 months
Primary result
As reported in the abstract
DRT incidence
- Overall device-related thrombus (DRT) incidence
- 3.9% (n = 70)
Further findings
Predictors of DRT
| HR (95% CI) | P value | ||
|---|---|---|---|
| AF at time of procedure | 2.44 (1.42–4.22) | P < 0.01 | |
| Female sex | 1.65 (1.01–2.71) | P = 0.04 | |
| Older age | 1.04 (1.01–1.08) | P = 0.02 | |
| 0.20.5125Hazard ratio (log scale) |
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| CV mortality, DRTvs non-DRT | 2.33 (1.01–5.39) | P = 0.04 | |
| 0.20.5125Hazard ratio (log scale) |
| Outcome | Amulet | Watchman |
|---|---|---|
| Timing of DRT (early ≤45 days vs late >45 days) | ||
| Early DRT | 19 of 31 | — not stated in the abstract |
| Late DRT | — not stated in the abstract | 31 of 42 |
— not stated in the abstract
- CV mortality, DRT vs non-DRT: DRT 8.7%
- CV mortality, DRT vs non-DRT: Non-DRT 3.9%
Safety
Events
| Outcome | Amulet | Watchman |
|---|---|---|
| Stroke following DRT | 0 | 3 |
Original publication
Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial. JACC Clin Electrophysiol. Published 28 September 2022. doi:10.
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