Dual-Seal Amulet vs. Watchman Device: 12-Month Closure Comparison
The Amulet IDE trial compared the dual-seal Amplatzer Amulet left atrial appendage occluder to the single-occlusive Watchman device. Results showed superior closure with the Amulet device at both 45 days and 12 months, indicating its effectiveness in patients with non-valvular atrial fibrillation at high stroke risk.
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Amulet IDE Trial 12-Month Closure Follow Up Dhanunjaya Lakkireddy, M.D. Stephan Windecker, M.D. David Thaler, M.D., Ph.D. on behalf of the Amulet IDE Investigators The Amulet IDE trial was funded by Abbott Medical
Presentations Conclusion The dual-seal AmplatzerTM AmuletTM left atrial appendage occluder demonstrated durably superior closure at 12 months compared to the single- occlusive mechanism WatchmanTM device
Purpose and Key Points about Methods Amulet IDE Primary Results: The Amulet occluder was superior with respect to left atrial appendage closure at 45 days and non-inferior with respect to safety and effectiveness in patients with non-valvular atrial fibrillation compared to the Watchman device Background: Limited data exists for long-term analysis of peridevice leaks (PDL) from prospective clinical studies Purpose: To present the 12-month PDL results in Amulet and Watchman devices from the Amulet IDE trial using a Moderate grade PDL size ( 3mm) in the analyses Population Studied: Patients with non-valvular atrial fibrillation at high risk of stroke
45-Day and 12-Month TEE Accountability 1878 Randomized 903 Amulet implanted 885 Watchman implanted Missed visit (8) Withdrawn (3) Dead (7) Missed visit (9) Withdrawn (2) Dead (3) 45-day visit completed: 885 45-day visit completed: 871 84 TEEs Missing: TEE not performed (7) TEE not evaluable (77) 79 TEEs Missing: TEE not performed (10) TEE not evaluable (69) 45-day TEEs assessed by core lab: 801 45-day TEEs assessed by core lab: 792 Missed visit (22) Withdrawn (9) Dead (35) Missed visit (22) Withdrawn (24) Dead (46) 12-month visit completed: 793 12-month visit completed: 837 175 TEEs Missing: TEE not performed (90) TEE not evaluable (85) 164 TEEs Missing: TEE not performed (64) TEE not evaluable (100) 12-month TEEs assessed by core lab: 618 12-month TEEs assessed by core lab: 673
45-Day and 12-Month PDL Severity N=618 N=801 N=792 N=673 10% 11% 22% 26% p<0.001* p<0.001* 27% 26% 25% Subjects % 28% 63% 63% 53% 46% Amulet-45D Watchman-45D 0mm Amulet-12M Watchman-12M >0 & <3mm Moderate Superiority of closure with Amulet LAAO to Watchman device at 45 days was durable at 12 months * From Chi-square test
PDL Progression from 45 Days to 12 Months N=792 N=801 N=792 N=801 11% 19% 22% 26% 3% 26% 5% 7% 16% Subjects % 28% 22% 18% 63% 49% 46% 39% Amulet-45D 0mm Watchman-45D >0 & <3mm Amulet-12M Dead Watchman-12M Missing TEEs Moderate For both groups, PDL rates are comparable between 45 days to 12 months
Key Messages Impact on clinical practice: Superiority of closure of the Amulet LAA occluder to the Watchman device at 45 days was durable at 12 months allowing patients to remain off oral anticoagulants Impact for the person on the street: The Amulet occluder offers immediate and durable closure to reduce the risk of stroke and freedom from long-term oral anticoagulants Final take away message for the public: Confidence in the Amulet occluder to provide immediate and prolonged closure so patients can safely remove oral anticoagulant medications from their everyday life
