Amulet IDE: Amulet LAA Occluder vs. Watchman Device at Three Years
The dual-seal mechanism Amulet Left Atrial Appendage (LAA) Occluder continued to demonstrate safety and effectiveness in patients with nonvalvular atrial fibrillation (AFib) compared with the single occlusive Watchman 2.5 device, according to three-year outcome findings from the Amulet IDE trial presented Sept. 17 during TCT 2022 in Boston.
The global trial randomized a total of 1,878 patients at 108 sites to the Amulet occluder or Watchman device. Of these, 1,833 underwent an implant (917 in the Amulet group and 916 in the Watchman group). At baseline, the average age across both groups was approximately 75 years and 60% were men. The average CHA2DS2-VASc score was 4.6 and HAS-BLED was 3.3.
Researchers noted that patients in the Amulet group were discharged on either dual antiplatelet therapy or aspirin plus oral anticoagulation (OAC) and patients in the Watchman group were discharged on aspirin plus OAC. If the residual flow was ≤5mm at the 6-month visit, patients in both groups continued same single APT (aspirin) indefinitely at the physician's discretion.
In presenting the findings, Dhanunjaya R. Lakkireddy, MBBS, FACC, said a significantly higher percentage of patients in the Amulet group were free of OAC usage at three years (96.2%) compared with those in the Watchman group (92.5%). Additionally, both cardiovascular and all-cause deaths trended higher in the Watchman group compared with the Amulet group. However, no pericardial effusion related deaths occurred in either group and ischemic stroke and major bleeding rates were comparable between both groups.
In other findings, withdrawals occurred at a higher rate in the Watchman group than the Amulet group and device factors (i.e., device-relate thrombus or peridevice leak) frequently preceded strokes in more Watchman patients (17 patients vs. 4 patients), Lakkireddy said.
Results from the Amulet IDE trial were first presented at ESC Congress 2021.
Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Atrial Appendage, Septal Occluder Device, Atrial Fibrillation
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