Long-term follow-up of patients with non-valvular atrial fibrillation (AF) receiving the Amplatzer Amulet left atrial appendage occlusion (LAAO) device have shown continued safety and efficacy through three-years, results from the Amulet IDE trial shared at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA) indicate.
The results, presented by Dhanunjaya Lakkireddy (Kansas City Heart Rhythm Institute at HCA Midwest Health, Kansas City, USA) suggest that the device offers “immediate and durable closure to reduce the risk of stroke,” Lakkireddy commented.
The randomised controlled trial pitted Amulet head-to-head with the Watchman (Boston Scientific) device, with primary results presented at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual), subsequently published in Circulation, having shown that Amulet was superior with respect to LAAO at 45 days and non-inferior with respect to safety and effectiveness through 18 months compared to the Watchman device.
Abbott’s Amulet features Dual-Seal technology—a lobe to fill the body of the LAA and a disc to close off the opening into the LAA—which, according to the device manufacturer, offers immediate closure of the LAA, reducing the risk of stroke and immediately eliminating the need for anticoagulation post-implant.
The trial enrolled more than 1,800 patients at sites internationally, 934 randomised to receive the Amulet, and 944 Watchman. Three-year follow-up data were available for 92% of patients in the Amulet arm, and 86.7% for Watchman.
Detailing the key findings from the trial, Lakkireddy reported that more patients in the Watchman arm (7%) were placed on oral anticoagulation, than those receiving Amulet (4%). Furthermore, cardiovascular death (6.6% vs. 8.5%) and all-cause death (14.6% vs. 17.9%) trended lower with Amulet than Watchman, while stroke and major bleeding where comparable between the two groups.
Device factors, including device-related thrombus or peri-device leak preceded strokes in more Watchman patients (17) than Amulet patients (4) after six months, Lakkireddy noted.
Offering up a final take away message from the trial, Lakkireddy commented that the results provide “confidence in the Amulet occlude to provide immediate and prolonged closure so patients can safely remove oral anticoagulant medications from their everyday life”.
