Quantitative considerations for choosing between Amulet and Watchman FLX and management of device related complications.

Abstract

Background: Left atrial appendage occlusion (LAA-O) with Amulet and Watchman FLX are approved for reducing stroke risk in patients with atrial fibrillation when oral anticoagulation is not tolerated. Real world clinical outcomes reported along with imaging data are needed to help clinicians choose between these two technologies and manage device-related complications.

Methods: The study retrospectively analyzed clinical, transesophageal (TEE), and available computed tomography (CT) data from 364 FLX and 292 Amulet procedures performed at an academic medical center over a 4-year period.

Results: LAA-O procedures were successful in 96.7% FLX and 97.3% Amulet cases. FLX implant success rate increased to 98.9% when only patients with LAA diameter to depth ratio < 1.8 and LAA area < 4.4 cm² were included. TTE LAA-orifice area correlated with CT-derived measurements. There were more late pericardial effusions for Amulet (3.1%) compared to FLX (0.3%), though the majority were conservatively managed. Mean procedure times were similar (FLX 64 ± 24, Amulet 65 ± 21 min) as were the rates of device related thrombus (FLX 1% and Amulet 1.4%). Clinically relevant peridevice leak (PDL) on follow-up TEE imaging was greater for FLX (16%) compared to Amulet (10%). Combined AF ablation-LAA-occlusion procedures exhibited lower rates of PDL and late pericardial effusions compared to solo procedures.

Conclusions: Based on retrospective analysis, an initial strategy with Watchman FLX in patients with favorable LAA anatomy would reduce the risk of late pericardial effusions at the expense of a higher rate of clinically relevant PDL compared to Amulet. Combined AF ablation and LAA-O procedures exhibit less PDL.