In patients with high risk for bleeding undergoing clinically-indicated left atrial appendage closure (LAAC), use of the Amulet device compared with the Watchman/FLX was associated with similar residual left atrial appendage (LAA) patency, lower peridevice leak (PDL) rates at transesophageal echocardiography (TEE), but higher procedural complications, according to findings from the SWISS-APERO trial presented Nov. 6 during TCT 2021 and simultaneously published in Circulation.

Roberto Galea, MD, and colleagues randomly assigned 221 patients undergoing percutaneous LAAC at eight European centers to receive either the Amulet device (n=11) or the Watchman 2.5 or FLX (n=110). Of those patients assigned to the Watchman group, 25 received the Watchman 2.5 and 85 received the Watchman FLX. The primary endpoint was the composite of justified crossover to a nonrandomized device during LAAC procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. Secondary endpoints included procedural complications, device-related thrombus, PDL at TEE and clinical outcomes at 45 days.

According to researchers, the primary endpoint occurred in 71 (67.6%) patients with Amulet and 70 (70.0%) patients with Watchman. Only one justified cross-over occurred in a patient assigned to the Amulet group. Clinical outcomes at 45 days did not significantly differ between the two groups. However, major procedure related complications were reported more frequently in the Amulet group (9.0% vs. 2.7%; p=0.047), largely due to more frequent bleeding (7.2% vs. 1.8%).

In other findings, the PDL rate at TEE was higher with Watchman (27.5%) than Amulet (13.7%) at 45 days. Device-related thrombus was observed in one patient in the Amulet group and three patients in the Watchman group at CCTA and in two Amulet-assigned patients and five Watchman-assigned patients at TEE.

“The SWISS-APERO trial is the first multicenter randomized, controlled trial comparing Amulet with Watchman FLX devices in terms of sealing capacity as evaluated by CCTA, procedural complications and short-term clinical outcomes,” said Galea, et al. They note that while “the clinical relevance of CCTA-detected LAA patency requires further investigation,” their findings suggest that both Amulet and Watchman can be successfully implanted in almost all LAAs deemed suitable for both devices as evaluated by pre-periprocedural TEE.”

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias

Keywords: Transcatheter Cardiovascular Therapeutics, TCT21, Atrial Appendage, Cardiac Surgical Procedures, Atrial Fibrillation, ACC International

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