Amulet did not reduce the composite of crossover or residual LAA patency compared with Watchman at 45 days, with device-related thrombus detected in 0.9% vs 3.0% of patients at CCTA.
RCT
Open-label
1:1
Yes
Does the Amulet device reduce the composite of crossover or residual LAA patency compared to the Watchman device in patients undergoing percutaneous LAA closure?
In patients undergoing percutaneous LAA closure, the Amulet device did not reduce the composite of crossover or residual LAA patency compared to Watchman, but demonstrated lower peridevice leak rates at the cost of higher procedural complications.
BACKGROUND: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure. METHODS: In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days. RESULTS: =0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups. CONCLUSIONS: Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03399851.
Galea et al. (Sat,) conducted a rct in Patients undergoing percutaneous left atrial appendage (LAA) closure. Amulet vs. Watchman 2.5 or FLX was evaluated on Composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. Amulet did not reduce the composite of crossover or residual LAA patency compared with Watchman at 45 days, with device-related thrombus detected in 0.9% vs 3.0% of patients at CCTA.