Galea, Roberto; De Marco, Federico; Meneveau, Nicolas; Aminian, Adel; Anselme, Frédéric; Gräni, Christoph; Huber, Adrian T.; Teiger, Emmanuel; Iriart, Xavier; Babongo Bosombo, Flora; Heg, Dik; Franzone, Anna; Vranckx, Pascal; Fischer, Urs; Pedrazzini, Giovanni; Bedogni, Francesco; Räber, Lorenz; Valgimigli, Marco (2022). Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation, 145(10), pp. 724-738. Lippincott Williams & Wilkins 10.1161/CIRCULATIONAHA.121.057859
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Galea_Circulation_2022.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (2MB) | Request a copy |
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 (LAAC). Methods: In the investigator-initiated SWISS APERO trial, patients undergoing LAAC were randomized (1:1) open-label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centres. The primary endpoint was the composite of justified crossover to a non-randomized device during LAAC procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary endpoints included procedural complications, device related thrombus (DRT), peridevice leak (PDL) at transesophageal echocardiography (TEE) and clinical outcomes at 45 days. Results: Between June 2018, and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary endpoint was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) Amulet and 70 (70.0%) Watchman patients respectively (risk ratio [RR] 0.97 [95% CI 0.80- 1.16]; P=0.713). A single justified cross-over occurred in an Amulet patient who fulfilled LAA patency criteria at 45-day CCTA. Major procedure related complications occurred more frequently in the Amulet group (9.0% vs. 2.7%; P=0.047), owing to more frequent bleeding (7.2% vs.1.8%). At 45 days, the PDL rate at TEE was higher with Watchman than Amulet (27.5% vs. 13.7%, p=0.020), albeit none was major (i.e. > 5 mm), whereas DRT 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 TEE, respectively. Clinical outcomes at 45 days did not differ between the groups. Conclusions: Amulet was not associated with lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, was however associated with lower PDL rates at TEE, higher procedural complications and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT03399851.
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