The Amplatzer Amulet (Abbott) achieves better left atrial appendage closure than the Watchman 2.5 and Watchman FLX (Boston Scientific) in patients with atrial fibrillation at risk of stroke. This imaging finding has not yet been associated with clinical adverse events.
This study called SWISS-APERO was presented at TCT 2021 and simultaneously published in Circulation. It shows that despite there are no differences in left appendage patency by cardiac CT angiography, fewer leaks were found by transesophageal echocardiography with the Amulet.
Experts agree that it is better to have no leaks (procedural goal), but this difference between devices is just one finding.
The AMULET IDE randomized 1,878 patients with atrial fibrillation and high risk of stroke or systemic embolism to left atrial appendage closure using the Amplatzer Amulet or the Watchman 2.5.
AMULET IDE outcomes got Abbott the FDA’s approval.
The SWISS-APERO reported closure rate based on a 12-month followup with transesophageal echocardiography. Between day 45 and one year some fluctuation was observed in leaks, with improvement in some and worsening in others.
Despite this fluctuation, the AMULET resulted superior in terms of percentage of patients with moderate leaks (>3 mm) at 45 days (11% vs 26% for the Watchman) and this difference was maintained at one year (9% vs 22%; p<0.001).
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The clinical impact of leaks will eventually be seen in the long term, which is why they are planning to follow up patients at 5 years.
Original Title: Amulet or Watchman device for percutaneous left atrial appendage closure: primary results of the SWISS-APERO randomized clinical trial.
Reference: Roberto Galea et al. Circulation. 2021 Nov 6. Online ahead of print. doi: 10.1161/CIRCULATIONAHA.121.057859.
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