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Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation

Philipp Jakob1, Priska Heinz2, Yiqi Gong1

  • 1Department of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.

Structural Heart : the Journal of the Heart Team
|December 1, 2025
PubMed

Insights

For patients with severe aortic stenosis and atrial fibrillation undergoing TAVI, combining left atrial appendage occlusion (LAAO) with standard therapy showed similar primary endpoint rates compared to TAVI alone. This pilot study suggests a comparable safety and efficacy profile for the combined approach.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Electrophysiology

Background:

  • Patients with severe aortic stenosis and atrial fibrillation (AF) face elevated risks of bleeding and cerebrovascular events during transcatheter aortic valve intervention (TAVI).
  • Left atrial appendage occlusion (LAAO) is a potential strategy to mitigate these risks in AF patients undergoing TAVI.

Purpose of the Study:

  • To assess the safety and efficacy of LAAO in conjunction with TAVI for patients with AF.
  • To compare a combined TAVI + LAAO strategy against standard medical therapy (SMT) post-TAVI.

Main Methods:

  • An investigator-initiated, randomized, multicenter, open-label pilot study.
  • Eighty-one high-risk patients were randomized to either TAVI + LAAO or TAVI + SMT.
  • The primary endpoint was a composite of cerebrovascular events, peripheral embolism, major bleeding, or cardiovascular mortality at 1 year.

Main Results:

  • The primary endpoint occurred in 33% of the TAVI + LAAO group versus 37% in the TAVI + SMT group (adjusted OR, 0.87; P=0.77).
  • Bleeding rates were comparable (13% vs. 17%), with no nonprocedural bleeding in the LAAO group.
  • Cerebrovascular events did not significantly differ between groups (10% vs. 2.4%). Per-protocol analysis also showed comparable primary endpoint rates.

Conclusions:

  • In high-risk AF patients undergoing TAVI, a combined LAAO and early oral anticoagulation cessation strategy demonstrated similar primary endpoint rates compared to TAVI with SMT.
  • This pilot study suggests the feasibility and comparable outcomes of combining LAAO with TAVI.
  • Further research is warranted to confirm these findings in larger trials.
Abstract

Keywords:
Antithrombotic therapyAortic valve stenosisAtrial fibrillationLeft atrial appendage occlusionTranscatheter aortic valve intervention

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