MAUDE Registry Analysis of Pericardial Effusions Following Watchman and Amulet Left Atrial Appendage Occlusion

Sneha S Limaye1, Karl Q Schwarz2, Mehmet K Aktas2

  • 1University of Rochester Medical Center, Rochester, New York, USA; Louis Stokes Veterans Affairs Medical Center, Cleveland, Ohio, USA.

JACC. Advances
|May 15, 2026
PubMed

Insights

Late pericardial effusion (LPE) after left atrial appendage occlusion (LAAO) device implantation is more common with the Amulet device and leads to significant morbidity. Long-term patient surveillance is crucial for identifying LPE complications post-LAAO.

Area of Science:

  • Cardiology
  • Medical Devices
  • Patient Safety

Background:

  • Percutaneous left atrial appendage occlusion (LAAO) devices offer an alternative to anticoagulation for stroke prevention in nonvalvular atrial fibrillation.
  • Pericardial effusion is the most frequent serious complication following LAAO, with delayed onset occurring in some cases.

Purpose of the Study:

  • To compare the incidence and outcomes of acute vs. late pericardial effusion (LPE) after LAAO device implantation.
  • To analyze complications associated with LPE following LAAO.

Main Methods:

  • Utilized the Manufacturer and User Facility Device Experience database for deidentified public data.
  • Searched for "Amplatzer Amulet" and "Watchman" LAAO devices from FDA approval through December 2024.
  • Selected reports specifically mentioning pericardial effusion post-LAAO implantation.

Main Results:

  • Amulet LAAO implants reported 290 pericardial effusions vs. 33 for Watchman.
  • Late pericardial effusions (LPE) were more frequent with Amulet (34.1%) compared to Watchman (6.1%).
  • Intervention was required in 54.5% of Amulet LPE cases versus 64.4% of acute effusion cases.

Conclusions:

  • Late pericardial effusions (LPE) following LAAO are associated with adverse patient outcomes and significant morbidity.
  • Findings underscore the necessity for extended patient monitoring to detect post-LAAO complications.
  • Device choice may influence the risk and timing of pericardial effusion development.
Abstract

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