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Updated: May 17, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
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.
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.
Background:
Percutaneous left atrial appendage occlusion (LAAO) devices are an important therapeutic alternative to oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. In patients undergoing LAAO, a pericardial effusion is the most common serious complication, with some effusions occurring in a delayed manner.
Objectives:
The purpose of this study was to investigate the incidence and outcomes of acute pericardial effusion vs late pericardial effusion (LPE) following LAAO device implant in those who develop pericardial effusion.
Methods:
The Manufacturer and User Facility Device Experience database consists of deidentified, public information. The terms "Amplatzer Amulet" were searched using the simple search method. A separate search for the term "Watchman" was performed using the same method. The results include data beginning at the time of the device's Food and Drug Administration approval through December 2024. Reports were selected if a pericardial effusion occurred.
Results:
In the Manufacturer and User Facility Device Experience database, 290 pericardial effusions were reported among patients receiving an Amulet LAAO device compared to 33 reported cases for those receiving a Watchman device. Among Amulet LAAO implants who developed a pericardial effusion, 99/290 (34.1%) were LPEs; 2/33 (6.1%) were LPEs in Watchman LAAO implants who developed pericardial effusion. Of patients who had Amulet implant and developed LPE, 54/99 (54.5%) needed intervention; of those with acute pericardial effusion, 123/191 (64.4%) needed intervention.
Conclusions:
These observations suggest that LPEs adversely affect patient outcomes and can cause significant morbidity. These findings highlight the importance of long-term surveillance of patients for complications after successful LAAO.
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