ArticleJACC. Advances2026
MAUDE Registry Analysis of Pericardial Effusions Following Watchman and Amulet Left Atrial Appendage Occlusion.
Article in JACC. Advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
backgroundPercutaneous 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.
objectivesThe 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.
methodsThe 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.
resultsIn 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.
conclusionsThese 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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