Key result
Among LAAO effusion cases, Amulet is linked to a ~459% higher late presentation rate versus Watchman.
Why the study?
Pericardial effusion is the most common serious complication after percutaneous LAAO, with some effusions occurring in a delayed manner, but data on the incidence and outcomes of acute versus late pericardial effusion in affected patients were needed.
Does the incidence of acute vs late pericardial effusion differ between Amulet and Watchman LAAO devices in patients who develop pericardial effusion?
Observational (n=323)
Yes
Does the incidence of acute vs late pericardial effusion differ between Amulet and Watchman LAAO devices in patients who develop pericardial effusion?
Late pericardial effusions account for a higher proportion of effusions following Amulet LAAO implantation compared to Watchman, emphasizing the importance of long-term surveillance.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These findings are novel and in contrast to the existing large prospective randomized controlled trials that have been performed on LAAO devices which report no morbidity and mortality associated with postprocedural PE.”
Late pericardial effusions occur more often after Amulet than Watchman LAAO; leaves open device-specific surveillance needs.
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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Limaye et al. (2026) conducted an observational in Nonvalvular atrial fibrillation (n=323). Amplatzer Amulet LAAO device vs. Watchman LAAO device was evaluated on Incidence of late pericardial effusion (LPE) among those who develop pericardial effusion. Among patients developing pericardial effusion after LAAO, late pericardial effusions were reported in 34.1% of Amulet cases compared to 6.1% of Watchman cases.
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