Periprocedural Pericardial Effusion Complicating Transcatheter Left Atrial Appendage Occlusion: A Report From the NCDR LAAO Registry

Abstract

Background : Pericardial effusion (PE) is a potential complication of transcatheter left atrial appendage occlusion (LAAO). The objective of this study was to investigate the incidence, associated characteristics, and outcomes of PE following LAAO. Methods : Patients in the NCDR LAAO Registry who underwent a Watchman procedure between January 1, 2016 and December 31, 2019 were included. The primary outcome was in-hospital PE requiring intervention (percutaneous drainage or surgery). Odds ratios [ORs] were calculated for adverse event rates associated with PE. Results : The study population consisted of 65,355 patients. The mean patient age was 76.2±8.1 years and the mean CHA2DS2-VASc score was 4.6±1.5. PE occurred in 881 patients (1.35%). Clinical variables independently associated with PE included older age, female sex, left ventricular function, paroxysmal atrial fibrillation, prior bleeding, lower serum albumin, and pre-procedural dual antiplatelet therapy; procedural variables included number of delivery sheaths used, sinus rhythm during the procedure, and moderate sedation rather than general anesthesia. PE was associated with increased risk of in-hospital stroke (OR, 6.58 [95% CI, 3.32 to 13.06], P<0.0001), death (OR, 56.88 [95% CI, 39.79 to 81.32], P<0.0001), and the composite of death, stroke, or systemic embolism (SE) (OR, 28.64 [95% CI, 21.24 to 38.61], P<0.0001). PE during the index hospitalization was associated with increased risk of death (OR 3.52 [95% CI, 2.23 to 5.54], P<0.0001) and the composite of death, stroke, or SE (OR 3.42 [95% CI, 2.31 to 5.07], P<0.0001) between discharge and 45-day follow-up. Conclusions : In-hospital PE during transcatheter LAAO is infrequent but associated with a substantially higher risk of adverse events, including in-hospital and early post-discharge mortality. Strategies to minimize PE are critical to improve the risk-benefit ratio for this therapy.

Cardiac magnetic resonance imaging for left atrial appendage closure planning

“…The patient was discharged the following day. The pericardial effusion was attributed to the inherent procedural risk of left atrial instrumentation and LAAC device deployment 9 …”

Pericardial effusion following percutaneous left atrial appendage closure using the LAmbre device

“…The reported incidence of PE following Watchman implantation is relatively low. In a recent study from the NCDR Left Atrial Appendage Occlusion Registry, the incidence of PE requiring intervention was reported to be 1.4% ( 7 ). A real-world analysis of >17,000 recipients of the Watchman implant reported the incidence of PE requiring intervention to be 1.2% ( 8 ).…”

“…In the Amulet IDE trial, the incidence of postprocedural PE was reported to be higher for procedures in which the Amplatzer Amulet occluder was implanted than when the Watchman device was used ( 6 ). Several factors associated with PE after LAAC have been reported, including older age, female sex, left ventricular function, paroxysmal AF, and higher CHA 2 DS 2 -VASc score ( 7 , 8 ).…”

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study

“…Percutaneous left atrial appendage occlusion (LAAO) is an effective alternative for stroke prevention in patients with nonvalvular AF who cannot tolerate long‐term oral anticoagulation (OAC). Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second‐generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous LAAO 1,2 . However, real‐world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking.…”

“…Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous LAAO. 1,2 However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking.…”