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Impact of Residual Leaks After Left Atrial Appendage Occlusion
Quick Takes
- Small leaks (>0-5 mm) were present in ∼25% of patients after left atrial appendage occlusion (LAAO) and were associated with higher thromboembolic and bleeding events during 1-year follow-up.
- Conversely, large (>5 mm) peri-device leaks after LAAO were not associated with adverse events but this study may have been underpowered to assess this association.
- Additional studies are indicated to determine the prevalence of peri-device leak and their association with adverse events with newer LAAO devices and also to assess techniques to mitigate and manage such peri-device leaks.
Study Questions:
What is the association of peri-device leak after left atrial appendage occlusion (LAAO) and adverse clinical events?
Methods:
The investigators queried the National Cardiovascular Data Registry LAAO Registry to identify patients undergoing LAAO between January 1, 2016–December 31, 2019. Patients were classified according to leak size on echocardiography at 45 ± 14 days (0 mm, no leak; >0-5 mm, small leak; and >5 mm, large leak). The authors built univariate and multivariate Cox proportional hazards models to adjust for differences in baseline characteristics. Variables included in the univariate model were race, type of atrial arrhythmia, diabetes, history of stroke, history of transient ischemic attack, fall risk, prior intracranial bleeding, labile international normalized ratio, abnormal liver function, coronary artery disease, pulse, platelets <50,000/μL, albumin level, creatinine level, CHA2DS2-VASc score components, and antiplatelet/anticoagulant regimen on discharge.
Results:
A total of 51,333 patients were included, of whom 37,696 (73.4%) had no leak, 13,258 (25.8%) had small leaks, and 379 (0.7%) had large leaks. The proportion of patients on warfarin at 45 days was higher in the large versus small or no leak cohorts (44.9% vs. 34.4% and 32.4%, respectively; p < 0.001). At 6 and 12 months, anticoagulant utilization decreased but remained more frequent in patients with large leaks. Thromboembolic and bleeding events were uncommon in all groups. However, compared with patients with no leak, those with small leaks had slightly higher odds of stroke/transient ischemic attack/systemic embolization (adjusted hazard ratio [HR], 1.152; 95% confidence interval [CI], 1.025-1.294), major bleeding (HR, 1.11; 95% CI, 1.029-1.120), and any major adverse events (HR, 1.102; 95% CI, 1.048-1.160). There were no significant differences in adverse events between patients with large leaks and patients with small or no leaks.
Conclusions:
The authors reported that small (>0-5 mm) leaks after LAAO were associated with a modestly higher incidence of thromboembolic and bleeding events but large leaks (>5 mm) were not associated with adverse events, although higher proportions of these patients were maintained on anticoagulation.
Perspective:
This large nationwide cohort study reported that small leaks (>0-5 mm) were present in approximately 25% of patients after LAAO and were associated with higher thromboembolic and bleeding events during 1-year follow-up. Conversely, large (>5 mm) peri-device leaks were not associated with adverse events but this study may be underpowered to assess the association between those leaks and subsequent events, given that large leaks were extremely rare (<1%) and that a large proportion of patients with large leaks were maintained on prolonged oral anticoagulation. Additional studies are indicated to determine the prevalence of peri-device leak and their association with adverse events with newer LAAO devices and also to assess techniques to mitigate and manage such peri-device leaks.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Echocardiography/Ultrasound
Keywords: Albumins, Anticoagulants, Arrhythmias, Cardiac, Atrial Appendage, Atrial Fibrillation, Blood Platelets, Coronary Artery Disease, Coronary Occlusion, Creatinine, Diabetes Mellitus, Echocardiography, Hemorrhage, Ischemic Attack, Transient, LAAO Registry, National Cardiovascular Data Registries, Patient Discharge, Secondary Prevention, Stroke, Thromboembolism, Thrombosis, Vascular Diseases, Warfarin
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