Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

Study Overview
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Brief Summary
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Closure of peri-device leaks (PDL) after incomplete LAAC have shown early feasibility, however no comparison study of all the leak closure modalities exists. Therefore, this is an attempt to report the first 3-way observational comparison study to date, with results in 160 total patients in 3 arms including detachable embolization coils, vascular plugs/septal occluders and Radiofrequency ablation.

Detailed Description
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Left Atrial Appendage (LAA) Closure (LAAC) is a potent technique of LAA isolation and exclusion for stroke prevention in patients with atrial fibrillation, with evidence from the PROTECT-AF and PREVAIL-AF trials, including their 5-year follow-up assessments, solidifying LAAC as a viable option in these patients with comparable stroke reduction in comparison to oral anticoagulation (OAC) as well as a reduction in bleeding risk, hemorrhagic CVA, and mortality. However, the surge in the multiple methods of LAA exclusion has also brought to attention postprocedural complications specific to LAAC, namely, peri-device leaks (PDL). The stroke implication and classification of PDL itself still lacks consensus, with an increased thromboembolic (TE) potential due to PDL seen in patients with LARIAT and surgical ligation procedures, yet no statistically significant relationship seen in percutaneous and endocardial LAA closure approaches. PDL > 5mm has been widely accepted as clinically significant, although there remains limited data with no current established guidelines. Placement of a septal occluder device such as Amplatzer Vascular Plug, Detachable embolization coils, Gore Cardioform Septal Occluder (CSO; W.L. Gore and Associates, Newark DE), and radiofrequency ablation (RFA) have all emerged as options to resolve residual PDL and post-surgical/ligation leaks. However, there exists no head-to-head comparison between these modalities. Given their emergence, this is a proposed a multi-center observational study to further assess and evaluate these three treatment modalities for their efficacy for leak closure, assessment of pre-, peri- and post-procedural characteristics after leak closure, TE events, and bleeding risk, and complication rates.

Official Title
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Comparison of the Efficacy of Successful Leak Closure Between Available Leak Closure Methods for Clinically Relevant and Persisting Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

Conditions
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Left Atrail Appendage Closure: Peri-device Leaks

Intervention / Treatment
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* Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC Patients undergoing any form of eccentric or centric/central leak closure with available modalities (detachable embolization coils, vascular plus/septal/ASD occluders, or RF Ablation). Criteria for this was made based on the judgement of the operator, with no specific cutoffs for leak size, follow-up time from LAAC to leak closure, etc) Age greater than 18 years Exclusion Criteria: Patients not undergoing leak closure after incomplete LAAC Patients unable to complete 45 day follow-up imaging for reevaluation of LAA leak Patients unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Detachable embolization coils group<br>Patients who have an intervention for leak closure with detachable embolization coils | Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA<br>* All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.<br>|
| Vascular plugs/septal occluders group<br>Patients who have an intervention for leak closure with vascular plugs/CSO | Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA<br>* All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.<br>|
| RF Ablation group<br>Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA) | Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA<br>* All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of closure (in mm) of PDL/reduction in size of PDL after leak closure procedure | Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and on 45 day follow-up TEE | 1/11/2015 - 3/14/2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural complications occurring from Postoperative day #0 - day 7 | Primary Safety Endpoint: periprocedural complications occurring from Postoperative days 0 - 7, including: device-related thrombus, pericardial effusion/pericardial tamponade requiring intervention and CVA. | 1/11/2015 - 6/8/2021 | 
| Delayed procedure-related complications and adverse events within 90 days of procedure | Secondary Safety Endpoint: Delayed procedure-related complications and adverse events within 90 days of procedure including device-related thrombus, pericardial effusion/ pericardial tamponade requiring intervention and CVA. | 1/11/2015 - 6/8/2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Atrial Appendage Closure, Central or peri-device leaks