Therapy Strategies After LAA Occluder Device Embolization

Study Overview
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Brief Summary
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The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).

Detailed Description
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The global burden of atrial fibrillation (AF) is high, and AF represents a major cause of morbidity, mortality and health-care expenditure. Thromboembolic stroke may be one of the fatal complications and oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation (i.e. high bleeding risk, poor drug tolerance or adherence), non- pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option. Occluders are implanted into the left atrial appendage (LAA) but they might dislocate and therefore embolize subsequently. In this case, surgical or percutaneous removal of the device may be indicated. Depending on the patient's status, implanting another device can be an alternative to returning to anticoagulation.

Official Title
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Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes

Conditions
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Device Embolisation, Left Atrial Appendage Occluder, Therapy Strategies, Risk Factors

Intervention / Treatment
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* Procedure: Removal or leaving of LAA occluders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after interventional or surgical left atrial appendage occlusion with device embolization Exclusion Criteria: n/a

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients experiencing device embolization after left atrial appendage occlusion<br>Device embolization following either surgical or interventional left atrial appendage occlusion | Procedure: Removal or leaving of LAA occluders<br>* After LAA device embolization there are different approaches to dealing with the occluder dislocation. The aim is to find out which way leads to the best outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural mortality | all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if>30days) | In-hospital stay, assessed up to 30 days | 
| Need for cardiac surgery |  | In-hospital stay, assessed up to 30 days | 
| Catheter-based retrieval of LAA Occluder | peri-procedural device removal | up to 5 years (after device implantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further complications | Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.) | up to 5 years (after device implantation) | 
| Risk factors | Favoring conditions for LAAO device dislocation (e.g., anatomical risk factors, risk factors related to the initial procedure) | up to 30 days (after device implantation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left atrial appendage occluder, device embolization, therapy strategy, risk factors