Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance

Study Overview
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Brief Summary
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Left atrial appendage occlusion is being widely recommended as a treatment strategy for patients with nonvalvular AF to prevent stroke, especially those who cannot tolerate long-term oral anticoagulation or have other reasons for nonpharmacologic therapy. Currently, there are a number of guidance for left atrial appendage occlusion, such as transesophageal echocardiography, intracardiac echocardiogram, fluoroscopy, computed tomographic/computed tomographic angiography and so on. Procedures such as atrial septal puncture, device size selection and operational view are guided by different methods in various centers. Our center has developed a new approach to guidance: Cone-beam CT and cardiac computed tomographic angiography were combined by three-dimensional - three-dimensional image fusion in guiding left atrial appendage occlusion.

Detailed Description
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Eligible NVAF patients were recruited consecutively and received our LAAO workflow of local anesthesia, intracardiac echocardiography-guided transseptal puncture, and 3DCTA-3DCBCTF fusion-guided occluder implantation. The primary outcome was optimal occluder implantation (successful implantation with no occluder recapture and replacement). Other outcomes were procedure/fluoroscopic time, contrast agent consumption, radiation dose, and peri-procedure complications. We compared our results with existing publications of LAAO guided by 3DCTA and two-dimensional fluoroscopy (3DCTA-2DF) fusion images.

Official Title
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Combination of Cone Beam Computed Tomography and Cardiac Computed Tomography Angiography: Left Atrial Appendage Occlusion Under Three-dimensional Computed Tomography Fusion Image Guidance

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Procedure: cone-beam computed tomography fusion image


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An age of >18 years; A CHA2DS2-VASc score of ≥2; Clinical conditions allowing TEE and sedation; Left ventricular ejection fraction >30%; And at least one of the following indications: (a) HAS-BLED score of ≥3; (b) intolerance to long-term OAC, and (c) stroke, transient ischemic attack, or thromboembolism even under oral anticoagulation treatment; Exclusion Criteria: A glomerular filtration rate of <50 mL/min/1.73 m2; The presence of a thrombus in the LA and LAA; Acute myocardial infarction or unstable angina, decompensated heart failure (New York Heart Association functional class III-IV), or heart transplantation; Stroke or transient ischemic attack within 30 days; Very poor peripheral vessel access not allowing device delivery; Moderate or massive pericardial effusion.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBCT guidance group<br>Left atrial appendage occlusion under cone-beam computed tomography fusion image guidance | Procedure: cone-beam computed tomography fusion image<br>* Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of success at first device selected | successful occluder deployment and release with no being resized | In surgery |