Circle Method Observational Project - Non-interventional, Retrospective, Multicenter International Data Collection

Study Overview
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Brief Summary
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The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI). The main aims are: to assess whether patients with bicuspid aortic valves that received a TAVI suffered from fewer complications if valve size was identical to the one determined using the circle method compared to a case where circle method derived valve size is different from the actually implanted valve to develop recommendations on how to size the valve using the circle method.

Detailed Description
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The bicuspid aortic valve (BAV) is the most common heart valve abnormality and is associated with a number of cardiac complications, including infective endocarditis, aortic dissection, aortic dilatation, and the development of severe aortic stenosis (AS). Due to its anatomical characteristics BAV has been considered a contraindication to transcatheter aortic valve implantation (TAVI), a standard treatment of AS. However, several recent trials have presented promising results indicating TAVI to be a safe alternative to surgery for low risk patients and more patients with BAV have been considered for TAVI. There are several sizing techniques for TAVI in BAV, including an annular sizing, a supra-annular sizing, and a balloon sizing, yet there is still no consensus on the most appropriate technique. Although annular sizing remains the major approach in most patients with BAV, some BAV anatomies may profit from the supra-annular sizing. Recently published consensus for sizing and positioning the balloon-expandable Edwards SAPIEN 3 transcatheter heart valve (THV) in BAV describes the anatomical features that influence sizing optimization. The novel circle technique has also been proposed in the presence of the unique anatomical factors and sizing at the supra-annular level. This method is particularly helpful for visually identifying anatomic features, indicating the sealing zone at the commissures, visually reassuring of the size and position, and treating patients with large annuli. Currently, there are limited data validating the circle method for identifying sizing and positioning for TAVI in BAV patients. In this non-interventional, retrospective, multicenter international data collection and analysis we aim to validate the circle method for sizing and positioning in bicuspid aortic valves. Due to the non-interventional character of the project, no additional burden will be put on the patients eligible for inclusion.

Official Title
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Circle Method Observational Project - Non-interventional, Retrospective, Multicenter International Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves

Conditions
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Aortic Stenosis With Bicuspid Valve

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra) Computed Tomography data available Exclusion Criteria: - none

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | To assess whether patients with bicuspid aortic valves that received a SAPIEN 3 / Ultra THV suffered from fewer complications if valve size was identical to the one determined using the circle method compared to a case where circle method derived valve size is different from the actually implanted valve | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sizing with Circle Method | To develop recommendations on how to size the valve using the circle method. | 12 months |