Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Study Overview
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Brief Summary
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The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation; the determinants of postoperative ascending aortic dilatation.

Detailed Description
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Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.

Official Title
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Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Conditions
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Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve

Intervention / Treatment
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* Procedure: Transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less; Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more; High risk of surgical aortic valve replacement; Suitability for a transfemoral vascular access. Exclusion Criteria: Dominant aortic regurgitation; History of surgical or transcatheter aortic valve replacement; History of aortic surgery; Connective tissue disorders.
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 |
| --- | --- |
| Transfemoral TAVR for AS<br>Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis | Procedure: Transcatheter aortic valve replacement<br>* All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascending aortic dilatation rate | The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period. | 1-year and 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality during the follow-up period | 1-year and 2-year | 
| Adverse aortic events | Aortic dissection, aortic rupture, and sudden death not attributable to other causes. | 1-year and 2-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve replacement, Ascending aortic diameter, Ascending aortic dilatation, Bicuspid aortic valve