Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David

Study Overview
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Brief Summary
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Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six centers (Nantes - Rennes - Brest - Angers - Tours [two centers]). The main objective of this study is to evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI).

Detailed Description
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Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David. Inclusion criteria: Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at one of the six centers: Nantes, Rennes, Brest, Angers, Tours (two centers). Non-inclusion criteria: Prosthetic replacement of the aortic valve intraoperatively during the first operation. Objectives and endpoints : The survival without re-intervention for aortic valve dysfunction (surgery or TAVI) The overall cardiovascular survival The survival without aortic insufficiency of grade equal to or greater than two The survival without aortic infective endocarditis Assessment of long-term stroke risk Assessment of the risk of a major bleeding event in the long term Data analysis : The AORTLANTIC study is included in the EPICARD registry which is the official, national database of the French Society of Cardiac Surgery. Study data will then be collected using EPICARD's electronic Case Report Form (eCRF) and then analyzed using a multivariate Cox model. For the follow-up, the WEPI eCRF is used.

Official Title
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Regional, Multicentric Registry of Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David

Conditions
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Aortic Root Aneurysm, Aortic Regurgitation

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at one of the six centers: Nantes, Rennes, Brest, Angers,Tours UH. Non inclusion criteria : Prosthetic replacement of the aortic valve intraoperatively during the first operation.
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 |
| --- | --- |
| AORTLANTIC registry<br>Patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at five centers (Nantes - Rennes - Brest - Angers - Tours University Hospital (UH)) | Other: No intervention<br>* There is no intervention in this retrospective study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI), after aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David | Number of patients alive without re-intervention for aortic valve dysfunction (surgery or TAVI) | Conditional survival starting at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the overall cardiovascular survival results | Number of patients alive | up to 17 months | 
| Evaluate the absence of aortic insufficiency greater than or equal to grade two between the two types of aortic tube graft (right prosthesis or Valsalva prosthesis) | Number of patients alive without aortic insufficiency of grade equal to or greater than two | up to 17 months | 
| Evaluate the risk of infective endocarditis | Number of patients alive without aortic infective endocarditis | up to 17 months | 
| Evaluate the risk of stroke | Number of patients alive without stroke | up to 17 months | 
| Evaluate the risk of major bleeding event | Number of patients alive major bleeding event | up to 17 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valve-sparing aortic root replacement, David procedure, Acute aortic dissection, Aortic Regurgitation, Bicuspid aortic valve, French multicentric registry