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

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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Regurgitation; Aortic Root Aneurysm
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 529

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 UH) .

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AORTLANTIC registry; 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; There is no intervention in this retrospective study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Jean Christian ROUSSEL, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Bicuspid aortic valve; Aortic Regurgitation; Valve-sparing aortic root replacement; David procedure; Acute aortic dissection; French multicentric registry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Diseases; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Valve Insufficiency; Aneurysm; Aortic Root Aneurysm
• Other Study ID Numbers: RC21_0540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No