Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of the CONTOUR Trial

Area of Science:

• Cardiovascular Surgery
• Medical Devices
• Clinical Trials

Background:

• Aortic valve repair is underutilized in young patients with bicuspid aortic valve (BAV) and aortic regurgitation (AR).
• Lack of standardization in current repair techniques leads to high rates of AR recurrence and reoperation.
• Stabilizing the BAV annulus is a critical, controversial aspect of aortic valve repair.

Purpose of the Study:

• To compare the effectiveness of two aortic valve annuloplasty concepts in BAV patients with AR.
• To assess the ability of internal vs. external annuloplasty to create symmetric BAV geometry post-repair.
• To evaluate the impact of different annuloplasty techniques on AR recurrence and reoperation rates.

Main Methods:

• The CONTOUR trial is a multicenter randomized controlled trial (RCT) involving 100 BAV AR patients.
• Patients are randomized to receive either internal HAART 200 annuloplasty or external Extra Aortic ring annuloplasty.
• 4D flow MRI will assess hemodynamic profiles and regurgitation fraction at baseline, discharge, and 1-year follow-up.

Main Results:

• The CONTOUR trial is the first RCT to directly compare two distinct annuloplasty techniques for BAV repair.
• The study aims to determine which technique is more effective in achieving symmetric BAV geometry and superior repair outcomes.
• Primary endpoints include postoperative reduction in flow eccentricity and 1-year regurgitation fraction.

Conclusions:

• Study findings are anticipated to significantly impact aortic valve repair practices for BAV patients with AR.
• Results are expected to contribute to refining guideline recommendations for managing BAV-associated AR.
• The trial seeks to establish a more standardized and effective approach to aortic valve repair.