Grant: Project Grant

Bicuspid aortic valve (BAV) is the most frequent congenital heart condition characterized by the presence of two, rather than three cusps in the aortic valve. The condition can lead to various complications, including aortic stenosis (narrowing of the valve opening) and aortic regurgitation (leaking of the valve), requiring aortic valve intervention. This intervention is generally performed using open heart surgery (surgical aortic valve replacement; SAVR). However, transcatheter aortic valve replacement (TAVR) has emerged and provides a much less invasive alternative. Despite TAVR procedure being approved for replacement of both tricuspid (normal) aortic valves and BAVs, the clinical trials conducted so far have generally excluded patients with BAV. The BELIEVERS randomized trial will thus compare TAVR vs. SAVR in BAV patients with regards to mortality, stroke, rehospitalization and valve reintervention at 3 years. In this grant application, we propose: i) to add a Canadian cohort of patients to this international trial and ii) to take the opportunity of the BELIEVERS trial to conduct an imaging (echocardiography) substudy to compare TAVR vs. SAVR with regards to the risk of valve dysfunction (residual valve stenosis, regurgitation, thrombosis) and durability. The echocardiograms will be performed by the participating sites annually until 10 years post procedure and will be analyzed centrally in an echocardiography core laboratory based at the Québec Heart & Lung Institute. The BELIEVERS trial and the imaging substudy that we propose are the first to determine whether there is a difference between the 2 main types of aortic valve replacement used nowadays, in terms of prosthetic valve function and durability, and clinical outcomes. If this study demonstrates that TAVR is at least as good as SAVR, this will have major implications for the management of BAV disease and will validate TAVR as a valuable option for the treatment of people with BAV.