Anteris Technologies has announced that the DurAVR transcatheter heart valve (THV) was used for the first time in a valve-in-valve (ViV) procedure as part of Health Canada’s Special Access Program (SAP).
DurAVR is a balloon-expandable, single-piece transcatheter aortic valve shaped to mimic the performance of a native human aortic valve.
A ViV procedure is required for patients in whom a bioprosthetic aortic valve is failing due to calcification or structural deterioration, and a new heart valve must be implanted inside the failing valve. Canada’s SAP exists so that life-saving technology not currently available for commercial use in Canada can be provided when no other commercially available alternatives are suitable.
Anita Asgar, co-director of the Structural Heart Program at the Institut de Cardiologie de Montreal (Montreal, Canada), made the request to Health Canada to use the DurAVR THV in a patient with a failing valve that needed optimal haemodynamic results as well as a short frame height as they were very high risk of poor haemodynamic result with a conventional ViV procedure.
Asgar performed the procedure on an 84-year-old male and implanted a DurAVR THV inside the failed surgical aortic valve replacement (SAVR).
The patient had an 88% reduction in mean gradient which brought the patient back to a near-normal physiologic state, with a final gradient of only 6mmHg after deploying the valve. These results mirror what DurAVR THV has seen in its extensive ViV bench-top studies.
Asgar commented: “The DurAVR THV provided a life-saving solution for a patient requiring a new valve to be implanted without compromising haemodynamic performance or future coronary access. These haemodynamic results are not seen with currently available products, which is important as there is a large need for a valve that can offer optimal haemodynamic performance in the valve-in-valve setting, particularly with a shorter frame height. Additionally, despite this being an incredibly complex case, using Anteris’ ComASUR delivery system and deploying the valve was remarkably easy. The unique design of DurAVR, including the low frame height and the single-piece design, makes the valve well-suited to address the needs of valve-in-valve patients.”
Chris Meduri, Anteris Technologies CMO, commented: “This successful procedure further validates our extensive pre-clinical work in valve-in-valve as well as our extensive clinical experience in native aortic stenosis. This signals the viability of a purpose-built valve designed to achieve life-saving outcomes in a patient population currently treated with tradeoffs in mind. Eliminating that compromise would be widely beneficial to a rapidly growing population of patients whose current valve is failing.”