DurAVR Biomimetic Transcatheter Heart Valve: Update from the First-in-Human and US Early Feasibility Studies

Background The Anteris DurAVR THV system is a first-in-class biomimetic TAVR with differentiating design features: single-piece leaflet geometry for optimal haemodynamics; ADAPT anti-calcification process to reduce bioprosthetic SVD; balloon-expandable platform with large open-cell geometry for coronary access. Methods Prospective, non-randomised, single-arm studies to evaluate safety and feasibility of DurAVR THV in subjects with severe AS. Clinical, echo, CT, and cardiac MRI (CMR) assessments will be performed up to 1 (FIH) and 10 years (EFS). Results Twenty-eight subjects were enrolled in FIH, and fifteen in EFS. Mean age 74±6 years and 81±7 years, and mean annulus diameter 22.6±1.3mm and 22.2±0.8mm, respectively. DurAVR was successfully implanted in 100% of the cases. No device-related complications, strokes, or reoperations occurred. One FIH subject died of a car accident (non-cardiac death), and, overall, 3 were implanted with a pacemaker (all had pre-existing conduction abnormalities). 30-day TTE showed excellent haemodynamics despite small aortic annuli: in FIH study, mean EOA was 2.1cm2, MPG 7.9mmHg and DVI 0.57. In EFS mean EOA=2.2cm2, MPG=7.5mmHg and DVI=0.64. The 1-year TTE completed for the first 12 subjects in FIH confirmed sustained haemodynamics with EOA=2.0cm2, MPG=9.2mmHg, DVI=0.55. No cases of moderate or severe PVL or prosthesis-patient mismatch were observed in either study. CMR performed in 5 FIH subjects confirmed consistent laminar flow similar to a matched healthy subject group. Conclusions Results from the DurAVR FIH study provide at 1 year encouraging echo and MRI evidence of improved haemodynamics and normalised flow. Results of the early feasibility study will provide further evidence of the benefits of this novel THV platform.