OR7-3 | DurAVR biomimetic transcatheter heart valve: first-in-human study results update

The Anteris DurAVR transcatheter heart valve (THV) system (Anteris Technologies, Minneapolis, USA) is a first-in-class biomimetic THV with differentiating design features: single-piece leaflet geometry for optimal hemodynamics and flow characteristics; ADAPT anti-calcification process to reduce bioprosthetic SVD; balloon-expandable platform with large open-cell geometry for coronary access. Prospective, non-randomized, single-arm, single-center, First-in-Human (FIH) study, designed to evaluate safety and feasibility in patients with severe symptomatic AS. Clinical, echo, CT, and Cardiac MRI assessments were performed up to 1 year. Twenty-eight (28) patients were enrolled. Baseline characteristics: mean age 73.68±6.21 years, 75% female, mean STS 2.73±1.76%, NYHA class II 64% and III 36%, and mean CT annulus diameter 22.61±1.27 mm. DurAVR THV was successfully implanted in 100% of the cases. Mean leaflet coaptation length was 8.3 mm at TEE. All patients showed excellent post-procedural hemodynamic results, in spite of a mean annulus diameter of 22.6 mm: effective orifice area (EOA) of 2.17±0.22 cm2, mean pressure gradient (MPG) of 8.34±1.87 mmHg, and dimensionless index (DI) of 0.61±0.07. No moderate or severe paravalvular leak (PVL) or central aortic regurgitation were observed. The 1-year TTE completed for the first 12 patients confirmed sustained hemodynamics with EOA=1.98±0.15 cm2 and MPG=9.22±3.01 mmHg. Additionally, laminar flow was consistently displayed on TEE and TTE. DurAVR showed a favorable safety profile in all patients at the latest follow-up. No valve-related complications, no strokes, no bleeding, and no reoperations occurred. One patient died of a car accident (non-cardiac death) on post-operative day (POD) 343, three had access site complications (resolved), and one with pre-existing conduction disturbances was implanted with a pacemaker on POD 6. No cases of moderate or severe prosthesis-patient mismatch were observed. The DurAVR THV FIH study provides at 1 year encouraging evidence of improved hemodynamics and normalized flow characteristics associated with its unique single-piece leaflet design. Additional studies are warranted.