LB-10 | Update from the First-in-human Study with the Novel DurAVR Biomimetic Transcatheter Heart Valve

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 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 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, despite a small mean annulus size: 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 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, strokes, bleeding, or reoperations occurred. One patient died of a car accident (non-cardiac death) on post-operative day (POD) 343, three had access site complications, and a pacemaker was implanted in a patient with pre-existing conduction disturbances. No cases of moderate or severe prosthesis-patient mismatch were observed. Additional Late-Breaking Science data is expected to be presented at SCAI 2024. 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.