E-25 | DurAVR biomimetic transcatheter heart valve: Early Feasibility Study 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; intra-annular balloon-expandable platform with large open-cell geometry for coronary access. Prospective, non-randomized, single-arm, multi-center, early feasibility study (EFS) designed to evaluate the safety and feasibility of DurAVR THV in patients with severe symptomatic AS. Clinical, echo, CT, and cardiac MRI (CMR) assessments will be performed up to 10 years and independently analyzed by core labs. Fifteen (15) patients presenting the following baseline characteristics were enrolled: mean age 81±7 years, 67% female, mean STS 5.8±4.8 %, NYHA class II 53%, NYHA class III 47%, and mean CT annulus diameter 22.2±0.8 mm. DurAVR THV was successfully implanted in 100% of the cases. 30-day transthoracic echo (TTE) showed excellent hemodynamic results, despite small aortic annuli: effective orifice area (EOA) was 2.2±0.5 cm2, mean pressure gradient (MPG) 7.8±2.0 mmHg, and dimensionless index 0.63±0.1. DurAVR showed a favorable safety profile in all subjects at 30 days. No device-related complications, strokes, bleeding, or reoperations occurred. One subject with pre-existing conduction abnormalities was implanted with a pacemaker. There was no moderate or severe PVL and no cases of moderate or severe prosthesis-patient mismatch were observed in the study. This is the first-time treatment with the DurAVR biomimetic THV of severe AS patients in the US. Results of this early feasibility study provide further evidence of the benefits of this novel THV platform with outstanding hemodynamic performance.