DurAVR - a novel biomimetic balloon-expandable transcatheter valve for TAVI, valve-in-valve TAVI and redo-TAVI.

Abstract

Background: The DurAVR transcatheter heart valve (THV) is a novel biomimetic balloon-expandable valve with promising early clinical results.

Aims: We aimed to assess the hydrodynamic performance of the DurAVR THV in native, valve-in-valve (ViV), and redo-transcatheter aortic valve implantation (TAVI) procedures against commercially available THVs on the bench.

Methods: The hydrodynamic function of the DurAVR THV was assessed by simulating native valve deployments at 0 mm, 3 mm, and 6 mm depths, compared to SAPIEN 3 (S3), Evolut PRO, Navitor, and ACURATE neo2 (ACn2) valves. For ViV simulations, THVs were implanted in 21 mm and 23 mm Magna Ease, Mosaic, and Hancock bioprostheses. For redo-TAVI simulations, the DurAVR THV was assessed within S3, Evolut PRO, Navitor, and ACn2 valves.

Results: For native TAVI simulations, the DurAVR THV demonstrated superior or comparable hydrodynamic performance, independent of implant depth, with an effective orifice area (EOA) ≥3 cm² and a mean gradient (MG) <6 mmHg. The DurAVR THV had nil to mild pinwheeling (0-2%) at all depths, while the S3 and Evolut PRO showed moderate pinwheeling at 6 mm depth. For ViV simulations, the DurAVR THV exhibited larger EOAs and lower MGs than the comparator THVs and showed no more than mild pinwheeling in all ViV configurations. For redo-TAVI simulations, the DurAVR THV exhibited larger EOAs and lower MGs in each simulation compared to all other THVs tested, with no more than mild pinwheeling observed in all configurations except when implanted within the Evolut PRO.

Conclusions: In this bench study, the DurAVR THV demonstrated excellent hydrodynamic performance in native, ViV, and redo-TAVI simulations. Future large-scale studies are needed to confirm these findings in clinical application and further characterise the valve's short- and long-term performance.