A Novel Transcatheter Device to Treat Calcific Aortic Valve Stenosis: An Ex Vivo Study

• DOI: 10.1007/s13239-025-00774-1
• Publication Date: 2025-02-05T20:52:12Z
• Authors: Francesca Perico; Eleonora Salurso; Fabio Pappalardo; Michal Jaworek; Enrico Fermi; Maria Chiara Palm...; Flavius Constanti...; Riccardo Vismara; Marco Vola
• Keywords: Ex vivo; Pulsatile flow; Valve replacement

Abstract Purpose Aortic valve stenosis (AVS) is the most common valvular disease in developed countries. Surgical or transcatheter bioprosthetic aortic (AV) replacement standard treatment for severe AVS. However, bioprostheses are prone to structural degeneration. Hence, terms of lifetime management, there a need therapies that can postpone AV replacement. With aim fragmenting calcifications and restoring leaflets flexibility, new debridement device (TDD) exploiting ultrasound under development. We performed an ex-vivo study on human hearts quantify how TDD affects stenotic AVs hemodynamic. Additionally, qualitative histological analysis was assess TDD’s impact leaflets. Methods Three affected by AVS were characterized pre- post-treatment beating heart simulator. To replicate physiological flowrates, pulsatile pump connected left ventricle, while systemic impedance simulator root reservoir atrium closed hydraulic circuit. Transvalvular pressure drop (ΔPsys), backflow volume, effective orifice area (EOA) evaluated. For analysis, sections stained with Haematoxylin/Eosin AlizarineRedS highlight calcifications. Results The induced reduction ΔPsys all tested samples, improving EOA, but caused increase volume. Moreover, histology suggested integrity. Conclusions procedure improved fluid-dynamics during systole without evidence damage tissues. This suggests could be promising option patients