4.4 Article

Performance of high conformability vs. high radial force devices in the virtual treatment of TAVI patients with bicuspid aortic valve

Journal

MEDICAL ENGINEERING & PHYSICS
Volume 89, Issue -, Pages 42-50

Publisher

ELSEVIER SCI LTD
DOI: 10.1016/j.medengphy.2021.02.004

Keywords

Transcatheter aortic valve implantation; Self-expandable devices; Patient-specific modeling; Finite element analysis; Bicuspid aortic valve; Paravalvular leakage

Funding

  1. IRCCS Policlinico San Donato, San Donato Milanese, Italy
  2. 5x1000 grant from IRCCS Policlinico San Donato, San Donato Milanese, Italy
  3. Programma Operativo Por FSE Regione Liguria 2014-2020 [RLOF18ASSRIC/38/1]

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This study compared the performance of devices featuring high conformability (HC) against those with high radial force (HRF) in TAVI procedures for patients with bicuspid aortic valve (BAV). The results showed that HRF devices had better outcomes in BAV anatomies, particularly in reducing paravalvular area and increasing stent-root contact area.
Objective: Transcatheter Aortic Valve Implantation (TAVI) is a consolidated procedure showing a low operative risk and excellent long-term outcomes in patients with aortic stenosis. Patients presenting a bicuspid aortic valve (BAV) often require valve replacement due to the highly calcific nature of the aortic leaflets. However, BAV patients have usually been contraindicated for TAVI due to their complex valve anatomy. The aim of this work was to compare the performance of devices featuring high conformability (HC) against those with high radial force (HRF). Methods: Four BAV patients undergoing TAVI were retrospectively selected. The aortic roots including the native leaflets and calcifications were reconstructed from pre-operative Computed Tomography scans. In each patient, both HC and HRF devices were virtually implanted using Finite Element Analysis simulations. After implantation, paravalvular orifice area, von Mises stress distribution, root contact area, and device eccentricity were calculated. Results: Simulations showed good agreement with intraoperative imaging. In 3 out of 4 patients, the HRF device resulted in a lower paravalvular area than the HC. Stress distribution was also more homogeneously distributed in the HRF group as compared with the HC group. Despite their lower adaptability, HRF devices showed consistently higher stent-root contact area. Conclusion: HRF devices showed improved results with respect to HC valves after being deployed in BAV anatomies. We hypothesize that the ability to reshape the annulus is the major determinant of success in this subgroup of patients featuring highly calcified leaflets. (C) 2021 IPEM. Published by Elsevier Ltd. All rights reserved.

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