Validation evidence with experimental and clinical data to establish credibility of TAVI patient-specific simulations

• Published in: Computers in biology and medicine 2024-11, Vol.182, p.109159, Article 109159
• Main Authors: Grossi, Benedetta, Barati, Sara, Ramella, Anna, Migliavacca, Francesco, Rodriguez Matas, Jose Felix, Dubini, Gabriele, Chakfé, Nabil, Heim, Frédéric, Cozzi, Ottavia, Condorelli, Gianluigi, Stefanini, Giulio G., Luraghi, Giulia
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aorta; Aortic stenosis; Aortic valve; Aortic Valve - diagnostic imaging; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Computed tomography; Coronary vessels; Female; Finite Element Analysis; Finite element method; Folding; Heart Valve Prosthesis; Heart valves; Humans; Implantation; Implants; Male; Material properties; Mathematical models; Mechanical properties; Medical equipment; Medical imaging; Models, Cardiovascular; Nickel titanides; Orifices; Patient-specific simulations; Patients; Prediction models; Prostheses; Qualitative analysis; Reliability; Sensitivity analysis; Simulation; Software; Stents; Surgical implants; TAVI; Tomography, X-Ray Computed; Transcatheter Aortic Valve Replacement - methods; Validation; Workflow
• ISSN: 0010-4825; 1879-0534; 1879-0534
• DOI: 10.1016/j.compbiomed.2024.109159

The objective of this study is to validate a novel workflow for implementing patient-specific finite element (FE) simulations to virtually replicate the Transcatheter Aortic Valve Implantation (TAVI) procedure. Seven patients undergoing TAVI were enrolled. Patient-specific anatomical models were reconstructed from pre-operative computed tomography (CT) scans and subsequentially discretized, considering the native aortic leaflets and calcifications. Moreover, high-fidelity models of CoreValve Evolut R and Acurate Neo2 valves were built. To determine the most suitable material properties for the two stents, an accurate calibration process was undertaken. This involved conducting crimping simulations and fine-tuning Nitinol parameters to fit experimental force-diameter curves. Subsequently, FE simulations of TAVI procedures were conducted. To validate the reliability of the implemented implantation simulations, qualitative and quantitative comparisons with post-operative clinical data, such as angiographies and CT scans, were performed. For both devices, the simulation curves closely matched the experimental data, indicating successful validation of the valves mechanical behaviour. An accurate qualitative superimposition with both angiographies and CTs was evident, proving the reliability of the simulated implantation. Furthermore, a mean percentage difference of 1,79 ± 0,93 % and 3,67 ± 2,73 % between the simulated and segmented final configurations of the stents was calculated in terms of orifice area and eccentricity, respectively. This study shows the successful validation of TAVI simulations in patient-specific anatomies, offering a valuable tool to optimize patients care through personalized pre-operative planning. A systematic approach for the validation is presented, laying the groundwork for enhanced predictive modeling in clinical practice. •A comprehensive workflow for validating TAVI simulations is presented.•Prosthetic valve models were successfully calibrated using experimental data.•FE simulations accurately replicated TAVI deployment in patient-specific anatomies.•Integrating various data sources enhances the credibility of the proof of concept.•TAVI patient-specific simulations could evolve into full-fledged digital twins.