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Feasibility of large-scale in silico transcatheter aortic valve implantation trials using a fast-to-evaluate model.

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Τίτλος: Feasibility of large-scale in silico transcatheter aortic valve implantation trials using a fast-to-evaluate model.
Συγγραφείς: Verstraeten S; Biomedical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands. sverstraeten06@gmail.com., van Driel M; Biomedical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands.; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands., Willems R; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands., Divi S; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands., Hoeijmakers M; Synopsys Inc, High Tech Campus 41, 5656 AE, Eindhoven, The Netherlands., van de Vosse F; Biomedical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands., Verhoosel C; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands., Huberts W; Biomedical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands.; Computational Science Lab, Faculty of Science, Informatics Institute, University of Amsterdam, Science Park 900, 1098 XH, Amsterdam, The Netherlands.
Πηγή: Biomechanics and modeling in mechanobiology [Biomech Model Mechanobiol] 2026 Sep 25; Vol. 25 (5). Date of Electronic Publication: 2026 Sep 25.
Τύπος έκδοσης: Journal Article
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Springer Country of Publication: Germany NLM ID: 101135325 Publication Model: Electronic Cited Medium: Internet ISSN: 1617-7940 (Electronic) Linking ISSN: 16177940 NLM ISO Abbreviation: Biomech Model Mechanobiol Subsets: MEDLINE
Imprint Name(s): Original Publication: Berlin ; New York : Springer, c2002-
Ιατρικοί όροι (MeSH): Aortic Valve*/surgery , Transcatheter Aortic Valve Replacement* , Computer Simulation* , Clinical Trials as Topic* , Models, Cardiovascular*, Aortic Valve Stenosis/surgery ; Humans ; Feasibility Studies ; Female
Περίληψη: Although transcatheter aortic valve implantation (TAVI) has been demonstrated to be a successful treatment for aortic stenosis, it remains associated with complications, such as paravalvular leakage (PVL). To address these, TAVI devices continue to undergo iterative development. Integration of in silico trials into the regulatory validation pathway offers a promising approach to accelerate the development and clinical implementation of novel TAVI devices. This study addresses the feasibility of conducting large-scale in silico TAVI trials using a virtual cohort generator (VCG) combined with a fast-to-evaluate model. The objective is to investigate anatomical and procedural predictors of PVL in silico, as was done in an earlier clinical study. A virtual cohort of 500 synthetic aortic stenosis patients was generated, that matched anatomical and demographic characteristics of the clinical population. Using a novel fast-to-evaluate TAVI deployment model, nearly 29,000 simulations were performed across multiple model parameter combinations per patient. Shape and demographic distributions in the in silico trial, remained within the bounds of the clinical study. Among the investigated anatomical parameters, a higher angle between left ventricular outflow tract and ascending aorta was found in patients with significant PLV, in both clinical and virtual cohorts. Additionally, the relationship between PVL and implantation depth appeared highly patient-specific, which is in line with findings in clinical studies. The ability to systematically test multiple TAVI deployments scenarios per patient, which is unfeasible in clinical practice, provides valuable insights for procedure design and optimisation. Overall, the results support the feasibility of implementing large-scale in silico TAVI trials, using the VCG and a fast-to-evaluate model, into the regulatory validation chain.
(© 2026. The Author(s).)
Competing Interests: Declarations. Conflict of interest: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Ethical approval: The geometrical data used in this study were collected by the Institute of Computer-assisted Cardiovascular Medicine, Charité Universitaetsmedizin Berlin, in the scope of the H2020 project SIMCor. Data were collected during clinical routine. The collection of informed consent was waived by the institutional review board which approved the study. The pressure signal data used in this study were collected in Catharina Hospital, Eindhoven between February and October 2016. All subjects gave written informed consent as approved by the medical ethics committee of the hospital.
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Grant Information: 101017578 Horizon 2020 Framework Programme
Contributed Indexing: Keywords: Fast-to-evaluate models; In silico trials; Paravalvular leakage; Transcatheter aortic valve implantation
Entry Date(s): Date Created: 20260925 Date Completed: 20260925 Latest Revision: 20260925
Update Code: 20260926
DOI: 10.1007/s10237-026-02136-9
PMID: 42791401
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1617-7940
DOI:10.1007/s10237-026-02136-9