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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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Title: Feasibility of large-scale in silico transcatheter aortic valve implantation trials using a fast-to-evaluate model.
Authors: 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.
Source: Biomechanics and modeling in mechanobiology [Biomech Model Mechanobiol] 2026 Sep 25; Vol. 25 (5). Date of Electronic Publication: 2026 Sep 25.
Publication Type: Journal Article
Language: English
Journal Info: 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-
MeSH Terms: Aortic Valve*/surgery , Transcatheter Aortic Valve Replacement* , Computer Simulation* , Clinical Trials as Topic* , Models, Cardiovascular*, Aortic Valve Stenosis/surgery ; Humans ; Feasibility Studies ; Female
Abstract: 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.
References: JACC Cardiovasc Interv. 2016 Mar 14;9(5):508-12. (PMID: 26965945)
J Biomech Eng. 2018 Oct 1;140(10):. (PMID: 30029247)
J Am Coll Cardiol. 2018 Apr 10;71(14):1513-1524. (PMID: 29622157)
Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. (PMID: 21793168)
Med Eng Phys. 2017 Sep;47:2-12. (PMID: 28728867)
Int J Numer Method Biomed Eng. 2024 Jan;40(1):e3778. (PMID: 37961993)
JACC Cardiovasc Interv. 2020 Mar 23;13(6):709-722. (PMID: 32192691)
Biomech Model Mechanobiol. 2024 Jun;23(3):959-985. (PMID: 38341820)
BMC Cardiovasc Disord. 2024 Jun 21;24(1):314. (PMID: 38907344)
Catheter Cardiovasc Interv. 2017 Oct 1;90(4):690-700. (PMID: 28471092)
JACC Cardiovasc Interv. 2016 Feb 8;9(3):255-258. (PMID: 26847117)
Med Biol Eng Comput. 2019 Oct;57(10):2129-2143. (PMID: 31372826)
Arch Cardiovasc Dis. 2012 Mar;105(3):165-73. (PMID: 22520800)
Open Heart. 2023 Feb;10(1):. (PMID: 36750275)
Eur Heart J Digit Health. 2026 Feb 03;7(2):ztag020. (PMID: 41716933)
J Cardiovasc Magn Reson. 2015 May 08;17:32. (PMID: 25953135)
Biomech Model Mechanobiol. 2019 Apr;18(2):435-451. (PMID: 30460623)
Proc Inst Mech Eng H. 2017 May;231(5):455-466. (PMID: 28427321)
Int J Cardiovasc Imaging. 2021 Oct;37(10):3081-3092. (PMID: 33988801)
Eur Heart J. 2018 Jul 21;39(28):2646-2655. (PMID: 29617762)
Front Med (Lausanne). 2018 Sep 25;5:241. (PMID: 30356350)
Cardiovasc Eng Technol. 2019 Sep;10(3):437-455. (PMID: 31309527)
Heart Vessels. 2022 Jun;37(6):1055-1065. (PMID: 34993586)
J Am Coll Cardiol. 2013 Apr 16;61(15):1585-95. (PMID: 23500308)
JACC Cardiovasc Imaging. 2015 Mar;8(3):340-360. (PMID: 25772838)
Biomech Model Mechanobiol. 2015 Jan;14(1):29-38. (PMID: 24736808)
Ann Vasc Surg. 2019 May;57:22-28. (PMID: 30710630)
Comput Biol Med. 2024 Nov;182:109159. (PMID: 39303394)
J Biomech. 2017 Feb 28;53:15-21. (PMID: 28139202)
EuroIntervention. 2012 Sep;8 Suppl Q:Q94-6. (PMID: 22995121)
Int J Numer Method Biomed Eng. 2012 Jun-Jul;28(6-7):626-41. (PMID: 25364842)
Circulation. 2013 Jan 22;127(3):397-407. (PMID: 23339094)
Eur Heart J. 2018 Jul 21;39(28):2625-2634. (PMID: 29718148)
J Interv Cardiol. 2020 May 22;2020:8249497. (PMID: 32523474)
J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. (PMID: 21050971)
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: 20260928
Update Code: 20260928
PubMed Central ID: PMC13615088
DOI: 10.1007/s10237-026-02136-9
PMID: 42791401
Database: MEDLINE
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  Data: Feasibility of large-scale in silico transcatheter aortic valve implantation trials using a fast-to-evaluate model.
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  Data: <searchLink fieldCode="AU" term="%22Verstraeten+S%22">Verstraeten S</searchLink>; Biomedical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands. sverstraeten06@gmail.com.<br /><searchLink fieldCode="AU" term="%22van+Driel+M%22">van Driel M</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Willems+R%22">Willems R</searchLink>; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Divi+S%22">Divi S</searchLink>; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Hoeijmakers+M%22">Hoeijmakers M</searchLink>; Synopsys Inc, High Tech Campus 41, 5656 AE, Eindhoven, The Netherlands.<br /><searchLink fieldCode="AU" term="%22van+de+Vosse+F%22">van de Vosse F</searchLink>; Biomedical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Verhoosel+C%22">Verhoosel C</searchLink>; Mechanical Engineering, Eindhoven University of Technology, Dominee Theodor Fliednerstraat 2, 5631 BN, Eindhoven, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Huberts+W%22">Huberts W</searchLink>; 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.
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  Data: 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.<br /> (© 2026. The Author(s).)
– Name: Abstract
  Label: Competing Interests
  Group: Ab
  Data: 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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  Label: References
  Group: RefInfo
  Data: JACC Cardiovasc Interv. 2016 Mar 14;9(5):508-12. (PMID: <searchLink fieldCode="PM" term="%2226965945%22">26965945)</searchLink><br />J Biomech Eng. 2018 Oct 1;140(10):. (PMID: <searchLink fieldCode="PM" term="%2230029247%22">30029247)</searchLink><br />J Am Coll Cardiol. 2018 Apr 10;71(14):1513-1524. (PMID: <searchLink fieldCode="PM" term="%2229622157%22">29622157)</searchLink><br />Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. (PMID: <searchLink fieldCode="PM" term="%2221793168%22">21793168)</searchLink><br />Med Eng Phys. 2017 Sep;47:2-12. (PMID: <searchLink fieldCode="PM" term="%2228728867%22">28728867)</searchLink><br />Int J Numer Method Biomed Eng. 2024 Jan;40(1):e3778. (PMID: <searchLink fieldCode="PM" term="%2237961993%22">37961993)</searchLink><br />JACC Cardiovasc Interv. 2020 Mar 23;13(6):709-722. (PMID: <searchLink fieldCode="PM" term="%2232192691%22">32192691)</searchLink><br />Biomech Model Mechanobiol. 2024 Jun;23(3):959-985. (PMID: <searchLink fieldCode="PM" term="%2238341820%22">38341820)</searchLink><br />BMC Cardiovasc Disord. 2024 Jun 21;24(1):314. (PMID: <searchLink fieldCode="PM" term="%2238907344%22">38907344)</searchLink><br />Catheter Cardiovasc Interv. 2017 Oct 1;90(4):690-700. (PMID: <searchLink fieldCode="PM" term="%2228471092%22">28471092)</searchLink><br />JACC Cardiovasc Interv. 2016 Feb 8;9(3):255-258. (PMID: <searchLink fieldCode="PM" term="%2226847117%22">26847117)</searchLink><br />Med Biol Eng Comput. 2019 Oct;57(10):2129-2143. (PMID: <searchLink fieldCode="PM" term="%2231372826%22">31372826)</searchLink><br />Arch Cardiovasc Dis. 2012 Mar;105(3):165-73. (PMID: <searchLink fieldCode="PM" term="%2222520800%22">22520800)</searchLink><br />Open Heart. 2023 Feb;10(1):. (PMID: <searchLink fieldCode="PM" term="%2236750275%22">36750275)</searchLink><br />Eur Heart J Digit Health. 2026 Feb 03;7(2):ztag020. (PMID: <searchLink fieldCode="PM" term="%2241716933%22">41716933)</searchLink><br />J Cardiovasc Magn Reson. 2015 May 08;17:32. (PMID: <searchLink fieldCode="PM" term="%2225953135%22">25953135)</searchLink><br />Biomech Model Mechanobiol. 2019 Apr;18(2):435-451. (PMID: <searchLink fieldCode="PM" term="%2230460623%22">30460623)</searchLink><br />Proc Inst Mech Eng H. 2017 May;231(5):455-466. (PMID: <searchLink fieldCode="PM" term="%2228427321%22">28427321)</searchLink><br />Int J Cardiovasc Imaging. 2021 Oct;37(10):3081-3092. (PMID: <searchLink fieldCode="PM" term="%2233988801%22">33988801)</searchLink><br />Eur Heart J. 2018 Jul 21;39(28):2646-2655. (PMID: <searchLink fieldCode="PM" term="%2229617762%22">29617762)</searchLink><br />Front Med (Lausanne). 2018 Sep 25;5:241. (PMID: <searchLink fieldCode="PM" term="%2230356350%22">30356350)</searchLink><br />Cardiovasc Eng Technol. 2019 Sep;10(3):437-455. (PMID: <searchLink fieldCode="PM" term="%2231309527%22">31309527)</searchLink><br />Heart Vessels. 2022 Jun;37(6):1055-1065. (PMID: <searchLink fieldCode="PM" term="%2234993586%22">34993586)</searchLink><br />J Am Coll Cardiol. 2013 Apr 16;61(15):1585-95. (PMID: <searchLink fieldCode="PM" term="%2223500308%22">23500308)</searchLink><br />JACC Cardiovasc Imaging. 2015 Mar;8(3):340-360. (PMID: <searchLink fieldCode="PM" term="%2225772838%22">25772838)</searchLink><br />Biomech Model Mechanobiol. 2015 Jan;14(1):29-38. (PMID: <searchLink fieldCode="PM" term="%2224736808%22">24736808)</searchLink><br />Ann Vasc Surg. 2019 May;57:22-28. (PMID: <searchLink fieldCode="PM" term="%2230710630%22">30710630)</searchLink><br />Comput Biol Med. 2024 Nov;182:109159. (PMID: <searchLink fieldCode="PM" term="%2239303394%22">39303394)</searchLink><br />J Biomech. 2017 Feb 28;53:15-21. (PMID: <searchLink fieldCode="PM" term="%2228139202%22">28139202)</searchLink><br />EuroIntervention. 2012 Sep;8 Suppl Q:Q94-6. (PMID: <searchLink fieldCode="PM" term="%2222995121%22">22995121)</searchLink><br />Int J Numer Method Biomed Eng. 2012 Jun-Jul;28(6-7):626-41. (PMID: <searchLink fieldCode="PM" term="%2225364842%22">25364842)</searchLink><br />Circulation. 2013 Jan 22;127(3):397-407. (PMID: <searchLink fieldCode="PM" term="%2223339094%22">23339094)</searchLink><br />Eur Heart J. 2018 Jul 21;39(28):2625-2634. (PMID: <searchLink fieldCode="PM" term="%2229718148%22">29718148)</searchLink><br />J Interv Cardiol. 2020 May 22;2020:8249497. (PMID: <searchLink fieldCode="PM" term="%2232523474%22">32523474)</searchLink><br />J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. (PMID: <searchLink fieldCode="PM" term="%2221050971%22">21050971)</searchLink>
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