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Computational Fluid Dynamics Assessment Associated with Transcatheter Heart Valve Prostheses: A Position Paper of the ISO Working Group

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Abstract

The governing international standard for the development of prosthetic heart valves is International Organization for Standardization (ISO) 5840. This standard requires the assessment of the thrombus potential of transcatheter heart valve substitutes using an integrated thrombus evaluation. Besides experimental flow field assessment and ex vivo flow testing, computational fluid dynamics is a critical component of this integrated approach. This position paper is intended to provide and discuss best practices for the setup of a computational model, numerical solving, post-processing, data evaluation and reporting, as it relates to transcatheter heart valve substitutes. This paper is not intended to be a review of current computational technology; instead, it represents the position of the ISO working group consisting of experts from academia and industry with regards to considerations for computational fluid dynamic assessment of transcatheter heart valve substitutes.

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Acknowledgment

The authors would like to thank Dr. Ajit Yoganathan and other ISO TC 150 committee members for their suggestions and comments on the paper. Dr. Wei Sun and Dr. Simon Johannes Sonntag in the author list are ISO members, and Dr. Zhenglun Alan Wei, Dr. Milan Toma, and Dr. Shelly Singh-Gryzbon are not ISO members but they are experts in relevant fields who work with the ISO group to develop this document.

Conflict of interest

Zhenglun Wei, Milan Toma, Shelly Singh, and Wei Sun report no conflict of interest; Simon J. Sonntag is an employee of enmodes GmbH.

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Authors and Affiliations

  1. Wallace H. Coulter School of Biomedical Engineering, Georgia Institute of Technology, Technology Enterprise Park, Room 206, 387 Technology Circle, Atlanta, GA, 30313-2412, USA

    Zhenglun Alan Wei, Milan Toma, Shelly Singh-Gryzbon & Wei Sun

  2. enmodes GmbH, Aachen, Germany

    Simon Johannes Sonntag

  3. Department of Mechanical Engineering, School of Engineering & Computing Sciences, New York Institute of Technology, New York, USA

    Milan Toma

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  1. Zhenglun Alan Wei
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  5. Wei Sun
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Correspondence to Wei Sun.

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Associate Editors Karyn Kunzelman and Ajit P. Yoganathan oversaw the review of this article.

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Wei, Z.A., Sonntag, S.J., Toma, M. et al. Computational Fluid Dynamics Assessment Associated with Transcatheter Heart Valve Prostheses: A Position Paper of the ISO Working Group. Cardiovasc Eng Tech 9, 289–299 (2018). https://doi.org/10.1007/s13239-018-0349-y

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