Abstract
Although generally manufactured as circular devices with symmetric leaflets, transcatheter heart valves can become non-circular post-implantation, the impact of which on the long-term durability of the device is unclear. We investigated the effects of five non-circular (EllipMajor, EllipMinor, D-Shape, TriVertex, TriSides) annular configurations on valve leaflet stresses and valve leaflet deformations through finite element analysis. The highest in-plane principal stresses and strains were observed under an elliptical configuration with an aspect ratio of 1.25 where one of the commissures was on the minor axis of the ellipse. In this elliptical configuration (EllipMinor), the maximum principal stress increased 218% and the maximum principal strain increased 80% as compared with those in the circular configuration, and occurred along the free edge of the leaflet whose commissures were not on the minor axis (i.e., the “stretched” leaflet). The D-Shape configuration was similar to this elliptical configuration, with the degree to which the leaflets were stretched or sagging being less than the EllipMinor configuration. The TriVertex and TriSides configurations had similar leaflet deformation patterns in all three leaflets and similar to the Circular configuration. In the D-Shape, TriVertex, and TriSides configurations, the maximum principal stress was located near the commissures similar to the Circular configuration. In the EllipMinor and EllipMajor configurations, the maximum principal stress occurred near the center of the free edge of the “stretched” leaflets. These results further affirm recommendations by the International Standards Organization (ISO) that pre-clinical testing should consider non-circular configurations for transcatheter valve durability testing.
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Acknowledgments
This work was supported by the FDA’s Office of Women’s Health and in part by an appointment to the ORISE Research Participation Program at the FDA/CDRH, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and FDA/CDRH. We are thankful to Edwards Lifesciences, for assisting with purchase of the surgical valves and constructive discussions on the results of the study. Special thanks to Michel Labrosse from Univ. of Ottawa and Hyuggun Kim from Univ. of Texas for providing us the initial geometry and experimental data, respectively.
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Associate Editor Ajit P. Yoganathan oversaw the review of this article.
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Duraiswamy, N., Weaver, J.D., Ekrami, Y. et al. A Parametric Computational Study of the Impact of Non-circular Configurations on Bioprosthetic Heart Valve Leaflet Deformations and Stresses: Possible Implications for Transcatheter Heart Valves. Cardiovasc Eng Tech 7, 126–138 (2016). https://doi.org/10.1007/s13239-016-0259-9
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DOI: https://doi.org/10.1007/s13239-016-0259-9