Cardiovascular Engineering and Technology

, Volume 7, Issue 2, pp 126–138 | Cite as

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

  • Nandini Duraiswamy
  • Jason D. Weaver
  • Yasamin Ekrami
  • Stephen M. Retta
  • Changfu Wu
Article

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.

Keywords

Transcatheter heart valve THV TAVR FEA Leaflet durability Non-circular deformation 

References

  1. 1.
    Caudron, J., J. Fares, C. Hauville, A. Cribier, J. N. Dacher, C. Tron, et al. Evaluation of multislice computed tomography early after transcatheter aortic valve implantation with the Edwards SAPIEN bioprosthesis. Am. J. Cardiol. 108:873–881, 2011.CrossRefGoogle Scholar
  2. 2.
    Crofts, C. E., and E. A. Trowbridge. The tensile strength of natural and chemically modified bovine pericardium. J. Biomed. Mater. Res. 22:89–98, 1988.CrossRefGoogle Scholar
  3. 3.
    Gleghorn, J. P., A. R. C. Jones, C. R. Flannery, and L. J. Bonassar. Boundary mode frictional properties of engineered cartilagenous tissues. Eur. Cells Mater. 14:20–29, 2007.Google Scholar
  4. 4.
    Gunning, P. S., T. J. Vaughan, and L. M. McNamara. Simulation of self expanding transcatheter aortic valve in a realistic aortic root: implications of deployment geometry on leaflet deformation. Ann. Biomed. Eng. 42(9):1989–2001, 2014.CrossRefGoogle Scholar
  5. 5.
    ISO 5840-3: Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques, 2013.Google Scholar
  6. 6.
    Kim, H., J. Lu, M. S. Sacks, and K. B. Chandran. Dynamic simulation of bioprosthetic heart valves using a stress resultant shell model. J. Biomech. Eng. 128:717–724, 2006.CrossRefGoogle Scholar
  7. 7.
    Kodali, S. K., M. R. Williams, C. R. Smith, L. G. Svensson, J. G. Webb, R. R. Makkar, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N. Engl. J. Med. 366(18):1686–1695, 2012.CrossRefGoogle Scholar
  8. 8.
    Labrosse, M. R., C. J. Beller, F. Robicsek, and M. J. Thubrikar. Geometric modeling of functional trileaflet aortic valves: development and clinical applications. J. Biomech. 39:2665–2672, 2006.CrossRefGoogle Scholar
  9. 9.
    Li, K., and W. Sun. Simulated thin pericardial bioprosthetic valve leaflet deformation under static pressure-only loading conditions: implications for percutaneous valves. Ann. Biomed. Eng. 38:2690–2701, 2010.CrossRefGoogle Scholar
  10. 10.
    Martin, C., and W. Sun. Simulation of long-term fatigue damage in bioprosthetic heart valves: effects of leaflet and stent elastic properties. Biomech. Model. Mechanobiol. 13:759–770, 2014.CrossRefGoogle Scholar
  11. 11.
    Morita, Y., N. Tomita, H. Aoki, M. Sonobe, S. Wakitani, Y. Tamada, et al. Frictional properties of regenerated cartilage in vitro. J. Biomech. 39:103–109, 2006.CrossRefGoogle Scholar
  12. 12.
    Saleeb, A. F., A. Kumar, and V. S. Thomas. The important roles of tissue anisotropy and tissue-to-tissue contact on the dynamical behavior of a symmetric tri-leaflet valve during multiple cardiac pressure cycles. Med. Eng. Phys. 35:23–35, 2013.CrossRefGoogle Scholar
  13. 13.
    Scharfschwerdt, M., R. Meyer-Saraei, C. Schmidtke, and H.-H. Sievers. Hemodynamics of the Edwards Sapien XT transcatheter heart valve in noncircular aortic annuli. J. Thorac. Cardiovasc. Surg. 148:126–132, 2014.CrossRefGoogle Scholar
  14. 14.
    Schoen, F. J., and R. J. Levy. Tissue heart valves: current challenges and future research perspectives. J. Biomed. Mater. Res. 47(4):439–465, 1999.CrossRefGoogle Scholar
  15. 15.
    Schultz, C. J., A. Weustink, N. Piazza, A. Otten, N. Mollet, G. Krestin, et al. Geometry and degree of apposition of the CoreValve ReValving system with multislice computed tomography after implantation in patients with aortic stenosis. J. Am. Coll. Cardiol. 54:911–918, 2009.CrossRefGoogle Scholar
  16. 16.
    Sun, W., A. Abad, and M. S. Sacks. Simulated bioprosthetic heart valve deformation under quasi-static loading. J. Biomech. Eng. 127:905–914, 2005.CrossRefGoogle Scholar
  17. 17.
    Sun, W., K. Li, and E. Sirois. Simulated elliptical bioprosthetic valve deformation: implications for asymmetric transcatheter valve deployment. J. Biomech. 43:3085–3090, 2010.CrossRefGoogle Scholar
  18. 18.
    Tang, G. H., S. L. Lansman, M. Cohen, D. Spielvogel, L. Cuomo, H. Ahmad, and T. Dutta. Transcatheter aortic valve replacement: current developments, ongoing issues, future outlook. Cardiol. Rev. 21:55–76, 2013.CrossRefGoogle Scholar
  19. 19.
    Thubrikar, M., W. C. Piepgrass, T. W. Shaner, and S. P. Nolan. The design of the normal aortic valve. Am. J. Cardiol. 241:H795–H801, 1981.Google Scholar
  20. 20.
    Vesely, I. The evolution of bioprosthetic heart valve design and its impact on durability. Cardiovasc. Pathol. 12:277–286, 2003.CrossRefGoogle Scholar
  21. 21.
    Young, E., J. F. Chen, O. Dong, S. Gao, A. Massiello, and K. Fukamachi. Transcatheter heart valve with variable geometric configuration: in vitro evaluation. Artif. Organs 35:1151–1159, 2011.CrossRefGoogle Scholar
  22. 22.
    Zegdi, R., D. Blanchard, P. Achouh, A. Lafont, A. Berrebi, B. Cholley, et al. Deployed Edwards Sapien prosthesis is always deformed. J. Thoracic Cardiovasc. Surg. 140:e54–e56, 2010.CrossRefGoogle Scholar
  23. 23.
    Zegdi, R., V. Ciobotaru, M. Noghin, G. Sleilaty, A. Lafont, C. Latremouille, et al. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J. Am. Coll. Cardiol. 51:579–584, 2008.CrossRefGoogle Scholar

Copyright information

© Biomedical Engineering Society (Outside the U.S.) 2016

Authors and Affiliations

  • Nandini Duraiswamy
    • 1
  • Jason D. Weaver
    • 1
  • Yasamin Ekrami
    • 1
  • Stephen M. Retta
    • 1
  • Changfu Wu
    • 2
  1. 1.Office of Science and Engineering Laboratories (OSEL)/Division of Applied Mechanics (DAM)Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)Silver SpringUSA
  2. 2.Office of Device Evaluation (ODE)/Division of Cardiovascular Devices (DCD)Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)Silver SpringUSA

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