Skip to main content
SpringerLink
Log in

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

  • Published:
Cardiovascular Engineering and Technology Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9

Similar content being viewed by others

References

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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. 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.

    Article  Google Scholar 

  5. ISO 5840-3: Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques, 2013.

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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. Vesely, I. The evolution of bioprosthetic heart valve design and its impact on durability. Cardiovasc. Pathol. 12:277–286, 2003.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

Download references

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.

Conflict of interest

None.

Disclaimer

The mention of commercial products, their sources, or their use in connection with materials reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. This material is declared a work of the U.S. Government and is not subject to copyright protection in the United States. Approved for public release; distribution is unlimited.

Author information

Authors and Affiliations

  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 Spring, MD, 20993, USA

    Nandini Duraiswamy, Jason D. Weaver, Yasamin Ekrami & Stephen M. Retta

  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 Spring, MD, 20993, USA

    Changfu Wu

Authors
  1. Nandini Duraiswamy
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jason D. Weaver
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yasamin Ekrami
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Stephen M. Retta
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Changfu Wu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Nandini Duraiswamy.

Additional information

Associate Editor Ajit P. Yoganathan oversaw the review of this article.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13239-016-0259-9

Keywords

Search

Navigation