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Cardiovascular Engineering and Technology

, Volume 9, Issue 3, pp 351–364 | Cite as

Impact of Clinically Relevant Elliptical Deformations on the Damage Patterns of Sagging and Stretched Leaflets in a Bioprosthetic Heart Valve

  • Deepa Sritharan
  • Parinaz Fathi
  • Jason D. Weaver
  • Stephen M. Retta
  • Changfu Wu
  • Nandini Duraiswamy
Article
  • 97 Downloads

Abstract

After implantation of a transcatheter bioprosthetic heart valve its original circular circumference may become distorted, which can lead to changes in leaflet coaptation and leaflets that are stretched or sagging. This may lead to early structural deterioration of the valve as seen in some explanted transcatheter heart valves. Our in vitro study evaluates the effect of leaflet deformations seen in elliptical configurations on the damage patterns of the leaflets, with circular valve deformation as the control. Bovine pericardial tissue heart valves were subjected to accelerated wear testing under both circular (N = 2) and elliptical (N = 4) configurations. The elliptical configurations were created by placing the valve inside custom-made elliptical holders, which caused the leaflets to sag or stretch. The hydrodynamic performance of the valves was monitored and high resolution images were acquired to evaluate leaflet damage patterns over time. In the elliptically deformed valves, sagging leaflets experienced more damage from wear compared to stretched leaflets; the undistorted leaflets of the circular valves experienced the least leaflet damage. Free-edge thinning and tearing were the primary modes of damage in the sagging leaflets. Belly region thinning was seen in the undistorted and stretched leaflets. Leaflet and fabric tears at the commissures were seen in all valve configurations. Free-edge tearing and commissure tears were the leading cause of valve hydrodynamic incompetence. Our study shows that mechanical wear affects heart valve pericardial leaflets differently based on whether they are undistorted, stretched, or sagging in a valve configuration. Sagging leaflets are more likely to be subjected to free-edge tear than stretched or undistorted leaflets. Reducing leaflet stress at the free edge of non-circular valve configurations should be an important factor to consider in the design and/or deployment of transcatheter bioprosthetic heart valves to improve their long-term performance.

Keywords

Bioprosthetic heart valve Pericardial tissue Leaflet durability Non-circular deformation Valve fatigue 

Abbreviations

CE

Commissure exposure

CT

Commissure tear

FE

Free-edge exposure

FT

Free-edge tear

FTh

Free-edge thinning

BTh

Belly region thinning

Circ

Circular

Emin

Ellipse minor

Emaj

Ellipse major

AWT

Accelerated wear testing

THV

Transcatheter heart valve

Nm

Nominal

Sg

Sagging

St

Stretched

M

Millions

Notes

Acknowledgments

This work was supported by the FDA’s Office of Women’s Health grants 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 for this study. We appreciate help from our colleagues, Jon Casamento, Terry Woods, and Shiril Sivan, and our interns Lena Karkar, Nick Lane, and Robyn Hall.

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 Stated. Approved for public release; distribution is unlimited.

Conflict of interest

There are no conflicts of interest.

Statement of Human and Animal Studies

None/not applicable.

Supplementary material

13239_2018_366_MOESM1_ESM.docx (1.6 mb)
Electronic supplementary material 1 (DOCX 1588 kb)

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Copyright information

© Biomedical Engineering Society 2018

Authors and Affiliations

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

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