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Assessing the Thrombogenic Potential of Heart Valve Prostheses: An Approach for a Standardized In-Vitro Method

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Abstract

Purpose

Thrombogenic complications are still a main issue in the general performance of cardiovascular implants, especially heart valves. To date, the thrombogenic potential of those prostheses is pre-clinically assessed in time consuming animal studies with questionable evidence.

Methods

In this study, we present a new in-vitro method to assess and compare deficiencies of heart valve substitutes concerning their thrombogenic performance and locate initial clot formation under physiological conditions using porcine blood. Therefore, an athrombogenic pulse duplicator (THIA3) was developed that simulates the anatomic and hemodynamic conditions in the vicinity of the aortic valve. Validation of this tester was carried out with regard to hemodynamics, reproducibility and using positive and negative control valves and by comparison of clot locations with literature data from chronic animal trials with sheep using a St. Jude bileaflet valve.

Results

Validation of the tester showed quasi-physiological hemodynamics and reproducible clot formation. Identical clot formations were found comparing findings in vitro with chronic animal trials.

Conclusion

The THIA 3 has proven its suitability for valid, reproducible evaluation of thrombogenic potential of heart valves in a short period of time.

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Acknowledgments

Parts of this research were funded by the German Research Foundation (DFG, SCHM1307/5-1). Both first authors contributed equally to this publication.

Funding

This study was funded by the German Research Foundation (DFG: Grant Number DFG, SCHM1307/5-1).

Conflict of interest

All authors declare that they have no conflict of interest. This article does not contain any studies with animals performed by any of the authors.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors. Presented animal data were taken from earlier studies.

Author information

Authors and Affiliations

  1. Department of Cardiovascular Engineering, Helmholtz Institute of Applied Medical Engineering, RWTH Aachen University, Aachen, Germany

    Torsten Linde, Johanna Clauser & Ulrich Steinseifer

  2. Department of Mechanical and Aerospace Engineering, Faculty of Engineering, Monash Institute of Medical Engineering, Monash University, Melbourne, Australia

    Ulrich Steinseifer

  3. Cardiac Surgery, Department of Cardiovascular Sciences, University Hospital Leuven, KU Leuven, Leuven, Belgium

    Bart Meuris

Authors
  1. Torsten Linde
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  2. Johanna Clauser
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  3. Bart Meuris
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  4. Ulrich Steinseifer
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Corresponding author

Correspondence to Torsten Linde.

Additional information

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

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Linde, T., Clauser, J., Meuris, B. et al. Assessing the Thrombogenic Potential of Heart Valve Prostheses: An Approach for a Standardized In-Vitro Method. Cardiovasc Eng Tech 10, 216–224 (2019). https://doi.org/10.1007/s13239-019-00408-3

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