In-Vitro Pulsatile Flow Testing of Prosthetic Heart Valves: A Round-Robin Study by the ISO Cardiac Valves Working Group

Abstract

Purpose

Hydrodynamic performance testing is one of the core in vitro assessments required by the ISO 5840 series of standards for all prosthetic heart valves. A round-robin study carried out in 2005 in accordance with ISO 5840:2005 revealed significant variabilities in prosthetic heart valve hydrodynamic performance measurements among the participating laboratories. In order to re-examine the inter-laboratory variability based on the “state-of-the-art” under ISO 5840-1 and 5840-2:2015, the ISO Cardiac Valve Working Groups decided in 2016 to repeat the round-robin study.

Methods

A total of 13 international laboratories participated in the study. The test valves were chosen to be the St. Jude Medical Masters Series mechanical valves (19 mm aortic, 25 mm aortic, 25 mm mitral, and 31 mm mitral), which were circulated among the laboratories. The testing was conducted according to a common test run sequence, with prespecified flow conditions.

Results

The study revealed improved, yet still significant variability among different laboratories as compared to the 2005 study. The coefficient of variation ranged from 7.7 to 21.6% for the effective orifice area, from 10.1 to 32.8% for the total regurgitant fraction, and from 14.7 to 45.5% for the mean transvalvular pressure gradient.

Conclusions

The study revealed the ambiguities in the current versions of the ISO 5840 series of standards and the shortcomings of some participating laboratories. This information has allowed the ISO Working Group to incorporate additional clarifying language into the ISO 5840-1, -2, and -3 standards that are currently under revision to improve in vitro assessments. The results presented here can also be used by the testing laboratories to benchmark pulse duplicator systems and to train and certify testing personnel.

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

Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9
Figure 10

References

  1. 1.

    Barbara, V., C. Daniele, M. Grigioni, A. Palombo, and A. Sargentini. In vitro evaluation of prosthetic heart valves: towards comparable testing. J. Med. Eng. Technol. 16:10–14, 1992.

    Article  Google Scholar 

  2. 2.

    Barbaro, V., P. Bartolini, C. Daniele, M. Grigioni, and A. Palombo. Prosthetic heart valve evaluation in vitro: critical aspects of data comparability. Int. J. Artif. Organs 14:343–349, 1991.

    Article  Google Scholar 

  3. 3.

    Cornhill, J. F. An aortic-left ventricular pulse duplicator used in testing prosthetic aortic heart valves. J. Thorac. Cardiovasc. Surg. 4:550–558, 1977.

    Google Scholar 

  4. 4.

    Davis K., J. H. Muller, C. J. Meyer, F. E. Smit. Evaluating the impact of air compliance chamber volumes on valve performance for three different heart valves. In: 2018 3rd Biennial South African Biomedical Engineering Conference (SAIBMEC), Stellenbosch, 2018, pp. 1–4.

  5. 5.

    ISO 5840-3:2013: Cardiovascular Implants—Cardiac Valve Prostheses—Part 3: Heart Valve Substitutes Implanted by Transcatheter Techniques. International Organization for Standardization, Geneva, Switzerland.

  6. 6.

    ISO 5840-2:2015. Cardiovascular Implants—Cardiac Valve Prostheses—Part 2: Surgically Implanted Heart Valve Substitutes. International Organization for Standardization, Geneva, Switzerland.

  7. 7.

    Raghav, V., S. Sastry, and N. Saikrishnan. Experimental assessment of flow fields associated with heart valve prostheses using particle image velocimetry (PIV): recommendations for best practices. Cardiovasc. Eng. Technol. 9:273–287, 2018.

    Article  Google Scholar 

  8. 8.

    Retta, S. M., J. Kepner, S. Marquez, B. A. Herman, M. C. S. Shu, and L. W. Grossman. In-vitro pulsatile flow measurement in prosthetic heart valves: an inter-laboratory comparison. J. Heart Valve Dis. 26:72–80, 2017.

    Google Scholar 

  9. 9.

    Robinson, R. A., R. F. Carey, and B. A. Herman. Evaluation of an in vitro cardiac pulse duplicator. J. Clin. Eng. 15:131–138, 1990.

    Article  Google Scholar 

  10. 10.

    Schichl, K., and K. Affeld. A computer controlled versatile pulse duplicator for precision testing of artificial heart valves. Int. J. Artif. Organs 16:10, 1993.

    Article  Google Scholar 

  11. 11.

    Wei, Z. A., S. J. Sonntag, M. Toma, S. Singh-Gryzbon, and W. Sun. Computational fluid dynamics assessment associated with transcatheter heart valve prostheses: a position paper of the ISO Working Group. Cardiovasc. Eng. Technol. 9:289–299, 2018.

    Article  Google Scholar 

  12. 12.

    Yoganathan, A. P., W. H. Corcoran, and E. C. Harrison. Pressure drops across prosthetic aortic heart valves under steady and pulsatile flow—in vitro measurements. J. Biomech. 12:153–164, 1979.

    Article  Google Scholar 

Download references

Acknowledgments

We thank St. Jude Medical, Inc. (now part of Abbott) for providing the test valves. The findings and conclusions in this article have not been formally disseminated by the U.S. FDA and should not be construed to represent any agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the U.S. Department of Health and Human Services.

Funding

The authors did not receive any funding to carry out the work.

Disclaimer

The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the U.S. Department of Health and Human Services.

Conflict of Interest

All authors declare that they have no conflicts of interest.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Informed Consent

This article does not contain any studies with human participants.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Changfu Wu.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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

Appendices

Appendix A

Appendix A contains the valve hydrodynamic performance results for Runs 2, 3, 4, 6, and 7.

Figure A.1
figure11

Valve hydrodynamic performances—19 mm aortic (Runs 2, 3, 4, 6, and 7).

Figure A.2
figure12

Valve hydrodynamic performances—aortic 25 mm (Runs 2, 3, 4, 6, and 7).

Figure A.3
figure13

Valve hydrodynamic performances—mitral 25 mm (Runs 2, 3, 4, 6, and 7).

Figure A.4
figure14

Valve hydrodynamic performances—mitral 31 mm (Runs 2, 3, 4, 6, and 7).

Appendix B

Appendix B contains the raw hydrodynamic waveforms obtained from the different laboratories.

Figure B.1
figure15figure15

Pressure and flow waveforms - aortic 19 mm. Curves shown are ventricular pressure (orange), aortic pressure (blue) and aortic flow (gray).

Figure B.2
figure16figure16

Pressure and flow waveforms - 25 mm aortic. Curves shown are ventricular pressure (orange), aortic pressure (blue) and aortic flow (gray).

Figure B.3
figure17figure17

Pressure and flow waveforms—mitral 25 mm. Curves shown are ventricular pressure (orange), atrial pressure (blue) and mitral flow (gray).

Figure B.4
figure18figure18

Pressure and flow waveforms - mitral 31 mm. Curves shown are ventricular pressure (orange), atrial pressure (blue) and mitral flow (gray)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Wu, C., Saikrishnan, N., Chalekian, A.J. et al. In-Vitro Pulsatile Flow Testing of Prosthetic Heart Valves: A Round-Robin Study by the ISO Cardiac Valves Working Group. Cardiovasc Eng Tech 10, 397–422 (2019). https://doi.org/10.1007/s13239-019-00422-5

Download citation

Keywords

  • Prosthetic heart valves
  • Hydrodynamic performance testing
  • Effective orifice area
  • Total regurgitant fraction
  • Mean pressure gradient
  • Waveform