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In Vitro Clot Trapping Efficiency of the FDA Generic Inferior Vena Cava Filter in an Anatomical Model: An Experimental Fluid–Structure Interaction Benchmark

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Abstract

Purpose

Robust experimental data for performing validation of fluid–structure interaction (FSI) simulations of the transport of deformable solid bodies in internal flow are currently lacking. This in vitro experimental study characterizes the clot trapping efficiency of a new generic conical-type inferior vena cava (IVC) filter in a rigid anatomical model of the IVC with carefully characterized test conditions, fluid rheological properties, and clot mechanical properties.

Methods

Various sizes of spherical and cylindrical clots made of synthetic materials (nylon and polyacrylamide gel) and bovine blood are serially injected into the anatomical IVC model under worst-case exercise flow conditions. Clot trapping efficiencies and their uncertainties are then quantified for each combination of clot shape, size, and material.

Results

Experiments reveal the clot trapping efficiency increases with increasing clot diameter and length, with trapping efficiencies ranging from as low as approximately 42% for small 3.2 mm diameter spherical clots up to 100% for larger clot sizes. Because of the asymmetry of the anatomical IVC model, the data also reveal the iliac vein of clot origin influences the clot trapping efficiency, with the trapping efficiency for clots injected into the left iliac vein up to a factor of 7.5 times greater than that for clots injected into the right iliac (trapping efficiencies of approximately 10% versus 75%, respectively).

Conclusion

Overall, this data set provides a benchmark for validating simulations predicting IVC filter clot trapping efficiency and, more generally, low-Reynolds number FSI modeling.

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Acknowledgments

The authors thank Dr. Luke Herbertson for providing the protocol to create the polyacrylamide clots, Sailahari Ponnaluri, who helped with the creation of the polyacrylamide clots, and Dr. Frank Lynch for technical consultation on best practices for IVC filter deployment. The authors also thank Confluent Medical Technologies for manufacturing the generic nitinol IVC filter. This study was funded by the U.S. FDA Center for Devices and Radiological Health (CDRH) Critical Path program. The research was supported in part by an appointment to the Research Participation Program at the U.S. FDA administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and FDA. The findings and conclusions in this article have not been formally disseminated by the 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 Department of Health and Human Services.

Author Contributions

JMR, NSP, HMS, and BCG performed the experimental work with KIA, BAC, and KBM providing input on experimental design. JMR, BCG, KIA, BAC, and KBM performed data analysis and writing of the manuscript, editing, and approving the manuscript submission.

Data Availability

The data that support the findings of this study are available from the corresponding author, KBM, upon reasonable request.

Funding

This study was funded by the U.S. FDA Center for Devices and Radiological Health (CDRH) Critical Path program.

Conflict of interest

J.M. Riley, N.S. Price, H.M. Saaid, B.C. Good, K.I. Aycock, and B.A. Craven declare that they have no conflict of interest. K.B. Manning serves as a consultant for Cordis Inc.

Research Involving Human and Animal Rights

No human studies were carried out by the authors for this article. Approval from the Penn State IACUC was received to conduct the bovine blood studies.

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Authors and Affiliations

  1. Department of Biomedical Engineering, The Pennsylvania State University, 122 Chemical and Biomedical Engineering Building, University Park, PA, 16802, USA

    J. M. Riley, N. S. Price, H. M. Saaid, B. C. Good & K. B. Manning

  2. Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD, USA

    K. I. Aycock & B. A. Craven

  3. Department of Surgery, Penn State Hershey Medical Center, Hershey, PA, USA

    K. B. Manning

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  1. J. M. Riley
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Riley, J.M., Price, N.S., Saaid, H.M. et al. In Vitro Clot Trapping Efficiency of the FDA Generic Inferior Vena Cava Filter in an Anatomical Model: An Experimental Fluid–Structure Interaction Benchmark. Cardiovasc Eng Tech 12, 339–352 (2021). https://doi.org/10.1007/s13239-021-00524-z

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