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Simulating Radial Pressure Waveforms with a Mock Circulatory Flow Loop to Characterize Hemodynamic Monitoring Systems

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Abstract

Purpose

Mock circulatory loops (MCLs) can reproducibly generate physiologically relevant pressures and flows for cardiovascular device testing. These systems have been extensively used to characterize the performance of therapeutic cardiac devices, but historically MCLs have had limited use for assessing patient monitoring systems. Here, we adapted an MCL to include peripheral components and evaluated its utility for qualitative and quantitative benchtop testing of hemodynamic monitoring devices.

Methods

An MCL was designed to simulate three physiological hemodynamic states: normovolemia, cardiogenic shock, and hyperdynamic circulation. The system was assessed for stability in pressure and flow values over time, repeatability, waveform morphology, and systemic-peripheral pressure relationships.

Results

For each condition, cardiac output was controlled to the nearest 0.2 L/min, and flow rate and mean arterial pressure remained stable and repeatable over a 60-s period (n = 5, standard deviation of ± 0.1 L/min and ± 0.84 mmHg, respectively). Transfer function analyses showed that the systemic-peripheral relationships could be adequately manipulated. The results from this MCL were comparable to those from other published MCLs and computational simulations. However, resolving current limitations of the system would further improve its utility. Three pulse contour analysis algorithms were applied to the pressure and flow data from the MCL to demonstrate the potential role of MCLs in characterizing hemodynamic monitoring systems.

Conclusion

Overall, the development of robust analysis methods in conjunction with modified MCLs can expand device testing applications to hemodynamic monitoring systems. Properly validated MCLs can create a stable and reproducible environment for testing patient monitoring systems over their entire operating ranges prior to clinical use.

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Acknowledgments

The authors would like to acknowledge Dr. Sungtae Shin for his work in developing the in-house software for controlling the MCL.

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 Department of Health and Human Services. This article reflects the research conducted by the authors and should not be construed to represent FDA’s views, guidance, or policies.

Funding

This project was supported by CDRH Critical Path Initiative funding and in part by an appointment to the Research Participation Program at the Center for Devices and Radiological Health, U.S. Food and Drug Administration, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and FDA.

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Authors and Affiliations

  1. Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Silver Spring, MD, USA

    Anna Packy, Gavin A. D’Souza, Masoud Farahmand & Luke Herbertson

  2. University of Maryland, College Park, MD, USA

    Anna Packy

  3. Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Bldg. 62 Rm 1129, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA

    Christopher G. Scully

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  1. Anna Packy
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Correspondence to Christopher G. Scully.

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Conflict of interest

Anna Packy, Gavin D’Souza, Masoud Farahmand, Luke Herbertson, and Christopher Scully declare that they have no conflict of interest.

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Electronic data reported in this study will be made available upon request.

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Code used in this study will be made available upon request.

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Packy, A., D’Souza, G.A., Farahmand, M. et al. Simulating Radial Pressure Waveforms with a Mock Circulatory Flow Loop to Characterize Hemodynamic Monitoring Systems. Cardiovasc Eng Tech 13, 279–290 (2022). https://doi.org/10.1007/s13239-021-00575-2

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  • DOI: https://doi.org/10.1007/s13239-021-00575-2

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