In vitro thrombogenicity evaluation of rotary blood pumps by thromboelastometry

Mario Klein; Jana Christine Tack; Ilona Mager; Judith Maas; Thomas Schmitz-Rode; Jutta Arens; Ulrich Steinseifer; Johanna Charlotte Clauser

doi:10.1515/bmt-2022-0078

Article

In vitro thrombogenicity evaluation of rotary blood pumps by thromboelastometry

Mario Klein , Jana Christine Tack , Ilona Mager , Judith Maas , Thomas Schmitz-Rode , Jutta Arens , Ulrich Steinseifer and Johanna Charlotte Clauser

Published/Copyright: August 31, 2022

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From the journal Biomedical Engineering / Biomedizinische Technik Volume 67 Issue 6

Abstract

In vitro thrombogenicity tests for rotary blood pumps (RBPs) could benefit from assessing coagulation kinematics, as RBP design improves. In this feasibility study, we investigated if the method of thromboelastometry (TEM) is able to assess coagulation kinematics under the in vitro conditions of RBP tests. We conducted in vitro thrombogenicity tests (n=4) by placing Deltastream^® DP3 pumps into test loops that were filled with 150 mL of slightly anti-coagulated porcine blood, adjusted to an activated clotting time (ACT) well below clinically recommended levels. Blood samples were taken at certain time points during the experiment until a continuous decrease in pump flow indicated major thrombus formation. Blood samples were analyzed for ACT, platelet count (PLT), and several TEM parameters. While visible thrombus formation was observed in three pumps, ACT indicated an ongoing activation of coagulation, PLT might have indicated platelet consumption. Unexpectedly, most TEM results gave no clear indications. Nonetheless, TEM clotting time obtained by non-anticoagulated and chemically non-activated whole blood (HEPNATEM-CT) appeared to be more sensitive for the activation of coagulation in vitro than ACT, which might be of interest for future pump tests. However, more research regarding standardization of thrombogenicity pump tests is urgently required.

Keywords: centrifugal blood pumps; clot formation; hemocompatibility; mechanical circulatory support; mock loop

Corresponding author: Johanna Charlotte Clauser, Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Medical Faculty, RWTH Aachen University, University Hospital Aachen, Pauwelsstr. 20, 52074 Aachen, Germany, Fax: +49 241 80-82442, E-mail: clauser@ame.rwth-aachen.de

Funding source: European Regional Development Fund http://dx.doi.org/10.13039/501100008530

Award Identifier / Grant number: EFRE-0800410

Acknowledgments

The authors thank Yasmin Kuhn, Gereon Fischer and Andrea Sieg (Institute of Applied Medical Engineering) for their assistance during the thrombogenicity tests.

Research funding: The authors acknowledge funding provided by the federal state of North Rhine-Westphalia and the European Regional Development Fund (ERDF), Grant number: EFRE-0800410, https://doi.org/10.13039/501100008530. The funding organizations played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: Not applicable.

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Received: 2022-02-17

Accepted: 2022-08-02

Published Online: 2022-08-31

Published in Print: 2022-12-16

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Articles in the same Issue

https://doi.org/10.1515/bmt-2022-0078

Keywords for this article

centrifugal blood pumps; clot formation; hemocompatibility; mechanical circulatory support; mock loop