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Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems

Simulators are expected to assume a prominent role in the process of design—development and testing of cardiovascular medical devices. For this purpose, simulators should capture the complexity of human cardiorespiratory physiology in a realistic way. High fidelity simulations of pathophysiology do...

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Autores principales: Fresiello, Libera, Muthiah, Kavitha, Goetschalckx, Kaatje, Hayward, Christopher, Rocchi, Maria, Bezy, Maxime, Pauls, Jo P., Meyns, Bart, Donker, Dirk W., Zieliński, Krzysztof
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9606213/
https://www.ncbi.nlm.nih.gov/pubmed/36311247
http://dx.doi.org/10.3389/fphys.2022.967449
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author Fresiello, Libera
Muthiah, Kavitha
Goetschalckx, Kaatje
Hayward, Christopher
Rocchi, Maria
Bezy, Maxime
Pauls, Jo P.
Meyns, Bart
Donker, Dirk W.
Zieliński, Krzysztof
author_facet Fresiello, Libera
Muthiah, Kavitha
Goetschalckx, Kaatje
Hayward, Christopher
Rocchi, Maria
Bezy, Maxime
Pauls, Jo P.
Meyns, Bart
Donker, Dirk W.
Zieliński, Krzysztof
author_sort Fresiello, Libera
collection PubMed
description Simulators are expected to assume a prominent role in the process of design—development and testing of cardiovascular medical devices. For this purpose, simulators should capture the complexity of human cardiorespiratory physiology in a realistic way. High fidelity simulations of pathophysiology do not only allow to test the medical device itself, but also to advance practically relevant monitoring and control features while the device acts under realistic conditions. We propose a physiologically controlled cardiorespiratory simulator developed in a mixed in silico-in vitro simulation environment. As inherent to this approach, most of the physiological model complexity is implemented in silico while the in vitro system acts as an interface to connect a medical device. As case scenarios, severe heart failure was modeled, at rest and at exercise and as medical device a left ventricular assist device (LVAD) was connected to the simulator. As initial validation, the simulator output was compared against clinical data from chronic heart failure patients supported by an LVAD, that underwent different levels of exercise tests with concomitant increase in LVAD speed. Simulations were conducted reproducing the same protocol as applied in patients, in terms of exercise intensity and related LVAD speed titration. Results show that the simulator allows to capture the principal parameters of the main adaptative cardiovascular and respiratory processes within the human body occurring from rest to exercise. The simulated functional interaction with the LVAD is comparable to the one clinically observed concerning ventricular unloading, cardiac output, and pump flow. Overall, the proposed simulation system offers a high fidelity in silico-in vitro representation of the human cardiorespiratory pathophysiology. It can be used as a test bench to comprehensively analyze the performance of physically connected medical devices simulating clinically realistic, critical scenarios, thus aiding in the future the development of physiologically responding, patient-adjustable medical devices. Further validation studies will be conducted to assess the performance of the simulator in other pathophysiological conditions.
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spelling pubmed-96062132022-10-28 Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems Fresiello, Libera Muthiah, Kavitha Goetschalckx, Kaatje Hayward, Christopher Rocchi, Maria Bezy, Maxime Pauls, Jo P. Meyns, Bart Donker, Dirk W. Zieliński, Krzysztof Front Physiol Physiology Simulators are expected to assume a prominent role in the process of design—development and testing of cardiovascular medical devices. For this purpose, simulators should capture the complexity of human cardiorespiratory physiology in a realistic way. High fidelity simulations of pathophysiology do not only allow to test the medical device itself, but also to advance practically relevant monitoring and control features while the device acts under realistic conditions. We propose a physiologically controlled cardiorespiratory simulator developed in a mixed in silico-in vitro simulation environment. As inherent to this approach, most of the physiological model complexity is implemented in silico while the in vitro system acts as an interface to connect a medical device. As case scenarios, severe heart failure was modeled, at rest and at exercise and as medical device a left ventricular assist device (LVAD) was connected to the simulator. As initial validation, the simulator output was compared against clinical data from chronic heart failure patients supported by an LVAD, that underwent different levels of exercise tests with concomitant increase in LVAD speed. Simulations were conducted reproducing the same protocol as applied in patients, in terms of exercise intensity and related LVAD speed titration. Results show that the simulator allows to capture the principal parameters of the main adaptative cardiovascular and respiratory processes within the human body occurring from rest to exercise. The simulated functional interaction with the LVAD is comparable to the one clinically observed concerning ventricular unloading, cardiac output, and pump flow. Overall, the proposed simulation system offers a high fidelity in silico-in vitro representation of the human cardiorespiratory pathophysiology. It can be used as a test bench to comprehensively analyze the performance of physically connected medical devices simulating clinically realistic, critical scenarios, thus aiding in the future the development of physiologically responding, patient-adjustable medical devices. Further validation studies will be conducted to assess the performance of the simulator in other pathophysiological conditions. Frontiers Media S.A. 2022-10-13 /pmc/articles/PMC9606213/ /pubmed/36311247 http://dx.doi.org/10.3389/fphys.2022.967449 Text en Copyright © 2022 Fresiello, Muthiah, Goetschalckx, Hayward, Rocchi, Bezy, Pauls, Meyns, Donker and Zieliński. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Physiology
Fresiello, Libera
Muthiah, Kavitha
Goetschalckx, Kaatje
Hayward, Christopher
Rocchi, Maria
Bezy, Maxime
Pauls, Jo P.
Meyns, Bart
Donker, Dirk W.
Zieliński, Krzysztof
Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
title Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
title_full Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
title_fullStr Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
title_full_unstemmed Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
title_short Initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
title_sort initial clinical validation of a hybrid in silico—in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems
topic Physiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9606213/
https://www.ncbi.nlm.nih.gov/pubmed/36311247
http://dx.doi.org/10.3389/fphys.2022.967449
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