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Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator.
Artif Organs. 2022 Aug; 46(8):1585-1596.AO

Abstract

BACKGROUND

Heart failure is a growing health problem worldwide. Due to the lack of donor hearts there is a need for alternative therapies, such as total artificial hearts (TAHs). The aim of this study is to evaluate the hemodynamic performance of the Realheart® TAH, a new 4-chamber cardiac prosthesis device.

METHODS

The Realheart® TAH was connected to a hybrid cardiovascular simulator with inflow connections at the left/right atrium, and outflow connections at the ascending aorta/pulmonary artery. The Realheart® TAH was tested at different pumping rates and stroke volumes. Different systemic resistances (20.0-16.7-13.3-10.0 Wood units), pulmonary resistances (6.7-3.3-1.7 Wood units), and pulmonary/systemic arterial compliances (1.4-0.6 ml/mm Hg) were simulated. Tests were also conducted in static conditions, by imposing predefined values of preload-afterload across the artificial ventricle.

RESULTS

The Realheart® TAH allows the operator to finely tune the delivered flow by regulating the pumping rate and stroke volume of the artificial ventricles. For a systemic resistance of 16.7 Wood units, the TAH flow ranges from 2.7 ± 0.1 to 6.9 ± 0.1 L/min. For a pulmonary resistance of 3.3 Wood units, the TAH flow ranges from 3.1 ± 0.0 to 8.2 ± 0.3 L/min. The Realheart® TAH delivered a pulse pressure ranging between ~25 mm Hg and ~50 mm Hg for the tested conditions.

CONCLUSIONS

The Realheart® TAH offers great flexibility to adjust the output flow and delivers good pressure pulsatility in the vessels. Low sensitivity of device flow to the pressure drop across it was identified and a new version is under development to counteract this.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Fresiello L
Department of Cardiovascular Sciences, Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium. Institute of Clinical Physiology, National Research Council, Pisa, Italy.
Najar A
R&D, Scandinavian Real Heart AB, Västerås, Sweden.
Brynedal Ignell N
R&D, Scandinavian Real Heart AB, Västerås, Sweden.
Zieliński K
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, Warsaw, Poland.
Rocchi M
Department of Cardiovascular Sciences, Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.
Meyns B
Department of Cardiovascular Sciences, Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.
Perkins IL
R&D, Scandinavian Real Heart AB, Västerås, Sweden.

MeSH

Heart AtriaHeart TransplantationHeart, ArtificialHemodynamicsHumansTissue Donors

Pub Type(s)

Journal Article

Language

eng

PubMed ID

35231138

Citation

Fresiello, Libera, et al. "Hemodynamic Characterization of the Realheart® Total Artificial Heart With a Hybrid Cardiovascular Simulator." Artificial Organs, vol. 46, no. 8, 2022, pp. 1585-1596.
Fresiello L, Najar A, Brynedal Ignell N, et al. Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator. Artif Organs. 2022;46(8):1585-1596.
Fresiello, L., Najar, A., Brynedal Ignell, N., Zieliński, K., Rocchi, M., Meyns, B., & Perkins, I. L. (2022). Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator. Artificial Organs, 46(8), 1585-1596. https://doi.org/10.1111/aor.14223
Fresiello L, et al. Hemodynamic Characterization of the Realheart® Total Artificial Heart With a Hybrid Cardiovascular Simulator. Artif Organs. 2022;46(8):1585-1596. PubMed PMID: 35231138.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator. AU - Fresiello,Libera, AU - Najar,Azad, AU - Brynedal Ignell,Nils, AU - Zieliński,Krzysztof, AU - Rocchi,Maria, AU - Meyns,Bart, AU - Perkins,Ina Laura, Y1 - 2022/03/27/ PY - 2021/12/28/revised PY - 2021/07/05/received PY - 2022/02/18/accepted PY - 2022/3/2/pubmed PY - 2022/7/7/medline PY - 2022/3/1/entrez KW - cardiovascular modeling KW - mock loop KW - total artificial heart SP - 1585 EP - 1596 JF - Artificial organs JO - Artif Organs VL - 46 IS - 8 N2 - BACKGROUND: Heart failure is a growing health problem worldwide. Due to the lack of donor hearts there is a need for alternative therapies, such as total artificial hearts (TAHs). The aim of this study is to evaluate the hemodynamic performance of the Realheart® TAH, a new 4-chamber cardiac prosthesis device. METHODS: The Realheart® TAH was connected to a hybrid cardiovascular simulator with inflow connections at the left/right atrium, and outflow connections at the ascending aorta/pulmonary artery. The Realheart® TAH was tested at different pumping rates and stroke volumes. Different systemic resistances (20.0-16.7-13.3-10.0 Wood units), pulmonary resistances (6.7-3.3-1.7 Wood units), and pulmonary/systemic arterial compliances (1.4-0.6 ml/mm Hg) were simulated. Tests were also conducted in static conditions, by imposing predefined values of preload-afterload across the artificial ventricle. RESULTS: The Realheart® TAH allows the operator to finely tune the delivered flow by regulating the pumping rate and stroke volume of the artificial ventricles. For a systemic resistance of 16.7 Wood units, the TAH flow ranges from 2.7 ± 0.1 to 6.9 ± 0.1 L/min. For a pulmonary resistance of 3.3 Wood units, the TAH flow ranges from 3.1 ± 0.0 to 8.2 ± 0.3 L/min. The Realheart® TAH delivered a pulse pressure ranging between ~25 mm Hg and ~50 mm Hg for the tested conditions. CONCLUSIONS: The Realheart® TAH offers great flexibility to adjust the output flow and delivers good pressure pulsatility in the vessels. Low sensitivity of device flow to the pressure drop across it was identified and a new version is under development to counteract this. SN - 1525-1594 UR - https://www.unboundmedicine.com/medline/citation/35231138/Hemodynamic_characterization_of_the_Realheart®_total_artificial_heart_with_a_hybrid_cardiovascular_simulator_ DB - PRIME DP - Unbound Medicine ER -