Abstract
Cardiac output (CO) is a key parameter in diagnostics and therapy of heart failure (HF). The thermodilution method (TD) as gold standard for CO determination is an invasive procedure with corresponding risks. As an alternative, thoracic bioimpedance (TBI) has gained popularity for CO estimation as it is non-invasive. However, systolic heart failure (HF) itself might worsen its validity. The present study validated TBI against TD. In patients with and without systolic HF (LVEF ≤ 50% or > 50% and NT-pro-BNP < 125 pg/ml, respectively) right heart catheterization including TD was performed. TBI (Task Force Monitor©, CNSystems, Graz, Austria) was conducted semi-simultaneously. 14 patients with and 17 patients without systolic HF were prospectively enrolled in this study. In all participants, TBI was obtainable. Bland-Altman analysis indicated a mean bias of 0.3 L/min (limits of agreement ± 2.0 L/min, percentage error or PE 43.3%) for CO and a bias of -7.3 ml (limits of agreement ± 34 ml) for cardiac stroke volume (SV). PE was markedly higher in patients with compared to patients without systolic HF (54% vs. 35% for CO). Underlying systolic HF substantially decreases the validity of TBI for estimation of CO and SV. In patients with systolic HF, TBI clearly lacks diagnostic accuracy and cannot be recommended for point-of-care decision making. Depending on the definition of an acceptable PE, TBI may be considered sufficient when systolic HF is absent.
Trial registration number: DRKS00018964 (German Clinical Trial Register, retrospectively registered)
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Acknowledgments
We are grateful to all study participants. We thank Miss Judith Kemper for technical support. English language editing assistance was provided by Nicola Ryan, independent medical writer.
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This study was an investigator-initiated trial without specific funding.
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JS and MB designed the study. IH was responsible for data collection. IH and JS performed the statistical analyses. JS and IH prepared the manuscript which was critically revised and amended by MB, IT, AR, HG, MD and FK. All authors read and approved the final manuscript.
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JS has been supported by the Else-Kröner-Fresenius Stiftung (Grant SP A109), by Kommission für Innovative Medizinische Forschung an der Medizinischen Fakultät Muenster (IMF Grant SP 11 18 15), by Deutsche Herzstiftung (DHS Grant S/01/19) and by young investigator research support from Scuola Superiore Sant´Anna Pisa (Curriculum Ph.D. in Translational Medicine) and has received travel grants and lecture honoraria from Astra Zeneca, Boehringer Ingelheim and Chiesi (all) outside the present work. MB has been supported by Sanofi Genzyme outside this work. MB has received speaker honoraria from Sanofi-Genzyme, UCB Pharma, Amicus Therapeutics, ITF Pharma and Loewenstein Medical and consultant fees from Sanofi-Genzyme and Biogen. AG has worked as a Scientific Advisor for Bayer, Berlin, Germany (2020-2021 – development of a new drug acting on peripheral chemoreceptors in heart failure) and Respicardia, Zoll Medical, Minnetonka, MN, US (2021- ongoing, study of phrenic nerve stimulation as a potential treatment for central apneas in heart failure). HR reports personal fees from Daiichi Sankyo, Pfizer, MedUpdate, StreamedUp, DiaPlan, NeoVasc, Pluristem, NovoNordisk and Corvia. Furthermore, institutional grants were received from Pluristem, BMS, Pfizer, Bard and Biotronik. IH, FK, MD and IT report no conflict of interest in the context of the present work.
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Husstedt, I., Spiesshoefer, J., Reinecke, H. et al. Bioimpedance based determination of cardiac index does not show enough trueness for point of care use in patients with systolic heart failure. J Clin Monit Comput 37, 1229–1237 (2023). https://doi.org/10.1007/s10877-023-00987-6
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DOI: https://doi.org/10.1007/s10877-023-00987-6