Key result
Noninvasive cardiac output measurement using ClearSight yielded a percentage error of 43.1% compared to thermodilution, indicating it is inaccurate for patients with severe aortic stenosis.
Why the study?
Noninvasive cardiac output measurement using ClearSight eliminates intra-arterial catheterization, but its accuracy required evaluation in patients with severe aortic valve stenosis.
Does noninvasive cardiac output measurement using the ClearSight system accurately measure cardiac output compared to pulmonary artery catheter thermodilution in patients with severe aortic valve stenosis undergoing TAVI?
Observational (n=28)
No
Does noninvasive cardiac output measurement using the ClearSight system accurately measure cardiac output compared to pulmonary artery catheter thermodilution in patients with severe aortic valve stenosis undergoing TAVI?
Noninvasive cardiac output measurement using the ClearSight system is inaccurate and has poor trending ability compared to invasive thermodilution in patients with severe aortic stenosis undergoing TAVI.
Answers are grounded in this paper and cite their sources.
ClearSight should not yet replace thermodilution in severe AS; this cohort study leaves open validation needs for noninvasive alternatives.
BACKGROUND: Noninvasive cardiac output (CO) measured using ClearSight™ eliminates the need for intra-arterial catheter insertion. The purpose of this study was to examine the accuracy of non-invasive CO measurement in patients with severe aortic valve stenosis (AS). METHODS: Twenty-eight patients undergoing elective transcatheter aortic valve implantation were prospectively enrolled in this study. The CO was simultaneously measured twice before and twice after valve deployment (total of four times) per patient, and the CO was compared between the ClearSight (COClearSight) system and the pulmonary artery catheter (PAC) thermodilution (COTD) method as a reference. The Bland-Altman analysis was used to compare the percentage errors between the methods. RESULTS: A total of 112 paired data points were obtained. The percentage error between the COClearSight and COTD was 43.1%. The paired datasets were divided into the following groups according to the systemic vascular resistance index (SVRI): low (< 1,200 dyne s/cm5/m2) and normal (1,200-2,500 dyne s/cm5/m2). The percentage errors were 44.9% and 49.4%, respectively. The discrepancy of CO between COClearSight and COTD was not significantly correlated with SVRI (r = -0.06, P < 0.001). The polar plot analysis showed the trending ability of the COClearSight after artificial valve deployment was 51.1% which below the acceptable cut-off (92%). CONCLUSIONS: The accuracy and the trending ability of the ClearSight CO measurements were not acceptable in patients with severe AS. Therefore, the ClearSight system is not interchangeable with the PAC thermodilution for determining CO in this population.
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Yahagi et al. (2021) conducted an observational in Severe aortic valve stenosis (n=28). ClearSight noninvasive cardiac output measurement vs. Pulmonary artery catheter thermodilution was evaluated on Percentage error between ClearSight and thermodilution cardiac output measurements (Percentage error 43.1%). Noninvasive cardiac output measurement using ClearSight yielded a percentage error of 43.1% compared to thermodilution, indicating it is inaccurate for patients with severe aortic stenosis.
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