Acute Crit Care.  2024 Nov;39(4):565-572. 10.4266/acc.2024.00731.

Performance evaluation of non-invasive cardiac output monitoring device (HemoVista) based on multi-channel thoracic impedance plethysmography technology

• Park J
• Choi BM

• KMID: 2563545
• DOI: http://doi.org/10.4266/acc.2024.00731

Abstract

Background
A non-invasive method of measuring cardiac output (CO) can be beneficial in the care of critically ill patients. HemoVista (BiLab Co., Ltd.) is a medical device that measures CO non-invasively using multi-channel impedance plethysmography technology. The purpose of this study was to exploratively evaluate the performance of HemoVista in critically ill patients undergoing CO monitoring with the FloTrac (Edwards Lifesciences).
Methods
After non-invasively installing the HemoVista sensor in critically ill patients whose CO was monitored with the FloTrac, CO values measured by both devices were collected for 30 minutes. Cardiac output measured by both devices was selected every 10 seconds, creating approximately 360 data pairs per patient. Linear correlation analysis with Pearson correlation coefficients, Bland-Altman analysis, and four-quadrant plot analysis were performed to evaluate the performance of HemoVista.
Results
A total of 7,138 pairs of CO data from the 20 patients were included in the analysis. A significant correlation was observed between the two methods of measuring CO (Pearson's r=0.489, P<0.001). The mean bias was 1.03 L/min, the 95% CI for the limit of agreement was –1.83 L/min to 3.93 L/min and the percentage error was 55.8%. The concordance rate of time-dependent CO between the two devices was 14.6%.
Conclusions
It was observed that the current version of HemoVista has unsuitable performance for use in intensive care units. To be used for critically ill patients, the algorithm must be improved and reevaluated with an enhanced version.

Keyword

cardiac output; critical care; impedance cardiography; transthoracic impedance

Figure

• 

  Figure 1. Test device and related sensor (ePAD). HemoVista (BiLab Co., Ltd.) was used as a test device to noninvasively measure cardiac output. (A) Practical situations of cardiac output measurement with HemoVista in a critically ill patient. (B) An example of the operating screen of the HemoVista device. (C) A HemoVista sensor.

• 

  Figure 2. Consort diagram. A total of 24 patients were screened, and of these, three patients were excluded due to violations of the inclusion criteria. A total of 21 patients were enrolled in this study, and one patient dropped out from the study because of the lack of estimation of cardiac output values from the test device. Hence, 20 patients were included in the analyses.

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  Figure 3. Cardiac output (CO) values measured with the test device (HemoVista) and reference device (FloTrac). The green dotted line indicates the line of identity. The red solid line is the simple regression line.

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  Figure 4. Bland-Altman plot of cardiac output (CO) measured by two devices (test: HemoVista, reference: FloTrac). Bias was defined as the average of the differences in CO measured between the reference device and the test device. The percentage error was 55.8%. SD: standard deviation.

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  Figure 5. Four-quadrant plots of cardiac output (CO). The values on the horizontal axis refer to ∆CO values of the reference device (FloTrac), whereas the vertical axis refers to the ∆CO values of the test device (HemoVista). ∆CO values mean differences between consecutively obtained CO values. The central green square refers to the exclusion zone (range, –0.25 to 0.25 L/min). Because very small ΔCO values should not be included in the trending analysis, and, thus, a central exclusion zone is applied.

Reference

1. Huygh J, Peeters Y, Bernards J, Malbrain ML. Hemodynamic monitoring in the critically ill: an overview of current cardiac output monitoring methods. F1000Res. 2016; 5:F1000 Faculty Rev-2855.

2. Youssef N, Whitlock RP. The routine use of the pulmonary artery catheter should be abandoned. Can J Cardiol. 2017; 33:135–41.

3. Arya VK, Al-Moustadi W, Dutta V. Cardiac output monitoring - invasive and noninvasive. Curr Opin Crit Care. 2022; 28:340–7.

4. Argueta E, Berdine G, Pena C, Nugent KM. FloTrac® monitoring system: what are its uses in critically ill medical patients? Am J Med Sci. 2015; 349:352–6.

5. McLean AS, Huang SJ, Kot M, Rajamani A, Hoyling L. Comparison of cardiac output measurements in critically ill patients: FloTrac/Vigileo vs transthoracic Doppler echocardiography. Anaesth Intensive Care. 2011; 39:590–8.

6. Nuttall G, Burckhardt J, Hadley A, Kane S, Kor D, Marienau MS, et al. Surgical and patient risk factors for severe arterial line complications in adults. Anesthesiology. 2016; 124:590–7.

7. Sangkum L, Liu GL, Yu L, Yan H, Kaye AD, Liu H. Minimally invasive or noninvasive cardiac output measurement: an update. J Anesth. 2016; 30:461–80.

8. Ko RE, Jang GY, Chung CR, Lee JY, Oh TI, Suh GY, et al. Noninvasive beat-to-beat stroke volume measurements to determine preload responsiveness during mini-fluid challenge in a swine model: a preliminary study. Shock. 2021; 56:850–6.

9. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999; 8:135–60.

10. Kanazawa H, Maeda T, Miyazaki E, Hotta N, Ito S, Ohnishi Y. Accuracy and trending ability of blood pressure and cardiac index measured by ClearSight system in patients with reduced ejection fraction. J Cardiothorac Vasc Anesth. 2020; 34:3293–9.

11. Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput. 1999; 15:85–91.

12. Saugel B, Grothe O, Wagner JY. Tracking changes in cardiac output: statistical considerations on the 4-quadrant plot and the polar plot methodology. Anesth Analg. 2015; 121:514–24.

13. Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014; 6:1022–9.

14. Nguyen LS, Squara P. Non-invasive monitoring of cardiac output in critical care medicine. Front Med (Lausanne). 2017; 4:200.

15. Putensen C, Hentze B, Muenster S, Muders T. Electrical impedance tomography for cardio-pulmonary monitoring. J Clin Med. 2019; 8:1176.

16. Ulbrich M, Mühlsteff J, Leonhardt S, Walter M. Influence of physiological sources on the impedance cardiogram analyzed using 4D FEM simulations. Physiol Meas. 2014; 35:1451–68.

17. Anand G, Yu Y, Lowe A, Kalra A. Bioimpedance analysis as a tool for hemodynamic monitoring: overview, methods and challenges. Physiol Meas. 2021; 42:03TR01.

18. Sanders M, Servaas S, Slagt C. Accuracy and precision of non-invasive cardiac output monitoring by electrical cardiometry: a systematic review and meta-analysis. J Clin Monit Comput. 2020; 34:433–60.

19. Van Wyk L, Gupta S, Lawrenson J, de Boode WP. Accuracy and trending ability of electrical biosensing technology for non-invasive cardiac output monitoring in neonates: a systematic qualitative review. Front Pediatr. 2022; 10:851850.

20. Chung CR, Ko RE, Jang GY, Lee K, Suh GY, Kim Y, et al. Comparison of noninvasive cardiac output and stroke volume measurements using electrical impedance tomography with invasive methods in a swine model. Sci Rep. 2024; 14:2962.

21. Braun F, Proença M, Lemay M, Bertschi M, Adler A, Thiran JP, et al. Limitations and challenges of EIT-based monitoring of stroke volume and pulmonary artery pressure. Physiol Meas. 2018; 39:014003.