Korean Circ J.  2024 Feb;54(2):93-104. 10.4070/kcj.2023.0303.

Feasibility and Effectiveness of a Ring-Type Blood Pressure Measurement Device Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device

• Lee H
• Park S
• Kwon H
• Cho B
• Park JH
• Lee HY

• KMID: 2552235
• DOI: http://doi.org/10.4070/kcj.2023.0303

Abstract

Background
s and Objectives: This study aimed to evaluate the applicability and precision of a ring-type cuffless blood pressure (BP) measurement device, CART-I Plus, compared to conventional 24-hour ambulatory BP monitoring (ABPM).
Methods
Forty patients were recruited, and 33 participants were included in the final analysis. Each participant wore both CART-I Plus and ABPM devices on the same arm for approximately 24 hours. BP estimation from CART-I Plus, derived from photoplethysmography (PPG) signals, were compared with the corresponding ABPM measurements.
Results
The CART-I Plus recorded systolic blood pressure (SBP)/diastolic blood pressure (DBP) values of 131.4±14.1/81.1±12.0, 132.7±13.9/81.9±11.9, and 128.7±14.6/79.3±12.2 mmHg for 24-hour, daytime, and nighttime periods respectively, compared to ABPM values of 129.7±11.7/84.4±11.2, 131.9±11.6/86.3±11.1, and 124.5±13.6/80.0±12.2 mmHg. Mean differences in SBP/DBP between the two devices were 1.74±6.69/−3.24±6.51 mmHg, 0.75±7.44/−4.41±7.42 mmHg, and 4.15±6.15/−0.67±5.23 mmHg for 24-hour, daytime, and nighttime periods respectively. Strong correlations were also observed between the devices, with r=0.725 and r=0.750 for transitions in SBP and DBP from daytime to nighttime, respectively (both p<0.001).
Conclusions
The CART-I Plus device, with its unique ring-type design, shows promising accuracy in BP estimation and offers a potential avenue for continuous BP monitoring in clinical practice.

Keyword

Blood pressure; Blood pressure monitor; ambulatory; Home blood pressure monitoring; Hypertension; Photoplethysmography

Figure

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  Figure 1 The CART-I Plus and the ABPM device. Each participant wore both for a 24H period, each was attached on the same arm.24H = 24-hour; ABPM = ambulatory blood pressure monitoring.

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  Figure 2 Analysis of agreement between CART-I Plus and ABPM for 24H Blood Pressure Monitoring. (A) Bland-Altman plot illustrating the agreement for SBP and DBP during 24H. (B) Bland-Altman plot showcasing the agreement for SBP and DBP during the daytime. (C) Bland-Altman plot highlighting the agreement for SBP and DBP during the nighttime. In each plot, the dashed line indicates the mean difference (bias) between the two devices, while dotted lines mark the 95% LOA.24H = 24-hour; ABPM = ambulatory blood pressure monitoring; DBP = diastolic blood pressure; LOA = limits of agreement; SBP = systolic blood pressure.

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  Figure 3 Comparative analysis between CART-I Plus and ABPM for 24H blood pressure monitoring. (A) Scatter plot illustrating the relationship for SBP and DBP over the entire 24H span. (B) Scatter plot showcasing the correlation for SBP and DBP during daytime hours. (C) Scatter plot highlighting the correlation for SBP and DBP taken at nighttime. The solid line in each plot represents the linear regression best fit, while the dashed line demonstrates the line of identity.24H = 24-hour; ABPM = ambulatory blood pressure monitoring; DBP = diastolic blood pressure; SBP = systolic blood pressure.

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  Figure 4 Comparative analysis between CART-I Plus and ABPM for 24-hour blood pressure monitoring for daytime-nighttime change.ABPM = ambulatory blood pressure monitoring; DBP = diastolic blood pressure; SBP = systolic blood pressure.

Reference

1. Fuchs FD, Whelton PK. High blood pressure and cardiovascular disease. Hypertension. 2020; 75:285–292. PMID: 31865786.

2. Ibrahim B, Jafari R. Cuffless blood pressure monitoring from a wristband with calibration-free algorithms for sensing location based on bio-impedance sensor array and autoencoder. Sci Rep. 2022; 12:319. PMID: 35013376.

3. Kario K, Shimada K, Pickering TG. Abnormal nocturnal blood pressure falls in elderly hypertension: clinical significance and determinants. J Cardiovasc Pharmacol. 2003; 41(Suppl 1):S61–S66. PMID: 12688399.

4. Kario K, Shimada K. Risers and extreme-dippers of nocturnal blood pressure in hypertension: antihypertensive strategy for nocturnal blood pressure. Clin Exp Hypertens. 2004; 26:177–189. PMID: 15038628.

5. Kario K, Pickering TG, Matsuo T, Hoshide S, Schwartz JE, Shimada K. Stroke prognosis and abnormal nocturnal blood pressure falls in older hypertensives. Hypertension. 2001; 38:852–857. PMID: 11641298.

6. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018; 39:3021–3104. PMID: 30165516.

7. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018; 71:e13–115. PMID: 29133356.

8. Sherwood A, Hill LK, Blumenthal JA, Hinderliter AL. The effects of ambulatory blood pressure monitoring on sleep quality in men and women with hypertension: dipper vs. nondipper and race differences. Am J Hypertens. 2019; 32:54–60. PMID: 30204833.

9. Agarwal R, Light RP. The effect of measuring ambulatory blood pressure on nighttime sleep and daytime activity--implications for dipping. Clin J Am Soc Nephrol. 2010; 5:281–285. PMID: 20019118.

10. Davies RJ, Jenkins NE, Stradling JR. Effect of measuring ambulatory blood pressure on sleep and on blood pressure during sleep. BMJ. 1994; 308:820–823. PMID: 8167489.

11. Stergiou GS, Palatini P, Parati G, et al. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens. 2021; 39:1293–1302. PMID: 33710173.

12. Teng X, Zhang YT. Proceedings of the 25th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (IEEE Cat. No.03CH37439). Piscataway (NJ): Institute of Electrical and Electronics Engineers;2003. p. 3153–3156.

13. Elgendi M, Fletcher R, Liang Y, et al. The use of photoplethysmography for assessing hypertension. NPJ Digit Med. 2019; 2:60. PMID: 31388564.

14. Stergiou GS, Mukkamala R, Avolio A, et al. Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2022; 40:1449–1460. PMID: 35708294.

15. El-Hajj C, Kyriacou PA. A review of machine learning techniques in photoplethysmography for the non-invasive cuff-less measurement of blood pressure. Biomed Signal Process Control. 2020; 58:101870.

16. Stergiou GS, Avolio AP, Palatini P, et al. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023; 41:2074–2087. PMID: 37303198.

17. Joung J, Jung CW, Lee HC, et al. Continuous cuffless blood pressure monitoring using photoplethysmography-based PPG2BP-net for high intrasubject blood pressure variations. Sci Rep. 2023; 13:8605. PMID: 37244974.

18. Charmoy A, Würzner G, Ruffieux C, et al. Reactive rise in blood pressure upon cuff inflation: cuff inflation at the arm causes a greater rise in pressure than at the wrist in hypertensive patients. Blood Press Monit. 2007; 12:275–280. PMID: 17890965.

19. International Organization for Standardization (ISO). ISO 81060-2:2018 Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type. Geneva: International Organization for Standardization;2018.

20. Islam SM, Cartledge S, Karmakar C, et al. Validation and acceptability of a cuffless wrist-worn wearable blood pressure monitoring device among users and health care professionals: mixed methods study. JMIR Mhealth Uhealth. 2019; 7:e14706. PMID: 31628788.

21. Nachman D, Gilan A, Goldstein N, et al. Twenty-four-hour ambulatory blood pressure measurement using a novel noninvasive, cuffless, wireless device. Am J Hypertens. 2021; 34:1171–1180. PMID: 34143867.

22. Falter M, Scherrenberg M, Driesen K, et al. Smartwatch-based blood pressure measurement demonstrates insufficient accuracy. Front Cardiovasc Med. 2022; 9:958212. PMID: 35898281.

23. Sola J, Cortes M, Perruchoud D, et al. Guidance for the interpretation of continual cuffless blood pressure data for the diagnosis and management of hypertension. Front Med Technol. 2022; 4:899143. PMID: 35655524.

24. Tan I, Gnanenthiran SR, Chan J, et al. Evaluation of the ability of a commercially available cuffless wearable device to track blood pressure changes. J Hypertens. 2023; 41:1003–1010. PMID: 37016925.

25. Park SW. Prospective, Single-center, Single group, Pivotal clinical trial to evaluate the blood pressure accuracy of ‘CART-I plus’ compared to the reference blood pressure reading with an auscultatory sphygmomanometer. J Korean Med Sci. 2024; [Epub ahead of print].

26. Nwankwo T, Coleman King SM, Ostchega Y, et al. Comparison of 3 devices for 24-hour ambulatory blood pressure monitoring in a nonclinical environment through a randomized trial. Am J Hypertens. 2020; 33:1021–1029. PMID: 32701144.