Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device

Dean Nachman, Yftach Gepner, Nir Goldstein, Eli Kabakov, Arik Ben Ishay, Romi Littman, Yuval Azmon, Eli Jaffe, Arik Eisenkraft, Dean Nachman, Yftach Gepner, Nir Goldstein, Eli Kabakov, Arik Ben Ishay, Romi Littman, Yuval Azmon, Eli Jaffe, Arik Eisenkraft

Abstract

Repeated blood pressure (BP) measurements allow better control of hypertension. Current measurements rely on cuff-based devices. The aim of the present study was to compare BP measurements using a novel cuff-less photoplethysmography-based device to a standard sphygmomanometer device. Males and females were recruited from within the general population who arrived at a public BP screening station. One to two measurements were taken from each using a sphygmomanometer-based and the photoplethysmography-based devices. Devices were considered equal if the mean difference between paired measurements was below 5 mmHg and the Standard Deviation (SD) was no greater than 8 mmHg. Agreement and reliability analyses were also performed. 1057 subjects were included in the study analysis. There were no adverse events during the study. The mean (± SD) difference between paired measurements for all subjects was -0.1 ± 3.6 mmHg for the systolic and 0.0 ± 3.5 mmHg for the diastolic readings. We found 96.31% agreement in identifying hypertension and an Interclass Correlation Coefficient of 0.99 and 0.97 for systolic and diastolic measurements, respectively. The photoplethysmography-based device was found similar to the gold-standard sphygmomanometer-based device with high agreement and reliability levels. The device might enable a reliable, more convenient method for repeated BP monitoring.

Conflict of interest statement

A.E., A.B.I. and R.L. are employed by Biobeat Technologies Ltd. All other authors report no potential conflicts of interest.

Figures

Figure 1
Figure 1
The Biobeat BB-613WP device. This PPG-based wearable provides non-invasive, cuffless, wireless and repeated measurement of blood pressure, heart rate, saturation, respiratory rate, stroke volume, cardiac output, cardiac index, systemic vascular resistance, pulse pressure, heart rate variability, mean arterial pressure, skin temperature, sweat, movement, and calories. Data is transmitted in real-time to a user App and to a medical management system. (A) The face side. (B) The back side with integrated sensors.
Figure 2
Figure 2
Percentage of measurements with a delta of less than 5, 5–7, 7–10 or above 10 mmHg between the reference device and the BB-613WP systolic measurements. Sys1 first systolic measurement. Sys2 second systolic measurement.
Figure 3
Figure 3
Bland Altman agreement plot of the first blood pressure measurement (n = 1057). (A) Systolic blood pressure. (B) Diastolic blood pressure.
Figure 4
Figure 4
Bland Altman agreement plot of the second blood pressure measurement (n = 491). (A) Systolic blood pressure. (B) Diastolic blood pressure.
Figure 5
Figure 5
ROC curves analysis illustrating the diagnostic ability of the BB-613WP device in comparison to the standard reference method (sphygmomanometer device).
Figure 6
Figure 6
Description of the different stages of the study.

References

    1. Weir, M.R. In the clinic: hypertension. Ann. Intern. Med. 161, ITC1–15 (2014).
    1. Flint AC, et al. Effect of systolic and diastolic blood pressure on cardiovascular outcomes. N. Engl. J. Med. 2019;381:243–251.
    1. Rapsomaniki E, et al. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014;383:1899–911.
    1. Aylett M, et al. Evaluation of normal and large sphygmomanometer cuffs using the Omron 705CP. J. Hum. Hypertens. 2001;15:131–134.
    1. Beevers DG, et al. Standards for blood pressure measuring devices. BMJ (Clin Res Ed) 1987;294:1614.
    1. Schoot TS, et al. A new cuffless device for measuring blood pressure: a real-life validation study. J. Med. Internet. Res. 2016;18:e85.
    1. Ruzicka M, Hiremath S. Accuracy-limiting factor of home blood pressure monitors? Am. J. Hypertens. 2017;30:661–664.
    1. Solá, J., et al. Wearable PWV technologies to measure Blood Pressure: eliminating brachial cuffs. In 2013 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society 4098–4101 (2013).
    1. Kronish IM, et al. Barriers to conducting ambulatory and home blood pressure monitoring during hypertension screening in the United States. J. Am. Soc. Hypertens. 2017;11:573–580.
    1. Pickering TG, et al. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005;111:697–716.
    1. Forouzanfar MH, et al. Global burden of hypertension and systolic blood pressure of at least 110 to 115 mm Hg, 1990–2015. JAMA. 2017;317:165–182.
    1. Greenland P, Peterson E. The new 2017 ACC/AHA guidelines “up the pressure” on diagnosis and treatment of hypertension. JAMA. 2017;318:2083–2084.
    1. Cifu AS, Davis AM. Prevention, detection, evaluation, and management of high blood pressure in adults. JAMA. 2017;318:2132–2134.
    1. Whelton PK, et al. 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–e115.
    1. Whelton PK, et al. 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. J. Am. Coll. Cardiol. 2018;71:2199–2269.
    1. Ding XR. Continuous blood pressure measurement from invasive to unobtrusive: celebration of 200th birth anniversary of Carl-Ludwig. IEEE J. Biomed. Health Inform. 2016;20:1455–1465.
    1. Muntner P, et al. Potential US population impact of the 2017 American College of Cardiology/American Heart Association High Blood Pressure Guideline. Circulation. 2018;137:109–118.
    1. Ioannidis JPA. Diagnosis and treatment of hypertension in the 2017 ACC/AHA guidelines and in the realworld. JAMA. 2018;319:115–116.
    1. Danaei G, et al. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009;6:e1000058.
    1. Roerecke M, et al. Comparing automated office blood pressure readings with other methods of blood pressure measurement for identifying patients with possible hypertension: a systematic review and meta-analysis. JAMA Intern. Med. 2019;179:351–362.
    1. Leung AA, et al. CHEP Guidelines Task Force. Hypertension Canada’s 2016 Canadian Hypertension Education Program guidelines for blood pressure measurement, diagnosis, assessment of risk, prevention, and treatment of hypertension. Can. J. Cardiol. 2016;32:569–88.
    1. Myers MG. The great myth of office blood pressure measurement. J. Hypertens. 2012;30:1894–1898.
    1. Myers MG. A short history of automated office blood pressure—15 years to SPRINT. J. Clin. Hypertens. (Greenwich) 2016;18:721–724.
    1. de la Sierra A, et al. Ambulatory blood pressure in hypertensive patients with inclusion criteria for the SPRINT trial. J. Am. Soc. Hypertens. 2016;10:947–953.
    1. ISO 81060-2:2013. Non-invasive Sphygmomanometers—Part 2: Clinical Investigation of Automated Measurement Type.
    1. Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J. Chiropr. Med. 2016;15:155–163.

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