Abstract
A cuffless blood pressure (BP) device (TestBP) using pulse transit time is in clinical use, but leads to higher BP values compared to a cuff-based 24 h-BP reference device (RefBP). We evaluated the impact of a recent software update on BP results and TestBP’s ability to differentiate between normo- and hypertension. 71 individuals had TestBP (Somnotouch-NIBP) and RefBP measurements simultaneously performed on either arm. TestBP results with software version V1.5 were compared to V1.4 and RefBP. Mean 24 h (± SD) BP for the RefBP, TestBP-V1.4 and TestBP-V1.5 were systolic 134.0 (± 17.3), 140.8 (± 20) and 139.1 (± 20) mmHg, and diastolic 79.3 (± 11.7), 85.8 (± 14.1) and 83.5 (± 13.0) mmHg, respectively (p-values < 0.001). TestBP-V1.5 area under the curve (95% confidence interval) versus RefBP for hypertension detection was 0.92 (0.86; 0.99), 0.94 (0.88; 0.99) and 0.77 (0.66; 0.88) for systolic and 0.92 (0.86; 0.99), 0.92 (0.85; 0.99) and 0.84 (0.74; 0.94) for diastolic 24 h, awake and asleep BP respectively. TestBP-V1.5 detected elevated systolic/diastolic mean 24 h-BP with a 95%/90% sensitivity and 65%/70% specificity. Highest Youden’s Index was systolic 133 (sensitivity 95%/specificity 80%) and diastolic 87 mmHg (sensitivity 81%/specificity 98%). The update improved the agreement to RefBP. TestBP was excellent for detecting 24 h and awake hypertensive BP values but not for asleep BP values.
Highlights
Hypertension is a global healthcare burden and the most important modifiable risk factor for cardiovascular disease and stroke[1]
The novelty of this study was that the measurements took place over a 24 h period with both devices simultaneously worn by the participant, capturing BP measurement (BPM) during daily activities and sleep
We showed a significant difference in all measurements, with the most divergence seen during assessment of blood pressure during sleep
Summary
Hypertension is a global healthcare burden and the most important modifiable risk factor for cardiovascular disease and stroke[1]. Different guidelines recommend non-invasive oscillometric, cuff-based, 24 h ambulatory BP pressure monitoring for the accurate diagnosis of arterial hypertension using validated d evices[2,3]. After initial calibration with a standard cuff-based measurement, this standard validation technique is carried out over an approximate 25-min period in a non-stimulating environment. This setting does not represent the usual circumstances with which the device is used, namely over a 24 h period with normal activities. We compared the cuffless device (TestBP) to a standard cuff-based device (RefBP). The cuffless device revealed systematically higher systolic and diastolic values, especially during the asleep phase. We evaluated diagnostic accuracy for the detection of hypertensive BP values to give clinical guidance and possibly derive device specific cut-off values against the gold standard (RefBP)
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