Abstract
Abstract Background Ambulatory Blood Pressure Monitoring is of high added value in determining blood pressure, but also highly relevant quantitatively, as hypertension is the single most common medical condition. Unfortunately, practical and qualitative limitations are numerous. Purpose To determine the accuracy of a novel wrist-worn cuff-calibrated photoplethysmography (PPG)-based remote patient monitoring device versus ambulatory blood pressure monitoring (ABPM). Methods The single-center prospective study included 40 adult patients with standard 24-hour ABPM with a 30-minute measurements. Participants used a wrist-worn PPG device during the ABPM period. Measurements of the average difference and standard deviation (SD) for the full 24-hour period as well as for awake and asleep periods were compared. Differences in awake-asleep BP change between the investigational and reference device were described for all, and per nighttime BP dipper category. And also, investigational BP monitoring accuracy under motion will be visualised. Results During the 24-hour period the absolute difference in average SBP and DBP was 3.65 (SD±4.57) and 2.98 (SD±3.91), respectively. Similar results were found for the subsets of day- and nighttime determinations. The absolute difference in average awake-asleep BP change was 2.36 (SD ± 2.40) for SBP and 2.17 (SD ± 2.13) for DBP. Comparable absolute differences were present within each of the nighttime dipper categories. The performance of the investigational device remained stable during motion. Conclusions This study demonstrates initial evidence supporting the accuracy of the evaluated wrist-worn PPG-based device in measuring 24-hour as well as day- and nighttime BP. In the average difference and SD remained within ISO-81060-2:2018 cut-off values from recent ESH guidelines. Therefore, the presented method can provide an accurate and more patient friendly alternative to ABPM.
Published Version
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