Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device.

Abstract

Ambulatory blood pressure monitoring (ABPM) using cuff-based devices is used for diagnosis and treatment of hypertension. Technical limitations, low compliance, and complex procedures limit their use. The aim of the present study was to test the accuracy of a new photoplethysmography-based, wearable device (Wrist-monitor) as compared with the standard cuff-based ABPM device. Twenty-four-hour (24H) ABPM was performed in parallel for both devices on volunteers aged 18-65 years, while documenting their daily activities. Level of comfort and activity disturbance of both devices were recorded. Linear regression and Bland-Altman were used to evaluate the agreement between devices. Receiver operating characteristic (ROC) curve analysis was used to classify hypertension based on the average Wrist-monitor measurements as compared with a cuff-based ABPM device. The study included 28 subjects (18 men) mean age 41.5 ± 16.2 years. Bland-Altman analysis resulted in 24H bias of -1.1 mm Hg for both diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean daytime bias was -1.9 mm Hg for DBP and SBP, while nighttime bias was smaller (0.7 and 0.4 mm Hg for DBP and SBP, respectively). ROC curve analysis yielded a mean area under the curve (AUC) of 1 for SBP and 24H blood pressure measurements. AUCs of 0.994 and 0.955 were found for the daytime DBP and night DBP, respectively. 24H ABPM with the Wrist-monitor caused significantly less inconvenience compared with the cuff-based device (P < 0.001). The cuffless device provides comparable measurements to those obtained with the currently used cuff-based ABPM device, with significantly less inconvenience to the subject. Trial Number NCT03810586.