24-HOUR AMBULTORY BLOOD PRESSURE MEASUREMENT USING A NOVEL NON-INVASIVE, CUFF-LESS, WIRELESS DEVICE

Abstract

Objective: Ambulatory blood pressure monitoring (ABPM) using cuff-based devices is used for the 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 (PPG)-based, wearable device (Wrist-monitor) as compared to the standard cuff-based ABPM device. Design and method: 24H ABPM was performed in parallel for both devices on volunteers aged 18–65 years while documenting their daily activities. The 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 to a cuff-based ABPM device. Results: The study included 28 subjects (18 men) mean age of 41.5 ± 16.2 years. The Bland-Altman analysis resulted in a 24H bias of -1.1 mmHg for both diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean daytime bias was -1.9 mmHg for DBP and SBP, while nighttime bias was smaller (0.7 and 0.4 mmHg for DBP and SBP respectively). ROC curve analysis yielded a mean area under the curve (AUC) of 1 for SBP and 24H BP 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 to the cuff-based device (p < 0.001). Conclusions: The cuff-less device provides comparable measurements to those obtained with the currently used cuff-based ABPM device, with significantly less inconvenience to the subject.