Key result
A novel cuffless wrist-monitor provided comparable 24-hour blood pressure measurements to a standard cuff-based device, with a 24-hour bias of -1.1 mm Hg for both DBP and SBP.
Why the study?
Technical limitations, low compliance, and complex procedures limit the use of standard cuff-based devices for ambulatory blood pressure monitoring in hypertension.
Does a novel noninvasive, cuffless, wireless device provide accurate 24-hour ambulatory blood pressure measurements compared to a standard cuff-based device in adult volunteers?
Cross-Sectional (n=28)
Does a novel noninvasive, cuffless, wireless device provide accurate 24-hour ambulatory blood pressure measurements compared to a standard cuff-based device in adult volunteers?
Mean Difference: -1.1
A novel cuffless, wireless wearable device provides comparable 24-hour ambulatory blood pressure measurements to standard cuff-based devices while causing significantly less patient inconvenience.
May enable convenient ambulatory BP monitoring; leaves open rigorous validation before clinical adoption.
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: The cuffless device provides comparable measurements to those obtained with the currently used cuff-based ABPM device, with significantly less inconvenience to the subject. CLINICAL TRIALS REGISTRATION: Trial Number NCT03810586.
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Nachman et al. (2021) conducted a cross-sectional in Hypertension (n=28). Photoplethysmography-based wearable device (Wrist-monitor) vs. Standard cuff-based ABPM device was evaluated on 24-hour bias for diastolic and systolic blood pressure (Bias -1.1 mm Hg). A novel cuffless wrist-monitor provided comparable 24-hour blood pressure measurements to a standard cuff-based device, with a 24-hour bias of -1.1 mm Hg for both DBP and SBP.
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