Accuracy and User Acceptability of 24-hour Ambulatory Blood Pressure Monitoring by a Prototype Cuffless Multi-Sensor Device Compared to a Conventional Oscillometric Device

Abstract Objective 24-hour ambulatory blood pressure monitoring (24ABPM) is state of the art in out-of-office blood pressure (BP) monitoring. Due to discomfort and technical limitations related to cuff-based 24ABPM devices, methods for non-invasive and continuous estimation of BP without the need for a cuff have gained interest. The main aims of the present study were to compare accuracy of a pulse arrival time (PAT) based BP-model and user acceptability of a prototype cuffless multi-sensor device (cuffless device), developed by Aidee Health AS, with a conventional cuff-based oscillometric device (ReferenceBP) during 24ABPM. Methods Ninety-five normotensive and hypertensive adults underwent simultaneous 24ABPM with the cuffless device on the chest and a conventional cuff-based oscillometric device on the non-dominant arm. PAT was calculated using the electrocardiogram (ECG) and photoplethysmography (PPG) sensors incorporated in the chest-worn device. The cuffless device recorded continuously, while ReferenceBP measurements were taken every 20 minutes during daytime and every 30 minutes during nighttime. Two-minute PAT-based BP predictions corresponding to the ReferenceBP measurements were compared with ReferenceBP measurements using paired t-tests, bias, and limits of agreement. Results Mean (SD) of ReferenceBP compared to PAT-based daytime and nighttime systolic BP (SBP) were 129.7 (13.8) mmHg versus 133.6 (20.9) mmHg and 113.1 (16.5) mmHg versus 131.9 (23.4) mmHg. Ninety-five % limits of agreements were [-26.7, 34.6 mmHg] and [-20.9, 58.4 mmHg] for daytime and nighttime SBP respectively. The cuffless device was reported to be significantly more comfortable and less disturbing than the ReferenceBP device during 24ABPM. Conclusions In the present study, we demonstrated that a general PAT-based BP model had unsatisfactory agreement with ambulatory BP during 24ABPM, especially during nighttime. If sufficient accuracy can be achieved, cuffless BP devices have promising potential for clinical assessment of BP due to the opportunities provided by continuous BP measurements during real-life conditions and high user acceptability. Plain Language Summary What is the context? Hypertension is a major risk factor for cardiovascular and cerebrovascular end-organ damage, morbidity, and mortality world-wide. Accurate measurement of blood pressure is essential for the diagnosis and management of hypertension. What is new? Cuffless blood pressure devices that allow measurement of blood pressure without a pressure cuff is a promising and novel method of blood pressure estimation. The objective of this study is to assess whether pulse arrival time alone can be used to estimate blood pressure accurately during 24-hour ambulatory blood pressure monitoring, using a prototype cuffless device placed on the chest. Our analysis shows that a general model based on pulse arrival time overestimated ambulatory blood pressure, especially during nighttime. User acceptability was higher with the cuffless device compared to a conventional cuff-based oscillometric device during 24-hour ambulatory blood pressure monitoring. What is the impact? This study provides further evidence that accurate blood pressure estimations cannot be achieved by using pulse arrival time alone as a surrogate for blood pressure measurements.