Validation of a popular consumer-grade cuffless blood pressure device for continuous 24 h monitoring
Bhavini J Bhatt1, Haashim Mohammad Amir1, Siana Jones1
1Institute of Cardiovascular Science, University College London, Gower Street, London WC1E 6BT, UK.
Insights
This study found that a popular wearable blood pressure monitor showed poor agreement with a medical-grade device, suggesting it may not replace standard 24-hour monitoring for hypertension detection.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Hypertension is a major global health concern, with many cases undiagnosed.
- Wearable, cuffless blood pressure (BP) monitors offer potential for widespread BP monitoring.
- The accuracy of consumer-grade wearable BP monitors requires rigorous validation.
Purpose of the Study:
- To validate a consumer-grade wearable BP monitor (W-BPM) against a medical-grade ambulatory BP monitor (A-BPM).
- To assess the accuracy of the W-BPM in identifying high blood pressure.
- To evaluate the W-BPM's ability to measure BP variability and nocturnal dipping.
Main Methods:
- Thirty-one participants simultaneously wore a W-BPM (Aktiia) and an A-BPM (Mobil-O-Graph) for 24 hours.
- Systolic BP (SBP), diastolic BP (DBP), and heart rate (HR) were recorded at set intervals and during rest.
- Agreement was assessed using standard statistical methods, including limits of agreement and correlation coefficients.
Main Results:
- The W-BPM showed poor to moderate agreement with the A-BPM (e.g., limits of agreement ~ -30/+30 mmHg for SBP).
- The W-BPM significantly underestimated BP variability and nocturnal BP dipping.
- Sensitivity and specificity for detecting high BP were approximately 50% and 80%, respectively.
Conclusions:
- The cuffless W-BPM demonstrated low agreement with cuff-based ambulatory monitoring.
- The device may not be a suitable replacement for current gold-standard 24-hour BP monitoring.
- Further research is needed to determine the clinical utility of cuffless BP monitors.
Aims:
Hypertension is a leading cause of death worldwide, yet many hypertensive cases remain undiagnosed. Wearable, cuffless blood pressure (BP) monitors could be deployed at scale, but their accuracy remains undetermined.
Methods And Results:
This study validated a popular consumer-grade wearable BP monitor (W-BPM, Aktiia), using a medical-grade ambulatory device (A-BPM, Mobil-O-Graph), for reference. Thirty-one participants (aged 19-62 years, 17 (55%) females, in office BP 121 ± 15 over 77 ± 12 mmHg) simultaneously wore both devices for 24 h. Systolic BP (SBP), diastolic BP (DBP), and heart rate (HR) were measured in pre-set intervals by the A-BPM and at rest by the W-BPM. Agreement was assessed using standard methods. Accuracy in identifying high BP (mean 24 h SBP/DBP > 130/80 mmHg) was assessed. Compared to A-BMP, mean SBP and DBP tended to be slightly lower during the day and not significantly different at night. Nocturnal BP dipping and BP variability were significantly underestimated by the W-BPM. Agreement between the two devices was poor to moderate (limits of agreement of about -30/+30 mmHg for SBP and -20/+15 mmHg for DBP, correlation coefficients between 0.20 and 0.42). Sensitivity and specificity for high BP detection were around 50% and 80%, respectively. Limiting the analysis to measures taken in similar conditions (within 10 min and with HR within ±10 b.p.m.) did not improve agreement.
Conclusion:
Low agreement suggests that the cuffless device may not be a suitable replacement for standard 24 h cuff-based ambulatory monitoring. Further data are required to assess the clinical role of cuffless BP monitors.
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