van Vliet Mariska, Aalberts Jan J J, Hamelinck Cora, Hauer Arnaud D, Hoftijzer Dieke, Monnink Stefan H J, Schipper Jurjan C, Constandse Jan C, Peters Nicholas S, Lip Gregory Y H, Steinhubl Steven R, Ronner Eelko
Department of Cardiology, Reinier the Graaf Hospital, Reinier de Graafweg 5, 2625 AD Delft, The Netherlands.
National Heart and Lung Institute, Imperial College London, London, UK.
Eur Heart J Digit Health. 2025 Mar 27;6(4):763-771. doi: 10.1093/ehjdh/ztaf027. eCollection 2025 Jul.
AIMS: Cardiovascular diseases are a global health crisis, with hypertension as a significant risk factor. Traditional cuff-based blood pressure measurements have various limitations, prompting the exploration of photoplethysmography as an alternative for continuous monitoring. This study aimed to assess a cuff-calibrated wrist-worn photoplethysmography-based blood pressure device against European Society of Hypertension recommendations. METHODS AND RESULTS: The study assessed photoplethysmography-based blood pressure measurement stability over 28 days in 150 patients by comparing measurements of the wrist-worn photoplethysmography-based device against three daily automated reference blood pressure measurements. Additionally, awake-asleep blood pressure changes were analysed in 40 patients receiving 24-h ambulatory blood pressure monitoring. Data analysis included overall accuracy and recalibration needs during long-term monitoring, the accuracy of monitoring awake-asleep blood pressure changes, and resilience against hydrostatic pressure changes due to variations in device position. Across 28 days, mean errors of 3.84 mmHg (SD 4.46) for systolic and 4.08 mmHg (SD 3.97) for diastolic blood pressure were achieved. Before recalibration on Day 28, mean errors were 2.49 (SD 3.10) for systolic and 2.98 (SD 3.48) for diastolic blood pressure. Awake-asleep blood pressure change accuracy was demonstrated with mean errors of 2.36 (SD ± 2.40) for systolic and 2.17 (SD ± 2.13) for diastolic blood pressure. Hydrostatic pressure testing indicated resilience against changes in device position. CONCLUSION: The studied wrist-worn photoplethysmography-based device demonstrated accurate and stable blood pressure monitoring over 28 days, during awake-asleep blood pressure changes and hydrostatic pressure changes. These findings support the device's potential for remote patient monitoring. STUDY REGISTRATION: ClinicalTrials.gov identifier: NCT05899959.
目的:心血管疾病是一场全球健康危机,高血压是一个重要的风险因素。传统的基于袖带的血压测量存在各种局限性,这促使人们探索将光电容积脉搏波描记法作为连续监测的替代方法。本研究旨在根据欧洲高血压学会的建议,评估一种经袖带校准的基于手腕佩戴式光电容积脉搏波描记法的血压设备。 方法与结果:该研究通过将基于手腕佩戴式光电容积脉搏波描记法的设备测量值与每日三次自动参考血压测量值进行比较,评估了150名患者在28天内基于光电容积脉搏波描记法的血压测量稳定性。此外,对40名接受24小时动态血压监测的患者的清醒-睡眠血压变化进行了分析。数据分析包括长期监测期间的总体准确性和重新校准需求、监测清醒-睡眠血压变化的准确性以及因设备位置变化而对静水压力变化的耐受性。在28天内,收缩压平均误差为3.84 mmHg(标准差4.46),舒张压平均误差为4.08 mmHg(标准差3.97)。在第28天重新校准之前,收缩压平均误差为2.49(标准差3.10),舒张压平均误差为2.98(标准差3.48)。清醒-睡眠血压变化准确性得到证实,收缩压平均误差为2.36(标准差±2.40),舒张压平均误差为2.17(标准差±2.13)。静水压力测试表明该设备对设备位置变化具有耐受性。 结论:所研究的基于手腕佩戴式光电容积脉搏波描记法的设备在28天内、清醒-睡眠血压变化以及静水压力变化期间均显示出准确且稳定的血压监测。这些发现支持了该设备用于远程患者监测的潜力。 研究注册:ClinicalTrials.gov标识符:NCT05899959。
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