Service of Nephrology and Hypertension, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Aktiia SA, Neuchâtel, Switzerland.
Blood Press. 2023 Dec;32(1):2281320. doi: 10.1080/08037051.2023.2281320. Epub 2023 Nov 16.
Accurate blood pressure (BP) measurement is essential for the correct diagnosis and management of hypertension (HTN) especially in the elderly population. As with of all BP devices, the accuracy of cuffless devices must be verified. This study (NCT04027777) aimed to evaluate the performance of a wrist cuffless optical BP device in an elderly population cohort in different body positions with auscultation as the reference measurement.
Patients aged 65-85 years with different BP categories but without diabetes were recruited. After an initial calibration based on auscultatory measurements, BP estimation from the Aktiia Bracelet (Aktiia SA, Switzerland) were compared to reference double-blinded auscultatory measurements in sitting, standing and lying positions on four separate visits distributed over one month. In the absence of a universal standard for cuffless BP device at the time of the study, modified ISO81060-2 criteria were used for performance analysis.
Thirty-five participants were included in the analysis fulfilling the inclusion requirements of ISO 81060-2. A total of 469 paired measurements were obtained with overall 83% acceptance rate. Differences (mean ± SD) between Aktiia Bracelet and auscultation for systolic BP were -0.26 ± 9.96 mmHg for all body positions aggregated (sitting 1.23 ± 7.88 mmHg, standing -1.81 ± 11.11 mmHg, lying -1.8 ± 9.96 mmHg). Similarly, differences for diastolic BP were -0.75 ± 7.0 mmHg (0.2 ± 5.55 mmHg, -5.35 ± 7.75 mmHg and -0.94 ± 7.47 mmHg, respectively). Standard deviation of the averaged differences per subject for systolic/diastolic BP was 3.8/2.5 mmHg in sitting and 4.4/3.7 mmHg for all body positions aggregated.
Overall, this study demonstrates a similar performance of the Aktiia Bracelet compared to auscultation in an elderly population in body positions representative of daily activities. The use of more comfortable, non-invasive, and non-occlusive BP monitors during long periods may facilitate e-health and may contribute to better management of HTN, including diagnosis and treatment of HTN, in the elderly.
准确的血压（BP）测量对于高血压（HTN）的正确诊断和管理至关重要，尤其是在老年人群中。与所有血压设备一样，无袖带设备的准确性必须经过验证。本研究（NCT04027777）旨在评估腕部无袖带光学血压设备在不同体位的老年人群中的性能，以听诊作为参考测量。
招募了年龄在 65-85 岁之间、血压类别不同但无糖尿病的患者。在基于听诊测量的初始校准后，将 Aktiia Bracelet（Aktiia SA，瑞士）的血压估计值与在 1 个月内 4 次单独就诊时的坐、站和躺位的双盲听诊参考测量值进行比较。在研究时，尚无通用的无袖带血压设备标准，因此使用了修改后的 ISO81060-2 标准进行性能分析。
35 名符合 ISO 81060-2 纳入标准的参与者被纳入分析。总共获得了 469 对配对测量值，总体接受率为 83%。Aktiia Bracelet 与听诊测量的收缩压差异在所有体位汇总时为-0.26±9.96mmHg（坐位为 1.23±7.88mmHg，站位为-1.81±11.11mmHg，卧位为-1.80±9.96mmHg）。类似地，舒张压差异为-0.75±7.0mmHg（0.20±5.55mmHg，卧位为-5.35±7.75mmHg，卧位为-0.94±7.47mmHg）。每个受试者平均差异的标准差为坐位收缩压/舒张压为 3.8/2.5mmHg，所有体位汇总时为 4.4/3.7mmHg。
总的来说，这项研究表明，在代表日常活动的体位中，Aktiia Bracelet 在老年人群中的表现与听诊相似。在较长时间内使用更舒适、非侵入性和非闭塞性的血压监测器可能有助于电子健康，并有助于更好地管理高血压，包括老年人的高血压诊断和治疗。
