Performance of the Aktiia optical blood pressure measurement device in the elderly: a comparison with double blinded auscultation in different body positions

Abstract

Background:

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.

Design and methods

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.

Results

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.

Conclusions

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.

Plain language summary

Accuracy of blood pressure measurements is essential in the diagnosis and the follow-up of patients with high blood pressure. As with any blood pressure measuring device, a validation is necessary. In this study including a elderly population, we compared values obtained by the cuffless Aktiia Bracelet (Aktiia SA, Switzerland) after an initial calibration with the reference auscultatory method during four separate study days distributed over one month. We show that the accuracy of the Aktiia Bracelet is similar to auscultation. The accuracy varies depending on the position in which the measurement is performed. Overall, the accuracy is not modified by a higher age category. The use of a cuffless device in the elderly population characterized by high prevalence of hypertension may facilitate the follow-up of blood pressure with more comfort and minimal constraints.

Keywords:

• elderly
• cuffless
• blood pressure measurement
• auscultatory

Acknowledgements

We wish to thank the auscultation team of nurses from of the Service of nephrology and hypertension at Lausanne University Hospital, which realised an outstanding long-run performance. We thank also Sibylle Fallet for the valuable discussions.

Authorship

Conception or design of the work: GW, JS and PV

Acquisition, analysis, or interpretation of data for the work: KT, JS, AD, TPA, AP, JA, PV and GW

Drafting the work or reviewing it critically for important intellectual content; KT, JS, AD, TPA, PV and GW

Final approval of the version to be published; all

Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: JS, PV, TPA and GW

Additional information

Funding

This study was supported by Aktiia SA