Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol...

Area of Science:

• Biomedical Engineering
• Cardiovascular Technology
• Medical Devices

Background:

• Accurate blood pressure (BP) monitoring is crucial for cardiovascular health management.
• Traditional BP measurement methods can be invasive or cumbersome.
• Noninvasive, cuffless BP monitoring offers potential for improved patient convenience and continuous tracking.

Purpose of the Study:

• To evaluate the accuracy and precision of the Aktiia Bracelet, a CE-marked noninvasive optical BP monitor.
• To assess the device's performance over a 1-month period in a clinical setting.
• To determine if the Aktiia Bracelet meets established validation criteria for BP measurement devices.

Main Methods:

• The study involved participants aged 21-65 years, adhering to ISO81060-2:2013 standards adapted for cuffless devices.
• Simultaneous BP measurements were taken using the Aktiia Bracelet and dual-blinded auscultation.
• Optical signals were processed by the Aktiia Bracelet algorithms for quality checks and BP estimation, calibrated using reference measurements.

Main Results:

• Eighty-six participants were analyzed, with mean differences of 0.46 ± 7.75 mmHg for systolic BP (SBP) and 0.39 ± 6.86 mmHg for diastolic BP (DBP).
• The standard deviation of averaged paired differences per subject met ISO81060-2 criteria, with 3.9 mmHg for SBP and 3.6 mmHg for DBP.
• The Aktiia Bracelet demonstrated high accuracy and precision, satisfying key validation criteria.

Conclusions:

• The Aktiia Bracelet achieved overall accuracy meeting ISO81060-2 validation criteria 1 and 2 after initialization and over 1 month.
• The device proved accurate and precise for blood pressure measurement in the sitting position.
• The Aktiia Bracelet is recommended for blood pressure monitoring in the adult population.