Ambulatory blood pressure monitoring by a novel cuffless device: a pilot study

Filippo Scalise1,2, Davide Margonato2, Andrea Sole2

  • 1European Society of Hypertension, Excellence Center, Istituto Clinico Verano Brianza, Policlinico di Monza, Monza, Italy.

Blood Pressure
|July 2, 2020
PubMed

Insights

Cuffless blood pressure (CL-BP) devices offer an alternative to traditional cuff-based (C-BP) monitoring. A new CL-BP device showed moderate accuracy, with improved precision in male and overweight individuals.

Area of Science:

  • Biomedical Engineering
  • Cardiovascular Technology
  • Medical Devices

Background:

  • Cuff-based blood pressure (BP) measurement is the standard but can be cumbersome for continuous monitoring.
  • Cuffless blood pressure (CL-BP) devices are emerging as a potential alternative for ambulatory BP monitoring.
  • Assessing the accuracy of novel CL-BP devices against established methods is crucial for clinical adoption.

Purpose of the Study:

  • To evaluate the accuracy of a new cuffless blood pressure (CL-BP) device compared to a standard cuff-occlusion-based (C-BP) device.
  • To assess the performance of the CL-BP device for 24-hour ambulatory blood pressure monitoring.
  • To identify demographic factors influencing the accuracy of CL-BP measurements.

Main Methods:

  • Eighty-four patients underwent simultaneous 24-hour BP monitoring using both a new CL-BP device and a standard oscillometric C-BP device.
  • Data analysis included calculation of 24-hour mean systolic BP (SBP), diastolic BP (DBP), and heart rate (HR).
  • Pearson correlation coefficients and Bland-Altman plots were used to compare measurements from both devices, with subgroup analysis based on BMI and sex.

Main Results:

  • The CL-BP device yielded higher mean 24-hour SBP (131.1 ± 15.9 mmHg) and DBP (80.2 ± 9.7 mmHg) compared to the C-BP device (125.4 ± 10.9 / 75 ± 8.3 mmHg).
  • Significant, moderate correlations were observed between CL-BP and C-BP measurements (SBP: r=0.58, DBP: r=0.65).
  • Accuracy, indicated by higher correlation coefficients, was better in male (SBP: r=0.71, DBP: r=0.77) and overweight (BMI > 25) patients (SBP: r=0.65, DBP: r=0.70) compared to females and normal-weight individuals.

Conclusions:

  • The evaluated CL-BP device demonstrated a moderate correlation with standard C-BP measurements for 24-hour ambulatory monitoring.
  • The device's accuracy was found to be influenced by patient characteristics, performing better in males and individuals with a BMI greater than 25.
  • Further research and device refinement are needed to enhance the accuracy and reliability of cuffless BP monitoring technologies.
Abstract

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