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. 2022 Mar 19;12(3):749.
doi: 10.3390/diagnostics12030749.

Comparability of a Blood-Pressure-Monitoring Smartphone Application with Conventional Measurements-A Pilot Study

Annina S Vischer  1 , Jana Rosania  1 , Thenral Socrates  1 , Christina Blaschke  1 , Jens Eckstein  2 , Yara-Maria Proust  3 , Guillaume Bonnier  3 , Martin Proença  3 , Mathieu Lemay  3 , Thilo Burkard  1   4
Affiliations

Comparability of a Blood-Pressure-Monitoring Smartphone Application with Conventional Measurements-A Pilot Study

Annina S Vischer et al. Diagnostics (Basel). .

Abstract

(1) Background: New cuffless technologies attempting blood-pressure measurements (BPM) offer possibilities to improve hypertension awareness and control. The aim of this study was to compare a smartphone application (app)-based algorithm with office BPM (OBPM). (2) Methods: We included consecutive patients with an indication for ambulatory BPM. The smartphone app (RIVA digital) acquired the pulse wave in the fingers’ arterial bed using the phone’s camera and estimated BP based on photoplethysmographic (PPG) waveforms. Measurements were alternatingly taken with an oscillometric cuff-based device and smartphone BPM (AppBP) on two consecutive days. AppBP were calibrated to the first OBPM. Each AppBP was compared to its CuffBP (mean of the previous/following OBPM). (3) Results: 50 participants were included, resulting in 50 AppBP values on Day 1 and 33 on Day 2 after exclusion of 225 AppBP due to insufficient quality. The mean ± SD of the differences between AppBP and CuffBP was 0.7 ± 9.4/1.0 ± 4.5 mmHg (p-value 0.739/0.201) on Day 1 and 2.6 ± 8.2/1.3 ± 4.1 mmHg (p-value 0.106/0.091) on Day 2 for systolic/diastolic values, respectively. There were no significant differences between the deviations on Day 1 and Day 2 (p-value 0.297/0.533 for systolic/diastolic values). Overall, there were 10 (12%) systolic measurement pairs differing by >15 mmHg. (4) Conclusions: In this pilot evaluation, the RIVA Digital app shows promising results when compared to oscillometric cuff-based measurements, especially regarding diastolic values. Its differences between AppBP−CuffBP have a good stability one day after calibration. Before clinical use, signal acquisition needs improvement and the algorithm needs to undergo formal validation against a gold-standard BPM method.

Keywords: arterial hypertension; blood-pressure measurement; blood-pressure monitoring; diagnostic techniques; monitoring; new technologies; smartphone application.

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Conflict of interest statement

A.S.V. and T.B. have received funding for this study from CSEM. Y.-M.P., G.B., M.P. and M.L. are with CSEM, the owner of the pulse-wave analysis technology used in the algorithm tested in the present study and assignee of the corresponding patent application (WO2016138965A1), of which M.P. and M.L. are inventors.

Figures

Figure 1
Figure 1
Blood-pressure measurement procedure applied in this trial. OBPM: (oscillometric) office blood-pressure measurement; AppBP: app-based blood-pressure measurement; CuffBP: cuff-based blood-pressure measurement: mean between two adjacent OBPM.
Figure 2
Figure 2
Bland–Altman plots comparing the mean of AppBP and CuffBP (x-axis) with the difference AppBP–CuffBP (y-axis). Uncalibrated AppBP Day 1 and Day 2: panels (A,B); calibrated AppBP, Day 1 and Day 2: panels (C,D); calibrated AppBP, Day 1: panels (E,F); calibrated AppBP, Day 2: panels (G,H). Systolic values: panels (A,C,E,G); diastolic values: panels (B,D,F,H).
Figure 3
Figure 3
Fail criteria for the AAMI/ESH/ISO validation protocol. The red line indicates the maximal allowed SD, the black line the minimally possible SD for the included AppBP–CuffBP differences. Uncalibrated AppBP: criterion 1: panel (A,B); Calibrated AppBP: criterion 1: panel (C,D); criterion 2: panel (E,F). Systolic values: panel (A,C,E); diastolic values: panel (B,D,F).
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