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. 2023 Dec 1;41(12):2074-2087.
doi: 10.1097/HJH.0000000000003483. Epub 2023 Jun 22.

European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

George S Stergiou  1 , Alberto P Avolio  2 , Paolo Palatini  3 , Konstantinos G Kyriakoulis  1 , Aletta E Schutte  4 , Stephan Mieke  5 , Anastasios Kollias  1 , Gianfranco Parati  6   7 , Roland Asmar  8 , Nikos Pantazis  9 , Achilleas Stamoulopoulos  9 , Kei Asayama  10 , Paolo Castiglioni  11 , Alejandro De La Sierra  12 , Jin-Oh Hahn  13 , Kazuomi Kario  14 , Richard J McManus  15 , Martin Myers  16 , Takayoshi Ohkubo  10 , Sanjeev G Shroff  17 , Isabella Tan  18 , Jiguang Wang  19 , Yuanting Zhang  20 , Reinhold Kreutz  21 , Eoin O'Brien  22 , Ramakrishna Mukkamala  23
Affiliations

European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

George S Stergiou et al. J Hypertens. .

Abstract

Background: There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use.

Objective: This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common.

Validation procedures: Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position.

Conclusion: The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.

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References

    1. Stergiou GS, Mukkamala R, Avolio A, Kyriakoulis KG, Mieke S, Murray A, et al. Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens 2022; 40:1449–1460.
    1. Schutte AE. The promise and pitfalls of novel cuffless blood pressure devices. Eur Heart J 2022; 43:4222–4223.
    1. Mukkamala R, Shroff SG, Landry C, Kyriakoulis KG, Avolio AP, Stergiou GS. The Microsoft Research Aurora Project: important findings on cuffless blood pressure measurement. Hypertension 2023; 80:534–540.
    1. Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. A Universal Standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens 2018; 36:472–478.
    1. Noninvasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type. International Organization for Standardization (ISO) 81060-2:2018. www.iso.org . [Accessed 15 April 2023].

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