Validation of the Withings BPM Core Device for Self-Blood Pressure Measurements in General Population According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard

Zoya Hakobyan,1 Parounak Zelveian,1 Jirar Topouchian,2 Lusine Hazarapetyan,1,3 Roland Asmar4 1Institute of Cardiology After Levon Hovhannisyan, Yerevan, Armenia; 2Diagnosis and Therapeutic Center, Hôtel Dieu Hospital, Paris, France; 3Yerevan State Medical University After Mkhitar Heratsi, Yerevan, Armenia; 4Foundation-Medical Research Institutes (F-MRI), Geneva, SwitzerlandCorrespondence: Roland Asmar, Foundation-Medical Research Institutes, Place St Gervais 1, Geneva, Switzerland, Tel +33640142239, Email ra@cmcv.orgBackground: Most of the scientific societies recommend assessing the accuracy of electronic devices for blood pressure (BP) measurements using established validation protocol.Objective: To determine the accuracy of the BP measurements using the Withings BPM Core device in the general population according to the “Universal Standard (ISO 81060-2:2018/AMD 1:2020)”.Methods: The Withings BPM Core is an oscillometric device measuring BP at the brachial level. The study was performed according to the “Universal Standard (ISO 81060-2:2018/AMD 1:2020) protocol” using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were included. Analysis was performed as required by the Universal protocol using Criterion 1 – differences between observers’ mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD); and Criterion 2 – The SD of the mean BP differences between the test device and reference BP per subject.Results: Eighty-six subjects were selected, 85 of whom were included. The mean BP differences between the simultaneous two observers’ measurements were − 0.2 ± 2.1 mmHg for systolic BP (SBP) and 0.3 ± 2.1 mmHg for diastolic BP (DBP). For validation criterion 1, the mean difference ± SD between the reference and device BP values was − 0.6 ± 4.8 mmHg for SBP and 0.1 ± 3.7 mmHg for DBP (≤ 5 ± 8 mmHg for both SBP and DBP). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 3.2/2.6 mmHg for SBP and DBP (≤ 6.91/6.95 mmHg).Conclusion: The results of this study showed that the Withings BPM Core oscillometric device for home BP measurement fulfilled the accuracy requirements of the (ISO 81060-2:2018/AMD 1:2020) Universal protocol in the general population.Keywords: blood pressure measurements, accuracy, validation, home blood pressure, oscillometric, Withings