Performance of wearable watch-type home blood pressure measurement devices in a real-world clinical sample.

Autor: Lunardi M; Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and University of Galway, Galway, H91 TK33, Ireland.; The Smart Sensors Laboratory at the Lambe Institute for Translational Medicine and CURAM, University of Galway, Galway, Ireland.; Division of Cardiology, University Hospital of Verona, Verona, Italy., Muhammad F; The Smart Sensors Laboratory at the Lambe Institute for Translational Medicine and CURAM, University of Galway, Galway, Ireland., Shahzad A; The Smart Sensors Laboratory at the Lambe Institute for Translational Medicine and CURAM, University of Galway, Galway, Ireland., Nadeem A; The Smart Sensors Laboratory at the Lambe Institute for Translational Medicine and CURAM, University of Galway, Galway, Ireland., Combe L; The Smart Sensors Laboratory at the Lambe Institute for Translational Medicine and CURAM, University of Galway, Galway, Ireland., Simpkin AJ; School of Mathematics, Statistics and Applied Mathematics, University of Galway, Galway, Ireland.; Insight Centre for Data Analytics, University of Galway, Galway, Ireland., Sharif F; Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and University of Galway, Galway, H91 TK33, Ireland., Wijns W; The Smart Sensors Laboratory at the Lambe Institute for Translational Medicine and CURAM, University of Galway, Galway, Ireland., McEvoy JW; Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and University of Galway, Galway, H91 TK33, Ireland. johnwilliam.mcevoy@universityofgalway.ie.
Jazyk: angličtina
Zdroj: Clinical research in cardiology : official journal of the German Cardiac Society [Clin Res Cardiol] 2024 Oct; Vol. 113 (10), pp. 1393-1404. Date of Electronic Publication: 2023 Dec 19.
DOI: 10.1007/s00392-023-02353-7
Abstrakt: Background: Independent testing of home blood pressure (BP) measurement (HBPM) devices is often lacking, particularly among older and multi-morbid patients.
Methods: We studied the Bpro G2 (using tonometry), Omron HeartGuide (using occlusive oscillometric technology), and Heartisans (using photoplethysmography) wrist watch HBPM devices against a gold standard brachial sphygmomanometer. To test device performance, we used the ISO81060-2 protocol (though this protocol cannot formally validate cuffless devices). We also used linear mixed models to compare adjusted longitudinal BP measurements between devices. Finally, as a surrogate for usability, we recorded instances of device failure where no BP measurement was returned.
Results: We enrolled 128 participants (median [Q1-Q3] age 53 [40-65] years, 51% male, 46% on antihypertensive drugs), of whom 100 were suitable for the primary analysis. All three devices had mean BP values within 5 mmHg of sphygmomanometry. However, due to insufficient reliability (e.g., wider than accepted standard deviations of mean BP), none of the three devices passed all criteria required by the ISO81060-2 protocol. In adjusted longitudinal analyses, the Omron device also systematically underestimated systolic and diastolic BP (- 8.46 mmHg; 95% CI 6.07, 10.86; p < 0.001; and - 2.53 mmHg; 95% CI - 4.03, - 1.03; p = 0.001; respectively). Nevertheless, compared to the Omron device, BPro and Heartisans devices had increased odds of failure (BPro: odds ratio [OR] 5.24; p < 0.0001; Heartisans: OR 5.61; p < 0.001).
Conclusions: While we could not formally validate the cuffless devices, our results show that wearable technologies will require improvements to offer reliable BP assessment. This study also highlights the need for validation protocols specifically designed for cuffless BP measurement technologies.
(© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
Databáze: MEDLINE
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