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Performance of a cuffless photoplethysmography-based device for continuous monitoring of blood pressure after cardiac surgery: a preliminary validation study

Journal of Human Hypertension volume 39, pages 894–902 (2025)Cite this article

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Abstract

Accurate and convenient monitoring of blood pressure (BP) is challenging and relies on cuff-based devices or in the postoperative/intensive care settings, on invasive measurements. The aim of this study was to prospectively evaluate the accuracy of BP measurements obtained from a novel, commercially available cuffless, non-invasive photoplethysmography (PPG)-based chest patch monitor in patients after cardiac surgery. This single center prospective preliminary validation study enrolled adults who underwent cardiac surgery. Data generated by the PPG-based device was compared to those of a standard invasive arterial pressure (IAP). Bland-Altman plots and Pearson’s correlations were used to assess the accuracy of the PPG-based device. Stability and BP changes were not formally evaluated. Ninety-six patients consented for the study. Mean age was 63.2 ± 12.2 years (range 24–84), and 32 (33%) were women. Average monitoring was 25.6 ± 17.2 h. In total, we evaluated 78,659 readings for systolic BP (SBP), 78,818 for diastolic BP (DBP), and 92,544 for heart rate (HR). The correlation coefficients were r = 0.959, 0.973, 0.966, and 0.962 for SBP, DBP, mean arterial pressure (MAP), and (HR), respectively. The bias ± SD was 0.1 ± 4.8 mmHg for SBP; 0.4 ± 2.1 mmHg for DBP; 0.26 ± 2.6 mmHg for MAP, and 0.15 ± 3.6 beats per minutes for HR. 95% of SBP, and 99.9% of DBP measurements were within 10 mmHg of the reference measurement. In conclusion, the tested cuffless device offers acceptable accuracy and is a promising novel noninvasive tool for continuous BP monitoring. Further studies are needed to validate these findings according to the most updated validation protocols for pulseless devices.

ClinicalTrials.gov ID NCT04071015.

Demonstrating (A) patient’s flow chart; (B) Photoplethysmography sensor principals of action; (C) Study design, parallel measurement of IAP and cuffless device for patients in ICCU; and (D) the main results of the study.Blood pressure (BP), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), and Heart rate (HR).

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Fig. 1: Experimental design.
Fig. 2: Correlation and bias of all collected blood pressure and heart rate data.
Fig. 3: Correlation and bias of the average blood pressure and heart rate data.
Fig. 4: Distribution of bias within each participant.
Fig. 5: Representative examples illustrating that the changes in BP and HR measured by IAP were matched by Biobeat over time.

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Data availability

Data underlying the article will be shared at reasonable request to the corresponding author.

References

  1. Guzik A, Bushnell C. Stroke epidemiology and risk factor management. Continuum. 2017;23:15–39.

    Article  PubMed  Google Scholar 

  2. Major RH. The history of taking the blood pressure. Ann Med Hist. 1930;2:47–55.

    PubMed  PubMed Central  Google Scholar 

  3. Hu JR, Martin G, Iyengar S, Kovell LC, Plante TB, Helmond NV, et al. Validating cuffless continuous blood pressure monitoring devices. Cardiovasc Digit Health J. 2023;4:9–20.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Sola J, Cortes M, Perruchoud D, De Marco B, Lobo MD, Pellaton C, et al. Guidance for the interpretation of continual cuffless blood pressure data for the diagnosis and management of hypertension. Front Med Technol. 2022;4:899143.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Administration FaD. Noninvasive Blood Pressure Measurement System - Biobeat Platform, BB-613WP Patch - FDA approval. Food and Drug Administration. March 2022. Accessed on March 1, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212153.pdf.

  6. Administration FaD. Noninvasive Blood Pressure Measurement System - LiveMetric, LiveOne - FDA approval. Food and Drug Administration, 2020. Accessed on March 1, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201302.pdf.

  7. Kario K, Williams B, Tomitani N, McManus RJ, Schutte AE, Avolio A, et al. Innovations in blood pressure measurement and reporting technology: international society of hypertension position paper endorsed by the world hypertension league, European society of hypertension, Asian pacific society of hypertension, and latin American society of hypertension. J Hypertens. 2024;42:1874–88.

    Article  CAS  PubMed  Google Scholar 

  8. Pecchioli V, Lomartire N, Valente L, Pecchioli L, Germanò GI. Comparison study for 24h ambulatory blood pressure measurement (abpm) with biobeat patch abpm® cuffless wearable device in subjects with different body mass index. J Hypertension. 2023;41:E247–E248.

    Article  Google Scholar 

  9. Kachel E, Constantini K, Nachman D, Carasso S, Littman R, Eisenkraft A, et al. A Pilot study of blood pressure monitoring after cardiac surgery using a wearable, non-invasive sensor. Front Med. 2021;8:693926.

    Article  Google Scholar 

  10. Harvey VM, Alexis A, Okeke CAV, McKinley-Grant L, Taylor SC, Desai SR, et al. Integrating skin color assessments into clinical practice and research: a review of current approaches. J Am Acad Dermatol. 2024;91:1189–98.

    Article  PubMed  Google Scholar 

  11. Performance Evaluation of Pulse Oximeters Taking into Consideration Skin Pigmentation, Race and Ethnicity. United States Food and Drug Administration, 2024. Accessed on March 1, 2025. https://www.fda.gov/media/175828/download.

  12. Saugel B, Kouz K, Meidert AS, Schulte-Uentrop L, Romagnoli S. How to measure blood pressure using an arterial catheter: a systematic 5-step approach. Crit Care. 2020;24:172.

    Article  PubMed  PubMed Central  Google Scholar 

  13. FDA. Biobeat Platform-2. Accessed on March 1, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222010.pdf.

  14. Dvir A, Goldstein N, Rapoport A, Balmor RG, Nachman D, Merin R, et al. Comparing cardiac output measurements using a wearable, wireless, noninvasive photoplethysmography-based device to pulse contour cardiac output in the general icu: a brief report. Crit Care Explor. 2022;4:e0624.

    PubMed  PubMed Central  Google Scholar 

  15. Halberthal M, Nachman D, Eisenkraft A, Jaffe E. Hospital and home remote patient monitoring during the COVID-19 outbreak: a novel concept implemented. Am J Disaster Med. 2020;15:149–51.

    Article  PubMed  Google Scholar 

  16. Nachman D, Eisenkraft A, Goldstein N, Ben-Ishay A, Fons M, Merin R, et al. Influence of sex, bmi, and skin color on the accuracy of non-invasive cuffless photoplethysmography-based blood pressure measurements. Front Physiol. 2022;13:911544.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Nachman D, Gilan A, Goldstein N, Constantini K, Littman R, Eisenkraft A, et al. Twenty-four-hour ambulatory blood pressure measurement using a novel noninvasive, cuffless, wireless device. Am J Hypertens. 2021;34:1171–80.

    PubMed  Google Scholar 

  18. ISO 81060-3:2022. Non-invasive sphygmomanometers; Part 3: Clinical investigation of continuous automated measurement type. December 2022 (edition 1). https://www.iso.org/standard/71161.html.

  19. Lee H, Park S, Kwon H, Cho B, Park JH, Lee HY. Feasibility and effectiveness of a ring-type blood pressure measurement device compared with 24 h ambulatory blood pressure monitoring device. Korean Circ J. 2024;54:93–104.

    Article  PubMed  Google Scholar 

  20. Kim J, Chang SA, Park SW. First-in-human study for evaluating the accuracy of smart ring based cuffless blood pressure measurement. J Korean Med Sci. 2024;39:e18.

    Article  PubMed  Google Scholar 

  21. Hove C, Saeter FW, Stepanov A, Botker-Rasmussen KG, Seeberg TM, Westgaard E, et al. A prototype photoplethysmography-based cuffless device shows promising results in tracking changes in blood pressure. Front Med Technol. 2024;6:1464473.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Tan I, Gnanenthiran SR, Chan J, Kyriakoulis KG, Schlaich MP, Rodgers A, et al. Evaluation of the ability of a commercially available cuffless wearable device to track blood pressure changes. J Hypertens. 2023;41:1003–10.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. McGillion MH, Dvirnik N, Yang S, Belley-Cote E, Lamy A, Whitlock R, et al. Continuous noninvasive remote automated blood pressure monitoring with novel wearable technology: a preliminary validation study. JMIR Mhealth Uhealth. 2022;10:e24916.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, et al. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep. 2020;10:16116.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Islam SMS, Chow CK, Daryabeygikhotbehsara R, Subedi N, Rawstorn J, Tegegne T, et al. Wearable cuffless blood pressure monitoring devices: a systematic review and meta-analysis. Eur Heart J Digit Health. 2022;3:323–37.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Stergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, et al. 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. J Hypertens. 2023;41:2074–87.

    Article  CAS  PubMed  Google Scholar 

  27. 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. Hypertension. 2018;71:368–74.

    Article  CAS  PubMed  Google Scholar 

  28. Mancia G, Kreutz R, Brunström M, Burnier M, Grassi G, Januszewicz A, et al. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European society of hypertension: endorsed by the international society of hypertension (ISH) and the European renal association (ERA): erratum. J Hypertens 2024;42:194.

  29. Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the american college of cardiology/american heart association task force on clinical practice guidelines. J Am Coll Cardiol. 2018;71:e127–e248.

    Article  PubMed  Google Scholar 

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Acknowledgements

We thank all staff, nurses and physicians who took part in performing this study as well as patients who consented to the study during the stressful event of heart surgery.

Funding

This study was supported by a grant from Biobeat LTD who provided the pulseless devices and the row data collected by the devices. The company did not have a role in the study design, analysis, interpretation of the results, or writing the manuscript.

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Author notes

  1. These authors contributed equally: Erez Kachel, Ziad Zoghby.

Authors and Affiliations

  1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA

    Elias Hellou, Parvin Kalhor, Matteo Manzato & Amir Lerman

  2. Department of Cardiac Surgery, Leviev Heart and Vascular Center, Chaim Sheba Medical Center, Ramat Gan, Israel

    Tamer Jamal, Elchanan Zuroff & Erez Kachel

  3. Division of Cardiovascular Medicine, Comprehensive Hypertension Center, University of Miami Miller School of Medicine, Miami, Florida, US

    Maria Delgado-Lelievre

  4. Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, Rochester, MN, USA

    Lilach O. Lerman & Ziad Zoghby

Authors
  1. Elias Hellou
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Contributions

EH and ZZ conceived, designed, wrote, and oversaw all aspects of the study and manuscript preparation. TJ, EZ, and EK were responsible for conducting the study, recruiting participants, and critically reviewing the manuscript. PK and MM performed the statistical analyses and contributed to manuscript review. MDL, LOL, and AL provided critical review and important intellectual input to the manuscript. All authors read and approved the final version of the manuscript.

Corresponding author

Correspondence to Ziad Zoghby.

Ethics declarations

Competing interests

Dr Amir Lerman serves as an advisor to Biobeat. All other co-authors declare no competing interests.

Ethics approval and consent to participate

The study was performed in accordance with the relevant guidelines and regulations. The study protocol was approved by the local institutional review board and registered in ClinicalTrials.gov ID NCT04071015. All participants provided an informed consent to participate in the study. The manuscript does not include identifiable images from human research participants.

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Hellou, E., Jamal, T., Zuroff, E. et al. Performance of a cuffless photoplethysmography-based device for continuous monitoring of blood pressure after cardiac surgery: a preliminary validation study. J Hum Hypertens 39, 894–902 (2025). https://doi.org/10.1038/s41371-025-01082-w

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