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Research Articles

Accuracy and User Acceptability of 24-hour Ambulatory Blood Pressure Monitoring by a Prototype Cuffless Multi-Sensor Device Compared to a Conventional Oscillometric Device

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Article: 2274595 | Received 23 Aug 2023, Accepted 18 Oct 2023, Published online: 26 Oct 2023

References

  • Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):1–16. doi:10.1093/eurheartj/ehy339.
  • O’Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, et al. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013;31(9):1731–68. doi:10.1097/HJH.0b013e328363e964.
  • Olsen MH, Angell SY, Asma S, Boutouyrie P, Burger D, Chirinos JA, et al. A call to action and a lifecourse strategy to address the global burden of raised blood pressure on current and future generations: the Lancet Commission on hypertension. Lancet. 2016;388(10060):2665–712. doi:10.1016/S0140-6736(16)31134-5.
  • Palatini P, Benetti E, Fania C, Malipiero G, Saladini F. Rectangular cuffs may overestimate blood pressure in individuals with large conical arms. J Hypertens. 2012;30(3):530–6. doi:10.1097/HJH.0b013e32834f98a0.
  • Mengden T, Weisser B. Monitoring of Treatment for Arterial Hypertension–The Role of Office, Home, and 24 h Ambulatory Blood Pressure Measurement. Dtsch Arztebl Int. 2021;118(27-28):473–8.
  • Nasothimiou EG, Karpettas N, Dafni MG, Stergiou GS. Patients’ preference for ambulatory versus home blood pressure monitoring. J Hum Hypertens. 2014;28(4):224–9. doi:10.1038/jhh.2013.104.
  • Ringrose JS, Bapuji R, Coutinho W, Mouhammed O, Bridgland L, Carpenter T, et al. Patient perceptions of ambulatory blood pressure monitoring testing, tolerability, accessibility, and expense. J Clin Hypertens (Greenwich). 2020;22(1):16–20. doi:10.1111/jch.13760.
  • 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(11):1171–80.
  • Vybornova A, Polychronopoulou E, Wurzner-Ghajarzadeh A, Fallet S, Sola J, Wuerzner G. Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device. Blood Press Monit. 2021;26(4):305–11. doi:10.1097/MBP.0000000000000531.
  • Ahn JH, Song J, Choi I, Youn J, Cho JW. Validation of Blood Pressure Measurement Using a Smartwatch in Patients With Parkinson’s Disease. Front Neurol. 2021;12:650929. doi:10.3389/fneur.2021.650929.
  • Falter M, Scherrenberg M, Driesen K, Pieters Z, Kaihara T, Xu L, et al. Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy. Front Cardiovasc Med. 2022;9:958212. doi:10.3389/fcvm.2022.958212.
  • Nair D, Tan SY, Gan HW, Lim SF, Tan J, Zhu M, et al. The use of ambulatory tonometric radial arterial wave capture to measure ambulatory blood pressure: the validation of a novel wrist-bound device in adults. J Hum Hypertens. 2008;22(3):220–2. doi:10.1038/sj.jhh.1002306.
  • Sayer G, Piper G, Vorovich E, Raikhelkar J, Kim GH, Rodgers D, et al. Continuous Monitoring of Blood Pressure Using a Wrist-Worn Cuffless Device. Am J Hypertens. 2022;35(5):407–13. doi:10.1093/ajh/hpac020.
  • 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(2):e24916. doi:10.2196/24916.
  • 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(3):534–40. doi: 10.1161/HYPERTENSIONAHA.122.20410.
  • 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(8):1449–60. doi:10.1097/HJH.0000000000003224.
  • Mukkamala R, Stergiou GS, Avolio AP. Cuffless Blood Pressure Measurement. Annu Rev Biomed Eng. 2022;24:203–30. doi: 10.1146/annurev-bioeng-110220-014644.
  • Sola J, Vybornova A, Fallet S, Polychronopoulou E, Wurzner-Ghajarzadeh A, Wuerzner G. Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. Sci Rep. 2021;11(1):20644. doi:10.1038/s41598-021-99294-w.
  • 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 (Lausanne). 2021;8:693926. doi:10.3389/fmed.2021.693926.
  • Schukraft S, Haddad S, Faucherre Y, Arroyo D, Togni M, Barison A, et al. Remote blood pressure monitoring with a wearable photoplethysmographic device in patients undergoing coronary angiography: the senbiosys substudy. Blood Press Monit. 2022;27(6):402–7. doi:10.1097/MBP.0000000000000615.
  • 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(1):16116. doi:10.1038/s41598-020-73172-3.
  • Krisai P, Vischer AS, Kilian L, Meienberg A, Mayr M, Burkard T. Accuracy of 24-hour ambulatory blood pressure monitoring by a novel cuffless device in clinical practice. Heart. 2019;105(5):399–405.
  • Proença M, Ambühl J, Bonnier G, Meister TA, Valentin J, Soria R, et al. Method-comparison study between a watch-like sensor and a cuff-based device for 24-h ambulatory blood pressure monitoring. Sci Rep. 2023;13(1):6149. doi:10.1038/s41598-023-33205-z.
  • 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.
  • Heimark S, Rindal OMH, Seeberg TM, Stepanov A, Boysen ES, Bøtker-Rasmussen KG, et al. Blood pressure altering method affects correlation with pulse arrival time. Blood Press Monit. 2022;27(2):139–46. doi:10.1097/MBP.0000000000000577.
  • Jones SC, Bilous M, Winship S, Finn P, Goodwin J. Validation of the OSCAR 2 oscillometric 24-hour ambulatory blood pressure monitor according to the International Protocol for the validation of blood pressure measuring devices. Blood Press Monit. 2004;9(4):219–23. doi:10.1097/00126097-200408000-00007.
  • Seeberg TM, Orr JG, Opsahl H, Austad HO, Roed MH, Dalgard SH, et al. A Novel Method for Continuous, Noninvasive, Cuff-Less Measurement of Blood Pressure: Evaluation in Patients With Nonalcoholic Fatty Liver Disease. IEEE Trans Biomed Eng. 2017;64(7):1469–78. doi:10.1109/TBME.2016.2606538.
  • Heimark S, Eitzen I, Vianello I, Bøtker-Rasmussen KG, Mamen A, Hoel Rindal OM, et al. Blood Pressure Response and Pulse Arrival Time During Exercise Testing in Well-Trained Individuals. Front Physiol. 2022;13:863855. doi:10.3389/fphys.2022.863855.
  • O’Brien E, Petrie J, Little W, de Swiet M, Padfield PL, Altma DG, et al. Short report: An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. Journal of Hypertension. 1993;11(6):677–9. doi:10.1097/00004872-199306000-00013.
  • Holdgate A, Asha S, Craig J, Thompson J. Comparison of a verbal numeric rating scale with the visual analogue scale for the measurement of acute pain. Emerg Med. 2003;15(5-6):441–6. doi:10.1046/j.1442-2026.2003.00499.x.
  • Marquié L, Duarte LR, Mariné C, Lauque D, Sorum PC. How patients and physicians rate patients’ pain in a French emergency department using a verbally administered numerical rating scale and a visual analog scale. Acute pain: international journal of acute pain management. 2008;10(1):31–7. doi:10.1016/j.acpain.2008.01.003.
  • Myles PS, Cui J. Using the Bland-Altman method to measure agreement with repeated measures. Br J Anaesth. 2007;99(3):309–11. doi: 10.1093/bja/aem214.
  • Mancia Chairperson G, Kreutz Co-Chair 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 European Renal Association (ERA) and the International Society of Hypertension (ISH). J Hypertens. 2023.
  • Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021–104. doi:10.1093/eurheartj/ehy339.
  • Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull. 1968;70(4):213–20. doi: 10.1037/h0026256.
  • Nyvad J, Christensen KL, Buus NH, Reinhard M. The cuffless SOMNOtouch NIBP device shows poor agreement with a validated oscillometric device during 24-h ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich). 2021;23(1):61–70. doi:10.1111/jch.14135.
  • Socrates T, Krisai P, Vischer AS, Meienberg A, Mayr M, Burkard T. Improved agreement and diagnostic accuracy of a cuffless 24-h blood pressure measurement device in clinical practice. Sci Rep. 2021;11(1):1143. doi: 10.1038/s41598-020-80905-x.
  • Miranda Hurtado M, Reyes Vasquez J, Rodriguez-Fernandez M. Comparison of a tonometric with an oscillometric blood pressure monitoring device over 24 hours of ambulatory use. Blood Press Monit. 2021;26(2):149–55. doi: 10.1097/MBP.0000000000000511.
  • 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.
  • Almeida TP, Cortes M, Perruchoud D, Alexandre J, Vermare P, Sola J, et al. Aktiia cuffless blood pressure monitor yields equivalent daytime blood pressure measurements compared to a 24-h ambulatory blood pressure monitor: Preliminary results from a prospective single-center study. Hypertens Res. 2023. doi:10.1038/s41440-023-01258-2.
  • Zhang G, Gao M, Xu D, Olivier NB, Mukkamala R. Pulse arrival time is not an adequate surrogate for pulse transit time as a marker of blood pressure. J Appl Physiol (1985). 2011;111(6):1681–6. doi:10.1152/japplphysiol.00980.2011.
  • Forouzanfar M, Baker FC, Colrain IM, Goldstone A, de Zambotti M. Automatic analysis of pre-ejection period during sleep using impedance cardiogram. Psychophysiology. 2019;56(7):e13355. doi:10.1111/psyp.13355.
  • Bilo G, Zorzi C, Ochoa Munera JE, Torlasco C, Giuli V, Parati G. Validation of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015;20(5):291–4. doi:10.1097/MBP.0000000000000124.
  • Mascaro SA, Asada HH. Photoplethysmograph fingernail sensors for measuring finger forces without haptic obstruction. IEEE Transactions on Robotics and Automation. 2001;17(5):698–708. doi:10.1109/70.964669.
  • Hsiu H, Hsu CL, Wu TL. Effects of different contacting pressure on the transfer function between finger photoplethysmographic and radial blood pressure waveforms. Proc Inst Mech Eng H. 2011;225(6):575–83. doi:10.1177/0954411910396288.
  • Chandrasekhar A, Yavarimanesh M, Natarajan K, Hahn JO, Mukkamala R. PPG Sensor Contact Pressure Should Be Taken Into Account for Cuff-Less Blood Pressure Measurement. IEEE Trans Biomed Eng. 2020;67(11):3134–40. doi:10.1109/TBME.2020.2976989.
  • Mukkamala R, Hahn JO, Inan OT, Mestha LK, Kim CS, Töreyin H, et al. Toward Ubiquitous Blood Pressure Monitoring via Pulse Transit Time: Theory and Practice. IEEE Trans Biomed Eng. 2015;62(8):1879–901. doi:10.1109/TBME.2015.2441951.
  • Haesler E, Lyon X, Pruvot E, Kappenberger L, Hayoz D. Confounding effects of heart rate on pulse wave velocity in paced patients with a low degree of atherosclerosis. J Hypertens. 2004;22(7):1317–22. doi:10.1097/01.hjh.0000125447.28861.18.
  • Tan I, Butlin M, Spronck B, Xiao H, Avolio A. Effect of Heart Rate on Arterial Stiffness as Assessed by Pulse Wave Velocity. Curr Hypertens Rev. 2018;14(2):107–22. doi:10.2174/1573402113666170724100418.
  • van der Steen MS, Lenders JW, Thien T. Side effects of ambulatory blood pressure monitoring. Blood Press Monit. 2005;10(3):151–5. doi:10.1097/00126097-200506000-00007.
  • Beltman FW, Heesen WF, Smit AJ, May JF, Lie KI, Meyboom-de Jong B. Acceptance and side effects of ambulatory blood pressure monitoring: evaluation of a new technology. J Hum Hypertens. 1996;10 Suppl 3:S39–S42.
  • Sheshadri V, Tiwari AK, Nagappa M, Venkatraghavan L. Accuracy in Blood Pressure Monitoring: The Effect of Noninvasive Blood Pressure Cuff Inflation on Intra-arterial Blood Pressure Values. Anesth Essays Res. 2017;11(1):169–73. doi:10.4103/0259-1162.181430.
  • Charmoy A, Würzner G, Ruffieux C, Hasler C, Cachat F, Waeber B, et al. Reactive rise in blood pressure upon cuff inflation: cuff inflation at the arm causes a greater rise in pressure than at the wrist in hypertensive patients. Blood Press Monit. 2007;12(5):275–80. doi:10.1097/MBP.0b013e3282c9ac9a.
  • Gnanenthiran SR, Liu H, Tan I, Chan J, Schlaich MP, Schutte AE. Cuffless blood pressure devices: the gap between patient acceptability and need for validation. J Hypertens. 2022;40(11):2317–9. doi:10.1097/HJH.0000000000003274.
  • Zeng WW, Chan SW, Tomlinson B. Patient preferences for ambulatory blood pressure monitoring devices: Wrist-type or arm-type? PLoS One. 2021;16(8):e0255871. doi:10.1371/journal.pone.0255871.
  • Basu S, Savani K. Choosing Among Options Presented Sequentially or Simultaneously. Curr Dir Psychol Sci. 2018;28(1):97–101. doi: 10.1177/0963721418806646.
  • Hsee CK, Leclerc F. Will Products Look More Attractive When Presented Separately or Together? Journal of Consumer Research. 1998;25(2):175–86. doi:10.1086/209534.