2024 Recommendations for Validation of Noninvasive Arterial Pulse Wave Velocity Measurement Devices

Bart Spronck^{1

2}, Dimitrios Terentes-Printzios³, Alberto P Avolio², Pierre Boutouyrie^{4

5}, Andrea Guala^{6

7}, Ana Jerončić⁸, Stéphane Laurent^{4

5}, Eduardo C D Barbosa⁹, Johannes Baulmann^{10

11}, Chen-Huan Chen¹², Julio A Chirinos¹³, Stella S Daskalopoulou¹⁴, Alun D Hughes¹⁵, Azra Mahmud¹⁶, Christopher C Mayer¹⁷, Jeong Bae Park¹⁸, Gary L Pierce¹⁹, Aletta E Schutte^{20

21}, Elaine M Urbina^{22

23}, Ian B Wilkinson²⁴, Patrick Segers²⁵, James E Sharman²⁶, Isabella Tan^{2

21}, Charalambos Vlachopoulos³, Thomas Weber²⁷, Elisabetta Bianchini²⁸, Rosa Maria Bruno^{4

5}; Association for Research into Arterial Structure and Physiology (ARTERY), the European Society of Hypertension Working Group on Large Arteries, European Cooperation in Science and Technology (COST) Action VascAgeNet, North American Artery Society, ARTERY LATAM, Pulse of Asia, and Society for Arterial Stiffness—Germany-Austria-Switzerland (DeGAG)

Affiliations

¹ Department of Biomedical Engineering, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Netherlands (B.S.).
² Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia (B.S., A.P.A., I.T.).
³ 1st Cardiology Department, Hippokration Hospital, National and Kapodistrian University of Athens, Greece (D.T.-P., C.V.).
⁴ Université Paris Cité, Inserm, Paris Cardiovascular Research Center (PARCC), France (P.B., S.L., R.M.B.).
⁵ Service de Pharmacologie et Hypertension, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Paris, France (P.B., S.L., R.M.B.).
⁶ Vall d'Hebron Institut de Recerca, Barcelona, Spain (A.G.).
⁷ Centro de Investigación en Red en Enfermedades Cardiovasculares (CIBER-CV), Instituto de Salud Carlos III, Madrid, Spain (A.G.).
⁸ Laboratory of Vascular Aging and Cardiovascular Prevention, Department of Research in Biomedicine and Health, University of Split School of Medicine, Croatia (A.J.).
⁹ Feevale University, Santa Casa Hospital, Porto Alegre, Brazil (E.C.D.B).
¹⁰ Praxis Dres. Gille/Baulmann, Rheinbach, Germany (J.B.).
¹¹ Division of Cardiology, Medical University of Graz, Austria (J.B.).
¹² College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan (C.-H.C.).
¹³ Cardiovascular Division, University of Pennsylvania Perelman School of Medicine and Hospital of the University of Pennsylvania, Philadelphia, PA (J.A.C.).
¹⁴ Department of Medicine, Research Institute McGill University Health Centre, McGill University, Montreal, QC, Canada (S.S.D.).
¹⁵ Department of Population Science and Experimental Medicine, Institute of Cardiovascular Science, University College London, United Kingdom (A.D.H.).
¹⁶ Department of Internal Medicine, Pharmacology, and Clinical Research, Shalamar Medical and Dental College, Lahore, Pakistan (A.M.).
¹⁷ AIT Austrian Institute of Technology, Center for Health & Bioresources, Medical Signal Analysis, Vienna (C.C.M.).
¹⁸ JB Lab and Clinic, Department of Precision Medicine and Biostatistics, Wonju College of Medicine, Yonsei University, Seoul, Republic of Korea (J.B.P.).
¹⁹ Department of Health and Human Physiology, University of Iowa, IA (G.L.P.).
²⁰ School of Population Health, University of New South Wales, Sydney, Australia (A.E.S.).
²¹ The George Institute for Global Health, Sydney, NSW, Australia (A.E.S., I.T.).
²² Cincinnati Children's Hospital Medical Center, OH (E.M.U.).
²³ University of Cincinnati, OH (E.M.U.).
²⁴ Experimental Medicine and Therapeutics, University of Cambridge, United Kingdom (I.B.W.).
²⁵ IBiTech-BioMMedA, Ghent University, Belgium (P.S.).
²⁶ Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia (J.E.S.).
²⁷ Cardiology Department, Klinikum Wels-Grieskirchen, Austria (T.W.).
²⁸ Institute of Clinical Physiology, Italian National Research Council, Pisa (E.B.).

PMID: 37975229
PMCID: PMC10734786
DOI: 10.1161/HYPERTENSIONAHA.123.21618

2024 Recommendations for Validation of Noninvasive Arterial Pulse Wave Velocity Measurement Devices

Bart Spronck et al. Hypertension. 2024 Jan.

. 2024 Jan;81(1):183-192.

doi: 10.1161/HYPERTENSIONAHA.123.21618. Epub 2023 Nov 17.

Authors

Affiliations

¹ Department of Biomedical Engineering, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Netherlands (B.S.).
² Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia (B.S., A.P.A., I.T.).
³ 1st Cardiology Department, Hippokration Hospital, National and Kapodistrian University of Athens, Greece (D.T.-P., C.V.).
⁴ Université Paris Cité, Inserm, Paris Cardiovascular Research Center (PARCC), France (P.B., S.L., R.M.B.).
⁵ Service de Pharmacologie et Hypertension, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Paris, France (P.B., S.L., R.M.B.).
⁶ Vall d'Hebron Institut de Recerca, Barcelona, Spain (A.G.).
⁷ Centro de Investigación en Red en Enfermedades Cardiovasculares (CIBER-CV), Instituto de Salud Carlos III, Madrid, Spain (A.G.).
⁸ Laboratory of Vascular Aging and Cardiovascular Prevention, Department of Research in Biomedicine and Health, University of Split School of Medicine, Croatia (A.J.).
⁹ Feevale University, Santa Casa Hospital, Porto Alegre, Brazil (E.C.D.B).
¹⁰ Praxis Dres. Gille/Baulmann, Rheinbach, Germany (J.B.).
¹¹ Division of Cardiology, Medical University of Graz, Austria (J.B.).
¹² College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan (C.-H.C.).
¹³ Cardiovascular Division, University of Pennsylvania Perelman School of Medicine and Hospital of the University of Pennsylvania, Philadelphia, PA (J.A.C.).
¹⁴ Department of Medicine, Research Institute McGill University Health Centre, McGill University, Montreal, QC, Canada (S.S.D.).
¹⁵ Department of Population Science and Experimental Medicine, Institute of Cardiovascular Science, University College London, United Kingdom (A.D.H.).
¹⁶ Department of Internal Medicine, Pharmacology, and Clinical Research, Shalamar Medical and Dental College, Lahore, Pakistan (A.M.).
¹⁷ AIT Austrian Institute of Technology, Center for Health & Bioresources, Medical Signal Analysis, Vienna (C.C.M.).
¹⁸ JB Lab and Clinic, Department of Precision Medicine and Biostatistics, Wonju College of Medicine, Yonsei University, Seoul, Republic of Korea (J.B.P.).
¹⁹ Department of Health and Human Physiology, University of Iowa, IA (G.L.P.).
²⁰ School of Population Health, University of New South Wales, Sydney, Australia (A.E.S.).
²¹ The George Institute for Global Health, Sydney, NSW, Australia (A.E.S., I.T.).
²² Cincinnati Children's Hospital Medical Center, OH (E.M.U.).
²³ University of Cincinnati, OH (E.M.U.).
²⁴ Experimental Medicine and Therapeutics, University of Cambridge, United Kingdom (I.B.W.).
²⁵ IBiTech-BioMMedA, Ghent University, Belgium (P.S.).
²⁶ Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia (J.E.S.).
²⁷ Cardiology Department, Klinikum Wels-Grieskirchen, Austria (T.W.).
²⁸ Institute of Clinical Physiology, Italian National Research Council, Pisa (E.B.).

PMID: 37975229
PMCID: PMC10734786
DOI: 10.1161/HYPERTENSIONAHA.123.21618

Abstract

Background: Arterial stiffness, as measured by arterial pulse wave velocity (PWV), is an established biomarker for cardiovascular risk and target-organ damage in individuals with hypertension. With the emergence of new devices for assessing PWV, it has become evident that some of these devices yield results that display significant discrepancies compared with previous devices. This discrepancy underscores the importance of comprehensive validation procedures and the need for international recommendations.

Methods: A stepwise approach utilizing the modified Delphi technique, with the involvement of key scientific societies dedicated to arterial stiffness research worldwide, was adopted to formulate, through a multidisciplinary vision, a shared approach to the validation of noninvasive arterial PWV measurement devices.

Results: A set of recommendations has been developed, which aim to provide guidance to clinicians, researchers, and device manufacturers regarding the validation of new PWV measurement devices. The intention behind these recommendations is to ensure that the validation process can be conducted in a rigorous and consistent manner and to promote standardization and harmonization among PWV devices, thereby facilitating their widespread adoption in clinical practice.

Conclusions: It is hoped that these recommendations will encourage both users and developers of PWV measurement devices to critically evaluate and validate their technologies, ultimately leading to improved consistency and comparability of results. This, in turn, will enhance the clinical utility of PWV as a valuable tool for assessing arterial stiffness and informing cardiovascular risk stratification and management in individuals with hypertension.

Keywords: aorta; cardiovascular diseases; guideline; methods; pulse wave analysis; vascular stiffness.

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Conflict of interest statement

Disclosures A.P. Avolio is a member of the Scientific Advisory Board of CardieX. P. Boutouyrie has participated in the past in the validation of multiple devices, among them Popmètre and WITHINGS Body Cardio. P. Boutouyrie has research grants with WITHINGS for the development of connected health devices. P. Boutouyrie, P. Segers, and R.M. Bruno are involved as researchers in an H2020 project working on the development of an integrated silicon photonics-based device that aims to measure pulse wave velocity. S. Laurent received research grants and honoraria as a speaker or chairperson and has been on the advisory board of Servier Laboratories, SOM Biotech, and WITHINGS. J. Baulmann has an interest in Redwave Medical GmbH and received equipment and lecture fees from IEM GmbH, BPLab, SMT Medical GmbH & Co, SOT Medical Systems, and Tensiomed. J.A. Chirinos received University of Pennsylvania research grants from the National Institutes of Health, Fukuda-Denshi, Bristol-Myers Squibb, Microsoft, and Abbott. J.A. Chirinos was named inventor in a University of Pennsylvania patent for the use of inorganic nitrates/nitrites for the treatment of heart failure and preserved ejection fraction and patent applications for the use of biomarkers in heart failure. J.A. Chirinos received payments for editorial roles from the American Heart Association, the American College of Cardiology, and Wiley. J.A. Chirinos received research device loans from ATCOR Medical, Fukuda-Denshi, Unex, Uscom, NDD Medical Technologies, Microsoft, and MicroVision Medical. S.S. Daskalopoulou is a cofounder of the start-up PLAKK that aims to identify individual atherosclerotic plaque instability and stroke risk using artificial intelligence methods. C.C. Mayer is an inventor (not holder) of a patent that is partly used in the ARCSolver algorithm in the Mobil-O-Graph 24h PWA Monitor (IEM GmbH). A.E. Schutte received speaker honoraria from Servier, Novartis, Abbott, Sanofi, Omron, Aktiia, and Medtronic. E.M. Urbina was on the Data Safety Monitoring Board of Astellas, Inc, and received an honorarium from Targus Medical, Inc. I. Tan was an employee of ATCOR Medical. E. Bianchini is a cofounder of QUIPU s.r.l., a spin-off company of the Italian National Research Council and the University of Pisa developing software for medical devices.

Figures

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References

1. Ben-Shlomo Y, Spears M, Boustred C, May M, Anderson SG, Benjamin EJ, Boutouyrie P, Cameron J, Chen CH, Cruickshank JK, et al. . Aortic pulse wave velocity improves cardiovascular event prediction: an individual participant meta-analysis of prospective observational data from 17,635 subjects. J Am Coll Cardiol. 2014;63:636–646. doi: 10.1016/j.jacc.2013.09.063 - PMC - PubMed
1. Laurent S, Boutouyrie P, Asmar R, Gautier I, Laloux B, Guize L, Ducimetiere P, Benetos A. Aortic stiffness is an independent predictor of all-cause and cardiovascular mortality in hypertensive patients. Hypertension. 2001;37:1236–1241. doi: 10.1161/01.hyp.37.5.1236 - PubMed
1. Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-Invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006;27:2588–2605. doi: 10.1093/eurheartj/ehl254 - PubMed
1. Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, et al. ; Artery Society. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012;30:445–448. doi: 10.1097/HJH.0b013e32834fa8b0 - PubMed
1. Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, et al. ; American Heart Association Council on Hypertension. Recommendations for improving and standardizing vascular research on arterial stiffness: a scientific statement from the American Heart Association. Hypertension. 2015;66:698–722. doi: 10.1161/HYP.0000000000000033 - PMC - PubMed

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2024 Recommendations for Validation of Noninvasive Arterial Pulse Wave Velocity Measurement Devices

Affiliations

2024 Recommendations for Validation of Noninvasive Arterial Pulse Wave Velocity Measurement Devices

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical