141. [Lancet Commission on Hypertension Group position statement on the global improvement of accuracy standards for devices that measure blood pressurePosicionamento do Grupo da
Sharman JE, O'Brien E, Alpert B, Schutte AE, Delles C, Olsen MH, Asmar R, Atkins N, Barbosa E, Calhoun D, Campbell NRC, Chalmers J, Benjamin I, Jennings G, Laurent S, Boutouyrie P, Lopez-Jaramillo P, McManus RJ, Mihailidou AS, Ordunez P, Padwal R, Palatini P, Parati G, Poulter N, Rakotz MK, Rosendorff C, Saladini F, Scuteri A, Barroso WS, Cho MC, Sung KC, Townsend RR, Wang JG, Hansen TW, Wozniak G, Stergiou G.
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The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.
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142. Seasonal blood pressure variation assessed by different measurement methods: systematic review and meta-analysis.
Kollias A, Kyriakoulis KG, Stambolliu E, Ntineri A, Anagnostopoulos I, Stergiou GS.
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143. Seasonal variation in blood pressure: Evidence, consensus and recommendations for clinical practice. Consensus statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.
Stergiou GS, Palatini P, Modesti PA, Asayama K, Asmar R, Bilo G, de la Sierra A, Dolan E, Head G, Kario K, Kollias A, Manios E, Mihailidou AS, Myers M, Niiranen T, Ohkubo T, Protogerou A, Wang J, O'Brien E, Parati G.
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: Blood pressure (BP) exhibits seasonal variation with lower levels at higher environmental temperatures and higher at lower temperatures. This is a global phenomenon affecting both sexes, all age groups, normotensive individuals, and hypertensive patients. In treated hypertensive patients it may result in excessive BP decline in summer, or rise in winter, possibly deserving treatment modification. This Consensus Statement by the European Society of Hypertension Working Group on BP Monitoring and Cardiovascular Variability provides a review of the evidence on the seasonal BP variation regarding its epidemiology, pathophysiology, relevance, magnitude, and the findings using different measurement methods. Consensus recommendations are provided for health professionals on how to evaluate the seasonal BP changes in treated hypertensive patients and when treatment modification might be justified. (i) In treated hypertensive patients symptoms appearing with temperature rise and suggesting overtreatment must be investigated for possible excessive BP drop due to seasonal variation. On the other hand, a BP rise during cold weather, might be due to seasonal variation. (ii) The seasonal BP changes should be confirmed by repeated office measurements; preferably with home or ambulatory BP monitoring. Other reasons for BP change must be excluded. (iii) Similar issues might appear in people traveling from cold to hot places, or the reverse. (iv) BP levels below the recommended treatment goal should be considered for possible down-titration, particularly if there are symptoms suggesting overtreatment. SBP less than 110 mmHg requires consideration for treatment down-titration, even in asymptomatic patients. Further research is needed on the optimal management of the seasonal BP changes.
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144. Prognostic Relevance of Short-Term Blood Pressure Variability: The Spanish ABPM Registry.
de la Sierra A, Banegas JR, Bursztyn M, Parati G, Stergiou G, Mateu A, Vinyoles E, Segura J, Gorostidi M, Ruilope LM.
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The prognostic relevance of short-term blood pressure (BP) variability in hypertension is not clearly established. We aimed to evaluate the association of short-term BP variability, assessed through ambulatory BP monitoring, with total and cardiovascular mortality in a large cohort of patients with hypertension. We selected 63 910 subjects from the Spanish ABPM Registry from 2004 to 2014, with a median follow-up of 4.7 years. Systolic and diastolic BP SD from 24 hours, daytime, and nighttime, weighted SD (mean of daytime and nighttime SD weighted for period duration), average real variability (mean of differences between consecutive readings), variation independent of the mean, and BP variability ratio (ratio between systolic and diastolic 24-hour SD) were calculated through 24-hour ambulatory BP monitoring performed at baseline. Association with total and cardiovascular mortality (obtained through death certificates) were assessed by Cox regression models adjusted for clinical confounders and BP. Patients who died during follow-up had higher values of BP variability compared with those remaining alive. In fully adjusted models, daytime, nighttime, and weighted SD, systolic and diastolic, as well as diastolic average real variability, were all significantly associated with total and cardiovascular mortality. Hazard ratios for 1 SD increase ranged from 1.05 to 1.09 for total mortality and from 1.07 to 1.12 for cardiovascular mortality. A nighttime systolic SD ≥12 mm Hg was independently associated with total (hazard ratio: 1.13 [95% CI, 1.06-1.21]) and cardiovascular mortality (hazard ratio: 1.21 [95% CI, 1.09-1.36]). We conclude that short-term BP variability is independently associated with total and cardiovascular mortality in patients with hypertension.
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145. Validation of the InBody BPBIO250 oscillometric blood pressure monitor for professional office use in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
Kollias A, Gravvani A, Anagnostopoulos I, Kyriakoulis KG, Bountzona I, Menti A, Stergiou GS.
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146. Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure.
Sharman JE, O'Brien E, Alpert B, Schutte AE, Delles C, Hecht Olsen M, Asmar R, Atkins N, Barbosa E, Calhoun D, Campbell NRC, Chalmers J, Benjamin I, Jennings G, Laurent S, Boutouyrie P, Lopez-Jaramillo P, McManus RJ, Mihailidou AS, Ordunez P, Padwal R, Palatini P, Parati G, Poulter N, Rakotz MK, Rosendorff C, Saladini F, Scuteri A, Sebba Barroso W, Cho MC, Sung KC, Townsend RR, Wang JG, Willum Hansen T, Wozniak G, Stergiou G.
+ Εμφάνιση Περίληψης
: The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organisation for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.
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147. Metabolic syndrome, clustering of cardiovascular risk factors and high carotid intima-media thickness in children and adolescents.
Zhao M, Caserta CA, Medeiros CCM, López-Bermejo A, Kollias A, Zhang Q, Pacifico L, Reinehr T, Litwin M, Bassols J, Romeo EL, Ramos TDA, Stergiou GS, Yang L, Xargay-Torrent S, Amante A, Estrela TM, Grammatikos E, Zhang Y, Prats-Puig A, Franklin de Carvalho D, Yang L, Carreras-Badosa G, de Oliveira Simões M, Hou Y, Lizarraga-Mollinedo E, Shui W, Guo T, Wang M, Zhang Y, Bovet P, Xi B.
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148. Diagnostic accuracy of a novel cuffless self-blood pressure monitor for atrial fibrillation screening in the elderly.
Kyriakoulis KG, Kollias A, Anagnostopoulos I, Gravvani A, Kalogeropoulos P, Destounis A, Stergiou GS.
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Blood pressure (BP) monitors equipped with atrial fibrillation (AF) detection algorithm are attractive screening tools for AF in elderly hypertensives. This study assessed the diagnostic accuracy of a novel cuffless pocket-size self-BP monitor (Freescan, Maisense) equipped with an AF detection algorithm, which displays results for the detection of "AF" or "Arrhythmia" during routine BP measurement. Subjects aged >65 years or 60-65 years with hypertension, diabetes, or cardiovascular disease were subjected to BP measurements using the Freescan device with simultaneous continuous Holter electrocardiography (ECG) monitoring. Readings with device notification "Instability" (29%) or "Error" (20%) were discarded. Data from 136 subjects with five valid Freescan BP measurements were analyzed (age 73.8 ± 7.1 years, males 63%, treated hypertensives 88%, AF in ECG 21%). Analysis of 680 Freescan readings vs ECG revealed specificity 99%, sensitivity 67%, and diagnostic accuracy 93% for AF diagnosis. When the "Arrhythmia" notification was considered as AF diagnosis, the sensitivity was improved (93%, 96%, and 93%, respectively). Analysis of AF diagnosis in subjects (diagnosis defined as at least three of five readings indicating "AF" or "Arrhythmia") revealed specificity, sensitivity, and diagnostic accuracy for AF detection at 94%, 100%, and 95%, respectively. These data suggest that the Freescan cuffless device could be used as a useful screening tool for AF detection during routine self-measurement of BP in the elderly.
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149. STRIDE BP: an international initiative for accurate blood pressure measurement.
Stergiou GS, O'Brien E, Myers M, Palatini P, Parati G.
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: The diagnosis and management of hypertension is dependent upon accurate blood pressure (BP) measurement. Despite intense efforts over several decades by the international medical community worldwide, the use of inaccurate devices has resulted in the misdiagnosis and poor management of hypertension, which remains a largely unresolved public health problem. STRIDE BP (www.stridebp.org) is an international nonprofit organization the mission of which is to improve the accuracy of BP measurement and the diagnosis of hypertension. STRIDE BP comprises a group of 24 recognized experts in BP monitoring from across the world and operates in affiliation with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. In the first stage, STRIDE BP has reviewed 419 validations of 260 devices and approved 69% of them, providing recommendations on accurate devices for office, ambulatory and home BP measurement in adults, children and during pregnancy. At the next stage, STRIDE BP intends to develop programs for on-line training and tools for use in clinical practice leading to improved measurement of BP and better diagnosis of hypertension world-wide.
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150. STRIDE BP international initiative for accurate blood pressure measurement: Systematic review of published validation studies of blood pressure measuring devices.
Stergiou GS, O'Brien E, Myers M, Palatini P, Parati G, Kollias A, Birmpas D, Kyriakoulis K, Bountzona I, Stambolliu E, Anagnostopoulos I, Karpettas N, Menti A.
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Blood pressure (BP) is a vital sign, and its measurement is essential for diagnosing and treating hypertension. The accuracy of BP monitors is therefore essential, but unfortunately very few devices available on the market have been validated using an established protocol. STRIDE BP (www.stridebp.org) is an international nonprofit organization with the mission to improve the accuracy of BP measurement and the diagnosis of hypertension. It has a prestigious Scientific Advisory Board and operates in affiliation with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. STRIDE BP provides lists of accurate office, ambulatory, and home BP monitors. STRIDE BP performed a systematic review of 419 published validations (270 articles and 260 devices). In these publications, 50 (12%) of the validations were rejected compared with 129 (31%) rejected by STRIDE BP (P < .001). Of 79 validations approved in publications but rejected by STRIDE BP, 7 (9%) were rejected due to device inaccuracy and 72 (91%) due to inadequate study quality (execution, analysis, and reporting). Errors in conducting and reporting published validations must be avoided. Peer review must ascertain that a comprehensive checklist of all aspects of a validation study have been adhered to. The implementation of a Universal Standard for device validation and the global dissemination of information on accurate devices by STRIDE BP are expected to improve the quality and accuracy of BP measurement, which should have a positive impact on the diagnosis and management of hypertension globally.
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151. Prognostic value of office blood pressure measurement in patients with atrial fibrillation on anticoagulation therapy: systematic review and meta-analysis.
Kollias A, Kyriakoulis KG, Stambolliu E, Stergiou GS.
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152. Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
Kollias A, Anagnostopoulos I, Gravvani A, Stambolliu E, Bountzona I, Menti A, Stergiou GS.
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153. Opposing Age-Related Trends in Absolute and Relative Risk of Adverse Health Outcomes Associated With Out-of-Office Blood Pressure.
Li Y, Thijs L, Zhang ZY, Asayama K, Hansen TW, Boggia J, Björklund-Bodegård K, Yang WY, Niiranen TJ, Ntineri A, Wei FF, Kikuya M, Ohkubo T, Dolan E, Hozawa A, Tsuji I, Stolarz-Skrzypek K, Huang QF, Melgarejo JD, Tikhonoff V, Malyutina S, Casiglia E, Nikitin Y, Lind L, Sandoya E, Aparicio L, Barochiner J, Gilis-Malinowska N, Narkiewicz K, Kawecka-Jaszcz K, Maestre GE, Jula AM, Johansson JK, Kuznetsova T, Filipovský J, Stergiou G, Wang JG, Imai Y, O'Brien E, Staessen JA.
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Participant-level meta-analyses assessed the age-specific relevance of office blood pressure to cardiovascular complications, but this information is lacking for out-of-office blood pressure. At baseline, daytime ambulatory (n=12 624) or home (n=5297) blood pressure were measured in 17 921 participants (51.3% women; mean age, 54.2 years) from 17 population cohorts. Subsequently, mortality and cardiovascular events were recorded. Using multivariable Cox regression, floating absolute risk was computed across 4 age bands (≤60, 61-70, 71-80, and >80 years). Over 236 491 person-years, 3855 people died and 2942 cardiovascular events occurred. From levels as low as 110/65 mm Hg, risk log-linearly increased with higher out-of-office systolic/diastolic blood pressure. From the youngest to the oldest age group, rates expressed per 1000 person-years increased (
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154. Phenotypes of masked hypertension: Isolated ambulatory, isolated home and dual masked hypertension.
Stergiou GS, Kyriakoulis KG, McManus RJ, Andreadis EA, Jula A, Kollias A, Lindroos A, Ntineri A, Schwartz C, Niiranen TJ.
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155. Ambulatory versus home blood pressure monitoring: frequency and determinants of blood pressure difference and diagnostic disagreement.
Ntineri A, Niiranen TJ, McManus RJ, Lindroos A, Jula A, Schwartz C, Kollias A, Andreadis EA, Stergiou GS.
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156. Blood pressure measurement in atrial fibrillation: review and meta-analysis of evidence on accuracy and clinical relevance.
Stergiou GS, Kyriakoulis KG, Stambolliu E, Destounis A, Karpettas N, Kalogeropoulos P, Kollias A.
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: Atrial fibrillation (AF) often coexists with hypertension in the elderly and multiplies the risk of stroke and death. Blood pressure (BP) measurement in patients with AF is difficult and uncertain and has been a classic exclusion criterion in hypertension clinical trials leading to limited research data. This article reviews the evidence on the accuracy of BP measurement in AF performed using different methods (office, ambulatory, home) and devices (auscultatory, oscillometric) and its clinical relevance in predicting cardiovascular damage. The current evidence suggests the following: (i) Interobserver and intra-observer variation in auscultatory BP measurement is increased in AF because of increased beat-to-beat BP variability and triplicate measurement is required; (ii) Data from validation studies of automated electronic BP monitors in AF are limited and methodologically heterogeneous and suggest reasonable accuracy in measuring SBP and a small yet consistent overestimation of DBP; (iii) 24-h ambulatory BP monitoring is feasible in AF, with similar proportion of errors as in individuals without AF; (iv) both auscultatory and automated oscillometric BP measurements appear to be clinically relevant in AF, providing similar associations with intra-arterial BP measurements and with indices of preclinical cardiac damage as in patients without AF, and predict cardiovascular events and death; (v) Screening for AF in the elderly using an AF-specific algorithm during routine automated office, home or ambulatory BP measurement has high diagnostic accuracy. In conclusion, in AF patients, BP measurement is important, reliable, and clinically relevant and should not be neglected in clinical research and in practice.
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157. Emergence of Home Blood Pressure-Guided Management of Hypertension Based on Global Evidence.
Kario K, Shimbo D, Hoshide S, Wang JG, Asayama K, Ohkubo T, Imai Y, McManus RJ, Kollias A, Niiranen TJ, Parati G, Williams B, Weber MA, Vongpatanasin W, Muntner P, Stergiou GS.
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158. Home Blood Pressure Monitoring in Children and Adolescents: Systematic Review of Evidence on Clinical Utility.
Stergiou G, Stambolliu E, Bountzona I, Ntineri A, Kollias A, Vazeou A, Soldatou A.
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159. Validation protocols for blood pressure measuring devices: the impact of the European Society of Hypertension International Protocol and the development of a Universal Standard.
O'Brien E, Stergiou G, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, McManus RJ, Myers MG, Shennan A, Wang J, Parati G.
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In the last three decades protocols for the validation of blood pressure measuring devices have been developed by the US Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League, the European Society of Hypertension Working Group on blood pressure Monitoring and the International Organization for Standardization. The European Society of Hypertension International Protocol required much smaller sample size than the other protocols, aiming to reduce the time, resources and cost of validation studies and thereby increase the number of validated devices. Given its specifications, the European Society of Hypertension International Protocol was adequate for 'high- and low-accuracy' devices, yet assessment of 'moderate accuracy' devices had high uncertainty with resultant high rate of device failure. Thus, devices validated using the European Society of Hypertension International Protocol should be considered to be as accurate as those validated with the previous Association for the Advancement of Medical Instrumentation or British Hypertension Society protocols. However, the European Society of Hypertension International Protocol did not allow subgroup evaluation (arm sizes, special populations, etc). The mission of the European Society of Hypertension International Protocol to promote the concept of validation has been well achieved, as almost double studies have been published using it than all the other protocols together. However, the maintenance of different validation protocols is confusing and therefore experts from the Association for the Advancement of Medical Instrumentation, European Society of Hypertension International Protocol and International Organization for Standardization have now developed the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) as the recommended 21st-century procedure for worldwide application. The European Society of Hypertension Working Group has published a practical guide for using the Universal Standard. It is in the interests of all scientific bodies to propagate the Universal Standard and ensure its wide implementation.
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160. Rising rural body-mass index is the main driver of the global obesity epidemic in adults.
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Body-mass index (BMI) has increased steadily in most countries in parallel with a rise in the proportion of the population who live in cities
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