Blood Pressure Monitoring

Future use of the European Society of Hypertension International Protocol for validation of automated sphygmomanometers No abstract available

Validation protocols for blood pressure measuring devices: the impact of the European Society of Hypertension International Protocol and the development of a Universal Standard 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.

The characteristics of 24-hour ambulatory blood pressure monitoring and its relationship with cardiovascular target organ damage in Chinese Han patients with concomitant type 2 diabetes and hypertension Objective: The objective of this study was to investigate the characteristics of 24-hour ambulatory blood pressure monitoring and its relationship with cardiovascular target organ damage (left ventricular hypertrophy and carotid atherosclerosis) in Chinese Han patients with concomitant type 2 diabetes mellitus and hypertension. Methods: A total of 830 hypertensive patients with or without type 2 diabetes mellitus were divided into four groups according to blood pressure patterns. Clinical characteristics and 24-hour ambulatory blood pressure monitoring indexes were compared among the four groups. Multivariable logistic regression was used to identify the associations among clinical characteristics, blood pressure variability and cardiovascular target organ damage. Results: The prevalence of the non-dipper blood pressure profile (51.32% vs. 24.33%) was higher in patients with type 2 diabetes mellitus and hypertension than in those without type 2 diabetes mellitus. Logistic regression analysis showed that glycosylated haemoglobin A1c, 24hSBP, 24hSSD, dSBP, nSBP and nSSD were independently associated with the non-dipper blood pressure pattern. Type 2 diabetes mellitus patients with the non-dipper blood pressure pattern showed a higher occurrence of target organ damage compared to patients in the other three groups. Multivariate regression analyses revealed that duration of hypertension, fasting blood glucose, dDBP and nDSD were associated with left ventricular hypertrophy. Age, haemoglobin A1c, LDL-C, nSBP and HDL-C were independently related to carotid atherosclerosis. Conclusion: In the Chinese Han population, patients with concomitant type 2 diabetes mellitus and hypertension showed a remarkably high prevalence of non-dipper blood pressure patterns. Abnormal systolic blood pressure level and hyperglycemia were significantly associated with a non-dipper blood pressure pattern. Non-dipper blood pressure pattern, hyperglycemia and dyslipidemia were closely related to left ventricular hypertrophy and carotid atherosclerosis.

Comparison of routine and automated office blood pressure measurement Objectives From April to October 2018, we implemented a blood pressure measurement quality improvement project at our Hypertension Center. We aimed to compare blood pressure measured using routine, non-standardized office blood pressure and Systolic Blood Pressure Intervention Trial-like automated office blood pressure protocols. Methods In 202 consecutive patients, we measured blood pressure using routine clinic methods and an automated office blood pressure protocol (5 min of rest followed by three blood pressure measurements at 1-min intervals). Results The mean routine blood pressure was 145.6/76.4 mmHg and the mean automated office blood pressure was 135.3/70.1 mmHg. The mean paired difference in blood pressure was 10.3/6.3 mmHg, and Bland-Altman plots demonstrated wide limits of agreement. Using the systolic blood pressure goal of 130 mmHg, 26.9% of the patients not at goal by routine blood pressure were at goal by automated office blood pressure. Conclusions Misclassifications of patient blood pressure control status and the wide variability between routine blood pressure and automated office blood pressure support the wider clinical implementation of automated office blood pressure to improve standardization, minimize incorrect blood pressure measurement and avoid over-treatment.

Prognostic value of average real variability of systolic blood pressure in elderly treated hypertensive patients Objective: The independent prognostic significance of ambulatory blood pressure variability in the elderly is incompletely clear. We investigated the prognostic value of average real variability of 24-hour blood pressure in elderly treated hypertensive patients. Methods: The occurrence of a combined end-point including stroke, coronary events, heart failure requiring hospitalization and peripheral revascularization was evaluated in 757 elderly treated hypertensive patients. According to tertiles of average real variability of 24-hour systolic blood pressure patients were classified as having low (≤8.66 mmHg; n = 252), medium (8.67–10.05 mmHg; n = 252) or high (>10.05 mmHg; n = 253) average real variability. Results: During the follow-up (6.9 ± 3.4 years, range 0.4–12.9 years), 195 events occurred. The event rate of the population was 3.74 per 100 patient-years. After adjustment for age, sex, previous events, diabetes, estimated glomerular filtration rate, left ventricular hypertrophy, left atrial enlargement, asymptomatic left ventricular systolic dysfunction at baseline, 24-hour systolic blood pressure, non-dipping and dipping with high morning surge of blood pressure, patients with high average real variability were at higher cardiovascular risk than those with low average real variability (hazard ratio 1.64, 95% confidence interval 1.12–2.40). Conclusions: In elderly treated hypertensive patients, high average real variability of 24-hour systolic blood pressure is associated with higher cardiovascular risk independently of other risk markers, average 24-hour systolic blood pressure and circadian blood pressure changes.

Dry-weight reduction improves intradialytic hypertension only in patients with high predialytic blood pressure Background The aim of this study was to investigate whether additional volume reduction by ultrafiltration can improve blood pressure in patients with intradialytic hypertension (IDH) defined as at least 10 mmHg systolic blood pressure (SBP) rise during hemodialysis. Patients and methods This prospective, open-label, single-center study included 11 IDH patients with normal predialytic blood pressure (BP) (group A), 11 IDH patients with high predialytic BP (group B), and 18 patients without IDH as control. Serum angiotensin-II, aldosterone (ALD), angiotensin-converting enzyme, endothelin-1, nitric oxide, and asymmetric dimethylarginine were measured before and after the treatments. Results Basic angiotensin-converting enzyme, ALD, endothelin-1, and asymmetric dimethylarginine serum levels were significantly increased in group B compared with control (P < 0.05). On comparing the results from the first and 13th dialysis sessions in group A, the dry weight was reduced by − 0.15 ± 0.16 kg after 12 sessions and the predialytic SBP increased by 3.18 ± 6.25 mmHg before and by 7.37 ± 14.90 mmHg at 4 h during the 13th session. In group B, the dry weight was reduced by 0.67 ± 0.53 kg (P = 0.006 vs. group A) at the 13th session and they had − 12.09 ± 16.20 mmHg less SBP before (P = 0.009 vs. group A) and − 11.82 ± 14.66 mmHg at 4 h of the 13th session. The decrease in dry weight was associated with significantly higher decreases in angiotensin-II and ALD serum levels in group B compared with group A. Conclusion Reducing fluid overload in IDH patients with high predialytic BP can effectively improve their BP, but had no effect on BP in normal predialytic BP IDH cases.

Home blood pressure in pregnancy–the upper reference limit Objectives: To investigate whether the upper home blood pressure reference limit in healthy pregnant women correspond to 135/85 mmHg as used when diagnosing white coat hypertension outside pregnancy. Methods: In this prospective observational study 103 healthy, singleton pregnant women with a mean age of 32 ± 4 (±SD) years and with a median pre-pregnancy body mass index of 21 (interquartile range 20–24) kg/m2 were included. Home blood pressure was measured with the device Microlife® BP 3A Plus twice daily for three days (18 measurements in total) in addition to routine office blood pressure measurements in early (median 12+1 (weeks+days)), mid (20+0) and late pregnancy (35+3). Upper blood pressure reference limits were calculated as mean +2 SD. Results: Office blood pressure versus home blood pressure were 115 ± 11/72 ± 7 versus 103 ± 7/64 ± 5 mmHg in early pregnancy, 112 ± 11/74 ± 7 versus 102 ± 7/63 ± 5 mmHg in mid pregnancy and 118 ± 11/75 ± 8 versus 107 ± 8/66 ± 6 mmHg in late pregnancy. The mean difference between office blood pressure and home blood pressure was 10 mmHg. In late pregnancy, the upper reference limit was 140/91 mmHg for office blood pressure and 123/78 mmHg for home blood pressure with slightly lower values in early and mid pregnancy, respectively. Conclusion: In late pregnancy, the upper home blood pressure reference limit in a population of healthy women was 123/78 mmHg. This value questions the generally proposed level of 135/85 mmHg to define white coat hypertension in pregnancy.

Does the duration of ambulatory blood pressure measurement matter in diagnosing arterial hypertension in children? Objectives The aim of our study was to establish if 48-hour ambulatory blood pressure monitoring (ABPM) is more reliable than 24-hour monitoring in order to reduce the impact of external factors on blood pressure (BP) in children. Methods Two hundred fifteen children with indications for ABPM underwent 48-hour ABPM. In the first part of the study, the values of systolic BP (SBP), diastolic BP (DBP) and heart rate between the first 24 hours and the total 48 hours were compared. In the second part, the same parameters between the first and second 24 hours were compared. In the third part, we determined whether the differences in measurements between the first and second 24 hours had clinical significance and meant a change of diagnosis. Results The results of the first part of the study showed no statistically significant differences. In the second part, the average values of SBP and DBP were statistically significantly higher during the first 24 hours as compared with the second 24 hours. In the second 24 hours, more children had normal BP (NBP) and a smaller number of them had high NBP or arterial hypertension (AH) compared with the first 24 hours, suggesting that this has clinical significance. Conclusions Within certain limits, the results of our study suggest that 48-hour ABPM is more reliable than 24-hour ABPM, where especially the second 24 hours are a period of measurement that should be taken into consideration for this purpose. These results could impact the diagnostics of AH in children.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol Objective: The present study aimed to evaluate the accuracy of the Health & Life automated oscillometric upper-arm blood pressure monitor HL868ED for blood pressure monitoring according to the British Hypertension Society Protocol. Method: We recruited individuals until there were 85 eligible participants and their blood pressure could meet the blood pressure distribution requirements specified by the British Hypertension Society Protocol. For each individual, we sequentially measured systolic and diastolic blood pressures using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). Data analysis was carried out according to the British Hypertension Society Protocol. Results: The device achieved grade A. The percentage of blood pressure differences within 5, 10 and 15 mmHg was 68%, 91% and 98%, respectively, for systolic blood pressure, and 79, 96 and 99%, respectively, for diastolic blood pressure. The average (±SD) of the device-observer differences was −1.8 ± 6.0 mmHg for systolic and 0.1 ± 4.7 mmHg for diastolic blood pressures, respectively. Conclusion: The Health & Life automated upper-arm blood pressure monitor HL868ED has passed the requirements of the British Hypertension Society Protocol, and hence can be recommended for blood pressure measurement in adults.

Evaluation of Meditech ABPM-06 ambulatory blood pressure measuring device, according to the European Society of Hypertension, the British Hypertension Society and the International Organization for Standardization Protocol Objective: The devices to be used in clinical practice should be tested for accuracy and should be validated through the validation protocol. The aim of this study was to determine the accuracy of the Meditech-ABPM-06 ambulatory blood pressure monitor. Materials and methods: The test was carried out in accordance with the protocol established by the European Society of Hypertension (ESH-IP), the British Hypertension Society, and the ANSI/AAMI/ISO 81060-2-2013 protocols. Results: In the European Society of Hypertension validation procedure the subjects with two or three of the absolute differences between observer and device SBP/DBP measurements within 5 mmHg were 31/31. The average device-observer difference was −0.4 ± 3.9 mmHg for SBP and −0.4 ± 2.8 mmHg for DBP. In the British Hypertension Society validation procedure the mean differences of the test device and observer readings were −1.0 ± 4.6 (systolic) and −1.1 ± 4.5 (diastolic). In the ANSI/AAMI/ISO 81060-2-2013 validation procedure (criterion 1) the mean ± SD of the differences between the test device and reference BP was −0.5 ± 4.0/−0.3 ± 4.5 mmHg (systolic/diastolic). The two criteria of the ANSI/AAMI/ISO were fulfilled. Conclusion: The Meditech ABPM-06 blood pressure measure device met the requirements specified by the British Hypertension Society, the European Society of Hypertension International Protocol and the AAMI, and therefore was considered acceptable to clinical use with a Grade of A/A.

Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos
Crete.Greece.72100
2841026182

6948891480

alsfakia@gmail.com