May Measurement Month 2019: an analysis of blood pressure screening results from Armenia.

Elevated blood pressure (BP) is an enormous public health problem and a growing burden worldwide and the biggest single risk factor for cardiovascular death. May Measurement Month (MMM) is a global initiative aimed to raise awareness of high BP and to act as a temporary solution to the lack of screening programmes worldwide. An opportunistic cross-sectional survey of volunteers aged ≥18 years was carried out in May to July 2019. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. The study was conducted in public areas (23 sites in the capital city Yerevan and 13 in other regions), both indoor and outdoor, as well as in primary and secondary healthcare centres. In total, 9818 individuals (11.3% participated in either MMM2017/2018 or both) were screened of which 9786 had three BP measurements available, 1.6% of them reported never having had their BP measured. The mean age of screened participants was 47.6 (SD ± 16.5) years, 61.9% were female. After multiple imputation, 41.6% of participants had hypertension and 72.8% of them were aware of their high BP, 65.4% were on treatment, and of those treated, 46.5% had controlled BP (<140/90 mmHg). Of 4088 participants with hypertension, 30.4% had controlled BP. Of all risk factors analysed, reported use of anti-hypertensive medication and a previous diagnosis of hypertension were the strongest predictors of higher levels of BP. We found that the prevalence of hypertension, untreated and treated, but uncontrolled hypertension is still substantial in Armenia, which maybe a vital contributor to the growing burden of non-communicable diseases.

An analysis of blood pressure screening of 21 112 participants in Armenia: May Measurement Month 2018.

Elevated blood pressure (BP) is a growing burden worldwide and is the leading cause of mortality and disability-adjusted life years all over the world. May Measurement Month (MMM) is a global initiative aimed to raise awareness of high BP and to act as a temporary solution to the lack of screening programmes worldwide. An opportunistic cross-sectional survey of volunteers aged ≥18 was carried out in May to July 2018. Blood pressure measurement, the definition of hypertension (HTN) and statistical analysis followed the standard MMM protocol. The study was conducted in public areas (17 sites in Yerevan and 22 in regions), both indoor and outdoor, as well as in 78 primary care centres. A total of 21 112 individuals were screened during MMM18, of which 20 732 had three BP measurements available. The mean age of screened individuals was 46.2 ± 17.3 years, 57.8% were female. At the time of screening, 26.1% were on antihypertensive medication. After imputation, the percentage of participants with HTN was 38.7%, and 76.7% of them were aware of their high BP. Of participants receiving treatment, 47.1% had a controlled BP. MMM18 was the largest BP screening campaign undertaken in Armenia. We found that the proportion of HTN is substantial in Armenia, which may be a vital contributor to the growing burden of non-communicable diseases. Our results also suggest that untreated HTN is common and when treated still not adequately controlled in Armenia. The current situation, with an insufficient control rate of HTN, must be changed as soon as possible.

May Measurement Month 2017: an analysis of blood pressure screening results in Armenia-Europe.

Elevated blood pressure (BP) is a growing burden worldwide, leading to over 10 million deaths each year. May Measurement Month (MMM) is a global initiative aimed at raising awareness of high BP and to act as a temporary solution to the lack of screening programmes worldwide. An opportunistic cross-sectional survey of volunteers aged ≥18 was carried out in May 2017. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. The study was conducted in public areas (14 sites in Yerevan and 18 in regions), both indoor and outdoor, as well as in 42 primary care centres. A total of 9199 individuals were screened during MMM17 of which 9186 had three BP measurements available. The mean age of screened individuals was 50 ± 16.7 years, 57.3% was female. At the time of screening 17.9% were on antihypertensive medication. After imputation, a percentage of participants with hypertension was 33.9%, and 52.9% of them were on treatment. Of those treated, 77.0% had uncontrolled BP. MMM17 was the largest BP screening campaign undertaken in Armenia. We found that in Armenia, untreated hypertension is common, as is not adequately treated hypertension.

Cardio-ankle vascular index for predicting cardiovascular morbimortality and determinants for its progression in the prospective advanced approach to arterial stiffness (TRIPLE-A-Stiffness) study.

BACKGROUND: The cardio-ankle vascular index (CAVI) measure of arterial stiffness is associated with prevalent cardiovascular risk factors, while its predictive value for cardiovascular events remains to be established. The aim was to determine associations of CAVI with cardiovascular morbimortality (primary outcome) and all-cause mortality (secondary outcome), and to establish the determinants of CAVI progression. METHODS: TRIPLE-A-Stiffness, an international multicentre prospective longitudinal study, enrolled >2000 subjects ≥40 years old at 32 centres from 18 European countries. Of these, 1250 subjects (55% women) were followed for a median of 3.82 (2.81-4.69) years. FINDINGS: Unadjusted cumulative incidence rates of outcomes according to CAVI stratification were higher in highest stratum (CAVI > 9). Cox regression with adjustment for age, sex, and cardiovascular risk factors revealed that CAVI was associated with increased cardiovascular morbimortality (HR 1.25 per 1 increase; 95% confidence interval, CI: 1.03-1.51) and all-cause mortality (HR 1.37 per 1 increase; 95% CI: 1.10-1.70) risk in subjects ≥60 years. In ROC analyses, CAVI optimal threshold was 9.25 (c-index 0.598; 0.542-0.654) and 8.30 (c-index 0.565; 0.512-0.618) in subjects ≥ or <60 years, respectively, to predict increased CV morbimortality. Finally, age, mean arterial blood pressure, anti-diabetic and lipid-lowering treatment were independent predictors of yearly CAVI progression adjusted for baseline CAVI. INTERPRETATION: The present study identified additional value for CAVI to predict outcomes after adjustment for CV risk factors, in particular for subjects ≥60 years. CAVI progression may represent a modifiable risk factor by treatments. FUNDING: International Society of Vascular Health (ISVH) and Fukuda Denshi, Japan.

Validation of the Withings BPM Core Device for Self-Blood Pressure Measurements in General Population According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

Background: Most of the scientific societies recommend assessing the accuracy of electronic devices for blood pressure (BP) measurements using established validation protocol. Objective: To determine the accuracy of the BP measurements using the Withings BPM Core device in the general population according to the "Universal Standard (ISO 81060-2:2018/AMD 1:2020)". Methods: The Withings BPM Core is an oscillometric device measuring BP at the brachial level. The study was performed according to the "Universal Standard (ISO 81060-2:2018/AMD 1:2020) protocol" using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were included. Analysis was performed as required by the Universal protocol using Criterion 1 - differences between observers' mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD); and Criterion 2 - The SD of the mean BP differences between the test device and reference BP per subject. Results: Eighty-six subjects were selected, 85 of whom were included. The mean BP differences between the simultaneous two observers' measurements were -0.2 ± 2.1 mmHg for systolic BP (SBP) and 0.3 ± 2.1 mmHg for diastolic BP (DBP). For validation criterion 1, the mean difference ± SD between the reference and device BP values was -0.6 ± 4.8 mmHg for SBP and 0.1 ± 3.7 mmHg for DBP (≤5 ± 8 mmHg for both SBP and DBP). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 3.2/2.6 mmHg for SBP and DBP (≤6.91/6.95 mmHg). Conclusion: The results of this study showed that the Withings BPM Core oscillometric device for home BP measurement fulfilled the accuracy requirements of the (ISO 81060-2:2018/AMD 1:2020) Universal protocol in the general population.

Accuracy of the Withings BPM Connect Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

Background: As recommended by various authorities and scientific societies, electronic devices for blood pressure (BP) measurements must undergo independent clinical validations for accuracy assessment. Objective: To assess the accuracy of the Withings BPM Connect device in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization "AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)". Methods: The Withings BPM Connect device measures BP at the brachial level using the oscillometric method. According to this protocol using the same-arm sequential BP measurement method, subjects (n ≥ 85) fulfilling the age, gender, BP and cuff distribution criteria must be included. Two criteria are used for the analysis: Criterion 1: differences between observers' mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD) must be ≤5 ± 8 mmHg for both systolic (SBP) and diastolic BP (DBP). Criterion 2: the SD of the mean BP differences between the test device and reference BP per subject must be ≤6.91/6.62 mmHg for SBP/DBP. Results: Ninety-two subjects were selected, 85 of whom were included. For validation criterion 1, the mean difference ± SD between the reference and device BP values was 0.6 ± 5.3 mmHg for SBP and 2.1 ± 4.3 mmHg for DBP. For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 4.2/3.6 mmHg (SBP/DBP). These results fulfilled the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) protocol requirements. Conclusion: The Withings BPM Connect oscillometric device for home BP measurement fulfilled all of the accuracy requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and consequently can be recommended for home BP measurements.

Clinical Accuracy of the Withings BPM Connect for Self-Blood Pressure Measurements in Pregnancy and Pre-Eclampsia: Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

Background: Electronic devices for blood pressure (BP) measurements require independent clinical validation as recommended by various authorities/societies, both in general and special populations such as pregnancy. Objective: To assess the accuracy of the Withings BPM Connect device in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol. Methods: The Withings BPM Connect device measures BP at the brachial level using the oscillometric method. The study was performed according to the so-called "modified AAMI/ESH/ISO (ISO 81060-2:2018) protocol" or the "Universal Standard Protocol". The validation study included 45 pregnant women in the second and third gestational trimester: 15 with pre-eclampsia, 15 with gestational hypertension and 15 normotensives. Differences between mercury sphygmomanometer BP measurements (reference) and device BP values (test) and their standard deviation (SD) were calculated. Results: The mean differences between the mercury standard and device BP values in pregnancy (n = 45) were -0.5 ± 5.7 mmHg for systolic BP (SBP) and -0.8 ± 3.8 mmHg for diastolic BP (DBP). In the preeclamptic patients (n = 15), the mean differences were 0.14 ± 5.5 mmHg for SBP and 0.39 ± 3.7 mmHg for DBP. These results fulfilled the protocol requirements (<5 ± 8 mmHg). Conclusion: The Withings BPM Connect fulfills the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, this device can be recommended for home BP measurements in this specific pregnancy population.

Reproducibility of the European Society of Hypertension - International Protocol for validation of blood pressure measuring devices in obese patients.

BACKGROUND: Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and special populations. Reproducibility of such validation protocols is unknown. OBJECTIVE: The aim of this study was to assess the inter-centre reproducibility of the European Society of Hypertension-International protocol (ESH-IP) in patients with large arm circumference at least 32 cm or obesity. METHODS: Two independent validation studies were performed in parallel according to the ESH-IP protocol in two centres (Serbia and Armenia). The two studies were performed blindly and independently. The ESH-IP criteria were applied for the analysis. The OMRON RS7 wrist oscillometric devices were used in both studies. RESULTS: The distribution of the mean differences values of 5 or less, 10 or less and 15 mmHg or less between the observers and the device were for the Serbia team: 74, 95 and 98 for SBP and 78, 95 and 99 for DBP; and for the Armenia team: 86, 95 and 99 for SBP and 90, 99 and 99 for DBP. The mean differences (SD) of BP values between the observers and the device were for the Serbia team of 1.7 ±â€Š4.8 mmHg for SBP and 1.2 ±â€Š4.6 mmHg for DBP and for the Armenia team of -1.1 ±â€Š4.2 mmHg for SBP and -0.3 ±â€Š3.5 mmHg for DBP. CONCLUSION: This study showed that the ESH-IP validation protocol presents a good inter-centre reproducibility. The OMRON RS7 device showed similar results, fulfilling the validation criteria in two independent studies in patients with arm circumference at least 32 cm.

Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol.

BACKGROUND: Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and in special populations such as pregnancy. OBJECTIVE: To evaluate the accuracy of the Omron Evolv® (HEM-7600T-E) and the Omron M3 Comfort® (HEM-7134-E) devices in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol. METHODS: Both devices, the Evolv and the M3 Comfort, measure BP at the brachial level using the oscillometric method. The study was performed according to the recently published protocol, the so-called "modified Advancement of Medical Instrumentation (AAMI)/British Hypertension Society (BHS)/European Society of Hypertension (ESH) protocol" or the "Universal Standard Protocol." Validation of each device included 45 pregnant women in the second and third gestational trimester of whom 15 had pre-eclampsia, 15 had gestational hypertension and 15 were normotensives. BP differences between the observer and the device BP values were classified into three categories (≤5, ≤10, and ≤15 mmHg) and the mean BP differences (test vs reference) and its SD were calculated. RESULTS: Both devices, the Evolv and the M3 Comfort, achieved a grade A/A in both pregnancy and pre-eclampsia. The mean difference (SD) between the mercury standard and the device BP values in pregnancy were: 1) for the Evolv of -0.7±2.3 mmHg for systolic blood pressure (SBP) and -0.1±1.8 mmHg for diastolic blood pressure (DBP); 2) for the M3 Comfort of -1.6±2.8 mmHg for SBP and -0.1±2.3 mmHg for DBP. CONCLUSION: Both devices, the Evolv and the M3 Comfort, achieved a grade A/A for both SBP and DBP and fulfill the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, these two devices can be recommended for home BP measurements in this specific population.

Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP).

BACKGROUND: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement. METHODS: Both devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely. RESULTS: QardioArm® and Omron M6 Comfort® fulfilled the requirements of the ESH-IP and passed the validation process successfully. For QardioArm®, a total of 69 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg and 82 out of 99 for diastolic blood pressure (DBP). As for Omron M6 Comfort®, a total of 83 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 77 out of 99 for DBP. The mean differences between the device and mercury readings were 0.7±5.9 mmHg for SBP and 0.3±4.1 mmHg for DBP for QardioArm® and -1.4±4.7 mmHg for SBP and -2.1±4.3 mmHg for DBP for Omron M6 Comfort®. With regard to part 2 of ESH-IP 2010, 27 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 subjects for DBP for the QardioArm®, and 29 out of 33 patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 26 out of 33 patients for DBP for Omron M6 Comfort®. CONCLUSION: QardioArm® and Omron M6 Comfort® readings differing from the mercury standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, these two devices are suitable for use in the general population and non-insulin-dependent type II diabetic patients, respectively.

Effects of metabolic syndrome on arterial function in different age groups: the Advanced Approach to Arterial Stiffness study.

OBJECTIVE: The aim of the Advanced Approach to Arterial Stiffness study was to compare arterial stiffness measured simultaneously with two different methods in different age groups of middle-aged and older adults with or without metabolic syndrome (MetS). The specific effects of the different MetS components on arterial stiffness were also studied. METHODS: This prospective, multicentre, international study included 2224 patients aged 40 years and older, 1664 with and 560 without MetS. Patients were enrolled in 32 centres from 18 European countries affiliated to the International Society of Vascular Health & Aging. Arterial stiffness was evaluated using the cardio-ankle vascular index (CAVI) and the carotid-femoral pulse wave velocity (CF-PWV) in four prespecified age groups: 40-49, 50-59, 60-74, 75-90 years. In this report, we present the baseline data of this study. RESULTS: Both CF-PWV and CAVI increased with age, with a higher correlation coefficient for CAVI (comparison of coefficients P < 0.001). Age-adjusted and sex-adjusted values of CF-PWV and CAVI were weakly intercorrelated (r = 0.06, P < 0.001). Age-adjusted and sex-adjusted values for CF-PWV but not CAVI were higher in presence of MetS (CF-PWV: 9.57 ±â€Š0.06 vs. 8.65 ±â€Š0.10, P < 0.001; CAVI: 8.34 ±â€Š0.03 vs. 8.29 ±â€Š0.04, P = 0.40; mean ±â€ŠSEM; MetS vs. no MetS). The absence of an overall effect of MetS on CAVI was related to the heterogeneous effects of the components of MetS on this parameter: CAVI was positively associated with the high glycaemia and high blood pressure components, whereas lacked significant associations with the HDL and triglycerides components while exhibiting a negative association with the overweight component. In contrast, all five MetS components showed positive associations with CF-PWV. CONCLUSION: This large European multicentre study reveals a differential impact of MetS and age on CAVI and CF-PWV and suggests that age may have a more pronounced effect on CAVI, whereas MetS increases CF-PWV but not CAVI. This important finding may be due to heterogeneous effects of MetS components on CAVI. The clinical significance of these original results will be assessed during the longitudinal phase of the study.