Automated office blood pressure measurements in primary care are misleading in more than one third of treated hypertensives: The VALENTINE-Greece Home Blood Pressure Monitoring study.

BACKGROUND: This study assessed the diagnostic reliability of automated office blood pressure (OBP) measurements in treated hypertensive patients in primary care by evaluating the prevalence of white coat hypertension (WCH) and masked uncontrolled hypertension (MUCH) phenomena. METHODS: Primary care physicians, nationwide in Greece, assessed consecutive hypertensive patients on stable treatment using OBP (1 visit, triplicate measurements) and home blood pressure (HBP) measurements (7 days, duplicate morning and evening measurements). All measurements were performed using validated automated devices with bluetooth capacity (Omron M7 Intelli-IT). Uncontrolled OBP was defined as ≥140/90 mmHg, and uncontrolled HBP was defined as ≥135/85 mmHg. RESULTS: A total of 790 patients recruited by 135 doctors were analyzed (age: 64.5 ± 14.4 years, diabetics: 21.4%, smokers: 20.6%, and average number of antihypertensive drugs: 1.6 ± 0.8). OBP (137.5 ± 9.4/84.3 ± 7.7 mmHg, systolic/diastolic) was higher than HBP (130.6 ± 11.2/79.9 ± 8 mmHg; difference 6.9 ± 11.6/4.4 ± 7.6 mmHg, p < 0.001). WCH phenomenon (high OBP with low HBP) was observed in 22.7% of the patients, MUCH (low OBP with high HBP) in 15.8%, uncontrolled hypertension (high OBP with high HBP) in 29.9%, and controlled hypertension (low OBP with low HBP) in 31.6%. In multivariate logistic regression analysis, WCH was determined by stage-1 systolic hypertension (odds ratio [OR] 8.6, 95% confidence intervals [CI] 5.7, 13.1) and female gender (OR 1.6, 95% CI 1.1, 2.4), whereas MUCH was determined by high-normal systolic OBP (OR 6.2, 95% CI 3.8, 10.1) and male gender (OR 2.0, 95% CI 1.2, 3.1). CONCLUSIONS: In primary care, automated OBP measurements are misleading in approximately 40% of treated hypertensive patients. HBP monitoring is mandatory to avoid overtreatment of subjects with WCH phenomenon and prevent undertreatment and subsequent excess cardiovascular disease in MUCH.

A novel cuffless device for self-measurement of blood pressure: concept, performance and clinical validation.

A pocket-size cuffless electronic device for self-measurement of blood pressure (BP) has been developed (Freescan, Maisense Inc., Zhubei, Taiwan). The device estimates BP within 10 s using three embedded electrodes and one force sensor that is applied over the radial pulse to evaluate the pulse wave. Before use, basic anthropometric characteristics are recorded on the device, and individualized initial calibration is required based on a standard BP measurement performed using an upper-arm BP monitor. The device performance in providing valid BP readings was evaluated in 313 normotensive and hypertensive adults in three study phases during which the device sensor was upgraded. A formal validation study of a prototype device against mercury sphygmomanometer was performed according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 2013 protocol. The test device succeeded in obtaining a valid BP measurement (three successful readings within up to five attempts) in 55-72% of the participants, which reached 87% with device sensor upgrade. For the validation study, 125 adults were recruited and 85 met the protocol requirements for inclusion. The mean device-observers BP difference was 3.2±6.7 (s.d.) mm Hg for systolic and 2.6±4.6 mm Hg for diastolic BP (criterion 1). The estimated s.d. (inter-subject variability) were 5.83 and 4.17 mm Hg respectively (criterion 2). These data suggest that this prototype cuffless BP monitor provides valid self-measurements in the vast majority of adults, and satisfies the BP measurement accuracy criteria of the ANSI/AAMI/ISO 2013 validation protocol.

Effect of supine versus sitting position on noninvasive assessment of aortic pressure waveform: a randomized cross-over study.

Biomarkers derived noninvasively from the aortic blood pressure (BP) waveform provide information regarding cardiovascular (CV) risk independently of brachial BP (bBP). Although body position has significant impact on the assessment of bBP, its effect on aortic hemodynamics remains unknown. This study investigated the changes in both brachial and aortic hemodynamics, between the supine and sitting position. In this randomized cross-over study, the bBP and the aortic pressure waveform were assessed after a 5 min rest (sitting and supine in randomized order); aortic BP, pulse pressure (PP) amplification, augmentation index (AIx) and subendocardial viability index (SEVR) were assessed. Sixty-one subjects were examined (36 males, mean age 50±12 years). Mean BP did not differ between the sitting and supine position (110.8±13.7 vs 110.9±14.9, respectively, P=0.945). However, significant difference between the sitting and supine position in brachial PP (45.9±16.0 vs 52.6±15.6, respectively, P<0.001), aortic PP (36.7±15.2 vs 43.1±13.9, P<0.001), PP amplification (1.28±0.1 vs 1.23±0.1, P<0.001), AIx (26.9±11.9 vs 31.1±10.2, P<0.001) and SEVR (179.6±25.7 vs 161.2±25.8, P<0.001) were found. Review of the literature identified underestimation of the role of body position on aortic hemodynamics. In conclusion, increased PP in both the aorta and brachial artery were found in the supine compared to the sitting position. Reduced PP amplification and SEVR were further observed in the supine position, due to increased pressure wave reflections (AIx).

Patients' preference for ambulatory versus home blood pressure monitoring.

Patient's preference might influence compliance with antihypertensive treatment and thereby long-term blood pressure (BP) control. This study compared patients' preference in using ambulatory (ABPM) versus home BP monitoring (HBPM). Subjects referred for hypertension were evaluated with 24-h ABPM and 7-day HBPM. Participants filled a questionnaire including demographics and Likert scale questions regarding their acceptance, preference, disturbance, activity restriction and feasibility of using ABPM and HBPM. A total of 119 patients were invited and 104 (87%) were included (mean age 51±11 years, 58% men, 38% time to work >8 h). A total of 82% reported a positive overall opinion for HBPM versus 63% for ABPM (P<0.05). 62% considered ABPM as more reliable than HBPM but 60% would choose HBPM for their next BP evaluation (P<0.05 for both comparisons). Moderate to severe discomfort from ABPM was reported by 55% and severe restriction of their daily activities by 30% compared with 13% and 7%, respectively, from HBPM (P<0.001 for both comparisons). The overall score for HBPM and ABPM (range 4-25; higher score indicating worse performance) was 6.6±2.5 and 10±4.0 (mean difference 4.4±4.6, P<0.001), respectively. In binary logistic regression models, neither previous experience with BP monitoring nor demographic characteristics appeared to influence patients' preference. These data suggest that HBPM is superior to ABPM in terms of overall acceptance and preference by hypertensive patients. Patients' preference deserves further research and should be taken into account in decision making in clinical practice.

Identification of the hemodynamic modulators and hemodynamic status in uncontrolled hypertensive patients.

Only 20-30% out of the treated hypertensive patients in Europe are achieving blood pressure (BP) control. Among other recognized factors, these poor results could be attributable to the fact that for many doctors it is very difficult to detect which is the predominant hemodynamic cause of the hypertension (hypervolemia, hyperinotropy or vasoconstriction). The aim of the study was to use non-invasive thoracic electrical bioimpedance (TEB) to evaluate hemodynamic modulators and subsequent hemodynamic status in uncontrolled hypertensive patients, receiving at least two antihypertensive drugs. A number of 134 uncontrolled hypertensive patients with essential hypertension were evaluated in nine European Hypertension Excellence centers by means of TEB (the HOTMAN(®) System). Baseline office systolic and diastolic BP averaged 156/92 mmHg. Hemodynamic measurements show that almost all patients (98.5%) presented at least one altered hemodynamic modulator: intravascular hypervolemia (96.4%) and/or hypoinotropy (42.5%) and/or vasoconstriction (49.3%). Eleven combinations of hemodynamic modulators were present in the study population, the most common being concomitant hypervolemia, hypoinotropy and vasoconstriction in 51(38%) patients. Six different hemodynamic states (pairs of mean arterial pressure and stroke index) were found. Data suggest that there is a strong relation between hypertension and abnormal hemodynamic modulators. This method might be helpful for treatment individualization of hypertensive patients.

A perfect replacement for the mercury sphygmomanometer: the case of the hybrid blood pressure monitor.

This study validated a hybrid mercury-free device as a replacement of the mercury sphygmomanometer for professional use, and also as a standard for future validations. A validation study was performed according to the European Society of Hypertension International Protocol 2010 (ESH-IP) in 33 subjects using simultaneous blood pressure (BP) measurements. A total of six BP measurements were taken per participant simultaneously by a supervisor (S; hybrid auscultatory device Nissei DM3000) and two observers (A and B; mercury sphygmomanometers). ESH-IP analysis (99 BP readings): mean device-observer systolic/diastolic BP difference 0.2±2.0/0.1±2.0 mm Hg; systolic BP differences ≤5/10/15 mm Hg in 97/99/99 readings, respectively (diastolic 98/99/99). All 33 subjects had 2 of 3 BP differences ≤5 mm Hg and none without a difference ≤5 mm Hg. Further analysis (198 BP readings): mean differences S-A 0.1±2.4/0.2±2.4 mm Hg (systolic/diastolic), S-B 0.3±2.1/0.2±2.2, A-B 0.2±2.4/0.0±2.3; differences ≤2 mm Hg S-A in 88/84% (systolic/diastolic), S-B 87/85%, A-B 87/86% and ≤4 mm Hg S-A 95/96%, S-B 95/96%, A-B 95/98%. In conclusion, a hybrid mercury-free auscultatory BP monitor comfortably passed the ESH-IP 2010 requirements and has the same level of accuracy as the mercury sphygmomanometer. This device appears to be a reliable alternative to the mercury sphygmomanometer for professional use and also as a standard for future validations.

Home versus ambulatory blood pressure monitoring in the diagnosis of clinic resistant and true resistant hypertension.

Ambulatory blood pressure (ABP) monitoring is recommended as a standard method for the evaluation of resistant hypertension (RH). This study assessed the diagnostic value of home blood pressure (HBP) monitoring in RH. Subjects on stable treatment with ≥3 antihypertensive drugs were included. Clinic RH (CRH) was defined as elevated clinic blood pressure and true RH (TRH) as elevated ABP. The diagnosis of CRH was verified by ABP and HBP monitoring. The diagnostic value of HBP was assessed by taking ABP as reference method. Threshold for hypertension diagnosis was ≥135/85 mm Hg (systolic and/or diastolic) for HBP and awake ABP and ≥140/90 mm Hg for clinic blood pressure. Among 73 subjects on ≥3 antihypertensive drugs, 44 (60%) had CRH and 40 (55%) TRH. There was agreement between ABP and HBP in diagnosing CRH in 82% of the cases (26 subjects (59%) with CRH and 10 (23%) without CRH; kappa 0.59). Regarding the diagnosis of TRH, there was agreement between ABP and HBP in 74% of the cases (36 subjects (49%) with TRH and 18 (25%) without TRH; kappa 0.46). The sensitivity, specificity, and positive and negative predictive values of HBP in detecting CRH were 93%, 63%, and 81% and 83%, respectively, and TRH were 90%, 55%, and 71%, and 82%, respectively (ABP taken as reference method). These data suggest that HBP is a reliable alternative to ABP in the evaluation of RH. These methods are necessary in both uncontrolled and controlled subjects on triple therapy to detect the white coat phenomenon and also masked RH.

Replacing the mercury manometer with an oscillometric device in a hypertension clinic: implications for clinical decision making.

Oscillometric devices are being widely used for ambulatory, home and office blood pressure (BP) measurement, and several of them have been validated using established protocols. This cross-sectional study assessed the impact on antihypertensive treatment decisions of replacing the mercury sphygmomanometer by a validated oscillometric device. Consecutive subjects attending a hypertension clinic had triplicate simultaneous same-arm BP measurements using a mercury sphygmomanometer and a validated professional oscillometric device. For each device, uncontrolled hypertension was defined as average BP ≥140/90 mm Hg (systolic/diastolic). A total of 5108 simultaneous BP measurements were obtained from 763 subjects in 1717 clinic visits. In 24% of all visits, the mercury and the oscillometric BP measurements led to different conclusion regarding the diagnosis of uncontrolled hypertension. In 4.9% of the visits, the diagnostic disagreement was considered as 'clinically important' (BP exceeding the diagnostic threshold by >5 mm Hg). These data suggest that the replacement of the mercury sphygmomanometer by a validated professional oscillometric device will result into different treatment decisions in about 5% of the cases. Therefore, and because of the known problems when using mercury devices and the auscultatory technique in clinical practise, the oscillometric devices are regarded as reliable alternatives to the mercury sphygmomanometer for office use.

Comparison of office, ambulatory and home blood pressure in children and adolescents on the basis of normalcy tables.

In children and adolescents, the diagnosis of hypertension is based on office, home and ambulatory blood pressure (BP) measurements. Different normalcy tables for each method have provided 95th percentiles of BP as thresholds for hypertension diagnosis. This study assessed the differences in BP thresholds among these methods when applied in the pediatric population. The most widely used office, home and ambulatory BP normalcy tables were compared in terms of the 50th and 95th percentiles by gender and age. The range of office BP change with increasing age is wider than for home or ambulatory BP in boys and girls, apart from systolic BP in boys. Percentiles of home BP are consistently lower than that of daytime ambulatory BP. There is a trend for office BP to be lower than home or daytime ambulatory BP in the younger age subgroups. This difference is progressively eliminated with increasing age, apart from systolic BP in boys. In conclusion, in children and adolescents, the relationship between office, home and ambulatory BP thresholds provided by the widely used normalcy tables is not the same as in the adults. These findings should be taken into account when evaluating BP measurements in children and adolescents in clinical practice.

European Society of Hypertension practice guidelines for home blood pressure monitoring.

Self-monitoring of blood pressure by patients at home (home blood pressure monitoring (HBPM)) is being increasingly used in many countries and is well accepted by hypertensive patients. Current hypertension guidelines have endorsed the use of HBPM in clinical practice as a useful adjunct to conventional office measurements. Recently, a detailed consensus document on HBPM was published by the European Society of Hypertension Working Group on Blood Pressure Monitoring. However, in daily practice, briefer documents summarizing the essential recommendations are needed. It is also accepted that the successful implementation of clinical guidelines in routine patient care is dependent on their acceptance by involvement of practising physicians. The present document, which provides concise and updated guidelines on the use of HBPM for practising physicians, was therefore prepared by including the comments and feedback of general practitioners.

Are there really differences between home and daytime ambulatory blood pressure? Comparison using a novel dual-mode ambulatory and home monitor.

Several studies compared blood pressure (BP) at home (HBP) with ambulatory BP (ABP), but using different devices, which contribute to differences in measured BP. A novel dual-mode device allowing ABP and HBP monitoring (Microlife WatchBPO3) was validated according to the European Society of Hypertension International Protocol and used to compare the two methods. In the validation study, 33 subjects were assessed with simultaneous BP measurements taken by 2 observers (connected mercury sphygmomanometers) 4 times, sequentially with 3 measurements taken using the tested device. Absolute observer-device BP differences were classified within 5/10/15 mm Hg zones. Measurements with

Masked, white coat and sustained hypertension: comparison of target organ damage and psychometric parameters.

Masked hypertension is defined as low clinic and elevated out-of-clinic pressure (blood pressure, BP) assessed either by patients at home or by ambulatory monitoring. This study compared the cardiovascular status and psychometric characteristics of masked, white coat and sustained hypertensives. Three groups of consecutive subjects with masked (n=100, age 59+/-11 years), white coat (n=100, 60+/-10 years) and sustained hypertension (n=100, 60+/-11 years) diagnosed by ambulatory BP monitoring were compared. Masked hypertensives had higher educational level, exercised more frequently, received fewer drugs and sensed more responsibilities at work than at home. Their left ventricular hypertrophy indexes fall in-between those with white coat and sustained, the latter having the highest values. The estimated total cardiovascular risk was intermediate between white coat and sustained, whereas their cardiovascular morbidity and renal disease was higher than that of white coat and similar to sustained. Psychological profile analysis showed lower score for type-A personality and their mood behaviour in the hypomania-euthymia range compared with white coat and sustained hypertensives. The cardiovascular risk of masked hypertensives is higher than that of white coat and similar to sustained. Masked hypertensives have higher educational level, better physical training and different personality/mood pattern than white coat and sustained.

The optimal home blood pressure monitoring schedule based on the Didima outcome study.

This study investigated the optimal schedule for home blood pressure (HBP) monitoring that has the greatest prognostic ability and provides the most reliable assessment of HBP. The Didima study assessed the value of HBP (duplicate morning and evening measurements, 3 days) in predicting cardiovascular events in the general population (662 adults, 8.2+/-0.2 years follow-up). Criteria for the optimal monitoring schedule were stabilization of mean HBP, its variability (standard deviation (s.d.)) and hazard ratios (HRs) of cardiovascular events per 1 mm Hg HBP increase. By averaging more readings (1-12), there was a progressive decline in average HBP and its s.d. and increase in HR, with most of these benefits achieved on the second day (8 readings) and little additional benefit obtained on the third day (12 readings). The first day gave higher and more unstable HBP values (higher s.d.) with less prognostic ability (lower HR). The first HBP readings per occasion gave higher values but with similar prognostic ability as the second readings taken 1 min later. There was little difference in average HBP between morning and evening readings with no prognostic superiority of morning readings. In conclusion, by averaging more readings the average HBP and its variability are reduced and the prognostic ability improved. Any aspect of HBP monitoring (first or second readings, morning or evening) has similar prognostic ability. The first day gives higher and unstable values with lower prognostic ability and should be better discarded. These data validate the HBP monitoring schedule proposed by the European Society of Hypertension.

Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation.

Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with an increased long-term risk of stroke. A screening test for early diagnosis has the potential to prevent AF-related strokes. This study assessed the diagnostic accuracy of an automated device for self-home blood pressure (BP) monitoring, which implements an algorithm for AF detection. A modified, automated oscillometric device for self-home BP monitoring (Microlife BPA100 Plus, Microlife, Heerbrugg, Switzerland) with an AF detector was used to carry out triplicate BP measurements in subjects with sinus rhythm, AF and non-AF arrhythmias. During each BP measurement, the electrocardiogram (ECG) was recorded simultaneously. A total of 217 simultaneous BP measurements and ECG recordings were obtained from 73 subjects. Twenty-seven subjects (37%) had AF, 23 (31%) non-AF arrhythmias and 23 (31%) had sinus rhythm. A single measurement had 93% sensitivity and 89% specificity for detecting AF. For two measurements, in which one of them was required to detect AF, the sensitivity was 100% and specificity 76%, whereas for three measurements, in which two of them were required to detect AF, the sensitivity was 100% and specificity 89% (kappa=0.86 for an agreement with ECG). Using the latter approach, there were five false positive cases all having irregularities in approximately 50% of the heartbeats. In patients with tachyarrhythmia, the device underestimated heart rate. These data suggest that an electronic device for self-home BP monitoring, which implements an algorithm for AF diagnosis has an excellent diagnostic accuracy and might, therefore, be used as a reliable screening test for the early diagnosis.

Unreliable oscillometric blood pressure measurement: prevalence, repeatability and characteristics of the phenomenon.

Oscillometric devices are being widely used for ambulatory, home and office blood pressure (BP) measurement. However, even successfully validated oscillometric devices fail to provide accurate measurements in some patients. This study investigated the prevalence, the reproducibility and the characteristics of the phenomenon of unreliable oscillometric BP (UOBP) measurement. A total of 5070 BP measurements were obtained simultaneously (Y connector) using a professional oscillometric device (BpTRU) and a mercury sphygmomanometer in 755 patients (1706 visits). UOBP readings were defined as those with >10 mm Hg difference (systolic or diastolic) between the two methods. UOBP was found in 15% of systolic and 6.4% of diastolic BP measurements. In all, 18% of the participants had UOBP in their first but not their second visit, or the reverse. However, 49% of these participants had at least one more UOBP visit after their second visit within the study database. Patients with persistent UOBP were more likely to be female and had lower arm circumference. The systolic BP discrepancy between the two methods was associated with pulse pressure (r=0.41) and inversely with diastolic BP (r=0.40) and arm circumference (r=0.30), whereas the diastolic discrepancy with diastolic BP (r=0.61) and inversely with pulse pressure (r=0.32). There was a consistent significant trend for larger systolic BP discrepancy and smaller diastolic from the lower to the higher pulse pressure quintile (P<0.0001). A decreasing arm circumference was a significant predictor of persistent UOBP. These data suggest that the UOBP measurement is particularly common, not very reproducible and mainly affected by pulse pressure and arm circumference.

Trends in high blood pressure prevalence in Greek adolescents.

A school-based screening with anthropometric and blood pressure (BP) measurements was performed in adolescents aged 12-17 years in the island of Samos, Greece, in 2004 and also in 2007. A total of 446 adolescents were included in the analysis in 2004 and 558 in 2007. The 2007 study population had higher levels of body mass index (BMI) (P<0.05) and systolic and diastolic BP (P<0.001), compared with 2004. The prevalence of high BP was 16.1% in 2004 and 22.9% in 2007 (P<0.01 for difference). Mean age-, sex- and BMI-adjusted BP increase was 4.1/10.5 mm Hg (systolic/diastolic). In multivariate analysis, BMI, male gender and age, but also modifiable factors (lack of physical activity, breakfast skipping, smoking and low milk consumption) were associated with increased BP levels in the study population. These data indicate that further to BMI, other factors such as adverse lifestyle and dietary habits appear to be associated with elevated BP levels in adolescents. Moreover, rising trends seem to characterize the prevalence of high BP.

Home and office blood pressure in children and adolescents: the role of obesity. The Arsakeion School Study.

Obesity is related to office blood pressure (OBP). Important discrepancies exist between OBP and home blood pressure (HBP), providing complementary information for the management of hypertension. The association between obesity and HBP has not been investigated in children. The evidence on the role of obesity in the predominance of systolic blood pressure (SBP) over diastolic (DBP) in paediatric hypertension is limited. A total of 778 healthy subjects aged 6-18 years were recruited in this study. OBP and HBP were measured using electronic devices validated in children. Anthropometric measurements were measured and expressed as z-scores for height or age. Among all indices of obesity (z-scores), body mass index (BMI) showed the best association with BP. The effect of obesity (BMI) was more pronounced on: (i) SBP than DBP and (ii) H-SBP than O-SBP (O-SBP: r2=0.09, O-DBP: r2=0.05, H-SBP: r2=0.12, H-DBP: r2=0.06). The prevalence of systolic hypertension was higher than that of diastolic hypertension. This difference was significant only in office readings and independent from obesity (normal weight: 6.3% systolic hypertension versus 1.2% diastolic; obese: 37.9% versus 6.9%, P<0.05 for both). These data imply that in children and adolescents the z-score of BMI is the most appropriate index of the association between BP and obesity. It also suggests that obesity is probably more closely associated with home than office BP. Finally, although obesity appears to affect SBP more than DBP, these results suggest that the predominance of systolic hypertension in children and adolescents might not be only related to obesity but also to the measurement setting (office).

Diagnostic value of rapid urease test and urea breath test for Helicobacter pylori detection in patients with Billroth II gastrectomy: a prospective controlled trial.

AIM: The aim of this work was to assess the reliability of rapid urease test (RUT) and urea breath test (UBT) for detecting Helicobacter pylori (H. pylori) in patients with Billroth II (BII) gastrectomy, using histology as reference. METHODS: In this prospective controlled study, 31 consecutive patients with BII gastrectomy and 73 controls who had an indication for endoscopy were included. Their H. pylori status was assessed with biopsies for histology, RUT and UBT. Histology served as the gold standard. Only the biopsies from the gastric fundus were evaluated. Specificity, sensitivity, positive and negative predictive value, degree of agreement and k-statistics were used. RESULTS: RUT and UBT for detecting H. pylori in the control group had excellent agreement [97%, kappa (k)=0.94 and 99%, k=0.97 respectively] with biopsies. In BII patients, RUT from fundic biopsies had very good agreement (87%, k=0.74) compared to histology from fundic biopsies, whereas the UBT was unreliable (agreement: 71%, k=0.41) compared to histology. CONCLUSION: The RUT from fundic biopsies in BII patients is a reliable test for H. pylori detection, whereas the UBT is unreliable.