Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less.

OBJECTIVE: A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm. METHODS: Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17-22 cm. Test device B was the YuWell YE660Е with the YuWell '360°' cuff (18-36 cm). Data from 37 participants aged 20.14 ± 2.23 (18-28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018. RESULTS: According to criterion 1, the mean ± SD of the BP differences for the device A was -7.81 ± 5.20/-10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was -8.00 ± 6.30/-16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements. CONCLUSION: Since devices A and B, which had passed in a general population study, failed in adults aged 18-28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.

Variable association of 24-h peripheral and central hemodynamics and stiffness with hypertension-mediated organ damage: the VASOTENS Registry.

OBJECTIVE: In this analysis of the telehealth-based Vascular health ASsessment Of The hypertENSive patients Registry, we checked how 24-h central and peripheral hemodynamics compare with hypertension-mediated organ damage (HMOD). METHODS: In 646 hypertensive patients (mean age 52 ±â€Š16 years, 54% males, 65% treated) we obtained ambulatory brachial and central SBP and pulse pressure (PP), SBP, and PP variability, pulse wave velocity and augmentation index with a validated cuff-based technology. HMOD was defined by an increased left ventricular mass index (cardiac damage, evaluated in 482 patients), an increased intima-media thickness (vascular damage, n = 368), or a decreased estimated glomerular filtration rate or increased urine albumin excretion (renal damage, n = 388). RESULTS: Ambulatory SBP and PPs were significantly associated with cardiac damage: the largest odds ratio was observed for 24-h central SBP [1.032 (1.012, 1.051), P = 0.001] and PP [1.042 (1.015, 1.069), P = 0.002], the weakest for brachial estimates. The association was less strong for vascular damage with a trend to the superiority of 24-h central [1.036 (0.997, 1.076), P = 0.070] over brachial PP [1.031 (1.000, 1.062), P = 0.052]. No statistically significant association was observed for renal damage. SBP and PP variabilities, pulse wave velocity and augmentation index were not associated with any form of HMOD. In the multivariate analysis, age was associated with any type of HMOD, whereas central SBP and PP were predictive of an increased risk of cardiac damage. CONCLUSION: In hypertensive patients a variable association exists between peripheral and central hemodynamics and various types of HMOD, with the most predictive power being observed for central SBP and PP for cardiac damage.

Ambulatory blood pressure and arterial stiffness web-based telemonitoring in patients at cardiovascular risk. First results of the VASOTENS (Vascular health ASsessment Of The hypertENSive patients) Registry.

The VASOTENS Registry is an international telehealth-based repository of 24-hour ambulatory blood pressure monitorings (ABPM) obtained through an oscillometric upper-arm BP monitor allowing combined estimation of some vascular biomarkers. The present paper reports the results obtained in 1200 participants according to different categories of CV risk. Individual readings were averaged for each recording and 24-hour mean of brachial and aortic systolic (SBP) and diastolic blood pressure (DBP), pulse wave velocity (PWV), and augmentation index (AIx) obtained. Peripheral and central BP, PWV and AIx values were increased in older participants (SBP only) and in case of hypertension (SBP and DBP). BP was lower and PWV and AIx higher in females. PWV was increased and BP unchanged in case of metabolic syndrome. Our results suggest that ambulatory pulse wave analysis in a daily life setting may help evaluate vascular health of individuals at risk for CV disease.

Relationships between 24-h blood pressure variability and 24-h central arterial pressure, pulse wave velocity and augmentation index in hypertensive patients.

Twenty-four-h blood pressure variability (BPV) predicts cardiovascular complications in hypertension, but its association with pulse wave indices (central arterial pressure, pulse wave velocity (PWV) and augmentation index (AIx)) is poorly understood. In the present study, we assessed the degree of the effect of 24-h BPV on 24-h pulse wave indices. Brachial blood pressure was measured non-invasively over the 24 h with an electronic, oscillometric, automated device (BPLab) in 661 uncomplicated treated or untreated hypertensive patients. Digitalized oscillometric waveforms were analyzed with a validated algorithm to obtain pulse wave indices. Twenty-four-h BPV was calculated as the unweighted (SDu) or weighted s.d. (SDw) of the mean blood pressure or as the average real variability (ARV). Twenty-four-h systolic BPV showed a direct and significant relationship with the central arterial systolic pressure (r=0.28 SDu, r=0.40 SDw, r=0.34 ARV), PWV (r=0.10 SDu, r=0.21 SDw, r=0.19 ARV) and AIx (r=0.17 SDu, r=0.27 SDw, r=0.23 ARV). After adjustment for age, sex, body mass index, antihypertensive treatment and 24-h systolic blood pressure, the relationship lost some power but was still significant for all measures, except for the AIx. Pulse wave indices were higher in patients with high BPV than in those with low BPV: after adjustment, these differences were abolished for the AIx. The diastolic BPV showed a weak association with the pulse wave indices. In conclusion, in hypertensive patients, 24-h systolic BPV is moderately and independently associated with 24-h central arterial pressure and stiffness.

Twenty-Four-Hour Ambulatory Pulse Wave Analysis in Hypertension Management: Current Evidence and Perspectives.

The predictive value of vascular biomarkers such as pulse wave velocity (PWV), central arterial pressure (CAP), and augmentation index (AIx), obtained through pulse wave analysis (PWA) in resting conditions, has been documented in a variety of patient groups and populations. This allowed to make appropriate recommendations in clinical practice guidelines of several scientific societies. Due to advances in technologies, largely operator-independent methods are currently available for estimating vascular biomarkers also in ambulatory conditions, over the 24 h. According to the acceptable accuracy and reproducibility of 24-h ambulatory PWA, it appears to be a promising tool for evaluating vascular biomarkers in daily life conditions. This approach may provide an opportunity to further improve the early cardiovascular screening in subjects at risk. However, concerning the clinical use of PWA over the 24 h in ambulatory conditions at the moment, there is no sufficient evidence to support its routine clinical use. In particular, long-term outcome studies are needed to show the predictive value of 24-h PWV, CAP, and AIx values, provided by these devices, over and beyond peripheral blood pressure, and to answer the many technical and clinical questions still open. To this regard, the VASOTENS Registry, an international observational prospective study recently started, will help providing answers on a large sample of hypertensive patients recruited worldwide.

Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for Ambulatory Blood Pressure and Arterial Stiffness.

BACKGROUND: Hypertension guidelines recommend ambulatory blood pressure (ABP), central aortic pressure (CAP), and pulse wave velocity (PWV) as parameters for estimating blood pressure (BP) control and vascular impairment. Recent advances in technology have enabled devices to combine non-invasive estimation of these parameters over the 24-hour ABP monitoring. However, currently there is limited evidence on the usefulness of such an approach for routine hypertension management. OBJECTIVE: We recently launched an investigator-initiated, international, multicenter, observational, prospective study, the Vascular health Assessment Of The Hypertensive patients (VASOTENS) Registry, aimed at (1) evaluating non-invasive 24-hour ABP and arterial stiffness estimates (through 24-hour pulse wave analysis, PWA) in hypertensive subjects undergoing ambulatory blood pressure monitoring (ABPM) for clinical reasons; (2) assessing the changes in estimates following treatment; (3) weighing the impact of 24-hour PWA on target organ damage and cardiovascular prognosis; (4) assessing the relationship between arterial stiffness, BP absolute mean level and variability, and prognosis; and (5) validating the use of a 24-hour PWA electronic health (e-health) solution for hypertension screening. METHODS: Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension of any severity or stage, will be recruited. Data collection will include ABPM, performed with a device allowing simultaneous non-invasive assessment of 24-hour CAP and arterial stiffness (BPLab), and clinical data (including cardiovascular outcomes). As recommended by current guidelines, each patient will be followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year depending on disease severity). A Web-based telemedicine platform (THOLOMEUS) will be used for data collection. The use of the telemedicine system will allow standardized and centralized data collection, data validation by experts and counseling to remote centers, setup and maintenance of the Registry, and prompt data analysis. RESULTS: First follow-up results are expected to be available in the next 2 years. CONCLUSIONS: The results of the VASOTENS Registry will help define the normalcy thresholds for current and future indices derived from 24-hour PWA, according to outcome data, and will also provide supporting evidence for the inclusion of this type of evaluation in hypertension management. TRIAL REGISTRATION: Clinicaltrials.gov NCT02577835; https://clinicaltrials.gov/ct2/show/NCT02577835 (Archived by WebCite at http://www.Webcitation.org/6hzZBKY2Q).

Evaluation of 24-Hour Arterial Stiffness Indices and Central Hemodynamics in Healthy Normotensive Subjects versus Treated or Untreated Hypertensive Patients: A Feasibility Study.

Objective. Central blood pressure (BP) and vascular indices estimated noninvasively over the 24 hours were compared between normotensive volunteers and hypertensive patients by a pulse wave analysis of ambulatory blood pressure recordings. Methods. Digitalized waveforms obtained during each brachial oscillometric BP measurement were stored in the device memory and analyzed by the validated Vasotens technology. Averages for the 24 hours and for the awake and asleep subperiods were computed. Results. 142 normotensives and 661 hypertensives were evaluated. 24-hour central BP, pulse wave velocity (PWV), and augmentation index (AI) were significantly higher in the hypertensive group than in the normotensive group (119.3 versus 105.6 mmHg for systolic BP, 75.6 versus 72.3 mmHg for diastolic BP, 10.3 versus 10.0 m/sec for aortic PWV, -9.7 versus -40.7% for peripheral AI, and 24.7 versus 11.0% for aortic AI), whereas reflected wave transit time (RWTT) was significantly lower in hypertensive patients (126.6 versus 139.0 ms). After adjusting for confounding factors a statistically significant between-group difference was still observed for central BP, RWTT, and peripheral AI. All estimates displayed a typical circadian rhythm. Conclusions. Noninvasive assessment of 24-hour arterial stiffness and central hemodynamics in daily life dynamic conditions may help in assessing the arterial function impairment in hypertensive patients.

The 24-hour pulse wave velocity, aortic augmentation index, and central blood pressure in normotensive volunteers.

The purpose of this study was to examine the pulse wave velocity, aortic augmentation index corrected for heart rate 75 (AIx@75), and central systolic and diastolic blood pressure during 24-hour monitoring in normotensive volunteers. Overall, 467 subjects (206 men and 261 women) were recruited in this study. Participants were excluded from the study if they were less than 19 years of age, had blood test abnormalities, had a body mass index greater than 2 7.5 kg/m(2), had impaired glucose tolerance, or had hypotension or hypertension. Ambulatory blood pressure monitoring (ABPM) with the BPLab(®) device was performed in each subject. ABPM waveforms were analyzed using the special automatic Vasotens(®) algorithm, which allows the calculation of pulse wave velocity, AIx@75, central systolic and diastolic blood pressure for "24-hour", "awake", and "asleep" periods. Circadian rhythms and sex differences in these indexes were identified. Pending further validation in prospective outcome-based studies, our data may be used as preliminary diagnostic values for the BPLab ABPM additional index in adult subjects.

Day-to-day repeatability of the Pulse Time Index of Norm.

The pulse wave velocity (PWV) threshold for hypertensive target organ damage is presently set at 10 meters per second. New 24-hour monitors (eg, BPLab® and Vasotens®) provide several PWV measurements over a period of 24-72 hours. A new parameter, ie, the Pulse Time Index of Norm (PTIN), can be calculated from these data. The PTIN is defined as the percentage of a 24-hour period during which the PWV does not exceed 10 meters per second. The aim of the present study was to test the new PTIN for clinical feasibility using day-to-day repeatability analysis. Oscillometrically generated waveform files (n=85), which were previously used for research studies, were reanalyzed using the new 2013 version software of the Vasotens technology program, which enables calculation of PTIN. The intraclass correlation coefficient was 0.98 and Cronbach's alpha was 0.97, indicating that the PTIN has excellent day-to-day repeatability and internal consistency. The present results show adequate repeatability, and PTIN assessment using the Vasotens technology appears to be feasible.

The "Pulse Time Index of Norm" highly correlates with the left ventricular mass index in patients with arterial hypertension.

BACKGROUND: Arterial stiffness, as measured by the pulse wave velocity (PWV), is recommended for routine use in clinical practice as an important parameter for the evaluation of cardiovascular risk.1 New 24-hour monitors (eg, with Vasotens technology; Petr Telegin Company, Nizhny Novgorod, Russian Federation) provide single PWV measurements as well as several PWV measurements over a period of 24 hours.2 Such 24-hour pulse wave analysis led to the development of the novel Pulse Time Index of Norm (PTIN), which is defined as the percentage of a 24-hour period during which the PWV does not exceed the 10 m/second PWV threshold. The aim of this study is to test the new PTIN for correlation with the left ventricular mass index (LVMI). METHODS: Oscillometrically generated waveform files (n=137) used for clinical research studies were reanalyzed using the new 2013 version of the Vasotens technology program, which enables PTIN calculations. RESULTS: A good correlation (r=-0.72) between the PTIN and the LVMI was shown, which was significantly above the blood pressure load (r=0.41). CONCLUSION: The PTIN generated by the Vasotens technology can be recommended as an indicator of end organ damage via hypertension.

Analysis of 24-hour pulse wave velocity in patients with renal transplantation.

The aim of our study was to assess the feasibility of using an approach to 24-hour pulse wave velocity (PWV) analysis similar to ambulatory blood pressure monitoring analysis in the management of patients with renal transplantation. Overall, 41 patients aged between 18 and 55 years who had end-stage renal disease resulting from glomerulopathy were recruited from the kidney transplant waiting list. All the measurements were performed before kidney transplantation and at 1 and 20 weeks after transplantation. The Pulse Time Index of Norm (PTIN) was calculated with the Vasotens® technology for the estimation of the 24-hour PWV, defined as the percentage of the 24-hour period during which the PWV does not exceed 10 m/second. Before kidney transplantation, the mean PTIN in the whole group was 56.3 (standard deviation, 18.4). Then, a week after the renal transplantation, a decrease in the PTIN was observed in most cases, going to 27.6 (standard deviation, 11.1). After 20 weeks, the mean PTIN in the whole group increased again to 52.0 (standard deviation, 23.6). In our study, we found that the persistence of arterial stiffness disturbances after kidney transplantation appears to be relatively predictable. We determined the cutoff value of PTIN that could predict the two states of PTIN: a state of improvement or a state of decline/without change. The cutoff value of PTIN at 45% had a sensitivity of 69%, specificity of 76%, and area under the curve of 0.65. The analysis of variance showed that in the group with an initial PTIN of 45% or higher, the PTIN in the remote period after transplantation changed significantly (P < 0.05), whereas in the group with an initial PTIN lower than 45%, there were no significant changes. Thus, the analysis of 24-hour pulse wave velocity in the management of patients with renal transplantation using PTIN is feasible.

Pulse wave velocity 24-hour monitoring with one-site measurements by oscillometry.

This review describes issues for the estimation of pulse wave velocity (PWV) under ambulatory conditions using oscillometric systems. The difference between the principles of measuring the PWV by the standard method and by oscillometry is shown, and information on device validation studies is summarized. It was concluded that currently oscillometry is a method that is very convenient to use in the 24-hour monitoring of the PWV, is relatively accurate, and is reasonably comfortable for the patient. Several indices with the same principles as those in the analysis of blood pressure in ambulatory monitoring of blood pressure, namely the assessment of load, variability, and circadian rhythm, are proposed.