IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS).

BACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severely debilitating condition which markedly restricts activity and function of affected people. Since the beginning of the COVID-19 pandemic ME/CFS related to post-acute COVID-19 syndrome (PACS) can be diagnosed in a subset of patients presenting with persistent fatigue 6 months after a mostly mild SARS-CoV-2 infection by fulfillment of the Canadian Consensus Criteria (CCC 2003). Induction of autoimmunity after viral infection is a mechanism under intensive investigation. In patients with ME/CFS, autoantibodies against thyreoperoxidase (TPO), beta-adrenergic receptors (ß2AR), and muscarinic acetylcholine receptors (MAR) are frequently found, and there is evidence for effectiveness of immunomodulation with B cell depleting therapy, cyclophosphamide, or intravenous immunoglobulins (IVIG). Preliminary studies on the treatment of ME/CFS patients with immunoadsorption (IA), an apheresis that removes antibodies from plasma, suggest clinical improvement. However, evidence from placebo-controlled trials is currently missing. METHODS: In this double-blinded, randomized, sham-controlled, exploratory trial the therapeutic effect of five cycles of IA every other day in patients with ME/CFS, including patients with post-acute COVID-19 chronic fatigue syndrome (PACS-CFS), will be evaluated using the validated Chalder Fatigue Scale, a patient-reported outcome measurement. A total of 66 patients will be randomized at a 2:1 ratio: 44 patients will receive IA (active treatment group) and 22 patients will receive a sham apheresis (control group). Moreover, safety, tolerability, and the effect of IA on patient-reported outcome parameters, biomarker-related objectives, cognitive outcome measurements, and physical parameters will be assessed. Patients will be hospitalized at the clinical site from day 1 to day 10 to receive five IA treatments and medical visits. Four follow-up visits (including two visits at site and two visits via telephone call) at month 1 (day 30), 2 (day 60), 4 (day 120), and 6 (day 180; EOS, end of study visit) will take place. DISCUSSION: Although ME/CFS including PACS-CFS causes an immense individual, social, and economic burden, we lack efficient therapeutic options. The present study aims to investigate the efficacy of immunoadsorption and to contribute to the etiological understanding and establishment of diagnostic tools for ME/CFS. TRIAL REGISTRATION: Registration Number: NCT05710770 . Registered on 02 February 2023.

MEDICATION ADHERENCE AND ITS IMPACT ON THE AVERAGE LIFE EXPECTANCY AFTER ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: THE RESULTS OF THE UKRAINIAN STIMUL REGISTRY.

OBJECTIVE: The aim: The present study aimed to evaluate the adherence to medications prior and within a two-year period after ST-segment elevation myocardial infarction (STEMI) and to estimate its impact on the average lifespan of patients after STEMI. PATIENTS AND METHODS: Materials and methods: 1,103 patients with STEMI were enrolled in the prospective Ukrainian STIMUL registry with 24-month follow-up. The relationship between adherence to medical treatment and average lifespan was evaluated. RESULTS: Results: The majority of prior STEMI patients were characterized with high and very high cardiovascular risk. The rate of revascularization was 29.9% (21.5% pPCI, 8.4% fibrinolytic therapy). The main reason for the low level of pPCI was late hospitalization and the inaccessibility of pPCI. This contributed greatly to in-hospital mortality (11.3%). Adherence to all medications progressively decreased (p < 0.001) within 24 months after STEMI. Permanent use of acetylsalicylic acid (ASA) and statins during the two-year follow-up was associated with 7.0% of the mortalities, whereas non-adherence to medications was related to a 15% risk of death (OR 4.2; 95% CI 0.2-0.9; p < 0.05). The average life expectancy with regular use of ASA and statins within 24 months after STEMI was 62.3 ± 1.1 years (95% CI 60.1-64.4; p < 0.05) and 61.2 ± 0.9 years with non-regular use of ASA and statins (95% CI 59.4-62.9; p < 0.05). CONCLUSION: Conclusions: Adherence to evidence-based medicines was low in the STIMUL population both prior and after STEMI. This worsened cardiovascular prognosis and reduced average lifespan by one year within the following two years after STEMI.

Evaluation and Comparison of the STIMUL Extended and Simplified Risk Scores for Predicting Two-Year Death in Patients Following ST-Segment Elevation Myocardial Infarction.

Background and Objectives: The management of ST-segment elevation myocardial infarction (STEMI) requires a patient's long-term risk to be estimated. The objective of this study was to develop extended and simplified models of two-year death risk estimation following STEMI that include and exclude cardiac troponins as prognostic factors and to compare their performance with each other. Materials and Methods: Extended and simplified multivariable logistic regression models were elaborated using 1103 patients with STEMI enrolled and followed up in the STIMUL (ST-segment elevation Myocardial Infarctions in Ukraine and their Lethality) registry. Results: The extended STIMUL risk score includes seven independent risk factors: age; Killip class ≥ II at admission; resuscitated cardiac arrest; non-reperfused infarct-related artery; troponin I ≥ 150.0 ng/L; diabetes mellitus; and history of congestive heart failure. The exclusion of cardiac troponin in the simplified model did not influence the predictive value of each factor. Both models divide patients into low, moderate, and high risk groups with a C-statistic of 0.89 (95% CI 0.84-0.93; p < 0.001) for the extended STIMUL model and a C-statistic of 0.86 (95% CI 0.83-0.99; p < 0.001) for the simplified model. However, the addition of the level of troponin I to the model increased its prognostic value by 10.7%. Conclusions: The STIMUL extended and simplified risk estimation models perform well in the prediction of two-year death risk following STEMI. The simplified version may be useful when clinicians do not know the value of cardiac troponins among the population of STEMI patients.

Non-invasive Oscillometry-Based Estimation of Cardiac Output - Can We Use It in Clinical Practice?

While invasive thermodilution techniques remain the reference methods for cardiac output (CO) measurement, there is a currently unmet need for non-invasive techniques to simplify CO determination, reduce complications related to invasive procedures required for indicator dilution CO measurement, and expand the application field toward emergency room, non-intensive care, or outpatient settings. We evaluated the performance of a non-invasive oscillometry-based CO estimation method compared to transpulmonary thermodilution. To assess agreement between the devices, we used Bland-Altman analysis. Four-quadrant plot analysis was used to visualize the ability of Mobil-O-Graph (MG) to track CO changes after a fluid challenge. Trending analysis of CO trajectories was used to compare MG and PiCCO® calibrated pulse wave analysis over time (6 h). We included 40 patients from the medical intensive care unit at the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin between November 2019 and June 2020. The median age was 73 years. Forty percent of the study population was male; 98% was ventilator-dependent and 75% vasopressor-dependent at study entry. The mean of the observed differences for the cardiac output index (COI) was 0.7 l∗min-1*m-2 and the lower, and upper 95% limits of agreement (LOA) were -1.9 and 3.3 l∗min-1*m-2, respectively. The 95% confidence interval for the LOA was ± 0.26 l∗min-1*m-2, the percentage error 83.6%. We observed concordant changes in CO with MG and PiCCO® in 50% of the measurements after a fluid challenge and over the course of 6 h. Cardiac output calculation with a novel oscillometry-based pulse wave analysis method is feasible and replicable in critically ill patients. However, we did not find clinically applicable agreement between MG and thermodilution or calibrated pulse wave analysis, respectively, assessed with established evaluation routine using the Bland-Altman approach and with trending analysis methods. In summary, we do not recommend the use of this method in critically ill patients at this time. As the basic approach is promising and the CO determination with MG very simple to perform, further studies should be undertaken both in hemodynamically stable patients, and in the critical care setting to allow additional adjustments of the underlying algorithm for CO estimation with MG.

Would Oscillometry be Able to Solve the Dilemma of Blood Pressure Independent Pulse Wave Velocity - A Novel Approach Based on Long-Term Pulse Wave Analysis?

The utility of pulse wave velocity (PWV) as a surrogate parameter of arterial vessel damage (AVD) beyond the traditional brachial blood pressure (BP) measurement may be questioned as changes in BP are often accompanied by the corresponding changes in PWV. We sought to establish a new way for BP-independent estimation of AVD with PWV. We retrospectively analyzed data from 507 subjects with at least one available 24 h ambulatory BP- and pulse wave analysis, performed with Mobil-O-Graph (I.E.M., Stolberg, Germany). Individual relationship between eaPWV and central systolic BP (cSBP) was analyzed for every 24 h recording. The analysis revealed linear relation between eaPWV and cSBP in all subjects, which is described by equation eaPWV = a∗cSBP + b. We termed "a" as PWVslope and "b" as PWVbaseline. All available demographic parameters and clinical data were correlated with eaPWV, PWVslope and PWVbaseline. 108 subjects had repeated 24 h recordings. Mean age was 60.7 years and 48.7% were female. 92.5% had hypertension, 22.9% were smoker, 20.5% had diabetes mellitus and 29.6% eGFR < 60 ml/min/1,73 m2. Direct correlation was observed between age, SBP and eaPWV, while diastolic BP (DBP) and eGFR correlated inversely with eaPWV. PWVbaseline correlated directly with age and inversely with DBP, while PWVslope didn't correlate with any inputted parameter. Using simple mathematical approach by plotting eaPWV and cSBP values obtained during ABPM, it is possible to visualize unique course of individual PWV related to BP. Using PWVslope and PWVbaseline as novel parameters could be a feasible way to approach BP-independent PWV, though their clinical relevance should be tested in future studies. Our data underline the importance of BP-independent expression of PWV, when we use it as a clinical surrogate parameter for the vascular damage.

True Arterial Stiffness Does Not Change between Dialysis Sessions during 1 Week in Outpatients on Intermitted Hemodialysis.

INTRODUCTION: End-stage renal disease (ESRD) is associated with exponentially elevated cardiovascular mortality. Arterial stiffness (AS) - usually expressed with pulse wave velocity (PWV) - is an established independent predictor of cardiovascular risk beyond the traditional risk factors. Higher PWV values are frequently observed in patients with ESRD. Due to the intrinsic physiologic relationship between PWV and prevailing arterial pressure, PWV can change without relevant changes in the arterial wall structure, and thus an individual pressure-independent expression of PWV is essential. METHODS: The study is a single-center observational study. Repeated measurements of blood pressure (BP) and pulse wave analysis were performed during each dialysis session of 1 week. Aortic PWV was then adjusted to 120 mm Hg central systolic BP (PWV120) based on individually determined relationship. PWV120 values were compared between single sessions. Calculation of the PWV120 was performed retrospectively. RESULTS: Fifty-four subjects were included, 61.1% of whom were male. The median age was 75.5 years, and median dialysis vintage was 33.1 months. Mean systolic/diastolic BP was 121.4/70.5 mm Hg, and the median heart rate was 64.6 beats/min. Mean PWV was 10.9 m/s, and mean PWV120 was 11.3 m/s. PWV120 did not change across single dialysis session during 1 week, while systolic, diastolic BP, PWV, and ultrafiltration volume differed significantly. DISCUSSION/CONCLUSIONS: Our data suggest that true AS does not change in the short-term course in dialysis patients. The observed changes in PWV are rather associated with BP change due to intrinsic pressure dependence. Our analytical approach represents a novel method for this purpose, which is easy in performance and also applicable for large interventional trials and clinical practice.

A Novel Long-Term ex vivo Model for Studying Vascular Calcification Pathogenesis: The Rat Isolated-Perfused Aorta.

The investigation of vascular calcification and its underlying cellular and molecular pathways is of great interest in current research efforts. Therefore, suitable assays are needed to allow examination of the complex calcification process under controlled conditions. The current study describes a new ex vivo model of isolated-perfused rat aortic tissue with subsequent quantification and vessel staining to analyze the calcium content of the aortic wall. A rat aorta was perfused ex vivo with control and calcification media for 14 days, respectively. The calcification medium was luminally perfused and induced a significant increase in calcium deposition within the media of the vessel wall detected alongside the elastic laminae. Perfusion with control medium induced no calcification. In addition, the mRNA expression of the osteogenic marker bone morphogenetic protein 2 (BMP-2) increased in aortic tissue after perfusion, while SM22α as smooth muscle marker decreased. This newly developed ex vivo model of isolated-perfused rat aorta is suitable for vascular calcification studies testing inducers and inhibitors of vessel calcification and studying signaling pathways within calcification progression.

Central Sleep Apnoea and Arrhythmogenesis After Myocardial Infarction-The CESAAR Study.

The prevalence of sleep disordered breathing (SDB) after acute myocardial infarction (AMI) is high. However, little is known about predominant SDB type and the impact of SDB severity on arrhythmogenesis. We conducted a prospective single-center observational study and performed an unattended sleep study and Holter monitoring within 10 days after AMI, and an unattended sleep study 11.3 months after AMI. All patients were included from the Department of Cardiology at the University Hospital Schleswig-Holstein, Lübeck, Germany. A total of 202 subjects with AMI (73.8% with ST-elevation; 59.8 years; 73.8% male) were included. The mean BMI was 27.8 kg/m2 and the mean neck/waist circumference was 41.7/103.3 cm. The mean left ventricular ejection fraction was 56.6%. The SDB prevalence defined as apnoea-hypopnea-index (AHI) ≥ 5/h was 66.7% with 44.9% having central (CSA), and 21.8% obstructive sleep apnoea (OSA). The mean AHI was 13.8 1/h. In 10.2% nsVT was detected in the Holter monitoring. AI >23/h was independently associated with higher risk of nsVT in the subacute AMI period. SDB is highly prevalent and CSA a predominant type of SDB in the subacute phase after uncomplicated AMI treated with modern revascularization procedures and evidence-based pharmacological therapy. Severe SDB is independently associated with higher risk for nsVT in the subacute AMI period and its course should be monitored as it can potentially have a negative impact on relevant outcomes of AMI patients. Further prospective studies are needed to assess long-term follow up of SDB after AMI and its impact on mortality and morbidity.

Author Correction: Predictors for success in renal denervation-a single centre retrospective analysis.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Ultrasound Time-Harmonic Elastography of the Aorta: Effect of Age and Hypertension on Aortic Stiffness.

OBJECTIVES: The aim of this study was to investigate ultrasound time-harmonic elastography for quantifying aortic stiffness in vivo in the context of aging and arterial hypertension. MATERIALS AND METHODS: Seventy-four participants (50 healthy participants and 24 participants with long-standing hypertension) were prospectively included between January 2018 and October 2018, and underwent ultrasound time-harmonic elastography of the upper abdominal aorta. Compound maps of shear-wave speed (SWS) as a surrogate of tissue stiffness were generated from multifrequency wave fields covering the full field-of-view of B-mode ultrasound. Blood pressure and pulse wave velocity were measured beforehand. Interobserver and intraobserver agreement was determined in 30 subjects. Reproducibility of time-harmonic elastography was assessed in subgroups with repeated measurements after 20 minutes and after 6 months. Linear regression analysis, with subsequent age adjustment of SWS obtained, receiver operating characteristic analysis, and intraclass correlation coefficients (ICCs) were used for statistical evaluation. RESULTS: Linear regression analysis revealed a significant effect of age on SWS with an increase by 0.024 m/s per year (P < 0.001). Age-adjusted SWS was significantly greater in hypertensives (0.24 m/s; interquartile range [IQR], 0.17-0.40 m/s) than in healthy participants (0.07 m/s; IQR, -0.01 to 0.06 m/s; P < 0.001). A cutoff value of 0.15 m/s was found to differentiate best between groups (area under the receiver operating characteristic curve, 0.966; 95% confidence interval, 0.93-1.0; P < 0.001; 83% sensitivity and 98% specificity). Interobserver and intraobserver variability was excellent (ICC, 0.987 and 0.937, respectively). Reproducibility was excellent in the short term (ICC, 0.968; confidence interval, 0.878-0.992) and good in the long term (ICC, 0.844; confidence interval, 0.491-0.959). CONCLUSIONS: Ultrasound time-harmonic elastography of the upper abdominal aorta allows quantification of aortic wall stiffness in vivo and shows significantly higher values in patients with arterial hypertension.

Quantitative Time-Harmonic Ultrasound Elastography of the Abdominal Aorta and Inferior Vena Cava.

The purpose of this study was to evaluate the sensitivity of quantitative time-harmonic ultrasound elastography (THE) of the inferior vena cava (IVC) and abdominal aorta (AA) to changes in central volume status. THE of the IVC and AA was performed in 20 healthy volunteers before and after oral intake of 1 L of water and before or during passive leg raising to augment venous filling. Compound maps of shear wave speed (SWS) as surrogate measures of vessel wall stiffness were generated within the full field of view from multifrequency harmonic wave fields. SWS was measured in regions of the IVC and AA. Blood pressure, stroke volume, cardiac output and pulse wave velocity were recorded. Statistical significance of SWS changes was tested using one-way repeated-measures analysis of variance. SWS measured in the IVC increased from 1.71 ± 0.1 m/s before water intake to 1.82 ± 0.1 m/s during passive leg raising and, further, to 1.87 ± 0.1 m/s after hydration and to 1.95 ± 0.1 m/s with hydration plus passive leg raising (p < 0.001). SWS in the AA did not change significantly after hydration (2.14 ± 0.13 m/s vs. 2.15 ± 0.16 m/s; p = 0.792). SWS was significantly higher in the AA than in the IVC across all experiments (p < 0.001). Water drinking did not significantly influence blood pressure, pulse wave velocity and cardiac output (all p values >0.1), whereas stroke volume increased significantly (p = 0.031). Time-harmonic ultrasound elastography enables quantification of the wall stiffness of the large abdominal vessels and is sensitive to different volume and pressure states in the IVC.

Validation of noninvasive oscillometric blood pressure 2020 up pressure upper arm blood pressure monitoring technology according to the European Society of Hypertension International Protocol revision 2010.

To validate noninvasive oscillometric blood pressure (NIBP) 2020 up pressure (UP) upper arm blood pressure (BP) monitoring technology according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010). According to the protocol, 33 participants were included. NIBP2020 UP technology was integrated into the BP+ host device, and common upper arm cuffs were used. The study included patients from ambulatory Hypertension Units. The validation procedure was performed exactly as required by ESH-IP revision 2010. Overall, 57.6% of the study population was female. Mean age was 45.5±16.3 years. Mean systolic blood pressure (SBP) was 142.9±30.6 mmHg and mean diastolic blood pressure (DBP) was 89.0±24.9 mmHg. The number of measurements within the difference range of up to 5 mmHg was 86 for SBP and 92 for DBP; 95 measurements of SBP and 99 of DBP were within the difference range of up to 10 mmHg, and 97 measurements of SBP and 99 measurement of DBP were in the difference range of up to 15 mmHg. Mean observer-test device differences were -0.2±4.6 mmHg for SBP and 0.6±3.1 mmHg for DBP. At least two observer-test differences were up to 5 mmHg for SBP in all participants and for DBP in 31 participants. All participants had at least one measurement with an observer-test difference of up to 5 mmHg for SBP and DBP. The NIBP2020 UP technology integrated into the BP+ host device using common upper arm cuffs passed the validation criteria according to the ESH-IP revision 2010.

Predictors for success in renal denervation-a single centre retrospective analysis.

Renal denervation (RDN) is one of the most frequently used invasive methods for the treatment of arterial hypertension. However, recent randomized sham-controlled studies raised concern about the efficacy and predictability of response. We retrospectively analyzed outcomes of patients, who underwent RDN in our hypertension center between November 2010 and April 2014 and report here outcomes twelve months after procedure based on 24-hours ambulatory blood pressure monitoring. We defined ten-mm Hg decrease in office systolic blood pressure (SBP) as a cut-off for response and looked for possible predictors of this response using binary multiple regression analysis. 42 patients were included. Their mean age was 59.6 ± 9.2 years and 24% were female. Baseline office SBP and diastolic blood pressure (DBP) were 164.1 ± 20.3 and 91.8 ± 12.4 mm Hg respectively. Mean 24 h-SBP significantly decreased from 149.8 ± 13.3 mm Hg to 141.2 ± 14.6 mm Hg. Mean 24 h-DBP significantly decreased from 83.3 ± 11.7 mm Hg to 78.8 ± 11.2 mm Hg. A higher level of mean 24 h-DBP and office DBP was shown to be predictive for response in office BP and a higher level of mean 24 h-DBP for response in 24 h-SBP and 24 h-DBP. Further properly designed randomized trials are warranted to confirm this finding as well as further investigate the role of diabetes mellitus and arterial stiffness in RDN.

Noninvasive oscillometric cardiac output determination in the intensive care unit - comparison with invasive transpulmonary thermodilution.

Assessment of the cardiac output (CO) is usually performed with invasive techniques requiring specialized equipment in the intensive care unit (ICU). With TEL-O-GRAPH (TG), CO can be derived from the oscillometrically obtained brachial pulse wave during the measurement of brachial blood pressure. CO and stroke volume (SV) determinations with TG were compared with transpulmonary thermodilution measurements with the PICCO system (PICCO) in 38 haemodynamically unstable ICU patients with a total of 84 comparison measurements performed. SV (33.3 ± 9.0 ml/m2 vs. 44.3 ± 14.4 ml/m2, p < 0.001) and CO (2.7 ± 0.5 l/min/m2 vs. 3.8 ± 1.2 l/min/m2, p < 0.001) were underestimated significantly with TG and oscillometric brachial systolic blood pressure (BP) was significantly lower and diastolic BP significantly higher than invasive femoral artery pressure. A linear correlation was found between CO dimension and CO underestimation with TG. Correct tracking of CO changes with a fluid challenge was possible in 69.5% of measurements. Oscillometric noninvasive CO is possible in the ICU, but accuracy and precision of this new method are lacking. Implementation of a correction factor accounting for the linear increase in CO underestimation observed with increasing CO could improve CO assessment with TG in haemodynamically unstable patients.

Time-Harmonic Ultrasound elastography of the Descending Abdominal Aorta: Initial Results.

Stiffening of central large vessels is considered a key pathophysiologic factor within the cardiovascular system. Current diagnostic parameters such as pulse wave velocity (PWV) indirectly measure aortic stiffness, a hallmark of coronary diseases. The aim of the present study was to perform elastography of the proximal abdominal aorta based on externally induced time-harmonic shear waves. Experiments were performed in 30 healthy volunteers (25 young, 5 old, >50 y) and 5 patients with longstanding hypertension (PWV >10 m/s). B-Mode-guided sonographic time-harmonic elastography was used for measurement of externally induced shear waves at 30-Hz vibration frequency. Thirty-hertz shear wave amplitudes (SWAs) within the abdominal aorta were measured and displayed in real time and processed offline for differences in SWA between systole and diastole (ΔSWA). Data were analyzed using the Kruskal-Wallis test and receiver operating characteristic curve analysis. The change in SWA over the cardiac cycle was reduced significantly in all patients as assessed with ΔSWA (volunteers: mean = 10 ± 5 µm, patients: mean = 4 ± 1 µm; p < 0.001). The best separation of healthy volunteers from patients was obtained with a ΔSWA threshold of 4.7 µm, resulting in a sensitivity of 0.9 and a specificity of 1.0, with an overall area under the curve of 0.96. Time harmonic elastography of the abdominal aorta is feasible and shows promise for the exploitation of time-varying shear wave amplitudes as a diagnostic marker for aortic wall stiffening. Patients with elevated PWVs suggesting increased aortic wall stiffness were best identified by ΔSWA-a parameter that could be related to the ability of the vessel walls to distend on passages of the pulse wave.

Oscillometric assessment of arterial stiffness in everyday clinical practice.

Measurement of carotid-femoral pulse wave velocity (cfPWV) is considered the gold standard for assessing arterial stiffness. Although widely used in clinical and observational studies, the detection of cfPWV has not yet been applied in everyday clinical practice due to technical and procedural difficulties. We, therefore, evaluated the applicability of oscillometric cfPWV assessment for everyday clinical practice. Eighty-nine patients were prospectively included in the study. Oscillometric calculations of cfPWV were performed with Tel-O-GRAPH and tonometric calculations with Sphygmocor. The accuracy, reproducibility, reliability and robustness of Tel-O-GRAPH calculations in different clinical situations were evalu??ated. The mean study population age was 48.8±19.1 years. More than half (59.6%) of the patients were male, and 15.1% were smokers. The mean difference of PWV between devices was 0.49±1.26 m s-1 (P<0.0001), and the Pearson correlation index was 0.86 (P<0.0001). The coefficient of variation and intraclass correlation coefficients between three single measured PWV values with the Tel-O-GRAPH and Sphygmocor were 2.38±6.13% vs. 6.3±4.33% (P<0.05) and 0.99; 0.99; and 0.99 vs. 0.78; 0.84; and 0.71, respectively. For Tel-O-GRAPH, there was no statistically significant difference between PWV in seated vs. supine positions or by experienced or inexperienced users. High reproducibility and reliability of the calculated single PWV values with Tel-O-GRAPH and considerable performance accuracy compared with Sphygmocor were observed. The reported evidence suggests that oscillometry might evolve as a favored method for the assessment of the PWV in everyday clinical practice and in clinical studies due to its ease of use, accuracy and robustness.

Validation of the Tel-O-GRAPH, a new oscillometric blood pressure-measuring device, according to the British Hypertension Society protocol.

OBJECTIVE: Hypertension is a major cardiovascular risk factor. Therefore, the accuracy of blood pressure (BP) measurement with self-measuring devices is of fundamental importance. Consequently, emerging BP devices should be evaluated against the gold standard according to an established and proven protocol. METHODS: Tel-O-GRAPH, a new oscillometric self-measuring device of brachial BP, was evaluated against auscultatory sphygmomanometry according to the BHS protocol. Bland-Altman plots were completed for systolic (SBP) and diastolic blood pressures (DBP), and the mean differences and SDs between the test device and the reference device were computed for all BP values. RESULTS: A total of 85 individuals (mean age 48.11±18.0 years; 61% men) were included after they provided informed consent. Overall, 510 measurements were performed. The mean device-observer difference was -0.2±6.6 for SBP and 0.2±6.6 for DBP. The device achieved grade A for SBP and DBP for both observers. Examination of the different BP ranges indicated grade B for SBP more than 160 mmHg and grade A for all BP ranges. CONCLUSION: Tel-O-GRAPH fulfilled the accuracy requirements of the BHS with the highest accuracy level (A) and can thus be used reliably in the oscillometric measurement of the brachial BP.