A proposed simplified definition of metabolic syndrome in children and adolescents: a global perspective.

Metabolic syndrome (MetS) is becoming prevalent in the pediatric population. The existing pediatric MetS definitions (e.g., the International Diabetes Federation (IDF) definition and the modified National Cholesterol Education Program (NCEP) definition) involve complex cut-offs, precluding fast risk assessment in clinical practice.We proposed a simplified definition for assessing MetS risk in youths aged 6-17 years, and compared its performance with two existing widely used pediatric definitions (the IDF definition, and the NCEP definition) in 10 pediatric populations from 9 countries globally (n = 19,426) using the receiver operating characteristic (ROC) curve analyses. In general, the total MetS prevalence of 6.2% based on the simplified definition was roughly halfway between that of 4.2% and 7.7% estimated from the IDF and NCEP definitions, respectively. The ROC curve analyses showed a good agreement between the simplified definition and two existing definitions: the total area under the curve (95% confidence interval) of the proposed simplified definition for identifying MetS risk achieved 0.91 (0.89-0.92) and 0.79 (0.78-0.81) when using the IDF or NCEP definition as the gold standard, respectively.The proposed simplified definition may be useful for pediatricians to quickly identify MetS risk and cardiometabolic risk factors (CMRFs) clustering in clinical practice, and allow direct comparison of pediatric MetS prevalence across different populations, facilitating consistent pediatric MetS risk monitoring and the development of evidence-based pediatric MetS prevention strategies globally.

Comparison of Integrase Strand Transfer Inhibitors (INSTIs) and Protease-Boosted Inhibitors (PIs) on the Reduction in Chronic Immune Activation in a Virally Suppressed, Mainly Male Population Living with HIV (PLWH).

Background and Objectives: The success of combined antiretroviral therapy (cART) has led to a dramatic improvement in the life expectancy of people living with HIV (PLWH). However, there has been an observed increase in cardiometabolic, bone, renal, hepatic, and neurocognitive manifestations, as well as neoplasms, known as serious non-AIDS events/SNAEs, compared to the general population of corresponding age. This increase is linked to a harmful phenomenon called inflammaging/immunosenescence, which is driven by chronic immune activation and intestinal bacterial translocation. In this study, we examined immunological and metabolic parameters in individuals receiving current cART. Materials and Methods: The study was conducted at Laiko General Hospital in Athens, Greece. Plasma concentrations of sCD14, IL-6, SuPAR, I-FABP, and LBP were measured in virally suppressed PLWH under cART with at least 350 CD4 lymphocytes/µL. We compared these levels between PLWH receiving integrase strand transfer inhibitors (INSTIs) and protease inhibitors (PIs) and attempted to correlate them with chronic immune activation and metabolic parameters. Results: Data from 28 PLWH were analyzed, with a mean age of 52 and 93% being males. Among the two comparison groups, IL-6 levels were higher in the PIs group (5.65 vs. 7.11 pg/mL, p = 0.03). No statistically significant differences were found in the other measured parameters. A greater proportion of PLWH under INSTIs had normal-range LBP (33% vs. 0%, p = 0.04). When using inverse probability of treatment weighting, no statistically significant differences in the measured parameters were found between the two groups (sCD14 p = 0.511, IL-6 p = 0.383, SuPAR p = 0.793, I-FABP p = 0.868, and LBP p = 0.663). Glucose levels were found to increase after viral suppression in the entire sample (92 mg/dL vs. 98 mg/dL, p = 0.009). Total (191 mg/dL vs. 222 mg/dL, p = 0.005) and LDL cholesterol (104 mg/dL vs. 140 mg/dL, p = 0.002) levels were higher in the PIs group. No significant differences were observed in liver and renal function tests. Conclusions: Further investigation is warranted for PLWH on cART-containing INSTI regimens to explore potential reductions in chronic immune activation and intestinal bacterial translocation.

Establishing international optimal cut-offs of waist-to-height ratio for predicting cardiometabolic risk in children and adolescents aged 6-18 years.

BACKGROUND: Waist-to-height ratio (WHtR) has been proposed as a simple and effective screening tool for assessing central obesity and cardiometabolic risk in both adult and pediatric populations. However, evidence suggests that the use of a uniform WHtR cut-off of 0.50 may not be universally optimal for pediatric populations globally. We aimed to determine the optimal cut-offs of WHtR in children and adolescents with increased cardiometabolic risk across different countries worldwide. METHODS: We used ten population-based cross-sectional data on 24,605 children and adolescents aged 6-18 years from Brazil, China, Greece, Iran, Italy, Korea, South Africa, Spain, the UK, and the USA for establishing optimal WHtR cut-offs. We performed an external independent test (9,619 children and adolescents aged 6-18 years who came from other six countries) to validate the optimal WHtR cut-offs based on the predicting performance for at least two or three cardiometabolic risk factors. RESULTS: Based on receiver operator characteristic curve analyses of various WHtR cut-offs to discriminate those with ≥ 2 cardiometabolic risk factors, the relatively optimal percentile cut-offs of WHtR in the normal weight subsample population in each country did not always coincide with a single fixed percentile, but varied from the 75th to 95th percentiles across the ten countries. However, these relatively optimal percentile values tended to cluster irrespective of sex, metabolic syndrome (MetS) criteria used, and WC measurement position. In general, using ≥ 2 cardiometabolic risk factors as the predictive outcome, the relatively optimal WHtR cut-off was around 0.50 in European and the US youths but was lower, around 0.46, in Asian, African, and South American youths. Secondary analyses that directly tested WHtR values ranging from 0.42 to 0.56 at 0.01 increments largely confirmed the results of the main analyses. In addition, the proposed cut-offs of 0.50 and 0.46 for two specific pediatric populations, respectively, showed a good performance in predicting ≥ 2 or ≥ 3 cardiometabolic risk factors in external independent test populations from six countries (Brazil, China, Germany, Italy, Korea, and the USA). CONCLUSIONS: The proposed international WHtR cut-offs are easy and useful to identify central obesity and cardiometabolic risk in children and adolescents globally, thus allowing international comparison across populations.

Venous thromboembolism in COVID-19: A systematic review and meta-analysis.

Severe coronavirus disease 2019 (COVID-19) is associated with increased risk of venous thromboembolism events (VTE). This study performed a systematic review in PubMed/EMBASE of studies reporting the prevalence of VTE in patients with COVID-19 who were totally screened/assessed for deep vein thrombosis (DVT) and/or for pulmonary embolism (PE). Among 47 candidate studies (n = 6459; 33 in Europe), 17 studies (n = 3973; weighted age 63.0 years, males 60%, intensive care unit (ICU) 16%) reported the prevalence of PE with a pooled estimate of 32% (95% CI: 25, 40%), and 32 studies (n = 2552; weighted age 62.6 years, males 57%, ICU 49%) reported the prevalence of DVT with a pooled estimate of 27% (95% CI: 21, 34%). A total of 36 studies reported the use of at least prophylactic antithrombotic treatment in the majority of their patients. Meta-regression analysis showed that the prevalence of VTE was higher across studies with a higher percentage of ICU patients and higher study population mean D-dimer values, and lower in studies with mixed dosing of anticoagulation in ⩾ 50% of the population compared to studies with standard prophylactic dosing of anticoagulation in < 50% of the population. The pooled odds ratio for death in patients with COVID-19 and VTE versus those without VTE (17 studies, n = 2882) was 2.1 (95% CI: 1.2, 3.6). Hospitalized patients with severe COVID-19 are at high VTE risk despite prophylactic anticoagulation. Further research should investigate the individualized VTE risk of patients with COVID-19 and the optimal preventive antithrombotic therapy. PROSPERO Registration No.: CRD42020185543.

Chlamydia pneumoniae-associated pleuropericarditis: a case report and systematic review of the literature.

BACKGROUND: Chlamydia pneumoniae is a common cause of atypical community acquired pneumonia (CAP). The diagnostic approach of chlamydial infections remains a challenge. Diagnosis of delayed chlamydial-associated complications, involving complex autoimmune pathophysiological mechanisms, is still more challenging. C. pneumoniae-related cardiac complications have been rarely reported, including cases of endocarditis, myocarditis and pericarditis. CASE PRESENTATION: A 40-year old female was hospitalized for pleuropericarditis following lower respiratory tract infection. The patient had been hospitalized for CAP (fever, dyspnea, chest X-ray positive for consolidation on the left upper lobe) 5 weeks ago and had received ceftriaxone and moxifloxacin. Four weeks after her discharge, the patient presented with fever, shortness of breath and pleuritic chest pain and was readmitted because of pericardial and bilateral pleural effusions (mainly left). The patient did not improve on antibiotics and sequential introduction of colchicine and methylprednisolone was performed. The patient presented impressive clinical and laboratory response. Several laboratory and clinical assessments failed to demonstrate any etiological factor for serositis. Chlamydial IgM and IgG antibodies were positive and serial measurements showed increasing kinetics for IgG. Gold standard polymerase chain reaction of respiratory tract samples was not feasible but possibly would not have provided any additional information since CAP occurred 5 weeks ago. The patient was discharged under colchicine and tapered methylprednisolone course. During regular clinic visits, she remained in good clinical condition without pericardial and pleural effusions relapse. CONCLUSIONS: C. pneumoniae should be considered as possible pathogen in case of pleuritis and/or pericarditis during or after a lower respiratory tract infection. In a systematic review of the literature only five cases of C. pneumoniae associated pericarditis were identified. Exact mechanisms of cardiovascular damage have not yet been defined, yet autoimmune pathways might be implicated.

Heterogeneity in reporting venous thromboembolic phenotypes in COVID-19: methodological issues and clinical implications.

COVID-19 is associated with increased risk of venous thromboembolic events (VTE). However, there is significant heterogeneity in the thromboembolic phenotypes of COVID-19 patients (deep vein thrombosis, pulmonary embolism/thrombosis). The latter might be partly attributed to the variation in VTE risk factors in COVID-19 patients including: (i) patients' characteristics; (ii) hospitalization conditions and interventions; and (iii) SARS-CoV-2-specific factors (coagulopathy, endothelial injury/microthrombosis). Furthermore, there is methodological heterogeneity in relation to the assessment of VTE (indications for screening, diagnostic methodology, etc). Physicians should be aware of the increased VTE risk, strongly consider VTE screening, and use thromboprophylaxis in all hospitalized patients.

Thromboembolic risk and anticoagulant therapy in COVID-19 patients: emerging evidence and call for action.

Emerging evidence shows that severe coronavirus disease 2019 (COVID-19) can be complicated with coagulopathy, namely disseminated intravascular coagulation, which has a rather prothrombotic character with high risk of venous thromboembolism. The incidence of venous thromboembolism among COVID-19 patients in intensive care units appears to be somewhat higher compared to that reported in other studies including such patients with other disease conditions. D-dimer might help in early recognition of these high-risk patients and also predict outcome. Preliminary data show that in patients with severe COVID-19, anticoagulant therapy appears to be associated with lower mortality in the subpopulation meeting sepsis-induced coagulopathy criteria or with markedly elevated d-dimer. Recent recommendations suggest that all hospitalized COVID-19 patients should receive thromboprophylaxis, or full therapeutic-intensity anticoagulation if such an indication is present.

Home Blood Pressure Monitoring in Children and Adolescents: Systematic Review of Evidence on Clinical Utility.

PURPOSE OF REVIEW: For the accurate diagnosis and management of hypertension, out-of-office blood pressure evaluation using ambulatory (ABPM) or home monitoring (HBPM) is currently recommended. In children, there is considerable evidence on the clinical utility of ABPM, whereas the evidence on HBPM is limited. This systematic review presents (i) the benefits of HBPM in children; (ii) the evidence on normal range, diagnostic accuracy, and relationship with preclinical organ damage; and (iii) guidance for devices, monitoring schedule, and interpretation. RECENT FINDINGS: HBPM is a useful adjunct to the conventional office measurements for the evaluation of children with suspected or treated hypertension. HBPM is feasible in children and has good reproducibility, diagnostic accuracy and acceptability by users, and relatively low cost. Thus, it has greater potential for widespread and long-term use than ABPM, which is more expensive and often not available or not tolerated. Automated monitors that have been clinically validated specifically in children should be used with appropriate cuff size. HBPM for 7 days (minimum 3) with duplicate morning and evening measurements (minimum 12 readings) should be performed in children with suspected or treated hypertension before each office visit. Until more data become available, in case of diagnostic disagreement between office blood pressure and HBPM, treatment decisions should be based on ABPM. HBPM is clinically useful in children with hypertension. More research is needed on its clinical application, and more automated devices need to be clinically validated in this population.

Efficacy of anthropometric measures for identifying cardiovascular disease risk in adolescents: review and meta-analysis.

INTRODUCTION: To compare the ability of Body Mass Index (BMI), waist circumference (WC) and waist to height ratio (WHtR) to estimate cardiovascular disease (CVD) risk levels in adolescents. EVIDENCE ACQUISITION: A systematic review and meta-analysis was performed after a database search for relevant literature (Cochrane, Centre for Review and Dissemination, PubMed, British Nursing Index, CINAHL, BIOSIS citation index, ChildData, metaRegister). EVIDENCE SYNTHESIS: The study included 117 records representing 96 studies with 994,595 participants were included in the systematic review, 14 of which (13 studies, N.=14,610) were eligible for the meta-analysis. The results of the meta-analysis showed that BMI was a strong indicator of systolic blood pressure, diastolic blood pressure, triglycerides, high-density lipoprotein cholesterol and insulin; but not total cholesterol, low-density lipoprotein or glucose. Few studies were eligible for inclusion in the meta-analysis considering WC or WHtR (N.≤2). The narrative synthesis found measures of central adiposity to be consistently valid indicators of the same risk factors as BMI. CONCLUSIONS: BMI was an indicator of CVD risk. WC and WHtR were efficacious for indicating the same risk factors BMI performed strongly for, though there was insufficient evidence to judge the relative strength of each measure possibly due to heterogeneity in the methods for measuring and classifying WC.

Does visceral adiposity index signify early metabolic risk in children and adolescents?: association with insulin resistance, adipokines, and subclinical inflammation.

BACKGROUND: Visceral adiposity index (VAI) is a novel gender-specific index based on waist circumference (WC), BMI, and lipid parameters. Although VAI does not actually estimate visceral adiposity, it accurately reflects visceral fat function and insulin resistance. This index has not been studied in children thus far. This study aims to fill this gap. METHODS: In a cohort of Saudi children and adolescents, anthropometric measurements and metabolic/hormonal profile were obtained. RESULTS: A total of 543 subjects, 292 of whom were boys, were included (mean age: 11.9 ± 3.3 y; BMI: 19.8 ± 5.6 kg/m(2)). In all subjects, VAI was inferior to BMI and WC regarding its correlations with adiponectin, leptin, insulin resistance (homeostasis model of assessment-insulin resistance (HOMA-IR)), C-reactive protein (CRP) level, and systolic blood pressure, but it exhibited a stronger association with glucose in boys (r = 0.23; P < 0.01). In stepwise multivariate analyses, only BMI was consistent as an independent predictor of adiponectin, leptin, HOMA-IR, and CRP. VAI was the only index independently associated with glucose. CONCLUSION: Although VAI is related to glucose in children, it seems to be inferior to BMI in terms of association with insulin resistance, adipokines, and subclinical inflammation. Until specific studies can be performed in children, VAI should be extrapolated with caution in this age range.

Home blood pressure monitoring: primary role in hypertension management.

In the last two decades, considerable evidence on home blood pressure monitoring has accumulated and current guidelines recommend its wide application in clinical practice. First, several outcome studies have shown that the ability of home blood pressure measurements in predicting preclinical target organ damage and cardiovascular events is superior to that of the conventional office blood pressure measurements and similar to that of 24-hour ambulatory monitoring. Second, cross-sectional studies showed considerable agreement of home blood pressure measurements with ambulatory monitoring in detecting the white-coat and masked hypertension phenomena, in both untreated and treated subjects. Third, studies have shown larger blood pressure decline by using home blood pressure monitoring instead of office measurements for treatment adjustment. Fourth, in treated hypertensives, home blood pressure monitoring has been shown to improve long-term adherence to antihypertensive drug treatment and thus, has improved hypertension control rates. These data suggest that home blood pressure should no longer be regarded as only a screening tool that requires confirmation by ambulatory monitoring. Provided that an unbiased assessment is obtained according to current recommendations, home blood pressure monitoring should have primary role in diagnosis, treatment adjustment, and long-term follow-up of most cases with hypertension.

Automated measurement of office, home and ambulatory blood pressure in atrial fibrillation.

1. Hypertension and atrial fibrillation (AF) often coexist and are strong risk factors for stroke. Current guidelines for blood pressure (BP) measurement in AF recommend repeated measurements using the auscultatory method, whereas the accuracy of the automated devices is regarded as questionable. This review presents the current evidence on the feasibility and accuracy of automated BP measurement in the presence of AF and the potential for automated detection of undiagnosed AF during such measurements. 2. Studies evaluating the use of automated BP monitors in AF are limited and have significant heterogeneity in methodology and protocols. Overall, the oscillometric method is feasible for static (office or home) and ambulatory use and appears to be more accurate for systolic than diastolic BP measurement. 3. Given that systolic hypertension is particularly common and important in the elderly, the automated BP measurement method may be acceptable for self-home and ambulatory monitoring, but not for professional office or clinic measurement. 4. An embedded algorithm for the detection of asymptomatic AF during routine automated BP measurement with high diagnostic accuracy has been developed and appears to be a useful screening tool for elderly hypertensives.

Atrial Fibrillation Screening During Routine Automated Office, Home, and Ambulatory Blood Pressure Measurement: A Diagnostic Test Accuracy Systematic Review and Meta-Analysis.

BACKGROUND: Atrial fibrillation (AF) is often asymptomatic and undiagnosed. As AF and hypertension often coexist, opportunistic AF detection during routine automated blood pressure (BP) measurement appears to be an attractive screening method. METHODS: A systematic literature search was conducted to identify studies assessing the diagnostic test accuracy of office, home, or 24-hour ambulatory BP measuring devices with AF detection algorithms versus reference electrocardiography. Analyses were performed per participant (AF status based on several BP readings; most office/home devices) or per reading (AF status based on individual readings; all ambulatory devices). A meta-analysis stratified by device type (office/home/ambulatory) was conducted to calculate pooled measures of diagnostic accuracy. Sensitivity/meta-regression analyses were also performed. RESULTS: Among 3096 records initially retrieved, 23 diagnostic test accuracy studies were included. Data derived from 11 093 individuals (weighted age 69 years, males 56%, hypertensives 79%, diabetics 24%, and AF prevalence 17%) indicated a pooled sensitivity 0.97 (95% CI, 0.92-0.99), specificity 0.93 (95% CI, 0.90-0.95), and accuracy 0.93 (95% CI, 0.89-0.95), with generally consistent results using office, home, or ambulatory BP devices (slightly lower specificity with the latter). The positive and negative predictive values were 0.70 (95% CI, 0.60-0.80) and 0.99 (95% CI, 0.98-1.00), respectively. Sensitivity analyses indicated lower specificity in studies implementing reading versus participant analyses. Most studies presented a low risk of bias and minor applicability concerns. CONCLUSIONS: There is considerable and consistent evidence suggesting high diagnostic accuracy of AF detection algorithms implemented in automated BP monitors during routine BP measurements in and out of the office. AF diagnosis requires verification (electrocardiography) before treatment is administered.

Prognostic value of home versus ambulatory blood pressure monitoring: a systematic review and meta-analysis of outcome studies.

OBJECTIVES: Ambulatory (ABP) and self-home blood pressure (HBP) measurements are known to be superior to office blood pressure (OBP) measurements in predicting cardiovascular events. Whether ABP has superior prognostic ability than HBP, or the reverse, has not been adequately investigated. METHODS: A systematic literature search was conducted to identify outcome studies investigating HBP and ABP in the same population. A meta-analysis was conducted to calculate the pooled measure of risk regarding the primary endpoint of each study for each method. Primary analysis included the comparison of pooled estimates of HBP versus 24 h ABP. RESULTS: Among 2587 articles retrieved, 6 fulfilled the inclusion criteria. Meta-analysis of five studies ( n  = 4439, weighted age 57 years, men 52%, hypertension 68%, diabetes 15%, cardiovascular disease 11%) indicated pooled hazard ratio per 10 mmHg increase in systolic HBP 1.36 (95% CI 1.23-1.50) and in 24 h ABP 1.38 (1.22-1.57) for the primary endpoint of each study ( z -test P  = NS). Meta-analysis of five studies ( n  = 4497, weighted age 58 years, men 51%, hypertension 65%, diabetes 15%, cardiovascular disease 9%) indicated pooled hazard ratio per 10 mmHg increase in systolic HBP 1.29 (1.14-1.47), daytime ABP 1.30 (1.15-1.46) and nighttime ABP 1.31 (1.14-1.50) ( z -test, P  = NS). Data for DBP were similar. All studies were deemed to have low risk of bias. In studies comparing all the three methods, OBP provided the lowest hazard ratio. CONCLUSION: This meta-analysis of the available prospective outcome studies suggested that HBP and ABP have similar ability in predicting outcome and superior to OBP.

Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 in a 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.

OBJECTIVE: This study evaluated the accuracy of the automated oscillometric upper-arm cuff device AVITA BPM82 intended for home use in a 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) and its Amendment 1.2020-01. METHODS: Participants were recruited to fulfill the age, sex, blood pressure (BP), and limb distribution criteria of the AAMI/ESH/ISO Universal Standard and its Amendment 1.2020-01 in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-33 (medium) and 33-42 cm (large). RESULTS: One-hundred-one individuals were recruited and 85 were analyzed [mean age 57.3 ±â€…15.1 (SD) years, 46 men, arm circumference 32 ±â€…5.1 cm, range 22.3-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was 1.3 ±â€…6.5/3.6 ±â€…5.9 mmHg (systolic/diastolic; threshold ≤5 ±â€…8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual (N = 85) was 5.70/5.25 mmHg (systolic/diastolic; threshold ≤6.82/5.89 mmHg). CONCLUSIONS: The automated oscillometric home BP monitor AVITA BPM82 comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 in a general population and can be recommended for clinical use.

Validation of the oscillometric home blood pressure monitor Braun BUA4000 with wide-range cuff in a 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.

OBJECTIVE: To evaluate the blood pressure (BP) measurement accuracy of the Braun BUA4000 automated oscillometric upper-arm cuff device for self-home use in a 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) and its Amendment 1.2020-01. METHODS: Participants were recruited to fulfill the age, sex, BP and limb circumference distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. A single wide-range cuff of the test device was used for arm circumference range 22-42 cm. RESULTS: A total of 98 individuals were recruited and 85 were analyzed [mean age 60.3 ±â€…16.1 (SD) years, 44 men, arm circumference 31.5 ±â€…5.1 cm, range 22-41.5 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N  = 255) was 0.9 ±â€…6.4/-0.3 ±â€…6.4 mmHg (systolic/diastolic; threshold ≤5 ±â€…8 mmHg). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N  = 85) was 5.15/5.81 mmHg (systolic/diastolic; threshold ≤6.88/6.95 mmHg). CONCLUSION: The Braun BUA4000 automated oscillometric BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard in a general population and can be recommended for self-monitoring of BP by patients at home.

Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV).

OBJECTIVE: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy. METHODS: The requirements of 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) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill the age, sex, BP, arm circumference, and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35, and 33-42 cm. RESULTS: Data from 85 individuals were analyzed [mean age: 56.4 ±â€…16.0 (SD) years, 50 men, arm circumference 23-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was -1.3 ± 6.0/1.5 ± 5.0 mmHg (systolic/diastolic; threshold ≤5 ±â€…8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N = 85) was 4.61/3.48 mmHg (systolic/diastolic; threshold ≤6.82/6.78 mmHg). CONCLUSION: The KOROT V2 Doctor (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.

Visual assessment of Korotkoff sounds improves the accuracy of a validated professional automated auscultatory blood pressure monitor KOROT P3 Accurate.

OBJECTIVE: A novel automated auscultatory upper-arm cuff blood pressure (BP) monitor for office use (KOROT P3 Accurate, previously InBody BPBIO480KV), which displays Korotkoff sound curves for each BP reading was recently developed. This study investigated whether the review of Korotkoff sound curves by healthcare professionals further improves the accuracy of the device by identifying unreliable BP readings. METHODS: Three observers assessed independently the morphology of Korotkoff sound curves of BP measurements obtained during an ISO 81060-2:2018 validation study, and classified them as of good, fair, or poor quality (low amplitude or sound intensity, aberrant morphology, background noise, signal artifact, auscultatory gap, irregular rhythm). The observers were blinded to the study BP measurements. RESULTS: Korotkoff sound curves of 255 BP readings obtained in 85 individuals were analyzed (mean age 57.3 ±â€Š15.0 years, 53 men). Of the SBP readings 80.4/12.2/7.4% were classified as good/fair/poor, and DBP 76.9/12.2/10.9%. Inter-observer agreement in detecting poor-quality curves was 84.7/83.1% (systolic/diastolic). Of poor-quality curves, 10.5/60.7% (systolic/diastolic) clustered in the same individuals. The validation criterion 1 [mean test-reference BP difference ≤5 ±â€Š8 (SD) mmHg] was satisfied for readings with good (0.1 ±â€Š4.9/0.3 ±â€Š3.8 mmHg, systolic/diastolic) and fair-quality curves (-0.4 ±â€Š6.4/0.2 ±â€Š5.0), but not for poor-quality ones (2.7 ±â€Š8.8/3.6 ±â€Š8.1). By excluding poor-quality readings (40 of 255), criterion 1 of the validation study was improved (0.2 ±â€Š4.9/0.2 ±â€Š3.9 versus 0.3 ±â€Š5.5/0.6 ±â€Š4.7 mmHg). CONCLUSION: The visual assessment of Korotkoff sounds generated during automated auscultatory BP measurement by the KOROT P3 Accurate professional monitor identifies unreliable readings and further improves the device accuracy.