Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR.

INTRODUCTION: Rapid antigen tests (RATs) are convenient for SARS-CoV-2 detection because they are simpler and faster than nucleic acid amplification tests (NAATs). This study aimed to assess the accuracy of a locally manufactured test; Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece) in a clinical setting and during mass screening. METHODS: Nasopharyngeal samples from 624 individuals were analyzed. The results of the rapid test were compared to real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR). At the end of the test's procedure, positive test strips were scanned in an S-Flow reader in order to roughly estimate the antigen concentration. RESULTS: The lower limit of detection of the test was 468.75 genome copies/mL. The PROGNOSIS rapid test displayed a sensitivity of 85.5% (141/165) (95%CI: 79.1-90.5) and a specificity of 99.8% (458/459) (95%CI: 98.8-100.0%). The general inter-rater agreement was 0.89 (95%CI: 85.1-93.3). The regression analysis between the S-flow reader measurements (viral antigen) and the viral load of the positive samples demonstrated a weak correlation (R2 = 0.288, p < 0.001). CONCLUSION: The Rapid Test Ag 2019-nCoV demonstrated sufficient sensitivity, excellent specificity and could be available to be used with low overall cost. Thus, it could be used as point of care test, but also for mass screening for rapid detection of infected persons (e.g., for travelers).

Transmission Dynamics of SARS-CoV-2 during an Outbreak in a Roma Community in Thessaly, Greece-Control Measures and Lessons Learned.

A COVID-19 outbreak occurred among residents of a Roma settlement in Greece (8 April-4 June 2020). The aim of this study was to identify factors associated with an increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and to evaluate the effectiveness of control measures implemented. Data were analyzed from individuals that were tested for SARS-CoV-2 during contact tracing, population screening or hospital visits. RT-PCR was used for the detection of SARS-CoV-2 in oropharyngeal samples. Risk factors for household secondary attack rates (SAR) and hospitalization with COVID-19 were examined using chi-square tests, Fisher's exact tests and logistic regression analyses. During the outbreak, 142 cases, 20 hospitalizations and 1 death were recorded, with a total of 2273 individuals tested. The risk of hospitalization was associated with age (OR: 1.04, 95% CI: 1.02-1.07) and Cycle threshold (Ct) values (OR for a decrease in Ct values by 1: 1.18, 95% CI: 1.07-1.31). Household SAR was estimated at 38.62% (95% CI: 32.50-45.01%). After the designation of an isolation facility for cases, household SAR declined from 74.42% to 31.03%. Household size was associated with the risk of infection (OR: 2.65, 95% CI: 1.00-7.07). The presence of COVID-19 symptoms among index cases was correlated with higher transmission (OR: 23.68, 95% CI 2.21-253.74) in multivariate analysis, while age was found to be associated with SAR only in univariate analysis. Roma communities can be particularly vulnerable to the spread of SARS-CoV-2. In similar settings, symptomatic cases are more important transmitters of SARS-CoV-2. Within these communities, immediate measures should be implemented to mitigate disease spread.

Combination of thrombolytic and immunosuppressive therapy for coronavirus disease 2019: A case report.

In a proportion of patients, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a multisystem syndrome characterized by hyperinflammation, acute respiratory distress syndrome (ARDS), and hypercoagulability. A 68-year-old man with coronavirus disease 2019 (COVID-19) was admitted to the intensive care unit with respiratory failure, cytokine release syndrome (CRS), and skin ischemia - microthrombosis. Specific coagulation and inflammatory markers (D-dimer, ferritin, and C-reactive protein), along with the clinical picture, triggered the trial of recombinant tissue plasminogen activator (rt-PA) and tocilizumab. This was followed by resolution of the skin ischemia and CRS, while respiratory parameters improved. No major complications associated with rt-PA or tocilizumab occurred. The combination of rt-PA with targeted anti-inflammatory treatment could be a new therapeutic option for patients with COVID-19, ARDS, hyperinflammation, and increased blood viscosity.

Predictors of Need for Critical Care Support, Adverse Events, and Outcome after Stroke Thrombolysis.

BACKGROUND: Results from trials and international registries exhibit heterogeneity regarding safety, efficacy, markers of prognosis, and markers of the need for critical care support after intravenous thrombolysis (IVT) for strokes. The purpose of our study was to indentify such markers after performance of comparisons among patients who received thrombolysis in our intensive care unit. MATERIALS AND METHODS: Our study included 124 patients who received IVT in accordance with international criteria. Outcome measures of univariate and regression analyses resulted from comparisons between groups of patients with or without the need for critical care support (advanced life support and neurocritical care interventions), groups of patients developing or not developing primary adverse events (symptomatic intracranial hemorrhage [SICH] and/or Death and/or Serious systemic bleeding and/or New stroke) and groups of patients with different main outcome variables (mortality, functional independence at 3 months). RESULTS: Our results suggested that higher severity scores (Simplified Acute Physiology Score II, National Institutes of Health Stroke Scale) correlated with the need for critical care support, primary adverse events, and main outcome variables, whereas older age was significantly associated with fewer adverse events. Hyperlipidemia, symptom-to-needle time, and vascular disease were associated with functional capacity at 3 months, whereas diabetes mellitus and vascular disease correlated with the need for critical care support. CONCLUSION: Patients' age, hyperlipidemia, presence of vascular disease, Simplified Acute Physiology Score II (a novel marker), and National Institutes of Health Stroke Scale at 2 hours and at 7 days are independent predictors of the need for critical care support, adverse events, and clinical outcomes after thrombolysis.

Clusters of ineffective efforts during mechanical ventilation: impact on outcome.

PURPOSE: The aim of this study was to investigate the role of ineffective efforts (IEs), specifically clusters of IEs, during mechanical ventilation on the outcome of critically ill patients. METHODS: In a prospective observational study, 24-h recordings were obtained in 110 patients on the 1st day of assisted ventilation (pressure support or proportional assist), using a prototype monitor validated to identify IEs. Patients remaining on assisted ventilation were studied again on the 3rd day (n = 37) and on the 6th day (n = 13). To describe the clusters of IEs, the concept of an IEs event was developed, defined as a 3-min period of time containing more than 30 IEs. Along with all patient data, to minimize selection bias by time of recording, analysis was performed only on 1st day data of patients with ≥16 h of recording (1st day group). RESULTS: The analysis included 2931 h of assisted ventilation and 4,456,537 breaths. Neither the IEs index (IEs as a percentage of total breaths) in general nor a value above 10 % was correlated with patient outcome. Overall, IEs events were identified in 38 % of patients. In multivariate analysis, the presence of events in the 1st day group (n = 79) was associated with the risk of being on mechanical ventilation ≥8 days after first recording [odds ratio 6.4, 95 % confidence interval (1.1-38.30)] and hospital mortality [20 (2.3-175)]. Analysis of the data for all patients revealed similarly increased risks for prolonged ventilation [3.4 (1.1-10.7)] and mortality [4.9 (1.3-18)]. CONCLUSIONS: Clusters of IEs are often present in mechanically ventilated critically ill patients and are associated with prolonged mechanical ventilation and increased mortality. Studies to find ways of improving patient-ventilator interaction are warranted.

A distinct adipose tissue gene expression response to caloric restriction predicts 6-mo weight maintenance in obese subjects.

BACKGROUND: Weight loss has been shown to reduce risk factors associated with cardiovascular disease and diabetes; however, successful maintenance of weight loss continues to pose a challenge. OBJECTIVE: The present study was designed to assess whether changes in subcutaneous adipose tissue (scAT) gene expression during a low-calorie diet (LCD) could be used to differentiate and predict subjects who experience successful short-term weight maintenance from subjects who experience weight regain. DESIGN: Forty white women followed a dietary protocol consisting of an 8-wk LCD phase followed by a 6-mo weight-maintenance phase. Participants were classified as weight maintainers (WMs; 0-10% weight regain) and weight regainers (WRs; 50-100% weight regain) by considering changes in body weight during the 2 phases. Anthropometric measurements, bioclinical variables, and scAT gene expression were studied in all individuals before and after the LCD. Energy intake was estimated by using 3-d dietary records. RESULTS: No differences in body weight and fasting insulin were observed between WMs and WRs at baseline or after the LCD period. The LCD resulted in significant decreases in body weight and in several plasma variables in both groups. WMs experienced a significant reduction in insulin secretion in response to an oral-glucose-tolerance test after the LCD; in contrast, no changes in insulin secretion were observed in WRs after the LCD. An ANOVA of scAT gene expression showed that genes regulating fatty acid metabolism, citric acid cycle, oxidative phosphorylation, and apoptosis were regulated differently by the LCD in WM and WR subjects. CONCLUSION: This study suggests that LCD-induced changes in insulin secretion and scAT gene expression may have the potential to predict successful short-term weight maintenance. This trial was registered at clinicaltrials.gov as NCT00390637.

Adipose tissue transcriptome reflects variations between subjects with continued weight loss and subjects regaining weight 6 mo after caloric restriction independent of energy intake.

BACKGROUND: The mechanisms underlying body weight evolution after diet-induced weight loss are poorly understood. OBJECTIVE: We aimed to identify and characterize differences in the subcutaneous adipose tissue (SAT) transcriptome of subjects with different weight changes after energy restriction-induced weight loss during 6 mo on 4 different diets. DESIGN: After an 8-wk low-calorie diet (800 kcal/d), we randomly assigned weight-reduced obese subjects from 8 European countries to receive 4 diets that differed in protein and glycemic index content. In addition to anthropometric and plasma markers, SAT biopsies were taken at the beginning [clinical investigation day (CID) 2] and end (CID3) of the weight follow-up period. Microarray analysis was used to define SAT gene expression profiles at CID2 and CID3 in 22 women with continued weight loss (successful group) and in 22 women with weight regain (unsuccessful group) across the 4 dietary arms. RESULTS: Differences in SAT gene expression patterns between successful and unsuccessful groups were mainly due to weight variations rather than to differences in dietary macronutrient content. An analysis of covariance with total energy intake as a covariate identified 1338 differentially expressed genes. Cellular growth and proliferation, cell death, cellular function, and maintenance were the main biological processes represented in SAT from subjects who regained weight. Mitochondrial oxidative phosphorylation was the major pattern associated with continued weight loss. CONCLUSIONS: The ability to control body weight loss independent of energy intake or diet composition is reflected in the SAT transcriptome. Although cell proliferation may be detrimental, a greater mitochondrial energy gene expression is suggested as being beneficial for weight control. This trial was registered at clinicaltrials.gov as NCT00390637.

Ebstein's anomaly: a potential cause of misinterpretation of myocardial perfusion scintigraphy.

We present the case of a 43-year-old woman with a history of Ebstein's anomaly, who was referred for a myocardial perfusion single-photon emission computed tomography (SPECT) study due to angina-like symptoms. Dilatation of the right ventricle and right atrium, apical displacement of the septal tricuspid leaflet, small left ventricle with good left ventricular and a moderate degree of tricuspid regurgitation with mild pulmonary hypertension were found on echocardiography. Myocardial SPECT perfusion imaging with [99m Tc]tetrofosmin demonstrated a large defect in the inferior septal wall in the stress study with mild partial reversibility at rest. Coronary angiography revealed normal coronary arteries. Histological studies have shown that these patients develop increased fibrosis in the left ventricular wall and ventricular septum, especially in the basal and middle region of the septum, which adjoins with the atrialized component of the right ventricle. This is in concordance with the findings of the myocardial perfusion scan in the case described.

Discordance between echocardiographic and MRI findings in two cases of acute myocarditis mimicking myocardial infarction.

Two male adolescents were admitted due to chest pain influenced by the respiratory movements. A lobar pneumonia caused by Mycoplasma pneumoniae, was radiographically and serologically diagnosed in the first patient (a 15-year-old boy) and a febrile diarrhea of unidentified etiology, despite repetitive stool cultures and serological assessments in the second one (a 19-year-old male). Both patients combined the aforementioned infectious conditions with outstanding thoracic pain the previous hours before admission, markedly elevated cardiac enzymes and ST-segment elevation in the inferior and left precordial leads with a normal coronary angiogram, thus composing a clinical setting highly indicative of acute myocarditis. Surprisingly however, the echocardiogram performed in both patients failed to reveal any regional or global wall motion abnormalities or even diastolic dysfunction and remained absolutely normal throughout their 3-month follow-up period. Cardiac MRI within 7 days, using T2-weighted and gadolinium-enhanced T1-weighted images demonstrated extensive focal contrast enhancement, consistent with acute inflammatory myocardial involvement. It can therefore be concluded that contrast MRI is a more sensitive method than the echocardiogram for the diagnosis of acute focal myocarditis.

Clinical and prognostic value of elevated CA125 levels in patients with congestive heart failure.

BACKGROUND: Increased serum levels of carbohydrate antigen 125 (CA125), a tumor marker associated with ovarian cancer, have also been reported in other malignant and non-malignant diseases. We assessed the correlation of the CA125 serum levels with the severity of congestive heart failure (CHF) and investigated their potential prognostic value in relation to major cardiovascular events. METHODS: CA125 levels were measured in 95 male patients aged 70+/-10 years, admitted for decompensated CHF. The patients were divided into three groups, according to their New York Heart Association (NYHA) functional class. Group A contained 23 patients in NYHA IV, group B 34 patients in NYHA III, and group C 38 patients in NYHA I-II. The patients were also divided into two groups according to their CA125 value on admission. Group 1 included 45 patients with normal CA125 levels and group 2 50 patients with elevated CA125. All patients were followed for 15+/-8.5 months and the major cardiovascular events (death and re-hospitalizations due to CHF) were recorded. RESULTS: Serum levels of CA125 were higher in groups A and B than in group C (36.4 [19.8-82] U/ml and 34.6 [26-78] U/ml vs. 25.3 [9.1-29] U/ml, respectively, p<0.05). No correlation was detected between CA125 levels and left ventricular ejection fraction. However, patients with pulmonary congestion and peripheral edemas had higher levels of CA125 (p=0.002 and p<0.03, respectively). Nineteen patients died during the follow-up period, but the mortality rate was not significantly different between groups 1 and 2 (p=0.8). Nevertheless, the patients of group 1 reported fewer re-hospitalizations than patients of group 2 (p=0.003). The relative risk (RR) for re-hospitalization was calculated to be RR: 0.4, 95% CI: 0.215-0.76 (p<0.005), in patients with elevated levels of CA125. Cox regression analysis revealed that CA125 had independent prognostic value (OR: 1.007 [95% CI: 1.004-1.010], p<0.0001) for re-hospitalizations. CONCLUSION: Serum levels of CA125 are associated with the severity of CHF and are also independent predictive markers for re-hospitalizations. We therefore conclude that CA125 can be used as a prognostic marker of disease severity and increased morbidity in patients with decompensated CHF.

Wide QRS tachycardia caused by severe hyperkalaemia and digoxin intoxication.

We report the case of a 78-year-old woman, with previous narrow QRS atrial fibrillation, who in the presence of mild digoxin intoxication and severe hyperkalaemia, caused by chronic renal failure and usage of potassium sparing drugs, presented on her ECG two distinct wide QRS tachycardias. Initial treatment with low doses of procainamide resulted in severe bradycardia. Her original rhythm was restored after partial correction of hyperkalaemia with haemodialysis under continuous infusion of lidocaine. The electrocardiographic manifestations of hyperkalaemia and digoxin intoxication as well as the effect of lidocaine and procainamide on hyperkalaemia-induced wide QRS tachycardias are discussed.

Atrioventricular conduction disturbances in a young patient with Fabry's disease without other signs of cardiac involvement.

A 30 year-old male patient with a history of Fabry's disease, was referred to hospital with symptoms of dizziness, hypotension and weakness. Fabry's disease had been diagnosed 2 years before, based on angiokeratoma and hypohidrosis on physical examination and complete lack of alpha-galactosidase A on laboratory examination. The ECG on admission demonstrated sinus bradycardia, with a poor response to atropine administration. Echocardiograms on admission and 2 years before were normal, as well as Holter ambulatory ECG recording. Subsequent electrophysiological study demonstrated mild AV conduction disturbances at a site proximal to His, and the patient was simply advised to be regularly followed up. It can therefore be concluded that even young patients with Fabry's disease and normal echocardiograms might develop cardiac symptoms due to AV conduction abnormalities.

The significance of CA125 levels in patients with chronic congestive heart failure. Correlation with clinical and echocardiographic parameters.

OBJECTIVE: To assess serum levels of carbohydrate antigen 125 (CA125) in patients with chronic congestive heart failure (CHF) and to assess any correlation with clinical symptoms and echocardiographic indices. PATIENTS AND METHODS: We enrolled 77 male patients (mean age: 73+/-10 years) admitted to the Cardiology Emergency Department (ED) with cardiac symptoms requiring hospitalization. Diagnosis of CHF was based upon medical history or initial echocardiographic evaluation on current admission. Serum CA125 was measured by an enzyme immunoradiometric assay, on admission and before discharge. RESULTS: The median overall CA125 value was 22.4 (11.5-48.9) U/ml. Serum CA125 levels were related to the severity of CHF [New York Heart Association (NYHA) class I: 19.2 (7.2-31) U/ml, NYHA class II: 17.6 (10-23) U/ml, NYHA class III: 32 (25-77) U/ml and NYHA class IV: 34.3 (18.6-77) U/ml (p<0.04)]. Patients in NYHA classes III and IV had significantly higher mean values of CA125, than patients in class II (p<0.005 and p<0.05, respectively). Moreover, patients with fluid congestion (pulmonary congestion, ankle edema) had higher levels of serum CA125 than patients without congestion (p=0.002 and p<0.03, respectively). Finally, levels of serum CA125 correlated weakly with right ventricular systolic pressure (RVSP) and renal function, while no significant correlation was found between CA125 and E wave deceleration time on Doppler echocardiography, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), liver function and the medical treatment prescribed. CONCLUSION: Serum CA125 is associated with the clinical severity of CHF and the symptoms and signs of fluid congestion and therefore may be a useful additional tool for the evaluation and clinical staging of these patients.