Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme

Defining Kawasaki disease and pediatric inflammatory multisystem syndrome-temporally associated to SARS-CoV-2 infection during SARS-CoV-2 epidemic in Italy: results from a national, multicenter survey

Background: There is mounting evidence on the existence of a Pediatric Inflammatory Multisystem Syndrome-temporally associated to SARS-CoV-2 infection (PIMS-TS), sharing similarities with Kawasaki Disease (KD). The main outcome of the study were to better characterize the clinical features and the treatment response of PIMS-TS and to explore its relationship with KD determining whether KD and PIMS are two distinct entities. Methods: The Rheumatology Study Group of the Italian Pediatric Society launched a survey to enroll patients diagnosed with KD (Kawasaki Disease Group - KDG) or KD-like (Kawacovid Group - KCG) disease between February 1st 2020, and May 31st 2020. Demographic, clinical, laboratory data, treatment information, and patients' outcome were collected in an online anonymized database (RedCAP®). Relationship between clinical presentation and SARS-CoV-2 infection was also taken into account. Moreover, clinical characteristics of KDG during SARS-CoV-2 epidemic (KDG-CoV2) were compared to Kawasaki Disease patients (KDG-Historical) seen in three different Italian tertiary pediatric hospitals (Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste; AOU Meyer, Florence; IRCCS Istituto Giannina Gaslini, Genoa) from January 1st 2000 to December 31st 2019. Chi square test or exact Fisher test and non-parametric Wilcoxon Mann-Whitney test were used to study differences between two groups. Results: One-hundred-forty-nine cases were enrolled, (96 KDG and 53 KCG). KCG children were significantly older and presented more frequently from gastrointestinal and respiratory involvement. Cardiac involvement was more common in KCG, with 60,4% of patients with myocarditis. 37,8% of patients among KCG presented hypotension/non-cardiogenic shock. Coronary artery abnormalities (CAA) were more common in the KDG. The risk of ICU admission were higher in KCG. Lymphopenia, higher CRP levels, elevated ferritin and troponin-T characterized KCG. KDG received more frequently immunoglobulins (IVIG) and acetylsalicylic acid (ASA) (81,3% vs 66%; p = 0.04 and 71,9% vs 43,4%; p = 0.001 respectively) as KCG more often received glucocorticoids (56,6% vs 14,6%; p < 0.0001). SARS-CoV-2 assay more often resulted positive in KCG than in KDG (75,5% vs 20%; p < 0.0001). Short-term follow data showed minor complications. Comparing KDG with a KD-Historical Italian cohort (598 patients), no statistical difference was found in terms of clinical manifestations and laboratory data. Conclusion: Our study suggests that SARS-CoV-2 infection might determine two distinct inflammatory diseases in children: KD and PIMS-TS. Older age at onset and clinical peculiarities like the occurrence of myocarditis characterize this multi-inflammatory syndrome. Our patients had an optimal response to treatments and a good outcome, with few complications and no deaths

Clinical features and outcomes of elderly hospitalised patients with chronic obstructive pulmonary disease, heart failure or both

Background and objective: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) mutually increase the risk of being present in the same patient, especially if older. Whether or not this coexistence may be associated with a worse prognosis is debated. Therefore, employing data derived from the REPOSI register, we evaluated the clinical features and outcomes in a population of elderly patients admitted to internal medicine wards and having COPD, HF or COPD + HF. Methods: We measured socio-demographic and anthropometric characteristics, severity and prevalence of comorbidities, clinical and laboratory features during hospitalization, mood disorders, functional independence, drug prescriptions and discharge destination. The primary study outcome was the risk of death. Results: We considered 2,343 elderly hospitalized patients (median age 81 years), of whom 1,154 (49%) had COPD, 813 (35%) HF, and 376 (16%) COPD + HF. Patients with COPD + HF had different characteristics than those with COPD or HF, such as a higher prevalence of previous hospitalizations, comorbidities (especially chronic kidney disease), higher respiratory rate at admission and number of prescribed drugs. Patients with COPD + HF (hazard ratio HR 1.74, 95% confidence intervals CI 1.16-2.61) and patients with dementia (HR 1.75, 95% CI 1.06-2.90) had a higher risk of death at one year. The Kaplan-Meier curves showed a higher mortality risk in the group of patients with COPD + HF for all causes (p = 0.010), respiratory causes (p = 0.006), cardiovascular causes (p = 0.046) and respiratory plus cardiovascular causes (p = 0.009). Conclusion: In this real-life cohort of hospitalized elderly patients, the coexistence of COPD and HF significantly worsened prognosis at one year. This finding may help to better define the care needs of this population

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

EFFECT OF ANNULUS FLOW CONDITIONS ON TURBINE RIM SEAL INGESTION

A systematic study of sealing performance for a chute style turbine rim seal using URANS methods is reported. This extends previous studies from a configuration without external flow in the main annulus to cases with a circumferentially uniform axial flow and vane generated swirling annulus flow (but without rotor blades). The study includes variation of the mean seal-to-rotor velocity ratio, main annulus-to-rotor velocity ratio, and seal clearance. The effects on the unsteady flow structures and the degree of main annulus flow ingestion into the rim seal cavity are examined. Sealing effectiveness is quantified by modeling a passive scalar, and the timescales for the convergence of this solution are considered. It has been found that intrinsic flow unsteadiness occurs in most cases, with the presence of vanes and external flow modifying, the associated flow structures and frequencies. Some sensitivities to the annulus flow conditions are identified. The circumferential pressure asymmetry generated by the vanes has a clear influence on the flow structure but does not lead to higher ingestion rates than the other conditions studied

Wall Modelled Large Eddy Simulations of Axial Turbine Rim Sealing

This paper presents WMLES simulations of a chute type turbine rim seal. Configurations with an axisymmetric annulus flow and with nozzle guide vanes fitted (but without rotor blades) are considered. The passive scalar concentration solution and WMLES are validated against available data in the literature for uniform convection and a rotor-stator cavity flow. The WMLES approach is shown to be effective, giving significant improvements over an eddy viscosity turbulence model, in prediction of rim seal effectiveness compared to research rig measurements. WMLES requires considerably less computational time than wall-resolved LES, and has the potential for extension to engine conditions. All WMLES solutions show rotating inertial waves in the chute seal. Good agreement between WMLES and measurements for sealing effectiveness in the configuration without vanes is found. For cases with vanes fitted the WMLES simulation shows less ingestion than the measurements, and possible reasons are discussed

Wall Modelled Large Eddy Simulations of Axial Turbine Rim Sealing

This paper presents WMLES simulations of a chute type turbine rim seal. Configurations with an axisymmetric annulus flow and with nozzle guide vanes fitted (but without rotor blades) are considered. The passive scalar concentration solution and WMLES are validated against available data in the literature for uniform convection and a rotor-stator cavity flow. The WMLES approach is shown to be effective, giving significant improvements over an eddy viscosity turbulence model, in prediction of rim seal effectiveness compared to research rig measurements. WMLES requires considerably less computational time than wall-resolved LES, and has the potential for extension to engine conditions. All WMLES solutions show rotating inertial waves in the chute seal. Good agreement between WMLES and measurements for sealing effectiveness in the configuration without vanes is found. For cases with vanes fitted the WMLES simulation shows less ingestion than the measurements, and possible reasons are discussed

WALL-MODELLED LARGE EDDY SIMULATIONS OF AXIAL TURBINE RIM SEALING

This paper presents WMLES simulations of a chute type turbine rim seal. Configurations with an axisymmetric annulus flow and with nozzle guide vanes fitted (but without rotor blades) are considered. The passive scalar concentration solution and WMLES are validated against available data in the literature for uniform convection and a rotor-stator cavity flow. The WMLES approach is shown to be effective, giving significant improvements over an eddy viscosity turbulence model, in prediction of rim seal effectiveness compared to research rig measurements. WMLES requires considerably less computational time than wall-resolved LES, and has the potential for extension to engine conditions. All WMLES solutions show rotating inertial waves in the chute seal. Good agreement between WMLES and measurements for sealing effectiveness in the configuration without vanes is found. For cases with vanes fitted the WMLES simulation shows less ingestion than the measurements, and possible reasons are discussed

Computational and Experimental Assessment of Rim Sealing Flows in Axial Turbine Chute Rim Seals

Hot gas ingestion in a chute seal configuration has been numerically and experimentally investigated. First, the NGVs were included to generate a swirled annulus flow. This staged approach to rig configuration is used to understand the relative contribution of rotation and NGVs induced pressure asymmetries in turbine rim sealing flow ingestion.Computations were performed with a URANS model and a novel LES code including near wall boundary layer modelling, the wall-modelled LES (WMLES). The experimental data was obtained in the Oxford Rotor Facility (ORF). The main focus of this study was the mean cavity flow aerodynamics and the sealing performance of the chute seal under a range of operating conditions. These are studied through measurements of pressure and gas concentration within the rotor-stator disc cavity and the rim seal which are compared to CFD predictions. In addition, experimental and CFD assessments of concentration-based sealing effectiveness in the gas path for the vaned configuration are presented. Measurements were taken at a representative rotor leading edge axial position to focus on the radial diffusion and interaction between the purge flow and annulus flow. Overall the WMLES code better captured the interaction between main annulus and turbine cavity flow positioning it as a powerful tool with potential to be implemented in the design and verification process