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Objective: The current study aimed to describe the clinical characteristics of mild SARS-CoV-2 infected pregnant women with abnormal liver function (ALF), explore the association between ALF with maternal and fetal outcomes. Method(s): This retrospective analysis included 87 pregnant patients with mild SARS-CoV-2 infection admitted and treated from December 1, 2022, to 31, 2022 in the department of Obestircs at Beijing Obstetrics and Gynecology Hospital. We evaluated patients for demographic and clinical features, laboratory parameters and pregnancy complications. Result(s): 27 Patients in this cohort had clinical presentations of ALF. Compared with the control group, the peripheral blood platelet (PLT), D-dimer quantitative determination (D-Dimer), lactate dehydrogenase (LDH), total protein (TP), albumin (ALB), indirect bilirubin (DBIL), gamma- glutamyltranspeptidase (GGT) and total bile acid (TBA) showed significantly differences (p<0.05). 12 cases (44.44%) complicated with pregnancy induced hypertension (PIH), 14 cases (51.85%) complicated with intrahepatic cholestasis of pregnancy (ICP), 2 cases (7.4%) complicated with acute fatty liver during pregnancy (AFLP) and 5 cases (14.81%) complicated with postpartum hemorrhage in patients with abnormal LFT were significantly higher than those in the control group (p<0.05). Compared with the control group, the incidence of premature delivery (22.22%) and fetal distress (37.04%) in the experiment group were significantly higher (p<0.05), and the incidence of neonatal asphyxia was not significantly different (p>0.05). Conclusion(s): Pregnant women are generally susceptible to mild SARS-CoV-2 and may induce ALF. ALF is associated with increased risk of mother and infant. The maternal and infant outcomes of those who terminated pregnancy in time are acceptable. Therefore, pregnant women with COVID-19 who received antiviral treatment should be closely monitored for evaluating liver function and relevant indicators. The long-term outcomes in the future are worth to further study.Copyright © 2023
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Background: COVID-19 has been associated with cerebral microbleeds (CMB). Previously, an association of ApoE4 with COVID-19 severity and CMBs in autopsy was found. In this study, we investigated if carrying the Apoe4 allele relates to the number of CMBs in magnetic resonance imaging (MRI) in patients recovered from COVID-19. Material(s) and Method(s): Adult patients recovered from COVID-19 and a control group without a history of COVID-19 was recruited. Exclusion criteria were major neurologic disease, developmental disability or pregnancy. The participants underwent brain MRI 6 months after infection, and a blinded neuroradiologist analyzed the findings. ApoE was genotyped using a microarray. Statistical analysis was performed using the statistical software R. A negative binomial model was chosen based on the distribution of CMBs. Result(s): Of the 216 subjects that underwent MRI, 168 consented to genetic testing, additionally 2 patients were excluded due to extensive CMBs and 1 due to diffuse axonal injury. We included 113 COVID-19 patients (49 ICU-treated, 29 ward-treated and 35 home-isolated) and 52 controls. The most prevalent comorbidities were hypertension, asthma and diabetes. CMBs was found in 47 subjects, with the number of CMBs ranging from 0 to 26. The ApoeE4 allele was carried by 37%, equally distributed among the groups. After adjustment, age (aRR = 1.06, p = 0.007) and COVID-19 (aRR = 2.59, p = 0.038) were independently associated with CMBs. The ApoE4 allele (aRR = 2.16, p = 0.07, CI = 0.94-5.10) was not significant. Conclusion(s): Age and previous COVID-19, but not possession of the ApoeE4 allele, were independently associated with the number of CMBs.
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Objectives: Treatment of severe respiratory distress syndrome (ARDS) due to COVID-19 by veno-venous extracorporeal membrane oxygenation (VV-ECMO) had a mortality of up to 70% in Germany. Many patients with COVID-19 need VV-ECMO support longer than 28 days (long-term VV-ECMO). Evidence on mortality, complications during intensive care, functional status after discharge and mortality-predictors for patients supported with long-term VV-ECMO is lacking. Method(s): Retrospective study of 137 consecutive patients treated with VV-ECMO for ARDS due to COVID-19 at University Hospital Regensburg from March 2020 to March 2022. Result(s): 38% (n=52;87% male) of patients needed longterm VV-ECMO support. In these, SOFA score (median [IQR]) at ECMO initiation was 9 [8-11], age 58.2 [50.6- 62.5] years, PaO2/FiO2-ratio 67 [52-88] mmHg, pCO262 [52-74] mmHg, Murray-Score 3.3 [3.0-3.6] and PEEP 15 [13 - 16] cmH2O. Duration of long-term support was 45 [35-65] days. 26 (50%) patients were discharged from the ICU. Only one patient died after hospital discharge. At VVECMO initiation, baseline characteristics did not differ between deceased and survivors. Complications were frequent (acute kidney injury: 31/52, renal replacement therapy: 14/52, pulmonary embolism: 21/52, intracranial hemorrhage 8/52, major bleeding 34/52 and secondary sclerosing cholangitis: 5/52) and more frequent in the deceased. Karnofsky index (normal 100) after rehabilitation was 70 [57.5-82.5]. Twelve of the 18 patients discharged from rehabilitation had a satisfactory quality of life according to their own subjective assessment. Four patients required nursing support. Mortality-predictors within the first 30 days on VV-ECMO only observed in those who deceased later, were: Bilirubin >5mg/dl for > 7 days, pulmonary compliance <10ml/mbar for >14 days, and repeated serum concentrations of interleukin 8 >150ng/L. Conclusion(s): Long-term extracorporeal lung support in patients with COVID-19 resulted in 50 % survival and subsequently lead to a satisfactory quality of life and functionality in the majority of patients. It should preferably be performed in experienced centers because of a high incidence of complications. Several findings during the early course were associated with late mortality but need validation in large prospective studies.
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Purpose: The aim of this study was to evaluate how prevalent asymptomatic SARS-CoV-2 virus infection (COVID-19) is among patients undergoing ophthalmic surgery at two tertiary referral hospitals. Material(s) and Method(s): This retrospective study included patients without COVID-19 symptoms who underwent preoperative screening using reverse transcription-polymerase chain reaction (RT-PCR) before ophthalmic surgery at the Kocaeli University and Gaziantep University departments of ophthalmology [between September 1, 2020, and December 15, 2020 (group 1);between March 1, 2021, and May 30, 2021 (group 2)]. Patients scheduled for surgery and followed up in the retina, glaucoma, pediatric ophthalmology and strabismus, cataract and refractive surgery, and cornea departments were examined. Result(s): RT-PCR was positive for SARS-CoV-2 in 12 (1.4%) of 840 patients in group 1 and 7 (1.1%) out of 600 patients in group 2. None of the patients were symptomatic of COVID-19. The majority of the patients were scheduled for retina or cataract and refractive surgery in both groups (group 1;retina: 29.2%, cataract and refractive: 57.0%, group-2;retina: 31.3%, cataract and refractive: 54.5%). SARS-CoV-2 RT-PCR testing was positive for seven patients in group 1 (7/245, 2.9%) and five patients in group 2 (5/188, 2.6%) who were scheduled for retinal surgery. Conclusion(s): The necessity, availability, and practicality of COVID-19 RT-PCR testing prior to ophthalmic surgeries varies depending on the protocols of each institution. COVID-19 RT-PCR testing is suggested especially before vitreoretinal surgeries and general anesthesia procedures, because of the difficulty in managing postoperative complications.Copyright © 2023 Gazi Eye Foundation. All rights reserved.
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Background: Since patients admitted to the intensive care unit have a compromised im-mune system and are more prone to infection than other patients, timely diagnosis and treatment of corneal ulcers among this group of patients can prevent vision loss. Therefore, it is necessary to treat eye infections and corneal ulcers promptly and economize prohibitive costs. Objective(s): Appropriate treatment with the most effective antibiotic before the answer is available to prevent corneal ulcer complications and blindness. Method(s): This study was conducted from November 2019 to November 2020 and after approval by the ethics committee of Hamedan University of Medical Sciences with the code of ethics: IR.UMSHA.REC.1398.716. First, the corneal secretions of 121 patients admitted to the intensive care unit of Sina Hospital are prepared by an ophthalmologist (after anesthetizing the cornea with tetra-caine drops and sterile swabs) and culture in four growth mediums (blood agar, chocolate agar, thio-glycolate, and EMB). Microbial cultures are examined after 48 hours and a fungal culture is examined one week later. Disc diffusions are placed in positive microbial cultures. Antibiotic susceptibility or resistance of the antibiogram was recorded. Other demographic data, including patients' age and sex, are extracted from ICU files. Also, test results and patient identifications are recorded in a checklist designed for this purpose. Result(s): Of all the antibiotics used against common bacteria, vancomycin (84%), colistin (80.43%), cefazolin (80%), and levofloxacin (60%) had the highest sensitivity and gentamicin (93.75%), ceftazidime (86.42%) Erythromycin (85%) had the highest resistance against isolated bacteria. Conclusion(s): The data obtained from this study showed that the most common microorganisms in the age group under the age of 30 years were Acinetobacter Baumannii, in the group of 30-60 years old was Klebsiella pneumonia, and age group over 61 years old was Staphylococcus aureus, and the most sensitive antibiotics in the age group under 30 years were vancomycin and levofloxacin and the age group30-60 were colistin and vancomycin and in the age group over 61 years were vancomycin and cefazolin.Copyright © 2023 Bentham Science Publishers.
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Background: Gastrointestinal bleeding is one of the consequences of COVID-19, which is associated with increased hospitalization and patient mortality. This study was conducted to determine the prevalence of endoscopic findings and the outcome of gastrointestinal bleeding in patients with COVID-19 who were hospitalized from September to December 2019 in Al-Zahra Hospital, Isfahan. Method(s): In this cross-sectional study, out of 5800 patients who were admitted to Al-Zahra Hospital in Isfahan from September to December 2019 due to COVID-19 (according to the positive PCR test result), 87 patients who underwent endoscopy due to upper gastrointestinal bleeding by a skilled gastroenterologist, were selected and studied. Demographic characteristics, underlying diseases, use of anticoagulants, and laboratory findings were studied and evaluated and finally, the disease was evaluated and compared based on endoscopic findings. Result(s): Based on the results obtained from this research, the patients with endoscopic lesions had higher average age (P=0.041), lower blood oxygen saturation percentage (P=0.028), and higher bleeding intensity (P=0.018). The frequency of using anticoagulant drugs in the group whose endoscopy results were abnormal was higher but insignificant. Hemoglobin, platelet, lymphocyte, and CRP levels were higher in the group whose endoscopy was normal, and NLR, LDH, and D-dimer levels were higher in the group whose endoscopy was abnormal (P<0.050). Three people (11.55%) from the group with normal endoscopy and 18 people (29.5%) from the group with abnormal endoscopy died, but the frequency of death was not significantly different between the two groups (P=0.070). Conclusion(s): The findings of the present study showed that the COVID patients with upper gastrointestinal bleeding who had endoscopic lesions had significant differences in some characteristics such as age, bleeding intensity, and blood oxygen saturation percentage with patients with normal endoscopy. Also, the frequency of death in patients with endoscopic lesions was relatively higher. Therefore, COVID patients with gastrointestinal bleeding should undergo endoscopy as soon as possible and necessary measures should be taken to control and prevent gastrointestinal bleeding.Copyright © 2022 Tabesh et al. Tehran University of Medical Sciences. Published by Tehran University of Medical Sciences.
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Thromboelastography (TEG) and rotational thromboelastometry (ROTEM) are point-of-care viscoelastic tests of whole blood that provide real-time analyses of coagulation. TEG and ROTEM are often used to guide blood product administration in the trauma and surgical settings. These tests are increasingly being explored for their use in other disease states encountered in critically ill patients and in the management of antithrombotic medications. As the medication experts, pharmacists should be familiar with how to interpret and apply viscoelastic tests to disease state and medication management. The purpose of this narrative review is to provide a primer for pharmacists on viscoelastic tests and their interpretation and to explore non-trauma indications for viscoelastic testing in critical care. Literature evaluating the use of TEG and ROTEM for patients with acute and chronic liver disease, ischemic and hemorrhagic stroke, myocardial infarction, cardiac arrest, coronavirus disease 2019, and extracorporeal membrane oxygenation are described. Current applications of viscoelastic tests by pharmacists and potential future roles of critical care pharmacists in expanding the use of viscoelastic tests are summarized.Copyright © 2023 The Authors. JACCP: Journal of the American College of Clinical Pharmacy published by Wiley Periodicals LLC on behalf of Pharmacotherapy Publications, Inc.
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Objectives: Globally, cataract and glaucoma are the predominant causes of blindness. Screening glaucoma in patients referred for cataract surgery is a convenient tool for detecting glaucoma cases in rural population. The COVID period has adversely affected eye care as the routine screening and follow-ups at hospital were substantially reduced owing to pandemic restrictions. We aim to study the impact of COVID on detection of glaucoma in patients with cataract. Method(s): It was a retrospective study conducted to compare the prevalence of glaucoma in rural patients presenting with cataract pre- and post-COVID. Details of 975 consecutive patients each were taken prior to March 2020 (pre-COVID) and after October 2021 (post-COVID) from hospital database and patient case files. Result(s): The prevalence of glaucoma was higher during the pre-COVID time (3.8%) as compared to pre-COVID (3.8%), but the result was not statistically significant. In both the groups, primary open-angle glaucoma was the pre-dominant form of glaucoma, with prevalence being 1.5% and 2.2% in the pre-COVID and post-COVID groups, respectively. The mean intraocular pressure and mean VCDR values were higher in the post-COVID group as compared to the pre-COVID group, and the result was statistically significant. Conclusion(s): This was the first study to compare the prevalence of glaucoma in patients with cataract in rural population in the pre-COVID and post-COVID periods. In the aftermath of the pandemic, the present study emphasizes the role of screening and follow-ups in glaucoma management to prevent irreversible loss of vision.Copyright © 2023 The Authors.
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Background: We aimed to report long-term brain magnetic resonance imaging (MRI) findings in survivors of ICU-treated COVID-19 compared to other groups. Material(s) and Method(s): In this prospective cohort study 70 ICU-treated, 46 ward-treated and 46 home-isolated patients, diagnosed with COVID-19 in 2020, underwent brain MRI 6 months after the acute phase to determine the presence of cerebral microbleeds (CMB) and Fazekas scale. Result(s): CMBs existed in 27 (38.6%) ICU-treated, 13 (28.3%) ward-treated, 8 (17.4%) home-isolated COVID-19 patients, and in 12 (22.6%) non-COVID controls (Figure 1). The number of CMBs in COVID-19 patients and controls was median 2 (IQR 1-4) and 1 (IQR 1-2), respectively. Patients with CMBs differed from those without, regarding age (median 62 vs. 52 years, p < 0.001), history of arterial hypertension (50% vs. 31%, p = 0.03), need of ICU (56% vs. 38%, p = 0.03) and ventilator treatment (42% vs. 22%, p = 0.01), length of hospital stay (median 21 vs. 12 days, p < 0.001), and supplementary oxygen therapy (median 18 vs. 10 days, p = 0.008), respectively. Within the ICU group, patients with and without CMBs differed regarding the duration of ICU stay (median 17 vs. 9 days, p = 0.006), and mechanical ventilation (median 14 vs. 6 days, p = 0.002). In multivariable analysis, only age was associated with CMBs (OR 1.06, 95% CI 1.02-1.09). The majority of subjects in all groups had Fazekas scale one for white matter hyperintensities (Figure 1). Conclusion(s): Although the severity of respiratory failure and history of arterial hypertension were associated with the presence of CMBs, only age was an independent predictor of CMBs.
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Aim: Standard diagnosis of gestational diabetes (GDM) is based on the Oral Glucose Tolerance test (OGTT). During the Covid-19 outbreak, due to Covid restrictions, criteria were modified i.e Fasting Blood Glucose >=5.3 and/ or HbA1c >= 39 for diagnosis of GDM. After the lifting of the Covid restrictions, the standard criteria were reimplemented and on analyzing the data, it was highlighted that some of the patients could have tested negative for GDM based on Covid Criteria. Method(s): We analyzed the data of 43 patients based on standard criteria (OGTT and HbA1c) after Covid restrictions, with the following results. Result(s): 11/43(28%) patients who were diagnosed on the basis of standard criteria could have been missed based on Covid criteria. Out of 11 deliveries, 2 babies with weight above 4 kg. There were no admissions to NICU. One patient had postpartum hemorrhage with 670 mL of blood loss. Conclusion(s): This was a retrospective study in which we analyzed the data of 45 pregnant females diagnosed with GDM based on testing using the Covid criteria and compared this to 43 pregnant females who were diagnosed with GDM on the basis of OGTT based on GOLD standard NICE criteria. In addition, we also examined maternal and obstetric outcomes in both groups such as the mode of delivery, the baby's birth weight, the incidence of shoulder dystocia, mean blood loss (MBL), and NICU admission. We understand that Covid GDM diagnosis was a necessity of time. In this study, we want to learn what could have been missed with that diagnostic criteria. For future pandemics, we need to revise our diagnostic criteria to avoid the risk of underdiagnosing GDM and associated complications.
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Objectives: To systematically review longitudinal studies to determine the prevalence and time-course of fatigue after stroke (post-stroke fatigue, PSF). Material(s) and Method(s): A study protocol was registered on PROSPERO. Five databases (PUBMED, MEDLINE, EMBASE, PSYCHINFO and CINAHL) were searched (10th to 13th June 2022). Citations were imported into Covidence software, s screened by one author, full texts of potentially eligible studies retrieved, and one author applied inclusion criteria (longitudinal cohort studies of patients with acute stroke). Quality assessment of included studies was performed using the Joanna Briggs institute tool for observational studies. A meta-analysis was performed for the prevalence of PSF at different time-points after stroke onset, and changes over time. Subgroup analyses were performed by type of stroke and study location. Result(s): A total of 13,991 records were returned from the searches. Nine studies were eligible and were included. Five studies were of strong and four of moderate quality. Of the studies suitable for meta-analysis, the prevalence of PSF was 42% (95% CI - 39-44%) at six months after ischaemic stroke;and 34% (95% CI - 28-40%) at one year in stroke survivors excluding subarachnoid haemorrhage. Subgroups analyses found no differences in PSF prevalence between Asian countries and others. Of those with PSF at first assessment, 66% (95% CI - 61-71%) remained fatigued at follow-up;of those without PSF initially, 15% (95% CI - 11-20%) developed PSF at follow-up. Conclusion(s): PSF is common and around two-thirds with fatigue remain fatigued. This justifies the development of new interventions for PSF treatment.Copyright © 2023 The Author(s)
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Cerebral venous thrombosis (CVT) is a form of cerebrovascular disorders that is difficult to recognize, it is potentially a life threatening condition and requires timely anticoagulant therapy. In the era of the COVID-19 pandemic, there is a steady increase in CVT (4.2% vs. 0.5-1%). At the same time, mortality in patients with CVT on the background of COVID-19 significantly exceeds the mortality in patients with CVT without COVID-19 (45.5% vs. 15%). Objective(s): to study the clinical course of CVT, to determine the diagnostic value of radiological methods and the significance of genetic risk factors for thrombosis in the development of CVT in young and middle-aged patients against the background of COVID-19. Material and methods. Seven patients were examined: six women (five of them of reproductive age) and one man, aged 26 to 57 years (mean age 37 years). The main clinical and neurological manifestations of CVT, the results of laboratory examination, neuroimaging, and the data of molecular genetic analysis of risk factors for thrombosis were analyzed. Results. The course of COVID-19 was severe in one case, and moderate in the rest of cases. The interval between the onset of COVID-19 symptoms and the development of CVT ranged from 7 to 25 days. In three cases CVT had an acute course and was accompanied by the development of a stroke (in two cases, hemorrhagic stroke was noted, in one case, multifocal ischemic stroke), in other cases, a subacute course of CVT was noted. Genetic risk factors for thrombosis were identified in all patients. Conclusion. The diagnosis of CVT in the era of the COVID-19 pandemic is particularly difficult, since the most common symptom of CVT - headache (90%) - can be regarded as a manifestation of COVID-19. At the same time, timely diagnosis of CVT and immediate initiation of anticoagulant therapy are associated with a relatively favorable prognosis.Copyright © 2023 Ima-Press Publishing House. All rights reserved.
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Introduction/Objective Since the emergence of a novel SARS-CoV-2 virus caused coronavirus disease 2019 (COVID-19), a great number of autopsy studies have been published. However, histopathologic studies focused on pulmonary barotrauma are very rare. Here we report an autopsy confined to the lungs on a young COVID-19 patient. Methods/Case Report The patient was a 37-year-old male, non-smoker, with no significant past medical history, and a body mass index of 24.1, who presented with shortness of breath and cough. A computerized tomography (CT) showed features of atypical pneumonia. The main abnormal laboratory data included elevated partial thromboplastin time, fibrinogen, and D-Dimer. The patient had been on mechanical ventilation for 35 days, and was complicated by recurrent pneumothoraces, hypotension, and worsening hypoxia. An autopsy limited to the lungs was performed after the patient expired. Grossly, the lungs showed increased weight, adhesions on visceral pleural surface, patchy consolidation and dilated subpleural cysts. Histological examination revealed cystically dilated/remodeled airspaces with extensive coagulative necrosis, focal alveolar hemorrhage and edema, focal confluent fibrosis, and subpleural blebs. Fresh fibrinous thrombi were seen in small- and medium-sized vessels. Viral cytopathic changes or significant inflammation were not observed. The findings in the lungs were consistent with barotrauma in COVID-19. Results (if a Case Study enter NA) NA. Conclusion This case demonstrates various histopathologic changes of the lungs in a previously healthy and young COVID-19 patient with prolonged hospital course of mechanical ventilation. The features of diffuse alveolar damage with inflammation usually seen in the early stage of barotrauma are not identified. Our findings in the lungs may represent the histopathologic characteristics of the later stage of barotrauma in COVID-19.
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Introduction: Critically-ill obstetric patients admitted to general intensive care units (ICU) are a rare and unique population for whom excellent care is essential to prevent devastating physical and psychological morbidity. Admissions are often unanticipated and can present challenges to obstetric and intensive care MDTs. 2018 Enhanced Maternal Care (EMC) Guidelines provide standards for caring for these women, and the 2022 Ockenden review exposed the association of peripartum ICU admission with undertreated psychological trauma and a desire for individualised debriefing [1,2]. We audited the care of obstetric admissions to general ICUs in our quaternary centre. We sought evidence of psychological morbidity to improve follow-up pathways in line with 2022 Ockenden actions. Method(s): Retrospective online case note review of maternity admissions to general ICUs between 1/1/2021-1/1/2022 compared to EMC audit standards. Exclusion criteria: <22/40 gestation, >6/52 postpartum and admissions to our level 2 labour ward high dependency unit. Result(s): 25 patients were admitted to general ICUs over 12 months. Median age was 35-39 years, mean parity was 1. The commonest indication was obstetric haemorrhage (n = 10). 15 of 25 patients required level 3 care, median length of stay was 1.5 days. Documentation of daily obstetric MDT ward round was variable, as was mother-baby contact. 0 of 25 women were seen in obstetric anaesthesia clinic after discharge, only 1 received outpatient ICU follow-up. 50% of postnatal admissions (n = 14) had documentation of significant psychological distress. In response a local checklist was developed with key colleagues to support collaborative working and standardise quality care. It includes automatic referral into obstetric anaesthesia clinic and access to a novel perinatal mental health service. Discussion(s): A peripartum admission to ICU is highly likely to be experienced as traumatic [2]. The incidence of obstetric ICU admissions may increase in the context of greater clinical complexity of the UK pregnant population and COVID-19, whilst the non-anaesthetic ICU workforce may have little obstetric training. Obstetric anaesthetists are therefore uniquely skilled to facilitate quality resuscitation and referral to ICU, but gold-standard holistic care extends beyond admission. We believe regular audit and dedicated local care pathways which incorporate proactive debriefing and psychological health can improve the care of this important group of women.Copyright © 2023 Elsevier Ltd
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Objectives: The objective of this study is to assess the clinical benefits and potential risks of using venovenous extracorporeal membrane oxygenation (VV ECMO) as a treatment for COVID-19 patients with severe respiratory failure. Method(s): Relevant studies were identified through searches of electronic databases, including PubMed, EMBASE, and the Cochrane Library, from January 2020 to December 2022. We included observational studies on adult patients who received venovenous (VV) ECMO support for COVID-19-induced ARDS. The primary outcome was in-hospital mortality, 3-month mortality, and complications associated with VV ECMO. Statistical analysis was performed using R version 4.0.3 and the metafor and meta packages. Result(s): The final analysis included 39 studies comprising 10,702 patients. In-hospital mortality for adults receiving ECMO was 34.2% (95% CI: 28.5% - 40.3%;I2 = 93%), while the 3-month mortality rate was 50.2% (95% CI: 44.4% - 56.0%;I2 = 51%). Bleeding requiring transfusion occurred in 33.7% of patients (95% CI, 23.9 - 45.1;I2 = 96%). The pooled estimates for other complications were as follows: overall thromboembolic events 40.9% (95% CI, 24.8 - 59.3;I2 = 97%), stroke 8.7% (95% CI, 5.7 - 13.2;I2 = 72%), deep vein thrombosis 15.4% (95% CI, 9.7 - 23.6;I2 = 80%), pulmonary embolism 15.6% (95% CI, 9.3 - 25.1;I2 = 92%), gastrointestinal haemorrhage 8.1% (95% CI, 5.5 - 11.8;I2 = 56%), and the need for any renal replacement therapy in 38.0% of patients (95% CI, 31.6 - 44.8;I2 = 84%). Bacterial pneumonia occurred in 46.4% of patients (95% CI, 32.5 - 61.0;I2 = 96%). Conclusion(s): Venovenous extracorporeal membrane oxygenation (VV ECMO) may be an effective treatment option for COVID-19 patients with severe respiratory failure. The use of VV ECMO was associated with reduced in-hospital and 3-month mortality. However, bleeding is a common complication that should be closely monitored. Further research is needed to determine the optimal use of VV ECMO in this patient population and to identify factors that may predict a favourable response to treatment.
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BackgroundSystemic sclerosis (SSc) is a severe, progressive multisystem rheumatic disease with high mortality, but without approved disease-modifying treatment to stop or reverse course of disease. Intravenous immunoglobulin G (IgG) may have a positive impact on SSc based upon available literature reports. However, to date, there have been no clinical trials evaluating subcutaneous IgG (SCIG) in SSc. In particular, the impact of pathologically altered skin in SSc on local safety and pharmacokinetics (PK) of SCIG has not been explored yet.ObjectivesThe primary and secondary objectives of this trial (NCT04137224) included safety, including local infusion safety, and bioavailability of subcutaneous IgG (IgPro20) in adults with diffuse cutaneous SSc (dcSSc).MethodsThis was a randomized, open-label, crossover study. Adult subjects with dcSSc diagnosis within 5 years from first non-Raynaud's phenomenon and modified Rodnan Skin Score of 15-45 at screening were randomized 1:1 to sequence A (IgPro20, 20% normal human subcutaneous immunoglobulin followed by IgPro10, 10% normal human intravenous immunoglobulin) or sequence B (IgPro10 followed by IgPro20). Each subject was to complete two treatment periods (16 weeks each), with up to 40 weeks (including screening) study duration for an individual subject. Doses received were 0.5g/kg/week split over two sessions for IgPro20, and 2g/kg/4 weeks split over 2-5 days for IgPro10. The primary endpoint was safety of IgPro20, described as treatment-emergent adverse events (TEAEs) and changes in clinical observations.Results27 subjects were randomized, with 13 subjects to sequence A and 14 subjects to sequence B. In total, 25 subjects completed the study. Of 27 treated subjects, 107 TEAEs occurred in 22 subjects (81.5%) over the 36-week study period, the majority of which were mild or moderate. The most common TEAEs (>10% of subjects) by preferred term (PT) were headache (12 events occurring in 6 subjects [22.2%]), COVID-19 (3 events occurring in 3 subjects [11.1%]), diarrhoea (3 events occurring in 3 subjects [11.1%]), and vomiting (3 events occurring in 3 subjects [11.1%]).A total of 10 serious AEs (SAEs) were reported in 6 subjects (Viral infection, Chronic gastritis, Vomiting, Dehydration, Upper gastrointestinal haemorrhage, Chest pain, Myocardial infarction, Myocardial ischemia, Breast cancer, Interstitial lung disease). Among these, one subject experienced 2 SAEs (myocardial ischemia & myocardial infarction) and was discontinued from study treatment. None of the SAEs were considered related to study treatment by the investigator, and no deaths were reported.For IgPro20, 14 infusion site reactions (ISRs) occurred in 5 subjects (19.2%), all were mild or moderate in severity. The most common ISRs were infusion site pain and infusion site swelling (3 events in 2 subjects each, 7.7%). In total, 686 IgPro20 infusions were performed, resulting in an overall ISR rate per infusion of 0.02, ie 2 ISRs per 100 infusions. No ISRs were reported for IgPro10.No clinically relevant trends in vital signs, body weight, clinical laboratory tests, electrocardiograms, or pulmonary function tests were observed.PK profiles and bioavailability in dcSSc subjects were similar to those observed in other approved indications such as Primary Immunodeficiency. Population relative bioavailability of IgPro20, based on dose-normalized, baseline-corrected AUC0-tau was 0.761 (90% CI: 0.7033, 0.8232), ie 76.1% compared to IgPro10 (intravenous IgG).ConclusionThe overall safety profiles of IgPro20 and IgPro10 in subjects with dcSSc were consistent with that in approved indications such as CIDP, including a relatively low ISR rate for IgPro20. PK profiles and bioavailability were also similar to other indications. This study indicates that subcutaneous administration of IgPro20 has acceptable safety, bioavailability and PK profiles in patients with dcSSc. AcknowledgementsEditorial assistance was provided by Meridian HealthComms Ltd., funded by CSL Behring.Disclosure of InterestsChristopher P Denton Speakers bureau: Ja ssen, Boehringer Ingelheim, Consultant of: GSK, CSL Behring, Boehringer Ingelheim, Merck, Roche, Sanofi, Grant/research support from: GSK, CSL Behring, Inventiva, Horizon, Otylia Kowal-Bielecka Speakers bureau: Abbvie, Janssen-Cilag, Boehringer Ingelheim, Medac, MSD, Novartis, Pfizer, Sandoz, Consultant of: Boehringer Ingelheim and Novartis, Grant/research support from: Received congress support from Abbvie, Boehringer Ingelheim, and Medac, Susanna Proudman Speakers bureau: Boehringer Ingelheim, Grant/research support from: Janssen, Marzena Olesińska Consultant of: AstraZeneca, Margitta Worm Consultant of: Novartis Pharma GmbH, Sanofi-Aventis Deutschland GmbH, DBV Technologies S.A, Aimmune Therapeutics UK Limited, Regeneron Pharmaceuticals, Inc, Leo Pharma GmbH, Boehringer Ingelheim Pharma GmbH &Co.KG, ALK-Abelló Arzneimittel GmbH, Kymab Limited, Amgen GmbH, Abbvie Deutschland GmbH & Co. KG, Pfizer Pharma GmbH, Mylan Germany GmbH (A Viatris Company), AstraZeneca GmbH, Lilly Deutschland GmbH and GlaxoSmithKline GmbH & Co. KG., Nicoletta Del Papa Speakers bureau: Janssen Cilag, Boehringer Ingelheim., Marco Matucci-Cerinic Speakers bureau: Biogen, Sandoz, Boehringer Ingelheim, Consultant of: CSL Behring, Boehringer Ingelheim, Grant/research support from: MSD, Chemomab, Jana Radewonuk Shareholder of: CSL Behring, Employee of: CSL Behring, Jeanine Jochems Shareholder of: CSL Behring, Employee of: CSL Behring, Amgad Shebl Shareholder of: CSL Behring, Employee of: CSL Behring, Anna Krupa Shareholder of: CSL Behring, Employee of: CSL Behring, Jutta Hofmann Shareholder of: CSL Behring, Employee of: CSL Behring, Maria Gasior Shareholder of: CSL Behring, Employee of: CSL Behring.
ABSTRACT
BackgroundAccuracy of diagnosis and prompt therapeutic intervention are the mainstay in patients with ANCA-associated vasculitis(AAV) suffering from life-threatening complications [1].However, there is no definition of therapeutic window in vital AAV, nor its impact on patient outcome regarding length of hospital stay, intensive care unit(ICU) admission or survival.ObjectivesThe aim of the study is to analyze the process of care from the perspective of time management in vital organ involvement AAV patients and to identify potential risk factors for ICU admission.MethodsA retrospective multicenter study identified AAV patients with life-threatening organ involvement, defined as alveolar hemorrhage, rapidly progressive renal failure, myocarditis and cerebral granuloma. Demographic data was collected. Key time frames were recorded, namely the interval from acute symptom onset to hospital presentation, days until imaging(plain X-ray, cardiac ultrasound, CT-scan), time to therapeutic intervention with corticosteroids or biologic/non-biologic immunosuppression(cyclophosphamide or rituximab) and to renal replacement therapy(RRT) or plasmapheresis. Time to ICU admission, hospital length-of-stay, Birmingham Vasculitis Activity Score(BVAS) were also noted. Statistical analysis was performed using SPSS and Chi-square and Pearson correlation tests were applied.Results66 patients with AAV were enrolled, out of which 17 fulfilled inclusion criteria. Mean age in the study group was 58.6±11.1 years old,10 patients(58.8%) were females and 7 (41.2%) males.11(64.7%) patients were c-ANCA positive, while 6 (35.3%) had p-ANCA and all were diagnosed with AAV prior to life-threatening event. Two patients had COVID-19 triggered AAV.In the study group, the most frequent critical organ suffering was rapidly progressive renal failure(12), followed by alveolar hemorrhages(10), 2 cerebral granulomas and one acute myocarditis. Three patients(17.6%) had more than one vital manifestation. Ten patients(58.8%) had more than three additional non-organ-threatening manifestations. Mean interval from AAV diagnosis to emergency admission was 30.1± 61.1 days, median 3 and from severe episode onset to hospitalization 1.65±0.18 days, median 1. There was only one death in the study group. Three patients were admitted in the ICU in 0.59±1.5 days following hospital presentation and required either RRT or plasma exchange within 2.66 days. Imaging examination was performed unanimously the day upon hospital admission. All patients received corticosteroids in the first 5.95±14.3 days, while immunosuppression was given to 13(76.5%) patients within 11.5±15.5 days from hospitalization.12 patients(70.5%) suffered from associated infections. Mean BVAS(13.6±6.76) correlated to ICU admission(p 0.013, r 0.58).Patients in ICU revealed higher BVAS(22±9.53) versus non-ICU(11.8±4.76).Hospital length of stay was 14.7±10.7 days(median 14) and showed no relationship to the type of severe organ involvement. The need for ICU caring was dominant in males(p 0.05) and confirmed in patients with proteinuria(p 0.012) and at least two major organ damage.ConclusionThis study shows that severity risk factors for potential ICU admission for life-threatening AAV appear to be male gender, proteinuria and the number of affected organs.Moreover, BVAS should be considered a useful tool to predict patients' risk for intensive care management since a higher score indicates a more aggressive disease.However, time to investigational or therapeutic intervention did not correlate to patient outcome in AAV.References[1]Geetha, D., Seo, P. (2011). Life-Threatening Presentations of ANCA-Associated Vasculitis. In: Khamashta, M., Ramos-Casals, M. (eds) Autoimmune Diseases. Springer, London. https://doi.org/10.1007/978-0-85729-358-9_8Acknowledgements:NIL.Disclosure of InterestsNone Declared.
ABSTRACT
Introduction: SARS-CoV-2 is responsible for the current global pandemic. SARS-CoV-2 infection underlies the novel viral condition coronavirus disease 2019 (COVID-19). COVID-19 causes significant pulmonary sequelae contributing to serious morbidities. The pathogenesis of COVID-19 is complex with a multitude of factors leading to varying levels of injury numerous extrapulmonary organs. This review of 124 published articles documenting COVID- 19 autopsies included 1,142 patients. Method(s): A PubMed search was conducted for COVID-19 autopsy reports published before March 2021 utilizing the query COVID-19 Autopsy. There was no restriction regarding age, sex, or ethnicity of the patients. Duplicate cases were excluded. Findings were listed by organ system from articles that met selection criteria. Result(s): Pulmonary pathology (72% of articles;866/1142 patients): diffuse alveolar damage (563/866), alveolar edema (251/866), hyaline membrane formation (234/866), type II pneumocyte hyperplasia (165/866), alveolar hemorrhage (164/866), and lymphocytic infiltrate (87/866). Vascular pathology (41% of articles;771/1142 patients): vascular thrombi (439/771)-microvascular predominance (294/439)-and inflammatory cell infiltrates (116/771). Cardiac pathology (41% of articles;502/1142 patients): cardiac inflammation (186/502), fibrosis (131/502), cardiomegaly (100/502), hypertrophy (100/502), and dilation (35/502). Hepatic pathology (33% of articles;407/1142 patients): steatosis (106/402) and congestion (102/402). Renal pathology (30% of articles;427/1142 patients): renal arteries arteriosclerosis (111/427), sepsis-associated acute kidney injury (81/427) and acute tubular necrosis (77/427). Conclusion(s): This review revealed anticipated pulmonary pathology, along with significant extrapulmonary involvement secondary to COVID-19, indicating widespread viral tropism throughout the human body. These diverse effects require additional comprehensive longitudinal studies to characterize short-term and long-term COVID-19 sequelae and inform COVID-19 treatment.
ABSTRACT
BackgroundSARS-Cov2 vaccination has been shown to be effective against severe forms of SARS-Cov2 infection. Several studies investigated the humoral and cellular response to SARS-Cov2 vaccines in patients followed for autoimmune and inflammatory diseases under immunosuppressive or immunomodulatory treatments. It has been shown that patients on immunosuppressive or immunomodulatory therapies have a poor humoral response to the vaccine[1]ObjectivesThe aim of our study was to investigate the humoral response in patients under conventional immunosuppressive and biotherapies compared to healthy controls.MethodsPatients followed for immuno-inflammatory diseases under immunosuppressive or immunomodulatory drugs who received at least one dose of anti- SARS-Cov2 vaccines were included. Quantitative Anti- SARS-Cov2 antibodies (IgM and IgG assay) VIDAS ® were assessed for all patients. Patients were then compared with healthy controls.ResultsWe enrolled 93 blood samples (63 patients with autoimmune and inflammatory disease and 30 healthy controls), the median age was 52 years [Q1 43, Q3 56]. The immuno-inflammatory diseases were: Crohn's disease (n=28), Rheumatoid arthritis (n=9), Hemorrhagic rectocolitis (n=5), Behçet's disease (n=5), Systemic lupus erythematosus (n=4), Sjogren's syndrome (n=3), Sarcoidosis (n=2), Takayasu disease (n=1). All patients continued their treatment during and after vaccination. Nineteen patients were on biotherapies: Infliximab (n=12), Adalimumab (n=3), etanercept (n=2), Ustekinumab (n=1), tocilizimab (n=1). Forty-three patients were on conventional immunosuppressive: azathioprine (n=18), methotrexate (n=16), corticosteroids > 10 mg/d (n=12). All patients had received at least one dose of vaccine: the median number of doses in both groups was 2[1-4] with no statistically significant difference between the 2 groups (p=0.2). The vaccines received in the group of patients were mRNA vaccine (n=35) and other type of vaccine (n=28). In the healthy control group, type of vaccine were mRNA (n=13) other type vaccine (n=17). The patient had a lower mean level of Ig G against SARS-Cov2 antibodies (24.64 IU +/- 16.65) comparing to healthy controls (33.05+/- 10) with statically significant difference (p= 0.014). No difference between the 2 groups was noted in Ig G levels according to the history of SARS-Cov2 infection. No difference was found between conventional immunosuppressive drugs and biotherapies regarding to the level of antibodies.ConclusionOur study highlights that patients with autoimmune disease and under immunosuppressive therapy displayed a decrease of humoral response comparing to healthy controls. This finding was reported in several studies, Geisen et al[2] reported that patients with chronic inflammatory condition and receiving TNF alfa blockers had a decreased protection and a low level Ig A against spike. Based on these data, patients with autoimmune and inflammatory diseases have decreased humoral immunity to SARS-Cov2 and should be encouraged to receive a booster dose of SARS-COv2 vaccine.References[1]Prendecki M, Clarke C, Edwards H, et al. Humoral and T-cell responses to SARS-CoV-2 vaccination in patients receiving immunosuppression. Ann Rheum Dis 2021;80:1322–9. doi:10.1136/annrheumdis-2021-220626[2]Geisen UM, Sümbül M, Tran F, et al. Humoral protection to SARS-CoV2 declines faster in patients on TNF alpha blocking therapies. RMD Open 2021;7:e002008. doi:10.1136/rmdopen-2021-002008AcknowledgementsMrs Hajer Mediouni.Disclosure of InterestsNone Declared.
ABSTRACT
Cerebral venous sinus thrombosis (CVST) is a cerebrovascular condition due to the thrombosis of cerebral venous sinuses, leading to intracranial hemorrhage, increased intracranial pressure, focal deficit, seizure, toxic edema, encephalopathy, and death. The diagnosis and therapeutic approach of CVST remain challenging because of its highly nonspecific clinical presentation including headaches, seizures, focal neurologic deficits, and altered mental status, etc. Anticoagulation is the mainstay of CVST treatment and should be started as soon as the diagnosis is confirmed. Here, we present the case of a 34-year-old male construction worker who presented to the emergency department with a complaint of right chest wall pain and swelling. He was admitted to the hospital following a diagnosis of anterior chest wall abscess and mediastinitis. During hospitalization, his complete blood count revealed pancytopenia with blast cells, and bone marrow biopsy revealed 78.5% lymphoid blasts by aspirate differential count and hypercellular marrow (100%) with decreased hematopoiesis. He developed concurrent CVST and intracranial hemorrhage while receiving CALGB10403 (vincristine, daunorubicin, pegaspargase, prednisone) with intrathecal cytarabine induction chemotherapy for acute lymphoblastic leukemia (ALL). The patient failed two standard chemotherapy for ALL and achieved remission while on third-line chemotherapy with an anti-CD19 monoclonal antibody, blinatumomab. Although this patient had an MRI scan of the brain with multiple follow-up non-contrast CT scans, it was CT angiography that revealed CVST. This showed the diagnostic challenge in CVST, with CT and MRI venography having excellent sensitivity in diagnosing CVST. Risk factors for CVST in our patient were ALL and its intensive induction chemotherapy with pegaspargase.