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Background: In patients with COVID-19, lung ultrasound can assess possible lung involvement. The examination is quick, performed at bedside and has a low risk of virus transmission. The aim of this study was evalute if lung ultrasound can predict the need for mechanical ventilation, admission to an intensive care unit, high-flow oxygen treatment, death of COVID-19. Method(s): A multicenter prospective cohort trial was performed during the first wave of the COVID-19 pandemic in Denmark. Film clips from focused lung ultrasound examinations were recorded and rated by blinded observers using different scoring systems. Result(s): A total of 3,889 film clips of 398 patients were analyzed. Patients who died of COVID-19 after receiving intensive care treatment, mechanical ventilation or high-flow oxygen supplement had a significantly higher ultrasound score than those who survived or did not need these treatments. Multivariable logistic regression analyses showed that lung ultrasound predicts mechanical ventilation (RR 2.44, 95% CI 1.32 - 5.52), admission to intensive care (RR 2.55, 95% CI 1.41 - 54.59) and high-flow oxygen treatment (RR 1.95, 95% CI 1.5 - 2.53) when adjusting for sex, age and relevant comorbidity. There was no diagnostic difference between a scoring system using only anterolateral thorax zones and a scoring system that also included dorsal zones. Interpretation(s): Focused lung ultrasound in patients with clinical suspicion of COVID-19 predicts respiratory failure requiring mechanical ventilation, admission to intensive care units and high-flow oxygen. Thus, focused lung ultrasound may be used to risk stratify patients with COVID-19 symptom.
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Background: Covid 19 infection associated glomerulopathy has most often been described as collapsing FSGS and occurs almost exclusively in black patients carrying APOL1 risk genotypes. Methods: We report an acute, COVID19-associated nephrotic glome-rulonephritis in a caucasian transplant recipient which led to terminal graft failure. Results: This 67 y old white female had received a living donor kidney 31 years ago for medullary cystic disease. Her clinical course on cyclos-porin/MMF had been stable with an eGFR around 20 ml/min/1.73 m in the last years. On her 31st annual checkup, she presented with an unusually high blood pressure (171/108), but afebrile (36.9°C), with an eGFR or 21 ml/min/1.73 m, a protein/creatinine ratio (PCR) of 503 mg/mmol and normal serum albumin. Physical examination was unremarkable except for some pain from thoracic herpes zoster 2 months previously. Her husband had tested positive for Covid19 on the same morning. She developed fever (38.9 °C) and cough on the same evening and tested positive for Covid19 the next day. MMF was paused and low dose steroids were instituted. In the following weeks, full nephrotic syndrome developed (edema, PCR of 1350 mg/mmol, serum albumin ↓ to 28 g/l). eGFR decreased to 8-10 ml/min/1.73 m. Renal biopsy on day 42 showed several instances of focal segmental sclerosis with collapsing morphology (Figure 1, consistent with "collapsing glomerulopathy"). In addition there were signs of capsular proliferation and electron dense deposits in the GBM, consistent with glome-rulonephritis. Sequencing of Exon 6 of the APOL1 gene was negative for G1 and G2 risk alleles in the patient and her kidney donor. Nephrotic syndrome never remitted, and renal function did not recover. Peritoneal dialysis was initiated 9 months after the Covid 19 infection. Figure 2: Self-rated health status over time Conclusions: Higher mortality in older recipients complies with data from the general population. The non-linear relationship between age and graft loss and the higher scored self-rated health status at all follow-up time-points compared to the pre-transplant status-regardless of age-highlight that age alone might not be an accurate measure for risk prediction and clinical decision making in kidney transplantation. Exploring other independent predictors, such as frailty as an indicator for biological age should be considered. Conclusions: This case documents an unusal Covid19-associated glo-merulonephritis with "collapsing features" which led to the loss of a 31 years functioning living donor kidney.
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INTRODUCTION: Tools to quickly triage and evaluate patients with suspected COVID-19 in an emergency department (ED) can improve patient care and reduce risk of overcrowding. The aim of this study was to evaluate if lung ultrasound (LUS) may provide valuable prognostic information in adult patients suspected of COVID-19. METHODS: A prospective cohort study of adult patients in an ED was conducted. LUS was performed within one hour of the patients' arrival;COVID-19 was defined by a respiratory syndrome coronavirus 2 RNA positive test. The primary outcome was the proportion of patients suspected of COVID-19 and normal LUS with critical outcomes during follow-up, defined as one or more of the following: need of non-invasive ventilation (NIV), invasive mechanical ventilation, intensive care unit (ICU) stay or death. Follow-up was 14 days. RESULTS: A total of 83 patients were included between 9 March and 12 April 2020. In all, 47 (57%;95% confidence interval (CI): 45.3-67.5%) had a normal LUS, 46 (98%;95% CI: 88.7-99.9%) of whom had no critical outcomes. A total of 36 (43%;95% CI: 32.5-54.7%) had an abnormal LUS, eight of whom (22%;95% CI: 10.1-39.2%) had critical outcomes. Nine (11%;95%: CI 5.1-19.6%) had one or more critical outcomes: three on NIV, five in ICUs, four on invasive mechanical ventilation and two died. Among the 12 patients (14%;95% CI: 7.7-23.9%) tested positive for COVID-19, 11 (92%;95% CI: 61.5-99.8%) had an abnormal LUS. CONCLUSIONS: Among adult ED patients suspected of COVID-19, a normal LUS is associated with a low risk of critical outcomes. LUS might be considered for routine use as a prognostic tool in patients suspected of COVID-19.none. TRIAL REGISTRATION: not relevant. Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
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The European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples. © 2020 by Walter de Gruyter Berlin/Boston 2020.