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Background: Tixagevimab/cilgavimab (TGM/CGM) are neutralizing monoclonal antibodies (mAbs) directed against different epitopes of the receptor-binding domain of the SARS-CoV-2 spike protein that have been considered as pre-exposure prophylaxis (PrEP). Objectives: This study seeks to assess the efficacy and safety of TGM/CGM to prevent COVID-19 in patients at high risk for breakthrough and severe SARS-CoV-2 infection who never benefited maximally from SARS-CoV-2 vaccination and for those who have a contraindication to SARS-CoV-2 vaccines. Design: This study is a systematic review and meta-analysis. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was followed. Methods: Electronic databases (PubMed, CINAHL, Embase, medRxiv, ProQuest, Wiley online library, Medline, and Nature) were searched from 1 December 2021 to 30 November 2022 in the English language using the following keywords alone or in combination: 2019-nCoV, 2019 novel coronavirus, COVID-19, coronavirus disease 2019, SARS-CoV-2, severe acute respiratory syndrome coronavirus 2, tixagevimab, cilgavimab, combination, monoclonal, passive, immunization, antibody, efficacy, clinical trial, cohort, pre-exposure, prophylaxis, and prevention. We included studies in moderate to severe immunocompromised adults (aged ≥18 years) and children (aged ≥12 years) who cannot be vaccinated against COVID-19 or may have an inadequate response to SARS-CoV-2 vaccination. The effect sizes of the outcome of measures were pooled with 95% confidence intervals (CIs) and risk ratios (RRs). Results: Of the 76 papers that were identified, 30 articles were included in the qualitative analysis and 13 articles were included in the quantitative analysis (23 cohorts, 5 case series, 1 care report, and 1 randomized clinical trial). Studies involving 27,932 patients with high risk for breakthrough and severe COVID-19 that reported use of TGM/CGM combination were analyzed (all were adults (100%), 62.8% were men, and patients were mainly immunocompromised (66.6%)). The patients’ ages ranged from 19.7 years to 79.8 years across studies. TGM/CGM use was associated with lower COVID-19-related hospitalization rate (0.54% vs. 1.2%, p = 0.27), lower ICU admission rate (0.6% vs. 5.2%, p = 0.68), lower mortality rate (0.2% vs. 1.2%, p = 0.67), higher neutralization of COVID-19 Omicron variant rate (12.9% vs. 6%, p = 0.60), lower proportion of patients who needed oxygen therapy (8% vs. 41.2%, p = 0.27), lower RT-PCR SARS-CoV-2 positivity rate (2.1% vs. 5.8%, p < 0.01), lower proportion of patients who had severe COVID-19 (0% vs. 0.5%, p = 0.79), lower proportion of patients who had symptomatic COVID-19 (1.8% vs. 6%, p = 0.22), and higher adverse effects rate (11.1% vs. 10.7%, p = 0.0066) than no treatment or other alternative treatment in the prevention of COVID-19. Conclusion: For PrEP, TGM/CGM-based treatment can be associated with a better clinical outcome than no treatment or other alternative treatment. However, more randomized control trials are warranted to confirm our findings and investigate the efficacy and safety of TGM/CGM to prevent COVID-19 in patients at risk for breakthrough or severe SARS-CoV-2 infection.

Background: Extracorporeal membrane oxygenation (ECMO) has been used as a rescue strategy in patients with severe with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 infection, but there has been little evidence of its efficacy., Objectives: To describe the effect of ECMO rescue therapy on patient-important outcomes in patients with severe SARS-CoV-2., Methods: A case series study was conducted for the laboratory-confirmed SARS-CoV-2 patients who were admitted to the ICUs of 22 Saudi hospitals, between March 1, 2020, and October 30, 2020, by reviewing patient's medical records prospectively., Results: ECMO use was associated with higher in-hospital mortality (40.2% vs. 48.9%; p = 0.000); lower COVID-19 virological cure (41.3% vs 14.1%, p = 0.000); and longer hospitalization (20.2 days vs 29.1 days; p = 0.000), ICU stay (12.6 vs 26 days; p = 0.000) and mechanical ventilation use (14.2 days vs 22.4 days; p = 0.000) compared to non-ECMO group. Also, there was a high number of patients with septic shock (19.6%) and multiple organ failure (10.9%); and more complications occurred at any time during hospitalization [pneumothorax (5% vs 29.3%, p = 0.000), bleeding requiring blood transfusion (7.1% vs 38%, p = 0.000), pulmonary embolism (6.4% vs 15.2%, p = 0.016), and gastrointestinal bleeding (3.3% vs 8.7%, p = 0.017)] in the ECMO group. However, PaO 2 was significantly higher in the 72-h post-ECMO initiation group and PCO 2 was significantly lower in the 72-h post-ECMO start group than those in the 12-h pre-ECMO group (62.9 vs. 70 mmHg, p = 0.002 and 61.8 vs. 51 mmHg, p = 0.042, respectively)., Conclusion: Following the use of ECMO, the mortality rate of patients and length of ICU and hospital stay were not improved. However, these findings need to be carefully interpreted, as most of our cohort patients were relatively old and had multiple severe comorbidities. Future randomized trials, although challenging to conduct, are highly needed to confirm or dispute reported observations., (© 2021. The Author(s).)

Aims: The accuracy of transcatheter aortic valve replacement (TAVR) sizing using three-dimensional transoesophageal echocardiography (3D-TEE) compared with the gold-standard multi-slice computed tomography (MSCT) remains unclear. We compare aortic annulus measurements assessed using these two imaging modalities., Methods and Results: We performed a single-centre prospective cohort study, including 53 consecutive patients undergoing TAVR, who had both MSCT and 3D-TEE for aortic annulus sizing. Aortic annular dimensions, expected transcatheter heart valve (THV) oversizing, and hypothetical valve size selection based on CT and TEE were compared. 3D-TEE and CT cross-sectional mean diameter (r = 0.69), perimeter (r = 0.70), and area (r = 0.67) were moderately to highly correlated (all P-values <0.0001). 3D-TEE-derived measurements were significantly smaller compared with MSCT: perimeter (68.6 ± 5.9 vs. 75.1 ± 5.7 mm, respectively; P < 0.0001); area (345.6 ± 64.5 vs. 426.9 ± 68.9 mm(2), respectively; P < 0.0001). The percentage difference between 3D-TEE and MSCT measurements was around 9%. Agreement between MSCT- and 3D-TEE-based THV sizing (perimeter) occurred in 44% of patients. Using the 3D-TEE perimeter annular measurements, up to 50% of patients would have received an inappropriate valve size according to manufacturer-recommended, area-derived sizing algorithms., Conclusion: Aortic annulus measurements for pre-procedural TAVR assessment by 3D-TEE are significantly smaller than MSCT. In this study, such discrepancy would have resulted in up to 50% of all patients receiving the wrong THV size. 3D-TEE should be used for TAVR sizing, only when MSCT is not available or contraindicated. The clinical impact of this information requires further study., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: Since 30 years, we have attempted to repair gastroschisis as early as possible, often even in the delivery room. We examined 12 recent years of patient records to evaluate the effect of immediate repair and other factors on the outcome of gastroschisis., Methods: We reviewed the medical records of patients presenting with gastroschisis (87) at the Children's Hospital of Michigan between 1998 and 2009. Data were evaluated specifically to determine the effect of the place of repair [obstetric hospital ("DR") vs. children's hospital ("OR")], the time of repair [less than an hour after delivery ("IR") or more than one hour ("ER")], and the type of repair [primary fascial repair and skin closure ("PR") vs. staged repair ("SR")]., Results: Patients in the PR group were more likely to spend one week or less on MV (66% in PR vs. 11% in SR, p<0.01). Patients in the DR group were more likely to spend 2 weeks or less on TPN, as were patients in the PR group (51% in PR vs. 17% in SR, p<0.01). Patients in the PR group were more likely to stay in hospital for less than 3 weeks, but the IR and ER groups had almost same hospital stay. Major associated anomalies were present in 19 patients (29%). These patients and those with little or no peel tended to outperform those with peel in each of our outcome measures., Conclusion: Repair immediately after delivery is beneficial in terms of achieving primary closure of the defect, leading to shorter times on assisted ventilation and parenteral nutrition, and shorter hospital stays., (© Georg Thieme Verlag KG Stuttgart · New York.)

Gastroschisis and omphalocele are usually considered together since they are both congenital abdominal wall defects, and yet their anatomy, embryogenesis, and clinical presentation and problems are quite different. In addition, it appears that the risk factors for their occurrence differ. Etiologic factors contributing to the development of these defects are unknown. To investigate this we have reviewed reports of risk factors for each anomaly and report them here. We conducted a literature search using PubMed (http://www.ncbi.nlm.nih.gov/pubmed/) for risk factors implicated in the development of gastroschisis and omphalocele. The data reviewed here from clinical studies in the literature, closely parallels the data in animal studies which we reported earlier. There is little evidence for a genetic cause in the development of gastroschisis and much evidence supporting the possibility that environmental teratogens are important contributors to the development of this defect. On the other hand, in the case of omphalocele, there was little evidence for environmental factors and substantial data indicating that genetic or familial factors may play an important role.

Aim: To evaluate the yield of brushing biliary strictures and the factors associated with a positive result in biliary strictures., Methods: Data on all consecutive patients (01/02-10/05) who were identified to have a biliary stricture and who underwent biliary brush cytology were collected. The yield of positive biliary brush cytology was evaluated and compared to results with the gold standard for diagnosis (defined as either definitive surgical histology or clinical course). Additionally, associated factors of positive results including stricture location, gender, age, mass size, length of stricture, and dilatation prior to brushing cytology were assessed., Results: From 199 patients who had brushing cytology samples (10 patients were excluded due to lack of gold standard diagnosis), 77 patients had positive brushing cytology (yield 41%). Variables associated with positive cytology brushing on initial endoscopic retrograde cholangiography were age 1.02 (1.00-1.05), mass size>1 cm 2.22 (1.01-4.89) and length of stricture>1 cm 3.49 (1.18-10.2). The sensitivity of biliary brushing was 61%, its specificity 98%, the positive predictive value reached 99%, and the negative predictive value was 57%., Conclusion: Our results revealed a 41% positive yield from brushing cytology. The sensitivity of biliary brushing cytology in our center was 61% and the specificity was 98%. Predictors of positive yield include older age, mass size>1 cm, and stricture length of >1 cm.

Background: Every centre has contraindications to liver transplantation and declares patients unsuitable for medical or nonmedical reasons. To date, there has been no published review of any centre's experience., Methods: A retrospective chart review was completed from 1997 to 2001, inclusive of all patients referred for liver transplant to the British Columbia Transplant Society who were declared unsuitable for transplantation, as well as the reasons for unsuitability., Results: One hundred fifty patients were considered to be unsuitable for transplantation. During this period, 167 transplants were performed and 737 patients were referred for candidacy. Data were missing on three patients; analysis was performed on the remaining 147. Patients' ages ranged from 15 to 72 years, and 33.3% were female. The most common primary liver disease was hepatitis C (n=53, 35%), followed by alcoholic liver disease (n=35, 24%) and autoimmune liver diseases (n=23, 16%). Medical contraindications constituted 74 patients (49.0%) and the most common reasons for unsuitability were no need of a liver transplant (29 patients [39%]), exclusion due to hepatoma or extrahepatic malignancy (20 patients [27%]) and multisystem failure (12 patients [16%]). Nonmedical contraindications constituted 73 patients. Failure to meet minimal alcohol criteria comprised the largest group (n=39, 53.4%) followed by inadequate social support (n=12, 16.4%), failure to follow up medical assessment (n=10, 13.7%) and drug abuse (n=6, 8.2%)., Conclusions: Although many patients were declined for transplantation, the proportion is relatively small compared with the number of referred patients. Nonmedical reasons, including failure to meet alcohol criteria and lack of social support, remain a significant reason for unsuitability in British Columbia. Community intervention before transplant referral is recommended.