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Improved outcome of COVID-19 over time in patients treated with CAR T-cell therapy: Update of the European COVID-19 multicenter study on behalf of the European Society for Blood and Marrow Transplantation (EBMT) Infectious Diseases Working Party (IDWP) and the European Hematology Association (EHA) Lymphoma Group.
No full textCOVID-19 has been associated with high mortality in patients treated with Chimeric Antigen Receptor (CAR) T-cell therapy for hematologic malignancies. Here, we investigated whether the outcome has improved over time with the primary objective of assessing COVID-19-attributable mortality in the Omicron period of 2022 compared to previous years. Data for this multicenter study were collected using the MED-A and COVID-19 report forms developed by the EBMT. One-hundred-eighty patients were included in the analysis, 39 diagnosed in 2020, 35 in 2021 and 106 in 2022. The median age was 58.9 years (min-max: 5.2-78.4). There was a successive decrease in COVID-19-related mortality over time (2020: 43.6%, 2021: 22.9%, 2022: 7.5%) and in multivariate analysis year of infection was the strongest predictor of survival (p = 0.0001). Comparing 2022 with 2020-2021, significantly fewer patients had lower respiratory symptoms (21.7% vs 37.8%, p = 0.01), needed oxygen support (25.5% vs 43.2%, p = 0.01), or were admitted to ICU (5.7% vs 33.8%, p = 0.0001). Although COVID-19-related mortality has decreased over time, CAR T-cell recipients remain at higher risk for complications than the general population. Consequently, vigilant monitoring for COVID-19 in patients undergoing B-cell-targeting CAR T-cell treatment is continuously recommended ensuring optimal prevention of infection and advanced state-of-the art treatment when needed
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure.
No full text20.500.12530/87909Hypertonic saline solution (HSS) plus intravenous (IV) loop diuretic appears to enhance the diuretic response in patients hospitalized for heart failure (HF). The efficacy and safety of this therapy in the ambulatory setting have not been evaluated. We aimed to describe the design and baseline characteristics of the SALT-HF trial participants. 'Efficacy of Saline Hypertonic Therapy in Ambulatory Patients with HF' (SALT-HF) trial was a multicenter, double-blinded, and randomized study involving ambulatory patients who experienced worsening heart failure (WHF) without criteria for hospitalization. Enrolled patients had to present at least two signs of volume overload, use ≥ 80 mg of oral furosemide daily, and have elevated natriuretic peptides. Patients were randomized 1:1 to treatment with a 1-h infusion of IV furosemide plus HSS (2.6-3.4% NaCl depending on plasmatic sodium levels) versus a 1-h infusion of IV furosemide at the same dose (125-250 mg, depending on basal loop diuretic dose). Clinical, laboratory, and imaging parameters were collected at baseline and after 7 days, and a telephone visit was planned after 30 days. The primary endpoint was 3-h diuresis after treatment started. Secondary endpoints included (a) 7-day changes in congestion data, (b) 7-day changes in kidney function and electrolytes, (c) 30-day clinical events (need of IV diuretic, HF hospitalization, cardiovascular mortality, all-cause mortality or HF-hospitalization). A total of 167 participants [median age, 81 years; interquartile range (IQR), 73-87, 30.5% females] were randomized across 13 sites between December 2020 and March 2023. Half of the participants (n = 82) had an ejection fraction >50%. Most patients showed a high burden of comorbidities, with a median Charlson index of 3 (IQR: 2-4). Common co-morbidities included diabetes mellitus (41%, n = 69), atrial fibrillation (80%, n = 134), and chronic kidney disease (64%, n = 107). Patients exhibited a poor functional NYHA class (69% presenting NYHA III) and several signs of congestion. The mean composite congestion score was 4.3 (standard deviation: 1.7). Ninety per cent of the patients (n = 151) presented oedema and jugular engorgement, and 71% (n = 118) showed lung B lines assessed by ultrasound. Median inferior vena cava diameter was 23 mm, (IQR: 21-25), and plasmatic levels of N-terminal-pro-B-type natriuretic peptide (NTproBNP) and antigen carbohydrate 125 (CA125) were increased (median NT-proBNP 4969 pg/mL, IQR: 2508-9328; median CA125 46 U/L, IQR: 20-114). SALT-HF trial randomized 167 ambulatory patients with WHF and will determine whether an infusion of hypertonic saline therapy plus furosemide increases diuresis and improves decongestion compared to equivalent furosemide administration alone
Factores asociados a las recidivas de las úlceras venosas: estudio observacional.
No full text20.500.12530/8785
Proportionate arthroscopic discopexy (PAD): a new therapeutic approach based on the arthroscopic roofing percentage.
No full textLenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study.
No full text20.500.12530/87854Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We present the final prespecified overall survival (OS) analysis of the open-label, phase III CLEAR study in treatment-naïve patients with advanced renal cell carcinoma (aRCC). With an additional follow-up of 23 months from the primary analysis, we report results from the lenvatinib plus pembrolizumab versus sunitinib comparison of CLEAR. Treatment-naïve patients with aRCC were randomly assigned to receive lenvatinib (20 mg orally once daily in 21-day cycles) plus pembrolizumab (200 mg intravenously once every 3 weeks) or sunitinib (50 mg orally once daily [4 weeks on/2 weeks off]). At this data cutoff date (July 31, 2022), the OS hazard ratio (HR) was 0.79 (95% CI, 0.63 to 0.99). The median OS (95% CI) was 53.7 months (95% CI, 48.7 to not estimable [NE]) with lenvatinib plus pembrolizumab versus 54.3 months (95% CI, 40.9 to NE) with sunitinib; 36-month OS rates (95% CI) were 66.4% (95% CI, 61.1 to 71.2) and 60.2% (95% CI, 54.6 to 65.2), respectively. The median progression-free survival (95% CI) was 23.9 months (95% CI, 20.8 to 27.7) with lenvatinib plus pembrolizumab and 9.2 months (95% CI, 6.0 to 11.0) with sunitinib (HR, 0.47 [95% CI, 0.38 to 0.57]). Objective response rate also favored the combination over sunitinib (71.3% v 36.7%; relative risk 1.94 [95% CI, 1.67 to 2.26]). Treatment-emergent adverse events occurred in >90% of patients who received either treatment. In conclusion, lenvatinib plus pembrolizumab achieved consistent, durable benefit with a manageable safety profile in treatment-naïve patients with aRCC
Shift from Widespread to Tailored Antifungal Prophylaxis in Lymphoma Patients Treated with CD19 CAR T Cell Therapy: Results from a Large Retrospective Cohort.
No full text20.500.12530/87854Patients undergoing CD19 chimeric antigen receptor (CAR)-T cell therapy exhibit multiple immune deficits that may increase their susceptibility to infections. Invasive fungal infections (IFIs) are life-threatening events in the setting of hematologic diseases. However, there is ongoing debate regarding the optimal role and duration of antifungal prophylaxis in this specific patient population. The objective of this study was to provide a comprehensive overview of the evolution of IFI prophylactic strategies over time and to assess IFI incidence rates in a cohort of patients with relapsed or refractory (R/R) lymphoma treated with CAR-T cell therapy. A single-center retrospective study was conducted on a cohort of patients with R/R B cell lymphoma treated with CD19 CAR-T cell therapy between April 2016 and March 2023. Group A (April 2016-August 2020) consisted of patients primarily treated with fluconazole, irrespective of their individual IFI risk profile. In Group B (September 2020-March 2023) antifungal prophylaxis was recommended only for high-risk patients. Overall, 330 patients were included. Antifungal prophylaxis was prescribed to 119/142 (84%) patients in Group A and 58/188 (31%) in Group B (
Hybrid deep learning models for the screening of Diabetic Macular Edema in optical coherence tomography volumes.
No full textSeveral studies published so far used highly selective image datasets from unclear sources to train computer vision models and that may lead to overestimated results, while those studies conducted in real-life remain scarce. To avoid image selection bias, we stacked convolutional and recurrent neural networks (CNN-RNN) to analyze complete optical coherence tomography (OCT) cubes in a row and predict diabetic macular edema (DME), in a real-world diabetic retinopathy screening program. A retrospective cohort study was carried out. Throughout 4-years, 5314 OCT cubes from 4408 subjects who attended to the diabetic retinopathy (DR) screening program were included. We arranged twenty-two (22) pre-trained CNNs in parallel with a bidirectional RNN layer stacked at the bottom, allowing the model to make a prediction for the whole OCT cube. The staff of retina experts built a ground truth of DME later used to train a set of these CNN-RNN models with different configurations. For each trained CNN-RNN model, we performed threshold tuning to find the optimal cut-off point for binary classification of DME. Finally, the best models were selected according to sensitivity, specificity, and area under the receiver operating characteristics curve (AUROC) with their 95% confidence intervals (95%CI). An ensemble of the best models was also explored. 5188 cubes were non-DME and 126 were DME. Three models achieved an AUROC of 0.94. Among these, sensitivity, and specificity (95%CI) ranged from 84.1-90.5 and 89.7-93.3, respectively, at threshold 1, from 89.7-92.1 and 80-83.1 at threshold 2, and from 80.2-81 and 93.8-97, at threshold 3. The ensemble model improved these results, and lower specificity was observed among subjects with sight-threatening DR. Analysis by age, gender, or grade of DME did not vary the performance of the models. CNN-RNN models showed high diagnostic accuracy for detecting DME in a real-world setting. This engine allowed us to detect extra-foveal DMEs commonly overlooked in other studies, and showed potential for application as the first filter of non-referable patients in an outpatient center within a population-based DR screening program, otherwise ended up in specialized care
Persistent Symptoms (Lasting Longer than 1 Year) in Children Hospitalized with Acute COVID-19 Versus Other Conditions.
No full text20.500.12530/87912Background: We evaluated the prevalence and characteristics of persistent signs and/or symptoms in children and young people (CYP) one year after hospitalization for acute COVID-19 compared with a control group of CYP hospitalized for other conditions. Methods: We conducted an observational study in three hospitals in Madrid, which included a group of children aged between 1 month and 18 years who were hospitalized due to acute COVID-19 from March 2020 to December 2021. We also selected a comparison group of patients hospitalized for other, unrelated conditions within the same month. Eligible participants had no history of COVID-19 at recruitment or during follow-up. Data were collected from clinical records and a standardized questionnaire completed by the patients' families. The primary outcome was the presence of persistent symptoms one year after hospitalization. Results: A total of 96 patients were enrolled and analyzed (50 acute COVID-19 patients and 46 non-COVID-19 participants). Of these, 34/96 (35%) met the criteria for persistent symptoms (CYP: 17/50 (34%) COVID-19 participants and 17/46 (37%) non-COVID-19 participants (p = 0.767)). Symptoms persisted ≥12 months in 14/50 (28%) COVID-19 participants and in 7/46 (15%) non-COVID-19 participants (p = 0.140). Both before and after admission, all of the participants provided similar ratings for all of the specific items related to emotional welfare, social relationships, and current activities. Readmissions occurred in 11/50 (22%) COVID-19 participants and in 6/46 (13%) non-COVID-19 participants (p = 0.267). Conclusions: We identified a non-significant difference in the prevalence of persistent symptoms 1 year after hospitalization between children and young people (CYP) with acute COVID-19 and those hospitalized for non-COVID-19-related conditions
Practical tool to identify Spasticity-Plus Syndrome amongst patients with multiple sclerosis. Algorithm development based on a conjoint analysis.
No full text20.500.12530/87854The Spasticity-Plus Syndrome (SPS) in multiple sclerosis (MS) refers to a combination of spasticity and other signs/symptoms such as spasms, cramps, bladder dysfunction, tremor, sleep disorder, pain, and fatigue. The main purpose is to develop a user-friendly tool that could help neurologists to detect SPS in MS patients as soon as possible. A survey research based on a conjoint analysis approach was used. An orthogonal factorial design was employed to form 12 patient profiles combining, at random, the eight principal SPS signs/symptoms. Expert neurologists evaluated in a survey and a logistic regression model determined the weight of each SPS sign/symptom, classifying profiles as SPS or not. 72 neurologists participated in the survey answering the conjoint exercise. Logistic regression results of the survey showed the relative contribution of each sign/symptom to the classification as SPS. Spasticity was the most influential sign, followed by spasms, tremor, cramps, and bladder dysfunction. The goodness of fit of the model was appropriate (AUC = 0.816). Concordance between the experts' evaluation vs. model estimation showed strong Pearson's (r = 0.936) and Spearman's (r = 0.893) correlation coefficients. The application of the algorithm provides with a probability of showing SPS and the following ranges are proposed to interpret the results: high (> 60%), moderate (30-60%), or low ( 60%), moderate (30-60%), or low ( This study offers an algorithmic tool to help healthcare professionals to identify SPS in MS patients. The use of this tool could simplify the management of SPS, reducing side effects related with polypharmacotherapy
A new mutation in the Parkinson's-related FBXO7 gene impairs mitochondrial and proteasomal function.
No full text20.500.12530/87854Around 10% of Parkinson's disease (PD) cases are associated with mutations in various genes, including FBXO7, which encodes the substrate-recognition component for the Skp1-Cullin-F-box (SCF) class of ubiquitin E3 ligases that target proteins for proteasomal degradation. In their recent study, Al Rawi et al. characterized a new mutation in FBXO7, L250P, in a pediatric patient. Their findings reveal that the L250P mutation abolishes Fbxo7 interaction with the proteasome regulator, proteasome inhibitor 31kD (PI31), affecting proteasomal activity and the ubiquitination of some of the ligase's targets. Furthermore, the authors show that this previously undescribed mutation impairs mitochondrial function and mitophagy, emphasizing the importance of mitochondrial and proteasomal dysfunction in PD pathogenesis