Single-center Retrospective Cohort Study Research Articles

Effectiveness of azvudine against severe outcomes among hospitalized COVID-19 patients in Xinjiang, China: a single-center, retrospective, matched cohort study

ABSTRACT Background Since the end of 2022, Azvudine was widely used to treat hospitalized novel coronavirus disease 2019 (COVID-19) patients in China. However, data on the clinical effectiveness of Azvudine against severe outcomes and post-COVID-19-conditions (PCC) among patients infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variants was limited. This study evaluates the effectiveness of Azvudine in hospitalized COVID-19 patients during a SARS-CoV-2 Omicron BA.5 dominance period. Methods From 1 November 2022 to 1 July 2023, we conducted a single-center retrospective cohort study based on hospitalized COVID-19 patients from a tertiary hospital in Shihezi, China, recruiting laboratory-confirmed hospitalized patients with SARS-CoV-2 infection. Patients treated with Azvudine and usual care were propensity-score matched (PSM) at a 1:1 ratio to a control group in which patients undergone usual care only, with matching based on covariates such as sex, age, ethnicity, number of preexisting conditions, antibiotic use upon admission, and complete blood cell count. The primary outcomes were all-cause death and PCC at short-term (60 days) post discharge. The secondary outcomes included the initiation of invasive mechanical ventilation and PCC at long-term post discharge (120 days). Cox proportional hazards (PH) regression models were employed to estimate the hazard ratios (HR) for both all-cause death and invasive mechanical ventilation, and logistic regression models were used to estimate the odds ratios (OR) for short-term and long-term PCC. Subgroup analyses were performed based on the matched covariates. Results A total of 2,639 hospitalized patients diagnosed with COVID-19 were initially identified, and 2,069 patients were screened following the exclusion criteria. After matching, 297 Azvudine recipients and 297 matched controls were eligible for analyses. The incidence rate of all-cause death was lower in the Azvudine group than in the control group (0.007 per person, 95% confidence interval [CI]: 0.001, 0.024 vs 0.128, 95% CI: 0.092, 0.171), and the use of Azvudine was associated with a significant lower risk of death and the use of Azvudine was associated with a reduced risk of death (HR: 0.049, 95% CI: 0.012, 0.205). Subgroup analyses indicated a significant effectiveness of Azvudine against the risk of all-cause death among men, age over 65, patients without the preexisting conditions, and patients with antibiotics dispensed at admission. Statistical difference were not observed between Azvudine group and control group in the invasive mechanical ventilation and short-term and long-term PCC. Conclusions The present findings indicate that receipt of Azvudine was associated with lower risk of all-cause death among hospitalized patients with Omicron BA.5 infection a in real-world setting. Further research is urgently needed to validate the effectiveness of Azvudine on the PCC.

Oncological Outcomes of Transoral Laser Microsurgery for Early Stage Glottic Cancer with Involvement of the Anterior Commissure.

To assess the value of carbon dioxide transoral laser microsurgery (CO2 TOLMS) for early-stage glottic cancer with special regard to involvement of the anterior commissure (AC). Single-center retrospective cohort study. Grade-A tertiary hospital. A retrospective analysis of patients with early-stage (Tis-T2) glottic cancer who underwent CO2 TOLMS. All patients had at least 2 years of follow-up. The univariate and multivariate survival analyses were used to identify the risk factors for recurrence and the Kaplan-Meier method was used to analyze OS and DSS rates. A total of 102 patients were included in the study. Eleven patients (10.78%) had recurrence. The univariate analysis showed that the recurrence was associated with the AC classification, T staging, tumor size, and tobacco use (P < .05). However, on multivariate analysis, the AC classification was the only independent risk factor for recurrence (P < .001, HR = 3.179). AC classification were distributed as follows: 59 (57.84%) AC0, 29 (28.43%) AC1, 8 (7.84%) AC2, and 6 (5.88%) AC3, 2-year/5-year OS and DSS rates were progressively reduced in the AC0, AC1, AC2, and AC3 groups (P < .001). At the same T staging, the OS rates incrementally decreased as the level of involvement of the AC became higher (P = .004). CO2 TOLMS is an effective treatment for early-stage glottic cancer. AC involvement is an independent risk factors for recurrence and poor prognosis. The AC classification system may be better at grading the prognosis of patients with early-stage glottic cancer and has prognostic value independent of T staging.

КЛИНИЧЕСКОЕ ЗНАЧЕНИЕ РЕАКТИВАЦИИ ГЕРПЕСВИРУСНЫХ ИНФЕКЦИЙ У ДЕТЕЙ С ОНКОЛОГИЧЕСКИМИ ЗАБОЛЕВАНИЯМИ

Herpesvirus infection (HVI) reactivation in children with cancer is a common complication during the period of postcytostatic immunosuppression and occurs mostly after courses of high-dose chemotherapy (HDCT) with hematopoietic stem cell transplantation (HSCT). Clinical manifestations can range from asymptomatic viral reactivation and chemo-induced cytopenia worsening to fatal outcomes of the disease coupled with multiorgan involvement. The purpose of the research was to analyze cases of HVI reactivation in oncological pediatric patients in order to identify the risk factors for HVI development, features of its clinical manifestations and the effectiveness of antiviral therapy. Materials and methods used: a single-center retrospective cohort study was provided. The register of HVI reactivation cases in patients receiving antitumor therapy at the V.A. Almazov National Medical Research Centre of the Ministry of Healthcare of Russia (Saint Petersburg, Russia) in Jan. 2017-Jul. 2021 was analyzed. Routine monitoring of HVI reactivation (CMV, HHV-6A/B, EBV) included determination of viral DNA in patients’ biological materials by PCR using the AmpliSens test system on a Rotor-Gene device (amplifier). Results: 40 cases of HVI reactivation were registered, 22 (55%) were associated with cytomegalovirus infection (CMV), 4 (10%) with human herpes virus 6 (HHV-6A/B), 3 (7.5%) with Epstein-Barr virus (EBV) and 11 (27.5%) mixed. DNAemia was registered in 55%, organ damage in 45%. More often, reactivation of HVI developed after allogeneic HSCT (alloHSCT) (42,5%), autologous HSCT (autoHSCT) (40%). A statistically significant decrease of HVI reactivation cases was observed in patients after alloHSCT without TCRaβ depletion (53% v. 5,5%, p=0.036). Antiviral therapy was carried out in all patients. The first-line drug most often was ganciclovir (60%). Second line antiviral therapy was required in 10% of cases and those were the only CMV infection cases. Conclusion: a statistically significant decrease of HVI reactivation cases was observed in patients without TCRaβ depletion in alloHSCT. The clinical signs usually are not specific and require routine laboratory monitoring. Adequate antiviral therapy allowed achieving infectious control over HVI in most of the cases.

СРАВНИТЕЛЬНЫЙ АНАЛИЗ РАННЕГО И ПОЗДНЕГО НАЗНАЧЕНИЯ БИОАНАЛОГА РИТУКСИМАБА BCD020 ПРИ СИСТЕМНОЙ КРАСНОЙ ВОЛЧАНКЕ У ДЕТЕЙ: РЕЗУЛЬТАТЫ ОДНОЦЕНТРОВОГО РЕТРОСПЕКТИВНОГО КОГОРТНОГО ИССЛЕДОВАНИЯ

Juvenile systemic lupus erythematosus (jSLE) is a severe life-threatening disease with an immunoinflammatory pathogenesis and possible involvement of several organs or organ systems, both sequentially and simultaneously. Early initiation of biological therapy may improve disease outcomes. The purpose of this research was to evaluate the benefits of early initiation of genetically engineered biological therapy for jSLE with the Rituximab biosimilar BCD020. Materials and methods used: a single-center retrospective cohort study performed at the Saint Petersburg State Pediatric Medical University (Saint Petersburg, Russia) in 2012-2022 that included information on 36 patients with early Rituximab prescription (ERP; within less than 6 months from the jSLE diagnosis) and late Rituximab prescription (LRP; after over one year). The main characteristics of the disease were compared at the onset, at the time of initiation of Rituximab therapy and at 12 months after that. Results: the main baseline differences between the groups were statistically significantly higher disease activity according to the SLEDAI scale (p=0.003) and a higher incidence of macrophage activation syndrome (p=0.096), a higher average daily dose of glucocorticosteroids (GCS) in the ERP group (p=0.027). At the end of the study there were no statistically significant differences in the main outcomes of SLE between the compared groups. The main advantages of ERP were a statistically significantly shorter time to achieve a low daily dose of GCS (&lt;0.2 mg/kg) - 1.2 (0.9; 1.4) years compared to 2.8 (2.3; 4 .0) years (p&lt;0.001) and a higher likelihood of achieving a low dose of corticosteroids (RR=57.8 [95% CI: 7.2; 463.2], p&lt;0.001) and achieving remission (SLEDAI=0); RR=37.6 [95% CI: 4.45; 333.3], p&lt;0.001). During the research there were no statistically significant differences in the incidence of adverse events, including severe adverse events, between the compared groups of patients. Conclusion: ERP makes it possible to improve the control over the activity of jSLE and minimize the volume of GCS drugs with similar treatment outcomes and safety profile. Further research is required in order to determine the indications for biological therapy for jSLE.

ОЦЕНКА БЕЗОПАСНОСТИ И ЭФФЕКТИВНОСТИ МЕТОДИКИ МОБИЛИЗАЦИИ И СБОРА ГЕМОПОЭТИЧЕСКИХ СТВОЛОВЫХ КЛЕТОК У ДЕТЕЙ РАЗНЫХ ВОЗРАСТНЫХ ГРУПП СО ЗЛОКАЧЕСТВЕННЫМИ НОВООБРАЗОВАНИЯМИ: ОПЫТ ОДНОГО ЦЕНТРА

High dose chemotherapy (HDCT) with autologous hematopoietic stem cell transplantation (auto-HSCT) is used currently as a consolidating stage in cancer treatment protocols for children from different age groups with various malignant neoplasms. Auto-HSCT can improve both progression-free survival and overall survival of such patients. At the same time the optimization of the collection of autologous hematopoietic stem cells (HSCs) seems to be an important factor in the successful implementation of auto-HSCT. The purpose of this research was to evaluate the safety and effectiveness of the HSCs mobilization and collection method in children from different age groups with various malignancies. Materials and methods used: a single-center retrospective cohort study of 258 pediatric patients (median body weight 20.0 [13.8; 42.0] (7.0-95.0) kg and median height 116 [97; 155] (55.0-189) cm) with various cancers aged 1 to 18 y/o (median 78.0 [36; 144] (3-215) months old) who received treatment in Jan. 2020-Jan. 2023 at the Research Institute of Pediatric Oncology and Hematology named after Academician L.A. Durnov with the N.N. Blokhin Russian Cancer Research Center (Moscow, Russia). Patients were divided into 3 age groups: younger than 1 y/o, 1 to 10 y/o and 11 to 18 y/o. Results: 242 (93.8%) of HSC apheresis procedures were successful on the first attempt, 16 patients underwent repeated apheresis (a total of 274 procedures were performed). The median number of CD34+ cells obtained was 110.95 [45.6; 276.4] (0.70-2338.2) cells/µl, median apheresis duration was 253.5 [189; 338] (82-575) min. No serious complications were observed during the HSCs mobilization and collection in any patient. None of the patients developed hemodynamic disturbances. The main criteria for effectiveness was the CD34+/kg level, the median of which was 5.1 [2.4; 12.7] (0.01-95.6)•106. One of the safety criteria for the patients from all the three age groups was the absence of hemodynamic disorders and citrate reactions in the form of numbness, cyanosis of the skin and respiratory disorders. Another important safety criteria were the absence of a significant decrease in both platelet and hemoglobin levels. The median platelet levels prior to the procedure was 125.5 [68; 210] (14.0-815)•109/l and 129 [73; 210] (17.0-823)•109/l at the end of the procedure (p&lt;0.001). Hemoglobin levels before and after the procedure were 100 [94; 110] (75-242) g/l and 99 [93; 109] (70-142) g/l, respectively (p&lt;0.001). Considering it safe to reduce hemoglobin (g/l) and/or platelets (•109/l) by no more than 10 units in each measurement, in 87.6±4.1% (83.0-91.1) of observed cases the procedure was safe without statistically significant differences in all age groups. The effectiveness of the HSCs mobilization and collection method proposed by the Authors in children of the older age group (11 to 18 y/o) was the lowest and was statistically significantly different from the effectiveness in the group of children aged 1 to 10 y/o (p&lt;0.001) with cancer and amounted to 84.5±4.4% (79.6-88.4). Conclusion: with the multidisciplinary team of practitioners, HSC apheresis in children is a safe and effective technique used as part of the complex cancer treatment in patients from poor prognosis groups. The apheresis algorithm that the Authors have proposed allows high-quality collection of CD34+ positive cells in amounts sufficient for further auto-HSCT.

Pregnancy Outcomes After Bariatric Surgery: Importance of Maternal Ferritin on Birth Weight.

The risks carried by pregnancy after bariatric surgery (BS) include small-for-gestational age (SGA) newborn and prematurity. However, the underlying mechanisms are not yet fully understood in pregnant women after BS. This single-center retrospective observational cohort study includes all women with a first and single pregnancy after BS who completed at least one clinical and biological nutritional assessment during pregnancy between 2010 and 2016. The quarterly biological assessment comprised blood count, ferritin, calcium, 25OH vitamin D, parathyroid hormone, fasting glucose, albumin, prealbumin, vitamin A, vitamin B12, folic acid, and zinc. Among 120 pregnancies analysed, two-thirds underwent gastric bypass (Roux-en-Y and one-anastomosis) and one-third a restrictive procedure (adjustable gastric band or sleeve gastrectomy). The median [Q1-Q3] preoperative BMI was 43.8 [41.1-47.7] kg/m2 and the mean age at pregnancy was 32.6 ± 5.3years. Weight loss and time from surgery to pregnancy were 35.1 ± 15.4kg and 2.9 [1.3-4.5] years, respectively. Ten women (8%) gave birth prematurely, and 22 newborns (19%) were SGA. Univariate analysis shows that ferritin was significantly higher in mothers with SGA than in those without SGA (35.5 [22.3-69.5] vs. 15 [10-32] ng/ml) at third trimester of pregnancy. Women who received pre-pregnancy nutritional assessment seemed less likely to give birth to a SGA newborn (32% vs. 54%, p = 0.07). Iron supplementation should be carefully prescribed and closely monitored during pregnancy in women who have undergone BS.

Congenital Heart Defects in Patients with Anorectal Malformations: A Retrospective Cohort Study of 281 Patients.

In patients born with anorectal malformations (ARM), additional congenital heart defects (CHD) can occur. We aimed to provide an overview on disease and treatment details of CHD identified in patients born with ARM, from a unique large cohort of a very rare disease. We performed a retrospective single-center cohort study between January 2000 and July 2023. All consecutive patients with ARM were included. Outcomes were the number of patients with CHD, and screening percentage and percentage of patients diagnosed with CHD over 3 time periods (2000-2006, 2007-2014, 2015-2023). We used uni- and multi-variable logistic regression analyses to search for associations between CHD present and baseline characteristics. In total, 281 patients were included. Some 241 (85.8%) underwent echocardiography, of whom 80 (33.2%) had CHD. Screening percentage with echocardiography increased (74.1% vs. 85.7% vs. 95.9%, p < 0.001) and percentage of patients diagnosed with CHD remained similar over time (30.2% vs. 34.5% vs. 34.0%, p = 0.836). Atrial and ventricular septal defects (n = 36, n = 29), and persistent left superior vena cava (n = 17) were most identified. The presence of VACTERL-association or a genetic syndrome was independently associated with the presence of CHD. CHD were present in 33% of patients with ARM that underwent echocardiography. Over time, the number of CHD identified through screening remained similar. Patients with the presence of VACTERL-association or a genetic syndrome had a higher risk of having CHD. Therefore, acknowledging the potential presence of CHD in patients with ARM remains important.

A new surgical concept for the efficient treatment of large and deep burns.

Effective burn surgery is based on two fundamental principles: prompt excision of necrotic tissue and definitive coverage preserving functional dermis and body contour. There is often compromise, either prioritizing the urgency of excision or opting for patient stability and optimal conditions prior to autografting. We propose a surgical concept that addresses this critical treatment gap. In 2022 we implemented a new three-phase protocol, EDM: (Excision phase, E) Immediate excision of the burn wound preserving body contour; (Dermis phase, D) definitive temporization of the wound bed, using Biodegradable Temporizing Matrix (BTM), to prepare it for successful grafting. (Meek phase, M): Upon complete dermal temporization, full autologous coverage in a single micrografting procedure. We performed a retrospective single-center cohort study to characterize the EDM protocol compared to the prior standard of care (>40%TBSA, n=5 in EDM vs. n=10 matched controls). Primary outcomes were total surgeries required, total surgeries to achieve>90% healing, uninterrupted recovery time without surgery, and time on mechanical ventilation. The EDM group required fewer surgeries in total (5 vs. 9.5 ; p=0.01) and to achieve>90% healing (3 vs. 6.5; p=0.001). EDM patients experienced longer uninterrupted recovery (24 vs. 14 days, p=0.001). Additionally, EDM patients spent less time on mechanical ventilation (210 vs. 1136 hours, p=0.005). The EDM protocol could improve surgical efficiency, ultimately having the potential to expedite rehabilitation in severely burned patients. The study underscores the potential of combining fundamentals of burn surgery, with innovative surgical techniques and materials, in order to bridge the gap between excision and grafting.

Comparison of scales for the evaluation of aneurysmal subarachnoid haemorrhage: a retrospective cohort study.

Aneurysmal subarachnoid haemorrhage (aSAH) is a life-threatening event with major complications. Delayed cerebral infarct (DCI) occurs most frequently 7 days after aSAH and can last for a prolonged period. To determine the most predictive radiological scales in grading subarachnoid or ventricular haemorrhage or both for functional outcome at 3 months in a large aSAH population, we conducted a single-centre retrospective study. A 3-year single-centre retrospective cohort study of 230 patients hospitalised for aSAH was analysed. Initial computed tomography (CT) scans in patients hospitalised for aSAH were blindly assessed using eight grading systems: the Fisher grade, modified Fisher grade, Barrow Neurological Institute scale, Hijdra scale, Intraventricular Haemorrhage (IVH) score, Graeb score and LeRoux score. Of 200 patients with aSAH who survived to day 7 and were included for DCI analysis, 39% of cases were complicated with DCI. The Hijdra scale was the best predictor for DCI, with a receiver operating characteristic area under the curve (ROCAUC) of 0.80 (95% confidence interval (CI), 0.74-0.85). The IVH score was the most effective grading system for predicting acute hydrocephalus, with a ROCAUC of 0.85 (95% CI, 0.79-0.89). In multivariate analysis, the Hijdra scale was the best predictor of the occurrence of DCI (hazard ratio, 1.18; 95% CI, 1.10-1.25). Although these results have yet to be prospectively confirmed, our findings suggest that the Hijdra scale may be a good predictor of DCI and could be useful in daily clinical practice. Better assessment of subarachnoid haemorrhage patients would allow for better prognostication and management of expectations, as well as referral for appropriate services and helping to appropriate use limited critical care resources. Aneurysmal subarachnoid haemorrhage is a life-threatening event that causes severe disability and leads to major complications such as delayed cerebral infarction. Accurate assessment of the amount of blood in the subarachnoid spaces on computed tomography with the Hijdra scale can better predict the risk of delayed cerebral infarct. The Hijdra scale could be a good triage tool for subarachnoid haemorrhage patients.

Pneumococcal vaccine uptake in patients with inflammatory arthritis: a single centre cohort study.

Current guidelines recommend pneumococcal vaccination in individuals who are over the age of 65 or are immunosuppressed due to a disease or treatment. The objective of this study was to assess vaccine uptake rates in people with inflammatory arthritis for the pneumococcal, influenza and Covid-19 vaccines and factors determining uptake. We conducted a retrospective single centre cohort study in the UK of individuals with rheumatoid arthritis, psoriatic arthritis and axial spondylarthritis between October and December 2023. Data were collected for age, gender, co-morbidities, immunosuppressive therapies, and dates of vaccines. Logistic regression was used to evaluate predictors of vaccine uptake, with adjustments for demographic and clinical factors. 906 individuals were identified. 46% were receiving treatment with csDMARD, 26% on biologic monotherapy, and 23% were on both biologic and csDMARDs. 316 individuals (35%) received a pneumococcal vaccine, lower than uptake for influenza (63%) and Covid-19 (87%) vaccines. Predictors of pneumococcal vaccine uptake included age, with older patients more likely to be vaccinated (odds ratio [OR] for age ≥ 65 years: 1.67, 95% CI 1.21-2.29). Those on biological therapy demonstrated higher likelihood of vaccination (OR for biologic therapy: 1.81, 95% CI 1.33-2.47). Additional Joint committee for immunisation and vaccination (JCVI) Green Book indicators also positively influenced vaccine uptake (OR: 1.67, 95% CI 1.19-2.33). Pneumococcal vaccine uptake in inflammatory rheumatic diseases is low, especially in younger patients and those not on biological therapy. The study highlights the need for a focused approach, distinct from strategies for other vaccines, to address this public health challenge.

Super-elderly, spinal surgery, evaluating the risks and benefits: a retrospective single-centre cohort study.

An increasingly ageing population presents emerging healthcare challenges. Adequate clinical evaluation and understanding of outcome-predicting factors are integral to delivering safe spinal surgery to super-elderly patients. To evaluate spine surgery outcomes in patients aged 80 or above. We retrospectively evaluated patients 80 years and above who underwent elective or emergency spinal surgery between 2017 and 2022. The Eurospine Surgery Classification (ESC) was used to classify operations into Large, Medium, and Small. We calculated and compared Clinical Frailty Scores (CFS) pre- and post-operatively. Two hundred forty-five patients met the inclusion criteria. Most were male (n = 145). The age range was 80 to 99 (mean 83.3). Most operations were elective (n = 151, 62%). In our cohort, 211, 22, 10,2 and 1patients had degenerative, trauma, tumour, infective and vascular pathologies, respectively. According to the Eurospine classification, 201 (82.0%) had Minor spine surgery (63 emergently and 138 electively), 38 had Medium surgery (15.5% - 30 emergently and 8 electively), and 6 had Large surgery (2.4% - 1 emergently and 5 electively). 163 (66.5%) were discharged or under follow-up. There were 11 in-patient mortalities (4.5%). Outpatient mortality was 51 (20.8%), with the median time from surgery to death being 504.5 days, all the outpatient mortalities were neither non-spinal pathology nor spinal surgical related. CFS improved across the cohort, from 5 pre-operatively to 4 post-operatively (p < 0.001). Spine surgery in those over the 80s can be performed safely and improve their quality of life, as demonstrated by improvements in the CFS. Good patient selection and adequate pre-operative workup is essential, although it may not be possible in emergencies.

Standardized procedure for preventing late intestinal complications following minimally invasive total gastrectomy for gastric cancer: a single-center retrospective cohort study.

Although minimally invasive total gastrectomy for gastric cancer is commonly performed, reports regarding late complications are limited. We have made several improvements each time we experienced severe late complications since 2009. This study aimed to evaluate the clinical efficacy of these improved procedures in preventing late complications. Between January 2009 and December 2019, 302 patients who underwent laparoscopic or robotic total gastrectomy for gastric cancer were enrolled. The patients were divided into two groups: Period-I (2009-2013, before established standardization of procedure, 166 patients) and Period-II (2014-2019, after established standardization of procedure, 136 patients). The standardized procedure comprised four major steps, including closure of the mesentery defects and diaphragm crus, circumferential fixation of the anastomotic site into the diaphragm, and linearization around the anastomotic site of esophagojejunostomy. The incidence of late complications was retrospectively compared between the two groups. Late overall complications that occurred over 30days after surgery were observed in 19 (6.3%) patients. In all, 14 of 24 (58.3%) patients admitted due to late intestinal complications eventually required reoperation for treatment. The most frequent complication was nonstenotic outlet obstruction of the distal jejunal limb. The incidence of late overall complications was significantly lower in Period-II than in Period-I (2.9 vs 9.0%, p = 0.030). Intestinal complications were reduced considerably in Period-II. The 3-year cumulative incidence rate of late overall complications was significantly lower in Period-II than in Period-I (0.03 vs 0.10, p = 0.035). Period-I as the only independent risk factor for the development of late intestinal complications. Late complications after laparoscopic total gastrectomy sometimes occurred, and more than half of the patients with intestinal complications required reoperation. Our standardized procedure was associated with a lower risk of late intestinal complications after minimally invasive total gastrectomy followed by intracorporeal esophagojejunostomy using linear staplers in a cohort of patients with gastric cancer.

Kidney transplantation in patients with ANCA-associated vasculitis is associated with a high incidence of post-transplant cancer.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease with limited data on outcomes after transplantation. In this single-center retrospective cohort study, we describe the outcomes of kidney transplant patients with AAV transplantedat our institute from February 2006 to January 2022. We identified 9 patients among 1026 with a pre-transplant diagnosis of AAV; all patients had received previous treatment with cyclophosphamide. Maintenance immunosuppression after transplantation was tacrolimus-based in 89% of the patients. At the end of a mean follow-up of 132 ± 61.1months after transplantation, only one case of extrarenal vasculitis relapse was observed. The relapse rate was 0.01 per patient per year, which is comparable to that reported in the literature. However, seven patients were diagnosed with cancer after a mean follow-up of 81.4months after transplantation; six had skin cancer and three had renal cell carcinoma (RCC) of the native kidneys (cumulative incidence of 78%). One patient died from metastatic squamous cell carcinoma. In this study, we found a noticeable decrease in disease relapse (1 relapse in the present cohort vs 7 relapses in 19 patients in the previous cohort) in kidney transplant patients with AAV compared with previous data from our group (December 1987-January 2006). Conversely, we found a high incidence of post-transplant cancer. This result could be attributed to reduced immunosurveillance due to immunosuppression therapy before and after transplantation. Therefore, constant cancer early diagnosis andprevention is mandatory during the post-transplant follow-up of AAV patients.

Cisplatin Monotherapy as a Treatment Option for Patients with HER-2 Negative Breast Cancer Experiencing Hepatic Visceral Crisis or Impending Visceral Crisis.

Hepatic visceral crisis (VC), characterized by a rapid total bilirubin increase with disease progression, poses a life-threatening risk in advanced breast cancer (ABC). International consensus guidelines define VC and touch on impending VC (IVC). Limited data exist on systemic treatments for hepatic VC/IVC. This study explores the safety and efficacy of cisplatin monotherapy in patients with Human Epidermal Growth Factor Receptor 2- negative breast cancer (BC) and hepatic IVC/VC. In this retrospective single-center cohort study data of patients treated with cisplatin monotherapy (60-80mg/m2, every 3-4weeks) between 2016 and 2023 at a reference Cancer Centre in Southern Poland were analyzed. 33 female patients (24/33 hormonal-positive) with the mean age 53.84years were included. Participants progressed on median 2 prior palliative systemic treatment lines. In 10/23 patients hepatic VC and in 23/33 IVC (rapid, symptomatic liver progression; extensive liver involvement; alanine or aspartate aminotransferase > 2 × normal limit; significant increases in lactate dehydrogenase, alkaline phosphatase, or gamma-glutamyl transferase) were identified. Median progression-free survival was 1.87months and median overall survival 2.67months. 33% of the patients presented stable disease or partial response. Eight patients experienced adverse events grade ≥ 3: in five the dose of cisplatin was reduced; two stopped the treatment. Due to the hepatotoxicity of BC-active drugs, specific recommendations for systemic treatment are scarce. Our study explored cisplatin's potential use, finding it to be a viable option in patients with performance status 0 or 1 experiencing hepatic IVC/VC, irrespective of liver function parameters and other factors.

Atrial fibrillation inpatient management patterns and clinical outcomes during the conflict in Syria: An observational cohort study.

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. However, there is no data on AF inpatient management strategies and clinical outcomes in Syria. The study aims were to review the inpatient management of patients with AF and assess cardiovascular (CV) mortality in a tertiary cardiology centre in Latakia, Syria. A single-centre retrospective observational cohort study was conducted at Tishreen's University Hospital, Latakia, Syria, from June 2021 to June 2023. Patients ≥16years of age presenting and being treated for AF as the primary diagnosis with or without a thromboembolic event were included. Medical records were examined for patients' demographics, laboratory results, treatment plans and inpatient details. Studied outcomes include inpatient all-cause and CV mortality, ischemic and bleeding events, and conversion to sinus rhythm (SR). The study included 596 patients. The median age was 58, and 61% were males. 121 patients (20.3%) were known to have AF. A rhythm control strategy was pursued in 39% of patients. Ischemic and bleeding events occurred in 62 (11%) and 12 (2%), respectively. CV and all-cause mortality occurred in 28 (4.7%) and 31 patients (5%), respectively. The presence of valvular heart disease (VHD) (adjusted odds ratio (aOR) = 9.1, 95% confidence interval (CI): 1.7 to 55.1, p < .001), thyroid disease (aOR: 9.7, 95% CI = 1.2 to 91.6, p < .001) and chronic obstructive pulmonary disease (COPD) (aOR: 82, 95% CI: 12.7 to 71, p < .001) were independent risk factors of increased CV inpatient mortality. Syrian inpatients admitted with AF in Latakia are relatively younger than those in other countries. Active thyroid disease, COPD and VHD were independent risk factors of inpatient CV mortality with AF.

Assessment of postoperative pain in children following sclerotherapy of vascular malformations: a retrospective single centre cohort study

BACKGROUND Inadequately controlled postprocedural pain following sclerotherapy in patients with vascular malformations is a well recognised problem. Reliable epidemiological data and risk factors associated with postprocedural pain in children are lacking. OBJECTIVES To evaluate and quantify postprocedural pain in children and identify possible risk factors based on characteristics of the patient, treatment, and medication. DESIGN A retrospective single centre cohort study. SETTING A tertiary single centre study in the Netherlands. PATIENTS Two hundred and nine chiuldren with ‘simple’ subtypes of congenital vascular malformation who had undergone sclerotherapy. PRIMARY OUTCOME MEASURE Quantifying inadequately controlled postprocedural pain. SECONDARY OUTCOME MEASURES Identifying potential patient and treatment characteristics associated with inadequately controlled postprocedural pain. RESULTS A total of 209 patients who underwent 679 procedures were included in this study. The mean age at first intervention was 11.8 ± 4.5 years. Inadequately controlled postprocedural pain was found in 34.8% of the 679 procedures. Venous malformations (VM) were the most prevalent subtype of vascular malformation (80%), followed by arteriovenous malformations (AVM) (14.6%) and lymphatic malformations (LM) (5.4%). The odds ratio (OR) (95% confidence intervals), and P values obtained from multivariable mixed effect logistic regression analysis for patient and treatment characteristics found to be associated with inadequately controlled postprocedural pain were: chronic use of analgesics (OR 2.74 (1.40 to 5.34), P = 0.003), treatment with ethanol (OR 2.39 (1.01 to 5.65, P = 0.05) or esketamine (OR 7.43 (1.32 to 41.81), P = 0.02). Patients treated with lauromacrogol (OR 0.42 (0.22 to 0.82, P = 0.01) and patients receiving intra-operative NSAIDs (OR 0.32, (0.12 to 0.85), P = 0.02) were less likely to experience inadequately controlled postprocedural pain. CONCLUSIONS Despite aiming to achieve best practice, the 34.8% incidence of unsatisfactory postoperative pain management in the children studied confirms that postprocedural pain after sclerotherapy is a common problem that requires further attention.

A single center retrospective cohort study of patients with metastatic breast cancer and leptomeningeal disease: Updated survival data and subgroup analyses by breast cancer subtype.

1108 Background: Patients (pts) with metastatic breast cancer (MBC) and leptomeningeal disease (LMD) have a poor prognosis with limited therapies. We previously reported data from our retrospective LMD registry; here we provide an update with additional pts and subgroup analyses highlighting differences in treatment and survival by breast cancer subtype. Methods: In this single center retrospective cohort study, we identified pts with MBC and LMD who received care from 2000-2024 and abstracted key clinical, treatment, and overall survival (OS) data. Results: We identified 111 pts with MBC and LMD, including pts with the following subtypes: HR+/HER2- (n=53, 47.7%), HER2+ (n=30, 27.0%), and triple negative breast cancer (TNBC; n=28, 25.2%). The majority of pts had concurrent brain metastasis (n=82, 73.9%). Median time from diagnosis of MBC to LMD was 16.4 months (mo) (range 0-101.3 mo). Pts received a median of 3 lines of therapy prior to the diagnosis of LMD (range 0-10) and 1 line after the diagnosis of LMD (range 0-4). Most pts received central nervous system-directed (CNS)-directed therapy (n=94, 84.7%), including intrathecal (IT) therapy (n=42, 37.8%) and/or CNS radiation (n=70, 63.1%). Median OS from the diagnosis of LMD to death was 4.1 mo (range 0.1-78.1 mo) and varied by subtype, with pts with HR+/HER2- or HER2+ MBC and LMD living longer than those with TNBC and LMD (4.2 and 6.8 mo respectively vs. 2.0 mo, p&lt;0.01, HR 2.15, 95% CI 1.36-3.39). There was no difference in OS by histology ductal vs. lobular or by presence or absence of concurrent parenchymal brain metastases. Pts who received IT therapy survived longer than those who did not (7.1 vs. 2.7 mo, p=0.01, HR 0.60, 95% CI 0.40-0.90). There was difference in OS by receipt of CNS-directed radiation therapy. Pts diagnosed with LMD from 2015-2024 lived longer than those diagnosed from 2000-2014 (6.4 vs. 2.9 mo, p=0.04, HR 0.67, 95% CI 0.46-0.99). On multivariable analysis, having TNBC was associated with shorter OS from time of LMD to death (p=0.004, HR 2.03, 95% CI 1.25-3.30). Conclusions: This study represents one of the largest case series of pts with MBC and LMD, including the most pts diagnosed after 2015 to our knowledge. Pts with lobular histology, HER2+ BC, TNBC, and those with de novo MBC were over-represented compared to the general MBC population. Pts with HR+/HER2- or HER2+ disease, LMD diagnosed after 2015, and those who received IT therapy survived longer than their respective cohorts. Novel diagnostic and therapeutic strategies for pts with MBC and LMD remains an area of unmet clinical need.

Effects of antibiotics, hospitalisation and surgical complications on self-reported immunological vulnerability following paediatric open-heart surgery and thymectomy: a single-centre retrospective cohort study

BackgroundPartial or complete thymectomy is routinely performed in paediatric open-heart surgeries when treating congenital heart defects. Whether or not thymectomised children require systematic immunological monitoring later in life is unknown....

Clinical decompensation after trauma laparotomy: It's probably not a pulmonary embolus

Introduction Computed Tomography (CT) to rule out pulmonary embolus (PE) is often ordered during post-trauma laparotomy clinical decompensation (CD) involving fever, tachycardia, tachypnea, and/or leukocytosis. We hypothesize this diagnostic modality is low-yield in the postoperative period when surgery-related sequelae are more probable.Methods This is a single-center retrospective cohort study of patients who underwent trauma laparotomy and had subsequent CT for CD from March 19, 2019 to June 30, 2022. Descriptive statistics and multiple logistic regression were performed. The primary outcome was saddle and lobar PE incidence.Results 1032 adult patients underwent trauma laparotomy with 434 undergoing CT for CD: 137 CT abdomen and pelvis only, 30 CTPE, 265 both. The majority (80.2 %) was male, age 33[interquartile range (IQR) 24–45], suffered penetrating mechanism (57 %), and had ISS 23[IQR16–30]. Injuries at laparotomy included 47 % solid organ, 62 % GI tract, 7 % biliary, 11 % vascular, and 42 % other. 176 (41 %) required damage control laparotomy. Median time to CT post-laparotomy was 174 h [111–235] with saddle and lobar PE in 3 (1 %), peripheral PE 18 (5 %), and abdominal abscess, leak, fluid, or pseudoaneurysm in 222 (51 %). Clinical management was altered (40 %) by antibiotics, therapeutic anticoagulation, drainage, aspiration, filter, thrombectomy, or surgical operation. Patients for whom CT findings changed management were more likely to have had GI tract surgery (69% vs 57 %, p = 0.021), higher white blood cell (WBC) (16.4 [13.1–20.5] vs 15.1 [9.9–19.5], p = 0.002), more hours between CT and laparotomy (184 [141–245] vs 162 [89–230], p = 0.002), and lower mortality (2% vs 8 %, p = 0.008). In-hospital mortality was 5 %; none were PE-related. Predictors of clinical intervention required based on CT imaging were GI tract injury (AOR: 1.65, p = 0.0182), and elevated WBC (AOR: 1.038, p = 0.010Conclusion Saddle and lobar PE incidence post-trauma laparotomy is low. SIRS-type symptoms prompting postoperative CT commonly have no procedural or antibiotic requirement. Postoperative decompensation is more likely related post-operative complications, and less likely a PE.

Predictors of mood-related psychiatric disorders after cancer diagnosis.

e23043 Background: Mood-related psychiatric disorders (MRPDs) such as anxiety and depression are more common among cancer patients vs. the general population and are related to decreased quality of life and poor cancer survival. However, individual risk factors for MRPDs among cancer patients are poorly understood. This study characterized individual predictors of a new MRPD after cancer diagnosis, with a focus on individual behavioral risk factors (IBRFs) (ie., tobacco use and human papillomavirus [HPV]-association). Methods: Single-center retrospective cohort study of 11,712 patients with newly diagnosed breast, prostate, colon, lung, oropharyngeal, anorectal, gynecologic (cervical, vaginal, and vulvar), or penile cancers between 2009-2020. Patients with breast, prostate, and colon cancer were used as controls because of the lack of an association with IBRFs. The primary outcome was a new MRPD post-cancer diagnosis, ascertained via electronic health record data and using ICD10 codes for MRPDs. Covariates included age, sex, race/ethnicity, sexual orientation, disease stage at diagnosis, and IBRFs. We conducted a time-to-event analysis to assess risk factors for MRPDs using a Cox proportional hazards model. Results: The average age of participants was 63 years (SD = 12 years). Most of the study sample was female (59%), non-Hispanic White (72%), heterosexual (67%), and diagnosed with stage I or II disease (63%). Breast (40%), prostate (26%) and lung (21%) were the most common cancers. 328 cases (3%) in the sample consisted of HPV-associated cancers. Half of the sample were current or former smokers. Univariate analyses revealed lower hazard ratios (HRs) of a new MRPD among individuals that identified as Asian/Pacific Islander (API) and among older patients ( &gt; 51 years). Higher HRs of MRPDs were found for females; sexual minorities; former and current smokers; those with HPV-associated cancers; and those with later cancer stages (III and IV). These associations were observed in the adjusted multivariate model: APIs (aHR 0.60, 95%CI 0.46-0.65); 51-64 years (aHR 0.83, 95%CI 0.76-0.92); &gt; 65 years (aHR 0.70, 95%CI 0.63-0.78); females (aHR 1.78, 95%CI 1.64-1.94); sexual minority (aHR 1.78, 95%CI 1.40-2.27); former smoker (aHR 1.40, 95%CI 1.30-1.52); current smoker (aHR 1.79, 95%CI 1.60-2.00); HPV-associated tumors (aHR 1.23, 95%CI 1.02-1.49); stage III diagnosis (aHR 1.58, 95%CI 1.34-1.85); stage IV diagnosis (aHR 2.31, 95%CI 1.96-2.73). Conclusions: IBRFs increased the risk of a new MRPD after being diagnosed with cancer. Prior work has associated HPV-positivity with anxiety and depression in patients without a cancer diagnosis. Our findings build on this and show that individuals diagnosed with HPV-associated cancers have a higher risk of developing new MRPDs after their cancer diagnoses. These findings can help identify patients at risk of developing new MRPDs post-cancer diagnosis to engage them in treatment.