Patients Median Age Research Articles

Relationship between intraoperative blood pressure variability and postoperative acute kidney injury in pediatric cardiac surgery.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a notably common complication in pediatrics, with an incidence rate ranging from 15 to 64%. This rate is significantly higher than that observed in adults. Currently, there is a lack of substantial evidence regarding the association between intraoperative blood pressure variability (BPV) during cardiac surgery with cardiopulmonary bypass (CPB) and the development of AKI in pediatric patients. This retrospective observational study encompassed children aged 0-7years undergoing cardiac surgery with CPB. Intraoperative BPV was calculated using coefficients of variation (CVs) and the area under the curve (AUC). Univariate and multivariate analyses were employed to identify risk factors associated with CSA-AKI. Among 570 patients (median age 1year) reviewed, 36.1% developed CSA-AKI (68.9% risk stage, 22.8% injury stage, and 8.3% failure stage). After adjusting for other variables, male gender (OR = 2.044, 95% CI 1.297-3.222, P = 0.002), congenital heart surgery risk assessment grade (RACHS-1) classification ≥ 3 (OR = 0.510, 95% CI 0.307-0.846, P = 0.009), longer CPB time (OR = 1.022, 95% CI 1.007-1.037, P = 0.004) and higher peak value of intraoperative vasoactive inotropic score (VIS) (OR = 1.072, 95% CI 1.026-1.119, P = 0.002) were identified as independent risk factors for CSA-AKI. ± 30% AUCm was different in univariate analysis (P = 0.014), however, not statistically different in multifactor analysis (P = 0.610). Greater BPV, specifically MAP variations exceeding 30% AUC during CPB, may be a potential risk factor for CSA-AKI in pediatric patients. Further large sample clinical studies are warranted to analyze the correlation between BPV and CSA-AKI.

Inconsistent Associations of Modified Frailty Index-5 With Adverse Head and Neck Reconstruction Outcomes.

To investigate the consistency of associations between modified frailty index-5 (mFI-5) and postoperative adverse outcomes in head and neck cancer (HNC) reconstruction. American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2017 to 2022 was utilized to identify HNC patients undergoing locoregional or microvascular free tissue transfers. Kaplan-Meier estimates and multivariable Cox regression analyses were utilized to compare risk of infections, bleeding, readmissions, reoperations, major adverse cardiovascular events (MACE), and mortality within the first postoperative month for each mFI-5 score with mFI-5 = 0 as reference. Further analyses investigated associations between individual mFI-5 components and the outcomes of interest. We included 5,573 patients (median age: 64; 31.5% female), 63% (n = 3,519) of whom underwent microvascular free tissue transfers. Unadjusted univariate analyses associated higher mFI-5 scores with longer hospital stays. In locoregional tissue transfers, adjusted hazard ratios (aHRs) for reoperation were 1.37 (p = 0.03) for mFI-5 = 1 and 2.19 (p = 0.03) for mFI-5 ≥ 3. In microvascular free tissue transfers, aHRs for MACE were 1.93 (p = 0.04) for mFI-5 = 2 and 6.53 (p < 0.001) for mFI-5 ≥ 3, while aHRs for mortality was 3.88 (p = 0.04) for mFI-5 ≥ 3. No associations were observed between increasing mFI-5 scores and increased relative risk of infection, bleeding, or readmission. Individual component analysis associated congestive heart failure with aHRs of 3.92 (1.84-8.35; p < 0.001) for MACE and 5.30 (2.03-13.88; p < 0.001) for mortality. Additionally, COPD was associated with an aHR of 1.39 (1.16-1.67; p < 0.001) for infections. The associations of higher mFI-5 scores with postoperative adverse outcomes following oncoplastic head and neck reconstruction were inconsistent and possibly driven by individual effects of its components. Level III (three) Laryngoscope, 2025.

Hospital Variability in the Use of Vasoactive Agents in Patients Hospitalized for Acute Decompensated Heart Failure for Clinical Phenotypes.

The absence of practice standards in vasoactive agent usage for acute decompensated heart failure has resulted in significant treatment variability across hospitals, potentially affecting patient outcomes. This study aimed to assess temporal trends and institutional differences in vasodilator and inotrope/vasopressor utilization among patients with acute decompensated heart failure, considering their clinical phenotypes. Data were extracted from a government-funded multicenter registry covering the Tokyo metropolitan area, comprising consecutive patients hospitalized in intensive/cardiovascular care units with a primary diagnosis of acute decompensated heart failure between January 2013 and December 2021. Clinical phenotypes, that is, pulmonary congestion or tissue hypoperfusion, were defined through a comprehensive assessment of clinical signs and symptoms, vital signs, and laboratory findings. We assessed the frequency and temporal trends in phenotype-based drug utilization of vasoactive agents and investigated institutional characteristics associated with adopting the phenotype-based approach using generalized linear mixed-effects models, with random intercepts to account for hospital-level variability. Among 37 293 patients (median age, 80 years; 43.7% female), 88.6% and 21.2% had pulmonary congestion and tissue hypoperfusion status, respectively. Throughout the study period, both overall and phenotype-based vasodilator utilizations showed significant declines, with overall usage dropping from 61.4% in 2013 to 48.6% in 2021 (Ptrend<0.001). Conversely, no temporal changes were observed in overall inotrope/vasopressor utilization from 24.6% in 2013 to 25.8% in 2021 or the proportion of phenotype-based utilization. Notably, there was considerable variability in phenotype-based drug utilization among hospitals, with a median ranging from 48.3% to 77.8%. In multivariable-adjusted models, a higher number of board-certified cardiologists were significantly associated with lower rates of phenotype-based vasodilator utilization and reduced inappropriate inotrope/vasopressor utilization, while tertiary care hospitals were linked to more appropriate inotrope/vasopressor utilization. Substantial variability existed among hospitals in phenotype-based drug utilization of vasoactive agents for patients with acute decompensated heart failure, highlighting the need for standardized treatment protocols. URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000013128.

Real‑world therapeutic strategies and survival outcomes in advanced HER2-mutant non-small cell lung cancer.

Limited information is available regarding the clinical features and outcomes of advanced human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) in Taiwan, despite expanding treatment options for this distinct subtype. The present study explored the clinical features and outcomes of HER2-mutant NSCLC in a real-world setting. Relevant data were collected from patients with advanced or recurrent HER2-mutant NSCLC who received systemic therapy between 2011 and 2021 and were followed up until 2022 at two medical centers in Taiwan. Clinical features, treatment responses, and survival-associated factors were analyzed. This study included 45 patients (median age: 59.7 [range: 41.3-78.7] years). A775_G776insYVMA was the most common NSCLC subtype (57.8%), followed by G778_P780dup (11.1%). Approximately 53.3% of the patients received first-line platinum-based chemotherapy (PC) alone, whereas 13.3% received PC combined with an immune checkpoint inhibitor (ICI). The median overall survival (OS) and progression-free survival (PFS) after first-line therapy were 25.8 and 4.4 months, respectively. The objective response rate was generally higher in patients receiving first-line PC + ICI than in those receiving PC alone (33.3% vs. 12.5%; p = 0.269). Furthermore, patients receiving PC + ICI had longer PFS than did those receiving PC alone (9.5 vs. 4.4 months; p = 0.131) and those receiving tyrosine kinase inhibitor/ICI monotherapy (9.5 vs. 0.5 months; p = 0.015). Compared with patients having other NSCLC subtypes, those carrying HER2 exon 20 insertion mutations had shorter median PFS (17.3 vs. 2.9 months; p = 0.043) and OS (not reached vs. 19 months; p = 0.031). This study highlights the clinical features and outcomes of advanced HER2-mutant NSCLC in Taiwan. PC + ICI may be more effective than other regimens as first-line therapy. The prognostic role of HER2 exon 20 insertion mutations warrants further investigation.

Distinct phenotypes of patients and healthcare resource utilization after hospitalization for COVID-19: an observational study

BackgroundLittle is known about postdischarge healthcare resource use (HCU) among patients hospitalized for coronavirus disease 2019 (COVID-19). The objective was to identify distinct profiles of patients based on postdischarge cares.MethodsThis was a retrospective cohort study using the French National Health System claims database. We followed up all patients hospitalized for COVID-19 between 2020/02/01 and 2020/06/30 for 6 months; the discharge date was the index date. We excluded patients who died during the index stay or within 30 days after discharge. We described patients’ HCU over 5 months from day 31 after the index date to the end of follow-up, i.e., the post-COVID-19 period. We described the sociodemographic and clinical characteristics of the participants and 44 selected types of HCU, including medical and emergency room visits, medications, medical and biological tests, oxygen therapy, rehabilitation, rehospitalization, nurse visits, and sick leave. We performed Ward’s ascendant hierarchical clustering (AHC) analysis to identify groups of patients with similar post-COVID-19 HCU and described HCU and clinical characteristics by cluster.ResultsThe study population included 68,822 patients (median age: 64.8 years, 47% women). Eight clusters of patients were identified, each comprising between 1,163 and 35,501 patients. Four clusters were characterized by older patients and high proportions of comorbidities, i.e. cancer (cluster 3), mental disorders (cluster 4), cardiac insufficiency (cluster 5) and respiratory failure (cluster 6). Cluster 8 was characterized by younger patients, often obese and with low mortality. Another cluster was characterized by complex index stays (cluster 7) and a last cluster (cluster 2) by specific medical contacts and therapy. The main cluster (cluster 1, n = 35,501) was similar to the overall study population. The duration and complexity of the index stay also varied across clusters.ConclusionsBased on HCU data, AHC identified 8 clinically relevant profiles of patients surviving the acute episode of COVID-19 hospitalization. The clusters illustrate the many impacts of COVID on the health status of infected patients and may help anticipate future needs of care in a similar context.

Health-related quality of life across heart failure categories: associations with clinical characteristics and outcomes.

The study aims to examine characteristics and outcomes associated with health-related quality of life (HRQoL) in patients with heart failure (HF) with preserved, mildly reduced and reduced ejection fraction (EF) (HFpEF, HFmrEF and HFrEF). Data on HRQoL were collected in the Swedish Heart Failure Registry (SwedeHF; 2000-2021) using the EuroQoL 5-dimensional visual analogue scale (EQ 5D-vas). Baseline EQ 5D-vas scores were categorized as 'best' (76-100), 'good' (51-75), 'bad' (26-50) and 'worst' (0-25). Independent associations between patients' characteristics and EQ 5D-vas, as well as between EQ 5D-vas and outcomes were assessed. Of 40809 patients (median age 74years; 32% female), 29% were in the 'best', 41% in the 'good', 25% in the 'bad' and 5% in the 'worst' EQ 5D-vas categories, similarly distributed across all EF categories. Higher New York Heart Association (NYHA) class was strongly associated with lower EQ 5D-vas regardless of EF categories, followed by chronic obstructive pulmonary disease, smoking, body mass index, higher heart rate, anaemia, previous stroke, ischaemic heart disease, use of diuretics and living alone, whereas higher income, male sex, outpatient status and higher systolic blood pressure were inversely associated with lower EQ 5D-vas categories. Patients in the 'worst' EQ 5D-vas category as compared with the 'best' had the highest risk of all-cause death [adjusted hazard ratios 1.97, 95% confidence interval (CI) 1.64-2.37 in HFrEF, 1.77, 95% CI 1.30-2.40 in HFmrEF and 1.43 95% CI 1.02-2.00 in HFpEF]. Most patients were in the two highest EQ 5D-vas categories. Higher NYHA class had the strongest association with lower EQ 5D-vas categories, across all EF categories. Patients in the worst EQ 5D-vas category were at the highest risk of mortality.

Squared diffusion-weighted imaging for improving the detection of clinically significant prostate cancer

Aim of this study was to proof the concept of optimizing the contrast between prostate cancer (PC) and healthy tissue by DWI post-processing using a quadrature method. DWI post-processing was performed on 30 patients (median age 67 years, prostate specific antigen 8.0 ng/ml) with PC and clear MRI findings (PI-RADS 4 and 5). Multiparametric MRI was performed at 3 Tesla. A multi-shot readout segmentation (rs-EPI) plus zoomed single-shot imaging (z-EPI) sequence was used in 15 patients (group 1) and a single-shot echo-planar imaging (ss-EPI) plus rs-EPI sequence in 15 patients (group 2). B-value images (b1000 and b1800/2000) were squared and then evaluated objectively software-based and subjectively using a 5-point. The squared DWI technique showed a significantly higher contrast ratio (CR) for ss-EPI b1800 (p < 0.001), rs-EPI b1000 (p < 0.001), rs-EPI b1800 (p < 0.001), z-EPI b1000 (p = 0.008) and for z-EPI b2000 (p < 0.001). After post-processing, a significant improvement in the subjective assessment of image quality was observed for rs-EPI b1000 (p < 0.001), rs-EPI b1800 (p < 0.001) and z-EPI b1000 (p < 0.001). The application of the square post-processing to DWI results in a significant improvement in the CR between PC and healthy tissue, especially at high b-values of ss-EPI or re-EPI. This method may help to improve the detection and differentiation of PC lesions.

Abstract B033: Long-Term quality of life and hearing preservation after stereotactic radiosurgery for vestibular schwannoma

Abstract Purpose/Objective(s): The aim of this study is to evaluate the long-term quality of life (QOL) and hearing preservation outcomes following definitive single-fraction Gamma Knife stereotactic radiosurgery (GKSRS) for vestibular schwannoma (VS). Materials/Methods: Baseline and follow-up QOL and audiogram data were collected from our prospectively maintained institutional database of VS patients treated with single-fraction GKSRS from 2006 to 2023. QOL metrics included the Hearing Handicap Inventory (HHI), Dizziness Handicap Inventory (DHI), Tinnitus Handicap Inventory (THI), and the 36-Item Short-Form Survey (SF-36). Serviceable hearing preservation was classified according to the Gardner-Robertson scale using pure-tone average (PTA) and speech discrimination (SD). Linear mixed-effects models were constructed for each QOL metric over time. Results: A total of 388 patients (median age 61 years) were included with a median follow-up of 48 months. Median tumor size was 1.6 cm (interquartile range [IQR] 1.1-2.1 cm), with a median tumor volume of 0.6 cc (IQR 0.2-1.6 cc). Most patients received a prescription marginal dose of 12.5 Gy with a median cochlear mean dose of 2.7 Gy (IQR 1.9-3.8 Gy). Baseline median HHI, DHI, THI, and SF-36 scores were 28, 12, 12, and 73 respectively. Linear mixed-effects analyses indicated no statistically significant decline in any of these QOL metrics up to 7 years after GKSRS. Of patients with serviceable hearing at baseline, hearing preservation was maintained in 79% at 12 months, 67% at 2 years, and 68% at 3 years. Conclusion: GKSRS preserves long-term patient quality of life and serviceable hearing in the definitive management of VS. Citation Format: Shayzal Siddiqui, Joseph S. Lee, Julia Abbo, Jessica Cummings, Avi Desai, Inga S. Grills, Peter Y. Chen, Jeffrey Jacob, Kuei C. Lee. Long-Term quality of life and hearing preservation after stereotactic radiosurgery for vestibular schwannoma. [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Translating Targeted Therapies in Combination with Radiotherapy; 2025 Jan 26-29; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(2_Suppl):Abstract nr B033.

Transcatheter Closure of Ventricular Septal Defects after Upfront Transvenous Antegrade Cannulation from the Right Ventricle.

Transcatheter closure (TCC) of certain ventricular septal defect (VSD) subtypes typically requires arteriovenous loop (AVL) formation or retrograde transarterial deployment. Upfront transvenous cannulation from the right ventricle avoids arterial access and loop-related complications. We retrospectively reviewed data of patients who underwent TCC for perimembranous, intraconal, and post-surgical residual VSDs at our institution (January 2019-December 2023). Patients receiving upfront transvenous VSD cannulation and closure were compared to those undergoing antegrade closure after AVL formation. Upfront retrograde closure cases were excluded. In a cohort of 163 patients, upfront transvenous cannulation was performed in 116 (71%) and AVL formation in 31 (19%). Upfront transvenous cannulation use increased from 25.6% in 2019 to 93% in 2023. For the upfront group, the median patient age was 55months (IQR, 17.8-120.8), median weight was 15.8kg (IQR, 9.6-29.8), indexed VSD size was 9.2mm/m2 (IQR, 5.5-14.8), and 68.9% had pulmonary arterial hypertension. Cannulation was successful in 83.6% (97/116) of cases, with a switch to retrograde transarterial cannulation in 16.4% (19/116). No deaths or pacemaker implantations occurred. Compared to AVL group, upfront group had significantly shorter procedural times (p = 0.002) and lower radiation exposure (p < 0.001). Smaller patient weight (OR: 0.97, 95%CI: 0.95-0.99), larger indexed VSD size to patient weight (OR: 36.5, 95%CI: 2.49-533.9) and to BSA (OR: 1.23, 95%CI: 1.06-1.4) were significant independent predictors for successful transvenous cannulation. Upfront transvenous VSD cannulation simplifies transvenous TCC by eliminating the need for arterial access and AVL formation, particularly successful in small patients with large defects.

Feasibility and safety of endoscopic submucosal dissection for superficial cancer of the remnant esophagus after esophagectomy.

Endoscopic treatment for second primary malignancies after esophagectomy has been increasingly performed; however, evidence regarding the outcomes of endoscopic submucosal dissection (ESD) for superficial cancer of the remnant esophagus after esophagectomy (SCREE) is limited. We retrospectively extracted cases of ESD for SCREE from our institutional database, which included 739 consecutive esophageal ESD procedures performed between January 2009 and September 2023. Information on prior treatment, clinical features of the lesions, and outcomes was evaluated. Overall, 20 patients (median age: 74years) with 27 lesions were enrolled. ESD was performed at a median of 15months after esophagectomy. All lesions were flat, with a median tumor diameter of 12mm. The median ESD procedure time was 70min. En bloc resection was achieved for all 27 lesions, with one minor perforation complication. The R0 resection rate was 96% (26 of 27). Endoscopic balloon dilation (EBD) of the anastomotic site at the beginning of ESD was required in 30% (8 of 27) of the cases. Among them, EBD was significantly more frequently performed in cases after partial esophagectomy (64%, 7 of 11) than in cases after other types of surgery. The resection speed was significantly faster in lesions after total pharyngo-laryngo-esophagectomy and slower in lesions after subtotal esophagectomy, located in the upper region, and near the anastomosis. Our study demonstrated the feasibility of ESD for SCREE although EBD or a longer procedure duration may be required depending on the pre-ESD surgical technique and location of the lesions.

Impact of PARP inhibitor maintenance therapy after initial treatment on the efficacy of subsequent therapy in ovarian cancer: a propensity score matching analysis

Introduction: progression of advanced epithelial ovarian cancer (EOC) on olaparib may diminish the efficacy of subsequent chemotherapy in recurrent disease setting. However, the impact of progression of EOC during maintenance therapy with olaparib after frontline therapy has not been well studied.Materials and methods: this retrospective study enrolled patients of BRCA / HRD + FIGO stage III–IV EOC with confirmed progressive disease after frontline treatment treated since 2014 until 2022 who either received (arm A) or not (arm B) olaparib as maintenance therapy. To ensure the balance of the compared groups during the study propensity score matching analysis was conducted (cardinality method using MatchIT package in R) with 1:1 ratio of patients in trial arms. The groups were balanced according to the presence of residual tumor after initial treatment, the duration of platinum-free interval after the frontline therapy, secondary local therapy for recurrent disease, treatment with platinum drugs for relapse and subsequent bevacizumab. The primary endpoint of the study was progression-free survival (PFS).Results: the initial population consisted of 259 patients, after the matching procedure 76 patients were enrolled in the study. The median age of patients was 48 years in the arm A and 50 years in the arm B (p = 0.989), 12 (32 %) had FIGO stage IV in both arms (p = 1.000), 25 (66 %) patients in both arms had platinum-free interval ≥ 12 months. With a median follow-up of 42.8 mo. (0.6–70.1 months) median PFS was 6.9 (95 % CI 6.2–10.6 months) and 12.2 (95 % CI 9. 6–21.3 months) in arm A and B, respectively (hazard ratio [HR] 2.89; 95 % CI 1.63–5.12; p &lt; 0.001). Median overall survival was 23.2 months. and 68.2 mo., respectively (HR 4.15; 95 % CI 1.62–10.6).Conclusion: efficacy of subsequent chemotherapy is apparently reduced following progression of BRCA / HRD + EOC on maintenance olaparib therapy in frontline setting. Further trials should assess optimal approaches for these patients.

Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer

Previous studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME. To evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer. This randomized, open-label, noninferiority, phase 3 clinical trial was performed in 16 different centers in China. Between April 2016 and June 2021, a total of 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled. The last date of participant follow-up was in June 2024. Participants were randomly assigned in a 1:1 ratio before their surgical procedure to undergo either transanal TME (n = 558) or laparoscopic TME (n = 557). The primary end point was 3-year disease-free survival, with a noninferiority margin of -10% for the comparison between transanal TME and laparoscopic TME. Secondary outcomes included 3-year overall survival and 3-year local recurrence. In the primary analysis set, the median patient age was 60 years. A total of 692 male and 397 female patients were included in the analysis. Three-year disease-free survival was 82.1% (97.5% CI, 78.4%-85.8%) for the transanal TME group and 79.4% (97.5% CI, 75.6%-83.4%) for the laparoscopic TME group, with a difference of 2.7% (97.5% CI, -3.0% to 8.1%). The lower tail of a 2-tailed 97.5% CI for the group difference in 3-year disease-free survival was above the noninferiority margin of -10 percentage points. Furthermore, the 3-year local recurrence was 3.6% (95% CI, 2.0%-5.1%) for transanal TME and 4.4% (95% CI, 2.6%-6.1%) for laparoscopic TME. Three-year overall survival was 92.6% (95% CI, 90.4%-94.8%) for transanal TME and 90.7% (95% CI, 88.3%-93.2%) for laparoscopic TME. In patients with mid-low rectal cancer, 3-year disease-free survival for transanal TME was noninferior to that of laparoscopic TME. ClinicalTrials.gov Identifier: NCT02966483.

Incidence of 12-month postoperative cognitive decline following regional vs. general anaesthesia in older patients undergoing hip fracture surgery: follow-up of the RAGA trial.

Data regarding the incidence of 12-month postoperative cognitive decline following regional or general anaesthesia in older patients undergoing hip fracture surgery remain observational. Compared with general anaesthesia, we hypothesised that regional anaesthesia would decrease the incidence of 12-month postoperative cognitive decline. This is substudy of a multicentre randomised trial of regional anaesthesia with no sedation vs. general anaesthesia with 12-month follow-up, conducted in nine university hospitals in south-eastern China. Patients aged ≥ 65 y with hip fractures requiring surgery were eligible for inclusion. The prespecified 1-year primary outcome was the incidence of postoperative cognitive decline at 12 months post-randomisation. Secondary outcomes included major or mild postoperative cognitive decline; changes in Mini-Mental State Examination; newly developed dementia; affective status; and health-related quality of life. We recruited 950 patients between October 2014 and September 2018 (n = 474 general and n = 476 regional), with the last participant interviewed in November 2019. A total of 293 patients (139 general vs. 154 regional) were included in the primary analysis of the 12-month outcome. Median (IQR [range]) age of patients was 78 (71-82 [65-96]) y and 217 (74.1%) were female. The incidence of cognitive decline at 12 months was 29.7% vs. 25.4% of patients allocated to general vs. regional anaesthesia, respectively (unadjusted OR 1.2 (95%CI 0.7-2.1), p = 0.43, Bayes factor = 0.28). Major cognitive decline developed in 8.6% vs. 8.5% of patients allocated to general vs. regional anaesthesia, respectively (unadjusted OR 1.0 (95%CI 0.4-2.4)). The incidence of 12-month postoperative cognitive decline was not significantly different in patients having general or regional anaesthesia for hip fracture surgery.

Value of Noncontrast-Enhanced Vessel Wall MRI in Longitudinal Venous System Invasion Before Robot-Assisted Radical Nephrectomy.

Objectives: To explore the value of vessel wall MRI (VW-MRI) in the preoperative assessment of T3 renal-cell carcinoma (RCC) with varying degrees of longitudinal venous system invasion. Materials and Methods: Patients with RCC with pathological T3 stage between January 2016 and December 2023 were included in this retrospective study. All the patients underwent contrast-enhanced CT (CECT), conventional MRI (con-MRI) or VW-MRI. Images were independently and blindly evaluated at 4-week intervals by three readers. The pathological features reported in the pathological report, combined with clinical data, were used as the reference standards. The incremental value was calculated using net reclassification improvement (NRI) and integrated discrimination improvement. Results: Eighty-two T3 RCC patients (median age, 65 years) were enrolled. The accuracy of T staging in CECT (n = 59), con-MRI (n = 49), and VW-MRI (n = 30) was 69.5%, 71.4%, and 93.3%, respectively. VW-MRI had a statistically incremental value for CECT in the preoperative evaluation of T3a-c stages (T3a: NRI = 0.066, p = 0.04. T3b: NRI = 0.085, p = 0.02. T3c: NRI = 0.178, P = 0.02), especially in renal pelvicaliceal invasion (NRI = 0.154, p = 0.04) and vena cava wall invasion (NRI = 0.263, p = 0.01). Besides, statistically significant preoperative incremental effects were obtained in the assessment of T3a-c stages (T3a: NRI = 0.264, p = 0.01. T3b: NRI = 0.373, p = 0.03. T3c: NRI = 0.202, p = 0.045), renal vein invasion (NRI = 0.630, p = 0.03), and vena cava wall invasion (NRI = 0.185, p = 0.02) when added VW-MRI into con-MRI. VW-MRI changed 24% (4/27) of the previous CECT and con-MRI-based surgical plan. Conclusion: VW-MRI added a preoperative value for evaluating T stage of T3 RCC, especially in the evaluation of renal vein invasion and vena cava wall invasion.

CiThroModel Improves Prediction of Symptomatic Venous Thromboembolism in Hospitalized Patients With Cirrhosis Without Hepatocellular Carcinoma.

Venous thromboembolism (VTE) is a recognized complication of acutely ill patients, but its incidence and risk factors in those with cirrhosis are uncertain. We retrospectively studied a consecutive cohort of cirrhosis patients non-electively admitted to our medical unit to determine the rates of symptomatic VTE during hospitalization. Firstly, we explored associations with baseline, clinical and laboratory characteristics using logistic regression. Secondly, we developed a clinical prediction model that could predict the risk of in-hospital VTE. We included 687 patients (median age 61years old; 68% male; Child-Pugh A/B/C, 13%/40%/47%). During hospitalization, 34 patients (4.9%) experienced VTE. Multivariate analysis showed that male sex (OR: 2.56, p=0.05), AKI (OR: 3.1, p=0.001), bacterial infections (OR: 2.6, p=0.008), Pugh score (OR: 1.6. p<0.001), family history of thrombosis (OR: 3.1, p=0.04), reduced mobility (OR: 4.6, p<0.001), and C-reactive protein (OR: 1.1, p=0.005) were independent predictors of VTE. We combined these variables in a prediction model (CirrhosisThrombosisModel) that accurately discriminated between high- and low-risk patients. The AUROC of CiThroModel was significantly higher than that of Padua prediction score (0.882 vs. 0.742). After validating the CiThroModel using bootstrapping, the adjusted model maintained optimal discrimination ability (0.862) and calibration. The adjusted formula to calculate the in-hospital risk of VTE was -9.00+0.82 [Male sex]+1.14 [AKI]+0.98 [Infection]+0.48*Child Pugh score+1.14 [VTE family history]+1.54 [Reduced mobility] + 0.15*PCR/10. The CiThroModel seems a valuable tool for identifying hospitalized patients with cirrhosis at risk of VTE (https://majinzin.shinyapps.io/vterisk/).

Prevalence and outcome of sarcopenia in patients with inflammatory bowel disease: a follow-up study.

Sarcopenia is implicated in inflammatory bowel disease (IBD) complications and surgical outcomes. This study aimed to investigate the prevalence and follow-up of sarcopenia in patients with IBD. Consecutive consenting patients with IBD aged > 18 years were included. Patients with associated sarcopenic diseases were excluded. All had measurements of anthropometry, body mass index (BMI), mid-arm muscle circumference, muscle strength, physical performance, and muscle mass (on computed tomography scan). They were followed up for up to 12 months, and incidence of flares, fractures, and surgery was noted. Of 157 patients screened, 35 refused participation; 5 with associated sarcopenic diseases were excluded. Of 117 patients (median age, 41 years; interquartile range, 18-81 years; 65 men), 73 had ulcerative colitis, 42 Crohn's disease, and 2 IBD-unclassified. Forty (34.2%) had probable sarcopenia; 47 (40.2%) had sarcopenia (29 ulcerative colitis and 18 Crohn's disease) including 10 (8.5%) with severe sarcopenia. Ten (21.3%) were in disease remission. Of factors associated with sarcopenia in univariate analysis, only BMI was significant in multivariate analysis. Ninety-nine patients followed up for a median of 7 months (interquartile range, 2-12 months). Freedom from flares was 5.3% in patients with sarcopenia and 46.1% in those without (P= 0.004). Three patients (1 with sarcopenia, 2 without) required surgery. Sarcopenia was present in 40% of patients with IBD; one-fifth of these had severe sarcopenia. One-fifth were in remission. Low BMI correlated with sarcopenia. More patients with sarcopenia had disease flare. Screening for sarcopenia should be considered in patients with IBD.

Clinical outcomes of switching to lonapegsomatropin from somatropin for treatment of pediatric growth hormone deficiency.

This study aimed to assess differences in insulin-like growth factor 1 (IGF-1) levels following the transition from somatropin to lonapegsomatropin in patients with pediatric growth hormone deficiency (GHD). Secondary objectives included the evaluation of dose titrations based on IGF-1 levels, changes in annualized height velocity (AHV) and body mass index (BMI), and assessing reported adverse effects associated with lonapegsomatropin therapy. A single-center, retrospective review was conducted including patients diagnosed with pediatric GHD initially treated with somatropin who transitioned to lonapegsomatropin between January 1, 2022, and December 31, 2023. Fourteen patients (median age: 9 years) were included. The median somatropin dose was 0.18 mg/kg/week (range, 0.09 to 0.29) at the time of transition and patients were initiated on a median lonapegsomatropin dose of 0.23 mg/kg/week (range, 0.15 to 0.26). This resulted in an IGF-1 increase of 2.3 SDS post-switch. Dose adjustments were made based on IGF-1 levels. Five patients required immediate dose reductions; four of these required further adjustments due to persistent elevation. There were no serious adverse effects reported. Lonapegsomatropin may be a favorable option to reduce injection burden for those with pediatric GHD, though the manufacturer's recommended starting dose of 0.24 mg/kg/week may require individualization. Careful monitoring and dose adjustment based on IGF-1 levels are necessary to maintain safety and efficacy.

Tocilizumab – a disease-modulating treatment for thyroid associated ophthalmopathy?

ABSTRACT Purpose To analyze Tocilizumab (TCZ, an interleukin 6 inhibitor) as a second-line treatment for thyroid-associated ophthalmopathy (TAO). Methods In this retrospective observational study, the charts of patients with moderately severe to severe TAO who received intravenous Tocilizumab as a second-line treatment 2020-2023 were reviewed. Results Twenty-three patients were enrolled in the study. At the follow-up visit 24 weeks after the initiation of treatment, 14 out of 22 patients (63.6%, one missing data) had a reduction of proptosis of 2 mm or more. The mean proptosis decreased from 21.07 (±3.23) to 19.18 (±2.52) mm in the right eye (RE) and from 20.61 (±3.12) to 19.95 (±2.81) mm in the left eye (LE). Twenty patients (87%) also showed a reduction of the clinical activity score (CAS) of at least two points with a mean decrease from 5.22 (±1.53) pre-treatment to 2.09 (±1.38) post-treatment points. The median patient total follow-up time after treatment was ten (range 6–26) months. The comparisons reached strong significance between pre-treatment and 24 weeks, as well as pre-treatment and final visit assessments for both proptosis and clinical activity scores. Serum TRAb levels also dropped significantly, and only two patients needed re-treatment with TCZ. Improvement of diplopia did not reach statistical significance. Conclusions Intravenous Tocilizumab as a second-line treatment for TAO led to a significant improvement of proptosis and CAS at 24 weeks follow-up, with a sustained effect over time.

P0706 Dose intensification of subcutaneous vedolizumab is an effective and safe option in Inflammatory Bowel Disease patients: Results from the multicentre OPTI-VEDO study

Abstract Background Subcutaneous (SC) vedolizumab (VDZ) has demonstrated its efficacy and safety in patients with moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). This study aimed to evaluate the effectiveness and safety of SC VDZ dose intensification in IBD patients with an incomplete clinical response or loss of response. Methods We conducted a retrospective international study in 25 IBD centers from August 2023 to April 2024. All patients with active CD or UC, as defined by patient-reported outcomes (PRO2), who had incomplete response or lost response and required intensified SC VDZ at 108 mg weekly or 216 mg every other week, were included. The endpoints at 3 months post-intensification were steroid-free (SF) clinical response (defined as at least a 50% PRO2 improvement, no treatment change, no surgery, and SC VDZ persistence) and SF clinical remission (CD: abdominal pain≤1 and liquid stool frequency≤3; UC: rectal bleeding=0 and stool frequency=0). Results 154 patients (66% UC, 34% CD) were included. Among the 52 CD patients (median age 36 years, disease duration 14 years), 85% had already been exposed to anti-TNF; among the 102 UC patients (median age 40 years, disease duration 7 years), 50% had prior anti-TNF exposure. The reason for SC VDZ intensification was an incomplete response in 73% of CD and 53% of UC patients, and a secondary loss of response in 27% of CD and 47% of UC patients. Intensification had been done at 108 mg weekly in 95% of patients. At 3 months, SF clinical response was observed in 18/52 (35%) CD and 44/102 (43%) UC patients. Clinical response occurred in 9/14 (64%) of CD patients and 23/48 (48%) of UC patients who had been intensified due to loss of response, and in 9/38 (24%) of CD patients and 21/54 (39%) of UC patients who were in incomplete clinical response. Among responders, all CD patients and 72% of UC patients achieved SF clinical remission. In multivariate analysis, factors associated with SC VDZ response after dose escalation were secondary loss of response (vs incomplete response) (OR=5.8(95%CI: 1.54-21.8);p=0.01) in CD patients, and prior anti-TNF exposure (OR=2.66(95%CI: 1.19-5.98);p=0.02) in UC patients. In survival analysis, 50% of patients had discontinued SC VDZ within 12 months for CD and within 8 months for UC following dose intensification. Adverse effects were reported in 11 patients (7%), including one severe case (pneumonia) and one systemic allergic reaction. Four patients underwent surgery (1 UC and 3 CD patients). Conclusion This first real-world study evaluating SC VDZ intensification demonstrated a SF clinical response at 3 months in more than one third of IBD patients, suggesting the interest of this strategy in clinical practice. Acknowledgment Takeda

P0393 Radiological healing in perianal fistulising Crohn’s disease: MRI predictors and disease course

Abstract Background Perianal fistulising Crohn’s disease (CD) is a disabling condition affecting up to 30% of patients. Studies suggest that greater fibrosis in the fistula tract is linked to improved clinical outcomes. This study aims to describe the natural history of perianal fistulising CD, including MRI parameters, and to identify clinical and radiological predictors of relapse and radiological healing Methods Pelvic MRIs for perianal fistula performed at CHU Liège, Belgium, from 2018 to 2023 were collected. MRI protocols used 1.5T [Siemens Aera/Sola] or 3T [Siemens Vida] machines, with sequences including T2 TSE, T2 TSE FS, and T1 TSE FS before and after gadolinium injection. The MAGNIFI-CD and modified Van Assche (VA) indices were assessed for each patient. Two blinded radiologists evaluated fistula tract fibrosis. For patients with perianal flare, only the first MRI was analysed (MRI 1). For others, the first and last MRI (MRI 2) within the study period were assessed. Perianal flare was defined as abscess drainage or stoma creation for active perianal CD, and radiological healing as ≥80% fistula fibrosis or a MAGNIFI-CD score of 0. Results A total of 102 pelvic MRIs from 84 patients were included. The median patient age was 39 years (31–51), with 40% female. The median duration of perianal CD was 52 months (2–144); 26% had a seton at MRI 1, 7% had a stoma, and 41% were on anti-TNF therapy. During follow-up, 22% required abscess drainage. No clinical factors were associated with perianal flare. Univariate analysis identified several MRI 1 radiologic predictors of flare: fibrosis percentage (OR=0.72, p=0.033), VA hyperintensity T2 (OR=3.22, p=0.028), VA rectal involvement (OR=1.75, p=0.040), VA inflammatory mass (OR=1.42, p=0.022), VA T1 post-contrast hyperintensity (OR=3.68, p=0.045), MAGNIFI-CD score (OR=1.13, p=0.022), MAGNIFI T1 post-contrast hyperintensity (OR=1.77, p=0.031), and MAGNIFI inflammatory mass (OR=1.40, p=0.033). In multivariate analysis, only MAGNIFI T1 post-contrast hyperintensity remained significant (OR=1.77, p=0.031). Radiological healing was achieved in 30% at MRI 1 (25/84) and 44% at MRI 2 (8/18). No factors at MRI 1 predicted healing at MRI 2, though T1 post-contrast hyperintensity at MRI 1 showed a trend towards predicting lack of healing (OR=0.11, p=0.071). Conclusion One-fifth of patients experienced perianal flare during follow-up. Clinical and therapeutic factors did not predict outcomes; only persistent MRI inflammation and low fistula fibrosis were linked to future abscess drainage. Specific MRI features may serve as therapeutic targets in perianal CD management, pending validation in a prospective cohort.