Prospective Multicenter Study Research Articles

The prognostic role of iron deficiency in acute ischemic stroke patients: A prospective multicentric cohort study.

Iron deficiency (ID) is a prognostic factor in heart failure and acute coronary syndrome. However, its role in cerebrovascular diseases is controversial. We aimed to determine the impact of ID on the functional outcome of acute ischemic stroke patients. This was an observational prospective multicentric cohort study. From January to December 2023, we enrolled acute ischemic stroke patients admitted to the stroke units of four comprehensive stroke centers. Venous blood samples were collected at admission to determine the iron status (serum iron, ferritin, transferrin). ID was defined as a serum ferritin concentration<100ng/mL or 100-299ng/mL with transferrin saturation (TSAT) <20%. The primary endpoint was the poor functional outcome at 90days defined as modified Rankin Scale (mRS) 3-6. We used binary logistic regression models including confounding factors to test the association between ID and the primary outcome. The analysis included 442 patients (mean age 73±13, 47.5% female, median NIHSS 7 [IQR 3-15], 61.3% treated with intravenous thrombolysis and/or endovascular treatment). ID prevalence was 65.6%. In all binary logistic regression models, ID predicted poor functional outcome at 3months irrespective from demographics, stroke severity and characteristics, anemia, risk factors, signs/symptoms of heart failure, glucose at admission, and inflammatory biomarkers (aOR 2.328, 95% CI 1.272-4.263, p=0.006). ID was strongly associated with poor functional outcome at 90days in acute ischemic stroke patients. Further research is required to explore whether iron supplementation could be a potential therapeutic strategy to improve patient outcomes.

Circulating tumour DNA in predicting and monitoring survival of patients with locally advanced rectal cancer undergoing multimodal treatment: long-term results from a prospective multicenter study.

Neoadjuvant chemoradiotherapy (nCRT) is the standard for locally advanced rectal cancer (LARC). However, distant metastasis remains the primary cause of treatment failure. Early identification of high-risk individuals for personalized treatment may offer a solution. Circulating tumour DNA (ctDNA) could assist in this process. From September 2017 to June 2019, the study prospectively recruited 113 patients with LARC (cT3-4N0M0 or cTanyN+M0) who underwent nCRT followed by radical surgery across 8 tertiary centers. ctDNA was analysed using large-panel targeted sequencing at baseline, during nCRT, pre-surgery, post-surgery, post-adjuvant chemotherapy (ACT), and during annual follow-ups for 3 years. We analysed 103 tissue and 669 plasma samples from 103 patients. With a median 53-month follow-up, significantly worse progression-free survival (PFS) and overall survival (OS) were observed if median variant allele frequency (mVAF) of baseline ctDNA per patient was ≥0.5% (PFS, HR 4.39, p<0.001; OS, HR 5.61, p=0.004) or ctDNA was still detectable two weeks into nCRT (PFS, HR 7.63, p<0.001; OS, HR 5.08, p<0.001). Furthermore, when compared to the low-risk (C1) group (characterized by "ctDNA undetected during nCRT with baseline mVAF <0.5%" or "ctDNA undetected during nCRT with TMB (tumour mutational burden)≥20/Mb"), the high-risk (C2) group (characterized by "ctDNA detected during nCRT" or "baseline mVAF ≥0.5% with TMB <20/Mb") showed significantly worse long-term outcomes (3y-PFS, 55.9% vs. 94.2%; 3y-OS, 79.4% vs. 100%). The ctDNA clearance during nCRT, baseline mVAF, and TMB may be effective prognostic indicators. Our findings reaffirm the clinical monitoring value of ctDNA and demonstrate the strong prognostic value of baseline ctDNA and its early clearance status in patients with LARC undergoing nCRT. This highlights the potential of dynamic ctDNA monitoring as actionable stratified indicators to guide personalized neoadjuvant treatment strategies. This work was supported by the Major Grants Program of Beijing Science and Technology Commission (No. D171100002617003) and the National High Level Hospital Clinical Research Funding (2022-PUMCH-C-005).

Bony integration of a hybrid glenoid component in anatomical shoulder arthroplasty : short-term CT scan analysis.

Loosening of the glenoid component in the long term remains an important complication of the anatomical total shoulder arthroplasty (aTSA). The aim of this study was to explore the bony integration of a hybrid glenoid component based on an analysis of CT scans. In a prospective multicentre study, patients who underwent primary aTSA, whose hybrid design of glenoid component included a fully-polyethylene flanged upper peg and a porous-coated titanium lower peg, and who were reviewed with CT scans between 12 and 24 months postoperatively, were included. Two independent observers reviewed the scans. Bony integration of the upper peg was scored as described by Arnold et al, and integration of the lower peg was scored as described by Gulotta et al. Perforation of the glenoid vault in any plane was also assessed. From an initial group of 120 aTSAs in 116 patients, 104 CT scans were analyzed in 100 patients (four bilateral shoulders, mean age 66 years (SD 11), 62 female and 38 male). Osteolysis around the upper peg was found in 32 patients (32 aTSAs; 31%). Of the remaining patients, 72 had a mean Arnold score of 5.6 points (SD 0.9), and 70 (67%) had perfect integration. The lower peg had a mean Gulotta score of 6.5 points (SD 1.4). There was perfect integration of the lower peg in 70 patients (70 aTSAs; 67%). A total of nine patients (nine aTSAs; 9%) had no bony integration at either peg. There was perforation of the glenoid in an anterior or posterior direction at the level of the upper peg in three and 28 patients, respectively. This occurred at the level of the lower peg in 11 and 18 patients, respectively. The inter- and intraobserver reliability was good (k = 0.782 and 0.86, respectively). No implant breakage occurred at a mean follow-up of 16 months (12 to 24). The clinical outcome was satisfactory at a mean follow-up of 32 months (24 to 35), as assessed by a visual analogue scale score for pain, the Constant-Murley score, Subjective Shoulder Value, and American Shoulder and Elbow Surgeons score. Short-term CT scan analysis of a new hybrid anatomical glenoid component found perfect bony integration around the lower porous coated titanium peg in 90% of patients. The upper polyethylene flanged peg had bony integration in 70 patients (70 aTSAs; 67%). Longer follow-up is needed to analyze the rate of survival of this component. The short-term clinical outcome was satisfactory.

Abstract TMP87: Reasons for Deferring Thrombectomy in Pediatric Large- and Medium Vessel Occlusion

Introduction: Mechanical thrombectomy (MT) is increasingly being performed in children with stroke due to large and medium vessel occlusion (LVO and MeVO). While retrospective series suggest favorable outcomes after MT, selection criteria for the pediatric population have not been defined. We aimed to analyze characteristics of children with LVO and MeVO and describe reasons for not pursing MT in children with acute vascular occlusion. Methods: The Stanford Pediatric Stroke Registry retrospectively enrolled pediatric patients with acute arterial ischemic stroke (AIS) admitted to our tertiary care center between 2007-2024. For this analysis, we included patients age 29 days-21 years with acute neuroimaging and clinical documentation available for direct review. LVO was defined as occlusion of the extra-/intracranial Internal Carotid Artery (eICA/iICA), Middle Cerebral Artery (MCA)-M1, Anterior Cerebral Artery (ACA)-A1, vertebral artery (VA) or basilar artery (BA). MeVO was defined as occlusion of the MCA-M2, MCA-M3 or ACA-A2. Patient charts were reviewed for documentation of medical decision-making, and reasons for forgoing MT were assigned by two pediatric neurologists trained in stroke (SL) and neurocritical care (EM). Clinical and imaging characteristics were compared using chi-squared or Fishers Exact test for categorical variables and Mann-Whitney U test or t-test for continuous variables. Results were reported using descriptive statistics. Results: Among 208 children with acute AIS, 82 (39.4%) had LVO/MeVO (Figure 1); 14 children had multiple occlusions for a total of 114 vascular occlusions (90 LVO, 24 MeVO). Patients with LVO/MeVO were older, had higher NIHSS and more often underwent contrast perfusion imaging compared to non-LVO/MeVO patients (Table 1). Among LVO/MeVO patients, Moyamoya Arteriopathy (MMA) was the final diagnosis in 10 (5 with a pre-existing diagnosis). Excluding those, 72 patients (34.6%) had a non-MMA vascular occlusion. MT was performed in 18 patients; of the 64 who did not undergo MT, the most common primary reasons intervention was not pursued were 1) concern for arteriopathy or infection (n=15) and 2) completed/large infarct burden (n=14, Figure 2). Conclusions: LVO/MeVO is not uncommon in children. In our cohort, LVO/MeVO was diagnosed in over 1/3 of children with acute AIS, and a quarter of those underwent MT. Further multicenter prospective studies are needed to define MT selection criteria in this unique population.

Overall impact of tethering and of its symmetric and asymmetric subtypes on early and long-term outcome of transcatheter edge-to-edge repair of significant mitral valve regurgitation.

Tethering is a common condition of the mitral valve apparatus in the presence of significant regurgitation. Its impact on outcomes of transcatheter edge-to-edge repair (TEER) remains poorly characterized. We appraised the prevalence, features, procedural details, and outcomes of patients with or without mitral valve tethering in a prospective multicenter observational study. The primary endpoint was the risk of cardiac death or rehospitalization for heart failure at mid-term follow-up. We included 2238 patients, 1467 (65.5%) without tethering and 771 (34.5%) with tethering (487 [21.8%] with symmetric and 284 [12.7%] with asymmetric tethering). Several differences in baseline features were evident among groups, yet procedural results were similar. After a median of 14months, rates of cardiac death or rehospitalization for heart failure was significantly higher at unadjusted analysis in patients with tethering (191 [24.8%] vs. 272 [18.5%] in those without tethering, p=0.001), but weres similar between tethering subtypes (p=0.666). At adjusted analysis, the presence of any tethering was no longer a significant predictor of cardiac death or rehospitalization for heart failure, and the same results were obtained focusing on tethering subtypes (all p>0.05). Tethering is common among patients with an indication to TEER, and is associated with adverse baseline and procedural features. In spite of this, device and procedural success rates are not significantly impacted by the presence of tethering that does not even have a negative prognostic effect at follow-up. Accordingly, tethering should not be considered a contraindication to TEER in suitable patients.

Aerosolized plus intravenous polymyxin B in comparison to intravenous polymyxin B alone for the management of HAP caused by carbapenem-resistant gram-negative bacteria: A prospective multicenter cohort study.

This study aimed to evaluate the clinical effectiveness of combined aerosolized (AER) and intravenous (IV) polymyxin B in managing patients with hospital-acquired pneumonia (HAP) caused by carbapenem-resistant gram-negative organism (CRO). This multicenter prospective cohort study was conducted across six intensive care units in municipal and above-municipal hospitals in Shaanxi, China, from January 1, 2021 to December 31, 2022. Patients with CRO pneumonia were categorized into the intravenous group (IV polymyxin B alone) and the combination group (AER plus IV polymyxin B). Primary outcomes included ICU mortality, 28-day mortality and bacterial clearance, while secondary outcomes included the duration of mechanical ventilation and length of ICU stay. A total of 64 patients were included in the study, with 29 receiving AER plus IV polymyxin B and 35 receiving IV polymyxin B alone. On the seventh day of treatment, the combination group showed a significant reduction in the APACHE II score (17.86 ± 5.03 vs. 19.17 ± 11.02, P = 0.041) and procalcitonin levels (1.27 ± 0.20 vs. 3.18 ± 0.69, P < 0.001) compared to the intravenous group. Additionally, the combination group exhibited a higher bacterial eradication rate (62.1% vs. 42.9%), lower ICU mortality (27.6% vs. 37.1%), shorter duration of mechanical ventilation (371.39 ± 68.97 h vs. 563.94 ± 100.25 h), and reduced ICU stay (34.41 ± 17.87 d vs. 35.03 ± 21.66 d), although the differences were not statistically significant. In patients with CRO pneumonia, combination therapy resulted in significant reductions in APACHE II scores and procalcitonin, but did not lead to statistically significant improvements in clinical outcomes, compared to IV polymyxin B alone.

WCN25-4117 A novel technique of Arteriovenous fistula creation by nephrologist and its outcomes: a prospective multicentric cohort study from South India

WCN25-4117 A novel technique of Arteriovenous fistula creation by nephrologist and its outcomes: a prospective multicentric cohort study from South India

Abstract TP236: Pretreatment Predictors Of 30-Day Very Poor Outcome After Thrombectomy In Large Ischemic Core Stroke: A Multicenter Prospective Cohort Study

Abstract TP236: Pretreatment Predictors Of 30-Day Very Poor Outcome After Thrombectomy In Large Ischemic Core Stroke: A Multicenter Prospective Cohort Study

The characteristics and parenthood aspirations of single women and lesbian couples seeking motherhood through sperm donation

IntroductionIn 2021, France authorized access to assisted reproductive technology (ART) for single women (SWs) and lesbian couples (LCs). We aimed to describe these new populations and compare their characteristics with those of the historical population of heterosexual couples (HCs) using ART with sperm donation. Material and methodsWe conducted a monocentric observational retrospective study at the Nancy Regional University Hospital Fertility Center from October 1, 2021, to June 30, 2023. The demographic and clinical characteristics of all the women/couples willing to engage in parenthood with sperm donation, as well as their parenthood aspirations data, were collected. ResultsWe included 638 women/couples; 49.7% were SWs; 44.5% were LCs; and only 5.8% were HCs. The mean age of the whole population was 33.4±5.5 years. The SW population was significantly older by 6 years and came from executive and intellectual professions. A total of 18.3% of the LCs were interested in the reception of oocytes from the partner (ROPA). HCs (77.8%) and LCs (73.2%) were more interested in phenotypic matching than SWs (49.1%) (p<0.001). Monocentric support was more common in SW patients (88.9%) than in LCs patients (79.5%) and HCs (56.8%) (p<0.001). DiscussionIn a large cohort, we focused on and discussed the characteristics and the aspirations of these intended parents. We found that new populations favored ART with sperm donation. The overall characteristics of both heterosexual and lesbian couples were broadly comparable, as were the two LCs members. A French multicenter large-scale prospective study and anthropological studies are necessary to confirm and explain this data.

MRI-assessed Dynamic Hyperinflation Induced by Tachypnea in Chronic Obstructive Pulmonary Disease: The SPIROMICS-HF Study.

Purpose To assess the repeatability of real-time cine pulmonary MRI measures of metronome-paced tachypnea (MPT)-induced dynamic hyperinflation and its relationship with chronic obstructive pulmonary disease (COPD) severity. Materials and Methods SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) (ClinicalTrials.gov identifier no. NCT01969344) is a multicenter prospective cohort study that recruited individuals with COPD with 20 or more pack-years smoking history and controls aged 40-80 years. SPIROMICS-HF is a cross-sectional study evaluating cardiopulmonary interactions in COPD from December 2019 to April 2024. Two-dimensional coronal real-time cine pulmonary MRI (3.2 frames/sec) was performed during MPT twice. Lung masks and lung MR images from an independent study were used for transfer learning to segment real-time cine pulmonary MR images. Dynamic hyperinflation was evaluated as the increase in end-expiratory lung volume (EELV) during tidal breathing to the end of MPT. Repeatability was assessed with intraclass correlation coefficients, and multivariable associations with COPD severity were examined. Results Of the 70 participants (mean age, 67 years ± 10 [SD]; 37 male, 33 female) included in the study, 59% had COPD. The transfer learning model achieved high accuracy in lung segmentation (Dice similarity coefficient, 0.94 ± 0.03). There was good scan-rescan agreement for EELV and dynamic hyperinflation (intraclass correlation coefficient, 0.99 and 0.87, respectively). Dynamic hyperinflation was associated with COPD severity (P trend = .01, with a mean difference between severe COPD and controls of 0.24 L). Conclusion A transfer learning model yielded reproducible quantification of MPT-induced dynamic hyperinflation at real-time cine pulmonary MRI, with greater dynamic hyperinflation in participants with more severe COPD. Keywords: Chronic Obstructive Pulmonary Disease, MR Imaging, Pulmonary, Lung, Technology Assessment Supplemental material is available for this article. ClinicalTrials.gov identifier: NCT01969344 © RSNA, 2025.

Plasma shallow whole-genome sequencing profiling in patients with RAS WT metastatic colorectal cancer (mCRC) undergoing first-line anti-EGFR therapy.

214 Background: Acquired resistance (AR) to first-line (1L) chemotherapy (CT) + anti-EGFR inhibitors is a major challenge in the management of RAS WT mCRC patients (pts). While AR in later lines has been explained with point mutations in the EGFR pathway, its real mechanisms in 1L remain poorly understood. Tumor molecular biology can be dynamically studied through circulating tumor DNA (ctDNA) analysis, a real-time, non-invasive approach to detect AR. In this context, we conducted the multicenter prospective PLATFORM-B study, which enrolled 100 RAS WT mCRC pts receiving 1L CT + cetuximab across 15 Spanish Medical Oncology Departments, alongside 30 RAS MUT pts (control) treated with 1L CT + bevacizumab. Peripheral blood samples have been collected at baseline (BL), week 8, and disease progression (PD). Next-generation sequencing analysis (Ion S5 system) of ctDNA at PD revealed AR mutations in only 10% of pts, suggesting that alterations in the EGFR pathway may only partially explain AR in 1L. Therefore, we conducted shallow whole-genome sequencing (shWGS) to further characterize genomic profiles possibly related with novel mechanisms of AR. Methods: Baseline and PD samples with sufficient remaining plasma were considered for this analysis. shWGS was performed with a coverage ranging 0.5X to 2.0X and analyzed using ichorCNA pipeline to evaluate various genomic characteristics such as copy number alterations (CNA), tumor fraction (TF), subclonal fraction (SF), and ploidy. Molecular results were correlated to clinical-pathological features and outcomes. Results: Overall, 35 mCRC pts (27 RAS WT and 8 RAS MUT ) were included in the study. At BL ( N = 26), median TF (mTF) was 0.19, median ploidy 2, median SC fraction 0.5, median SC genome fraction 0.21, and median subclonal CNA fraction 0.41. At PD ( N = 33), mTF was 0.08, median ploidy 2, median SC fraction 0.5, median SC genome fraction 0.17, and median subclonal CNA fraction 0.38. Of all the features analyzed, only the TF showed potential prognostic value. At BL, pts with TF levels above the median had poorer overall survival (OS) compared to those with lower levels, approaching statistical significance ( P = .055). At PD, higher TF levels were statistically significantly associated with worse OS ( P = .02). No meaningful differences between the RAS WT and RAS MUT groups were observed. Specific variations in CNA, TF, SF, or ploidy under treatment are being correlated to clinical data to seek for predictive value. Conclusions: This preliminary analysis of the PLATFORM-B using shWGS showed the prognostic value of TF. Further analyses are undergoing to better understand the molecular landscape of acquired resistance to 1L anti-EGFR-based therapy in RAS WT mCRC pts.

Development and Validation of a Predictive Model for Fall Risk in Pre-Frail Older Adults.

To develop a predictive model for fall risk in pre-frail older adults, providing a basis for early identification and prevention of falls among this population. This was a multicenter prospective cohort study. A total of 473 pre-frail older adults were included, 335 as the training set and 142 as the test set. Univariate and stepwise binary logistic regression analyses were conducted to identify the relationship between pre-frail and fall risk and establish the frailty risk prediction nomogram. The nomogram was constructed based on the results of logistic regression. The model assessment relied on the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test, calibration curves, and decision curve analysis. Fall incidence rate among pre-frail older adults within 6 months was 13.63%. The final fall risk prediction model identified that sex, history of falls in the past year, visual impairment, increased nocturia, and fear of falling are the most critical risk factors for falls in pre-frail older adults. The model exhibited good accuracy in the testing set, with an area under the ROC curve of 0.825 (95% confidence interval [0.736, 0.914]). Pre-frail older adults have a higher incidence of falls. The logistic regression model constructed in this study shows promising predictive capabilities and can be used as a screening tool to identify pre-frail older adults at high risk of falls in clinical practice. We anticipate that this model will assist clinical nurses in enhancing the efficiency of fall prevention efforts and reducing the incidence of falls among pre-frail older adults. [Research in Gerontological Nursing, 18(1), 29-39.].

Risk Factors and Predictive Model for Day-case ERCP Surgery: A Multi-center Prospective Post-hoc Study and Validation

Risk Factors and Predictive Model for Day-case ERCP Surgery: A Multi-center Prospective Post-hoc Study and Validation

WCN25-4521 A Multicentre Prospective Observational Study of Ambulatory Blood Pressure Monitoring in Indian Patients With and Without Chronic Kidney Disease

WCN25-4521 A Multicentre Prospective Observational Study of Ambulatory Blood Pressure Monitoring in Indian Patients With and Without Chronic Kidney Disease

Deglutition preservation after swallowing (Swoars)-sparing IMRT in head and neck cancers: Definitive results of A multicenter prospective study of the italian association of radiotherapy and clinical oncology (Airo)

BackgroundTo investigate changes of objective instrumental measures and correlate with patient reported outcomes (PROs) of radiation-induced dysphagia (RID) after swallowing organs at risk (SWOARs)-sparing IMRT. MethodsPatients (pts) underwent Fiberoptic Endoscopic Evaluation of Swallowing (FEES), Videofluoroscopy (VFS) and M.D. Anderson Dysphagia Inventory (MDADI) questionnaire at baseline, 6 and 12 months after treatment. They were categorized in two groups: MDADI-C ≥ 80 and MDADI-C < 80. Pharyngeal residue (PR) and penetration (P) or aspiration (A) were considered as surrogate of RID. ResultsBetween 2016 and 2022 we enrolled 75 pts, 40 (53 %) MDADI-C ≥ 80 and 35 (47 %) MDADI-C < 80 at baseline.Among MDADI-C ≥ 80 the mean baseline PR score at FEES was 0,42 rising to 1,36 at 6 months (p = 0,001) and stabilizing to 1,15 at 12 months (p = 0,21); indeed, the mean baseline PR score at VFS was 0,55 rising to 1 at 6 months (p = 0,069) and slightly dropping to 0,7 at 12 months (p = 0,069). Among MDADI-C < 80 the mean baseline PR score at FEES was 0,56 rising to 1,07 at 6 months (p = 0,012) and stabilizing to 1,07 at 12 months (p = 0,99); indeed the mean baseline PR score at VFS was 0,67 rising to 1,19 at 6 months (p = 0,04) and dropping to 0,78 at 12 months (p = 0,04). No correlation was found between PROs and objective measures. ConclusionOur results show optimal acceptable deglutition preservation from major complications after SWOARs-sparing IMRT by means of low objective scores in both MDADI-C groups. Lack of correlation between PROs and objective measures suggest that referred RID is likely associated to persistence of SWOARs inflammation rather than to a real impairment of function.

A multicenter prospective study to evaluate the efficacy of resection for initially unresectable hepatocellular carcinoma after atezolizumab combined with bevacizumab (the RACB study): Short-term outcomes.

521 Background: The IMbrave150 study showed that atezolizumab plus bevacizumab (atezo+bev) is superior to sorafenib in progression-free survival and overall survival, making it the recommended first-line systemic therapy for unresectable hepatocellular carcinoma (HCC). The RACB study was scheduled to evaluate the efficacy of atezo+bev in achieving conversion surgery for initially unresectable HCC. This time, we report the short-term outcomes of the RACB study. Methods: This prospective, single-arm, multicenter Phase II trial evaluates atezo+bev to achieve conversion surgery in patients with technically or oncologically unresectable HCC. Eligible patients had unresectable HCC without prior systemic chemotherapy and at least one target lesion based on RECIST ver1.1. Patients received atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) every three weeks. If resectable on radiological assessment at 12 weeks, atezolizumab monotherapy was given followed by surgery. The primary endpoint was the progression-free survival. The secondary endpoints included the overall response rate, overall survival, resection rate, curative resection rate, on-protocol resection rate, and ICG retention rate at 15 min after atezo+bev therapy. The study is registered with the Japan Registry of Clinical Trials (jRCTs051210148). Results: Between March 2022 and March 2024, 55 patients from 17 centers were enrolled. Four patients were excluded due to ineligible lesions or other reasons. A total of 50 patients were included in the efficacy evaluation set. Macrovascular invasion and extrahepatic metastases were observed in 38 (76.0%) and 6 patients (12.0%), respectively. Two patients (4.0%) had metachronous extrahepatic metastases without intrahepatic tumors. The complete and partial response rates were 0% and 13% based on RECIST, and 2.2% and 26.1% based on mRECIST. The overall resection rate was 48%, corresponding to 24 cases. R0, R1, and R2 resections were performed in 21 (87.5%), 1 (4.2%), and 2 (8.3%) patients, respectively. Complications ≥Grade III according to the Clavien-Dindo classification included 3 bile leakages, 2 infections, 1 anastomotic leakage, and 1 hemoptysis. There were no surgery-related deaths. Of the 51 patients included in the safety analysis set, adverse events occurred in 34 cases (66.7%), with 16 Grade 3 or higher instances with one Grade 4 upper gastrointestinal bleeding, 1 Grade 4 encephalopathy, and 1 unexpected death after 1 cycle of atezo+bev. Conclusions: The RACB study's short-term outcomes demonstrated the feasibility of conversion surgery after atezo+bev in patients with initially unresectable HCC. The response rate of atezo+bev, as measured by mRECIST, was similar to IMbrave150, with a 48% resection rate, though careful monitoring of severe adverse events is essential. Clinical trial information: 051210148.

Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease-Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study.

Screening for advanced fibrosis (AF) resulting from metabolic dysfunction-associated steatotic liver disease (MASLD) is recommended in diabetology. This study aimed to compare the performance of noninvasive tests (NITs) with that of two-step algorithms for detecting patients at high risk of AF requiring referral to hepatologists. We conducted a planned interim analysis of a prospective multicenter study including participants with type 2 diabetes and/or obesity and MASLD with comprehensive liver assessment comprising blood-based NITs, vibration-controlled transient elastography (VCTE), and two-dimensional shear-wave elastography (2D-SWE). AF risk stratification was determined by a composite criterion of liver biopsy, magnetic resonance elastography, or VCTE ≥12 kPa depending on availability. Of 654 patients (87% with type 2 diabetes, 56% male, 74% with obesity), 17.6% had an intermediate/high risk of AF, and 9.3% had a high risk of AF. The area under the empirical receiver operating characteristic curves of NITs for detection of high risk of AF were as follows: Fibrosis-4 (FIB-4) score, 0.78 (95% CI 0.72-0.84); FibroMeter, 0.74 (0.66-0.83); Fibrotest, 0.78 (0.72-0.85); Enhanced Liver Fibrosis (ELF) test, 0.82 (0.76-0.87); and SWE, 0.84 (0.78-0.89). Algorithms with FIB-4 score/VCTE showed good diagnostic performance for referral of patients at intermediate/high risk of AF to specialized care in hepatology. An alternative FIB-4 score/ELF test strategy showed a high negative predictive value (NPV; 88-89%) and a lower positive predictive value (PPV; 39-46%) at a threshold of 9.8. The FIB-4 score/2D-SWE strategy had an NPV of 91% and a PPV of 58-62%. The age-adapted FIB-4 score threshold resulted in lower NPVs and PPVs in all algorithms. The FIB-4 score/VCTE algorithm showed excellent diagnostic performance, demonstrating its applicability for routine screening in diabetology. The ELF test using an adapted low threshold at 9.8 may be used as an alternative to VCTE.

A program to improve sepsis management in the Emergency Department: a multicenter prospective study in France.

Implementation of a regional sepsis program to improve compliance with sepsis care bundles and optimize septic patient management and outcomes in the Emergency Department (ED). The program included a multifaceted intervention in 8EDs: creation of a regional sepsis team, meetings, education (yearly 6-h course and site visits) and sepsis alert. Clinical practice was evaluated in each ED during 1month every year over 3years. The primary outcome was the initiation of all criteria of the Surviving Sepsis Campaign (SSC) bundle within 3h after triage. Secondary outcomes were the initiation of the 3-h bundle in patients with hypotension (SBP ≤ 100mmHg), admission related to infection or not, proportion of organ supports, subsequent intensive care unit (ICU) admission, and early mortality (day 7). During the 3-month study period, 739 patients were identified with a sepsis including 8% with septic shock. Compliance with the SSC bundle improved during the three periods (P1: 28/176 (16%), P2: 42/272 (15%), P3:69/291 (24%), p = 0.023). In patients with hypotension (n = 142, 19%), no improvement was observed (P1:12/38 (32%), P2:18/46 (39%), P3: 28/58 (48%), p = 0.255). Mortality on day 7 was also similar (10% vs 11% vs 9%, p = 0.621). In multivariate analysis, age (OR = 1.03; 95% CI 1.01-1.05, p = 0.003) and confusion (OR = 2.37; 95% CI 1.37-4.14, p = 0.002) were independently associated with D7 mortality. Patients referred to ED for infection had a better prognosis compared to those with a non-specific reason (OR = 0.56; 95% CI 0.32-0.97, p = 0.038). A regional sepsis educational program appears to improve compliance with the SSC bundle. Pre-hospital identification of sepsis appears to improve further management.

Dynamics of retinal changes in early-stage Parkinson’s disease

Parkinson’s disease (PD) is a neurodegenerative disorder primarily characterized by motor symptoms, with emerging evidence suggesting retinal pathology, particularly in the ganglion cell-inner plexiform layer (GCIPL), detectable via optical coherence tomography (OCT). This study aimed to characterize early retinal dynamics in PD using OCT. We conducted a prospective one-year longitudinal multicenter study involving 53 early-stage PD patients with a disease duration of 5 years or less and 52 controls. The participants underwent retinal spectral-domain OCT, primary visual function and cognitive examinations. We examined baseline retinal measures and short-term longitudinal differences between groups via linear mixed effects models. In PD patients, the baseline GCIPL thickness in central regions was increased by up to 4 μm, and the rate of thinning in the parafoveal GCIPL was − 0.61 [0.29] µm/year faster over a one-year follow-up period than in controls in the 2- to 3-mm ring (p = 0.039). In PD patients, greater central GCIPL thickness was associated with poorer contrast sensitivity and reduced performance on the Farnsworth D15 color vision test. It also predicted subsequent thinning in both the GCIPL (2- to 3-mm ring) and the inner nuclear layer (2- to 5-mm rings). However, this increased thickness was not linked to prevalent or progressive motor or cognitive manifestations. In conclusion, this study provides the first detailed topographical description of early retinal dynamics in PD patients, revealing increased central GCIPL thickness and accelerated parafoveal GCIPL thinning in PD. However, the macular region shows complex and variable dynamics among PD patients, but these changes precede detectable progression in clinical scales.

Paradigm Shift from Conventional to Virtual Surgery Using Three-dimensional Model of Fibula as Preoperative Planning and Guide Technique in Mandibular Reconstruction in Oral Carcinoma: A Prospective Multicentric Comparative Study

Abstract Background: Mandibular reconstruction using a free fibula osseocutaneous flap is a commonly performed and well-established technique accepted worldwide, as the postoperative restoration of form and function of the oral cavity and facial features is superior compared to pedicled flaps. However, this requires precise preoperative planning, followed by execution to correctly restore the loss caused by the complex defect created after the surgical extirpation. With the incorporation of virtual surgical planning (VSP) and computer-assisted design and manufacturing (CAD/CAM) techniques in medical science, their incorporation as preoperative tools holds a lot of promise for a better surgical outcome. Aim: The aim of study was to assess the utility and benefits of VSP using CAD/CAM techniques over preexisting preoperative planning methods for mandibular reconstruction using a free fibular flap. Materials and Methods: A multicentric prospective comparative study was carried out at two tertiary care hospitals of the Armed Forces. Two-year data were collected from October 2020 to October 2022. A total of 39 consecutive cases of oral carcinoma requiring mandibular reconstruction using a free fibular flap were included in the study. Nineteen cases underwent free fibula flap reconstruction using already established preoperative planning in one center, whereas 20 cases underwent VSP as a preoperative tool in another center. The primary objectives assessed were the operative time and intraoperative blood loss in each arm. The secondary objectives assessed were the incidence of flap loss, the presence of oral incompetence postsurgery, the total hospital stay, and the presence of facial symmetry. Results: The total flap harvest time in the VSP group (68 min ± 13 standard deviation [SD]) was lower than that in the control group (88 min ± 14 SD), which was statistically significant (P &lt; 0.001). There was no statistical difference in total operative time (P = 0.06), although in the VSP group, the mean was 10.6 h ± 1.5 SD as opposed to 11.5 h ± 1.6 SD in the control group. Nearly 26.3% of cases in the control group, as compared to 10.5% in the VSP group, had flap-related complications. In the early postoperative period, oral competence was achieved in 94.7% of cases (18/20) in the VSP group as opposed to 68.4% (13/19) in the conventional arm, which was statistically significant (P = 0.04). The mean overall hospital stay was higher in the VSP group (7.1 weeks ± SD) compared to the conventional group (4.4 weeks ± 0.9 SD), which was statistically significant (P &lt; 0.001). Nearly 73.7% (14/20) of cases in the VSP group were satisfied with their facial symmetry, compared to 63.2% (12/19) in the conventional group in the postoperative rehabilitation phase. However, this was not statistically significant (P &lt; 0.48). Conclusions: This index multicentric study carried out in two tertiary care hospitals of the Armed Forces Medical Services, where this emerging technology was adopted as its test arm to prove a better postoperative outcome, may have exhibited equivocal results so far, but it is encouraging results, although not proven statistically significant, hold lots of promises for the future.