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Comparison of glycosylated fibronectin versus soluble fms-like tyrosine kinase/placental growth factor ratio testing for the assessment of pre-eclampsia: protocol for a multicentre diagnostic test accuracy study
Introduction
Pre-eclampsia is a condition associated with significant maternal and neonatal morbidity and mortality. The prediction of pre-eclampsia in high-risk populations using angiogenic markers, such as serum placental growth factor (PlGF) assessment, has been shown to improve maternal outcomes and is recommended by the National Institute for Health and Care Excellence (NICE). However, such tests are not yet available at the point of care (POC). Glycosylated fibronectin (GlyFn) level for the prediction of pre-eclampsia development is available as a POC test (Lumella) and has the potential to aid rapid clinical decision making. This study aimed to test the hypothesis that the sensitivity of the GlyFn test is not inferior to that of the current gold standard of soluble fms-like tyrosine kinase (sFlt)/PlGF-based laboratory testing for pre-eclampsia.
Methods and analysis
This is a multicentre prospective study. Women at risk for pre-eclampsia based on predefined clinical and/or obstetric risk factors will be invited to participate in the study. The recruitment target is 400 participants. Consenting participants will have paired samples for sFlt/PlGF together with POC GlyFn testing. Two follow-up visits are planned at 2 and 4 weeks after the initial recruitment where repeat testing with both tests will be performed. The clinical team will be blinded to the results of the GlyFn test but not that of the sFlt/PlGF test. Clinical care will be based on established protocols incorporating maternal/fetal evaluation and the results of sFlt/PlGF levels. Maternal and neonatal outcome data will be collected to compare the sensitivity and specificity of the tests, with the primary outcome being delivery for pre-eclampsia within 4 weeks.
Ethics and dissemination
Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales Ethics Committee. The results of this study will be published in peer-reviewed journals and presented at scientific conferences.
Trial registration number
ISRCTN13430018
Abstract WP187: Graph neural networks for impossible transfemoral access pre-procedural prediction in stroke mechanical thrombectomy
Stroke, Volume 56, Issue Suppl_1, Page AWP187-AWP187, February 1, 2025. Introduction:3 to 5% of patients undergoing endovascular thrombectomy present impossible catheter access to the occlusion site from transfemoral access (TFA), largely attributed to complex arterial anatomy. Radial access can be an effective bailout strategy, but intraprocedural delays may negatively impact outcomes. Novel image processing algorithms allow for advanced characterization of vascular pathways from baseline neuroimaging, enabling the exploration of predictive models of impossible TFA before arterial puncture.Methods:A retrospective cohort of patients with an anterior large vessel occlusion who received thrombectomy from TFA between 2017 and 2023 were included in this study. A previously described automatic vascular analysis software was used to generate centerline graphs from the aorta to the intracranial occlusion site from baseline CTA. ArterialGNet, a graph neural network based on graph attention designed to integrate descriptors of centerline pathways extracted at three different distance scales, was trained for impossible TFA prediction. Five-fold cross validation was used for model derivation. The method was compared to a previously introduced random forest ensemble model with extreme gradient boosting (XGBRF) based on six vascular tortuosity descriptors of the aortic and supra-aortic regions.Results:A total of 745 patients (aged 78 years IQR 68-85, 56% women) were included in this study. Patients treated between 2017 to 2022 (n=568, 3.2% with impossible TFA) were used for model training and validation. Patients treated in 2023 (n=177, 3.4% with impossible TFA) were held out for testing. In validation, the best-performing configuration of ArterialGNet achieved a C-statistic of 0.82 (95%CI 0.74-0.90), similar to the baseline model (0.82, 95%CI 0.77-0.88). Comparable outcomes were observed in the final testing for ArterialGNet (0.84, 95%CI: 0.82–0.86). In contrast, the XGBRF model exhibited signs of overfitting (0.65, 95% CI: 0.53–0.78). In final testing, ArterialGNet predicted impossible TFA with a sensitivity of 0.80 (95%CI 0.66-0.94) and a specificity of 0.84 (95%CI 0.76-0.91). Median processing time for ArterialGNet was below 4 min.Conclusions:A novel model for impossible TFA prediction was validated with a large dataset. Impossible TFA prediction before arterial puncture may assist in decision support for initial access selection in thrombectomy, reducing intraprocedural delays and potentially improving clinical outcomes.
Abstract TMP76: Inadequate Pre-Procedure Antiplatelet Medication Use May Explain the Higher Risk of Peri-Procedural Stroke and/or Death with Carotid Stent Placement within First 7 Days after Qualifying Ischemic Event
Stroke, Volume 56, Issue Suppl_1, Page ATMP76-ATMP76, February 1, 2025. Background and Purpose:In randomized trials, carotid artery stent (CAS) may have higher risk of periprocedural risk compared with carotid endarterectomy (CEA) if performed within the first 7 days after the onset of symptoms.Methods:We analyzed the data from Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). The time interval between the most recent qualifying ischemic event and CAS/CEA procedure was divided in four strata: 1-7 days, 8-14 days, 15-30 days and >30 days. We analyzed the effect of time interval strata between most recent qualifying ischemic event and procedure and procedure type (CEA versus CAS) on peri-procedural stroke and/or death after adjusting for age, gender, symptomatic status and initial severity of stenosis (≥70% versus 30 days (CAS 7.8% versus CAE 4.3%, p=0.12), after the most recent qualifying event. In the multivariate analysis, patients who underwent CAS had higher rate of peri-procedural stroke and/or death (odds ratio [OR] 2.36, 95% confidence interval [CI] 1.25- 4.66) but timing of procedure were not associated with higher rate of peri-procedural stroke and/or death after adjustment for potential confounders. The interaction between procedure type and timing of procedure was not significant. The rate of peri-procedural stroke and/or death was significantly higher in CAS patients who received clopidogrel bolus (without 48-hour maintenance dose) among patients treated 7 days or less after the qualifying event compared with those undergoing CEA (6.6% versus 0%, p=0.012) but was not different between CAS patients who received 48 hours of clopidogrel maintenance and those undergoing CEA (0% versus 0%).Conclusions:The higher rate of peri-procedural stroke and/or death seen with CAS (compared with CEA) within the first 7 days may be attributed to factors such as inadequate pre-procedure antiplatelet medication use. The results of CAS and CEA may become comparable within the first 7 days after the qualifying ischemic event with use of newer generation P2Y12 platelet inhibitors that achieve rapid antiplatelet inhibition.