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    Implications of sedation during the use of noninvasive ventilation in children with acute respiratory failure (SEDANIV Study).

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    20.500.12530/87858The objective of this study was to analyze the effects of sedation administration on clinical parameters, comfort status, intubation requirements, and the pediatric intensive care unit (PICU) length of stay (LOS) in children with acute respiratory failure (ARF) receiving noninvasive ventilation (NIV). Thirteen PICUs in Spain participated in a prospective, multicenter, observational trial from January to December 2021. Children with ARF under the age of five who were receiving NIV were included. Clinical information and comfort levels were documented at the time of NIV initiation, as well as at 3, 6, 12, 24, and 48 h. The COMFORT-behavior (COMFORT-B) scale was used to assess the patients' level of comfort. NIV failure was considered to be a requirement for endotracheal intubation. A total of 457 patients were included, with a median age of 3.3 months (IQR 1.3-16.1). Two hundred and thirteen children (46.6%) received sedation (sedation group); these patients had a higher heart rate, higher COMFORT-B score, and lower SpO2/FiO2 ratio than did those who did not receive sedation (non-sedation group). A significantly greater improvement in the COMFORT-B score at 3, 6, 12, and 24 h, heart rate at 6 and 12 h, and SpO2/FiO2 ratio at 6 h was observed in the sedation group. Overall, the NIV success rate was 95.6%-intubation was required in 6.1% of the sedation group and in 2.9% of the other group (p = 0.092). Multivariate analysis revealed that the PRISM III score at NIV initiation (OR 1.408; 95% CI 1.230-1.611) and respiratory rate at 3 h (OR 1.043; 95% CI 1.009-1.079) were found to be independent predictors of NIV failure. The PICU LOS was correlated with weight, PRISM III score, respiratory rate at 12 h, SpO2 at 3 h, FiO2 at 12 h, NIV failure and NIV duration. Sedation use was not found to be independently related to NIV failure or to the PICU LOS. Sedation use may be useful in children with ARF treated with NIV, as it seems to improve clinical parameters and comfort status but may not increase the NIV failure rate or PICU LOS, even though sedated children were more severe at technique initiation in the present sample

    Hypertensive states of pregnancy.

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    20.500.12530/87909Hypertensive disorders in pregnancy (HDP) remain a leading cause of pregnancy-related maternal and foetal morbidity and mortality worldwide, including chronic hypertension, gestational hypertension, and pre-eclampsia. Affected women and newborns also have an increased risk of cardiovascular disease later in life, independent of traditional cardiovascular disease risks. Despite these risks, recommendations for optimal diagnosis and treatment have changed little in recent decades, probably due to fear of the foetal repercussions of decreased blood pressure and possible drug toxicity. In this document we review the diagnostic criteria and classification of (HDP), as well as important aspects regarding pathophysiology and early detection that allows early identification of women at risk, with the aim of preventing both immediate and long-term consequences. Prophylactic treatment with aspirin is also reviewed early and a therapeutic approach is carried out that involves close maternal and foetal monitoring, and if necessary, the use of safe drugs in each situation. This review aims to provide an updated vision for the prevention, diagnosis, and treatment of HDP that is useful in our usual clinical practice

    <i>BRAF</i> mutational status is associated with survival outcomes in locally advanced resectable and metastatic NSCLC

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    20.500.12530/87893Background: Immunotherapy-based treatments have demonstrated high efficacy in patients with advanced and locally advanced non-small-cell lung cancer (NSCLC). BRAF mutations affect a small but significant fraction of NSCLC. The efficacy of these therapies in this subgroup of patients is unknown. Materials and methods: Plasma and tissue samples from 116 resectable stage IIIA/B NSCLC patients, included in NADIM and NADIM II clinical trials (NADIM cohort), and from a prospective academic cohort with 84 stage IV NSCLC patients (BLI-O cohort), were analyzed by next-generation sequencing. Results: The p.G464E, p.G466R, p.G466V, p.G469V, p.L597Q, p.T599I, p.V600E (n = 2) BRAF mutations, were identified in four (3.45 %) samples from the NADIM cohort, all of which were cases treated with neoadjuvant chemoimmunotherapy (CH-IO), and four (4.76 %) samples from the BLI-O cohort, corresponding to cases treated with first-line immunotherapy (n = 2) or CH-IO (n = 2). All these patients were alive and had no evidence of disease at data cut-off. Conversely, patients with BRAF wild-type (wt) tumors in the BLI-O cohort had a median progression-free survival (PFS) of 5.49 months and a median overall survival (OS) of 12.00 months (P-LogRank = 0.013 and 0.046, respectively). Likewise, PFS and OS probabilities at 36 months were 60.5 % and 76.1 % for patients with BRAF-wt tumors in the NADIM cohort. The pathological complete response (pCR) rate after neoadjuvant CH-IO in patients with BRAF-positive tumors (n = 4) was 100 %, whereas the pCR rate in the BRAF-wt population was 44.3 % (RR: 2.26; 95 % CI: 1.78-2.85;

    Aspergillus granulosus femoral osteomyelitis in a cardiac transplant patient: first reported case and literature review.

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    20.500.12530/87858Aspergillus osteomyelitis is a rare complication of extrapulmonary invasive aspergillosis, which usually presents as spondylodiscitis. The clinical picture is usually paucisymptomatic and of long evolution, which leads to diagnostic difficulties, especially in immunosuppressed patients presenting a delayed systemic host response. We report a case of femoral osteomyelitis caused by Aspergillus granulosus in a heart transplant recipient successfully treated with a combined surgical and antifungal approach. A 65-year-old heart transplant male presented with left knee pain lasting 3 months. X-ray and magnetic resonance imaging identified a lesion with aggressive characteristics at the distal third of the left femur, due to which the patient underwent excisional surgery. Aspergillus granulosus was cultured from the removed material and antifungal treatment with oral isavuconazole was started. Chest imaging excluded pulmonary aspergillosis, while the positron emission tomography/computed tomography (PET/CT) identified a remnant of a prosthetic vascular graft sewn to the proximal third of the right axillary artery, through which a catheter-based micro-axial left ventricular assist device was implanted previously as bridge to transplant therapy. The patient presented a rapid clinical improvement with complete functional recovery following the surgical treatment and the antifungal therapy and finally underwent surgical removal of the residual vascular graft. This is the first reported episode of long bone osteomyelitis due to A. granulosus that occurred in a heart transplant recipient without pulmonary infection and was successfully treated with isavuconazole. The PET/CT was useful in supporting the diagnostic process and follow-up. Cryptic fungal species can cause invasive infections, particularly in immunocompromised patients. Molecular methods are crucial in fungal identification

    Risk Factors of Ischemic Stroke in Patients With Atrial Fibrillation After Transcatheter Aortic Valve Implantation from the Randomized ENVISAGE-TAVI AF Trial.

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    20.500.12530/87913In patients with prevalent or incident atrial fibrillation (AF) after successful transcatheter aortic valve implantation (TAVI) enrolled in the EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation - in Atrial Fibrillation (ENVISAGE-TAVI AF) trial, the incidence of ischemic stroke (IS) and any stroke was numerically less in the edoxaban group than in the vitamin K antagonist (VKA) group. The present study aimed to identify risk factors associated with IS in an on-treatment subanalysis in patients from ENVISAGE-TAVI AF who received ≥1 dose of edoxaban or VKA. Baseline patient characteristics were compared in patients with and those without IS. Numerical variables were compared using a 1-way analysis of variance; categorical variables were compared using Fisher's exact test. Stepwise Cox regression determined patient characteristics associated with the first IS event. Of 1,377 patients, 41 (3.0%) experienced an IS, and 1,336 (97.0%) did not; baseline demographics and clinical characteristics were well balanced between groups. Most ISs occurred within 180 days of TAVI for edoxaban (57.9%) and VKA (68.2%). The rate of IS was 2.0/100 person-years for edoxaban versus 2.7/100 person-years for VKA. Independently associated with IS were history of systemic embolic events (hazard ratio 2.96, 95% confidence interval 1.26 to 7.00, p = 0.01) and pre-TAVI use of VKAs (hazard ratio 2.17, 95% confidence interval 1.12 to 4.20, p = 0.02). In conclusion, although the overall incidence of IS was small for patients with AF on edoxaban or VKA after successful TAVI, patients with a history of systemic embolic events or pre-TAVI use of VKAs may be at greater risk of IS after TAVI

    Implementation of the Versius robotic surgical system for thoracic surgery: first clinical evaluation of feasibility and performance.

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    20.500.12530/87908The aim of this study is to demonstrate the ability of the Versius surgical system to successfully and safely complete a range of thoracic procedures aligned with Stage 2a (Development) of the Idea, Development, Exploration, Assessment and Long-term follow-up framework for surgical innovation. This prospective study included the first 30 consecutive patients who underwent robotic surgery with Versius by 2 surgeons without prior robotic experience between 1 April 2023 and 30 December 2023 [25 lung resections (wedge, segmentectomy and lobectomy) and 5 thymectomies]. There were no specific predetermined selection criteria for each case. The primary outcome was safe completion of the procedure without unplanned conversion. Secondary outcomes included intraoperative and postoperative complications, intraoperative device-related outcomes and pathology results. Twenty-eight (93.3%) cases were completed without conversion. Both conversions were to thoracoscopy, one due to a 'console alarm' and the other due to pulmonary artery bleeding. In lung resections, median console time was 103 (90-129) min. Five (20%) patients experienced postoperative complications, most frequent was persistent air leak (16%). Median length-of-stay was 3 (2-4) days. Neither readmissions nor mortality was observed. In thymectomies, no intraoperative or postoperative complications, readmissions, reinterventions or mortality were observed. Median console time was 77 (75-89) min and median length of stay was 1 (1-1) day. This phase 2a IDEAL-D study confirms lung resections and thymectomies are feasible with the use of Versius system, laying the foundation for larger phase 2b and 3 clinical studies within the IDEAL-D framework

    Routine invasive strategy and frailty burden in non-ST-segment elevation acute myocardial infarction.

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    20.500.12530/87885To assess the prognostic impact of a routine invasive strategy according to the frailty burden in patients with non-ST-segment elevation myocardial infarction (NSTEMI) from the MOSCA-FRAIL clinical trial. The MOSCA-FRAIL trial randomized 167 frail patients, defined by a Clinical Frailty Scale (CFS) ≥ 4, with NSTEMI to an invasive or conservative strategy. The primary endpoint was the number of days alive and out of hospital (DAOH) one year after discharge. For this subanalysis, we compared the impact of an invasive strategy on the outcomes between vulnerable (CFS = 4, n = 43) and frail (CFS > 4, n = 124) patients. Compared to vulnerable patients, frail patients presented lower values of DAOH (289.8 vs. 320.6, P = 0.146), more readmissions (1.03 vs. 0.58, P = 0.046) and higher number of days spent at the hospital during the first year (10.8 vs. 3.8, P = 0.014). The causes of readmission were mostly non-cardiac (56%). Among vulnerable patients, DAOH were similar regardless of strategy (invasive vs. conservative: 325.7 vs. 314.7, P = 0.684). Among frailest patients, the invasive group tended to have less DAOH (267.7 vs. 311.1, P = 0.117). Indeed, patients with CFS > 4, invasively managed lived 29 days less than their conservative counterparts. In contrast, there were no differences in the subgroup with CFS = 4. Adult patients with frailty and NSTEMI showed different prognosis according to the degree of frailty. A routine invasive strategy does not improve outcomes and might be harmful to the frailest patients

    Femoral Extra-articular Deformity in the Context of Prosthetic Knee Surgery and Application of Customized Treatment Using 3D Planning and Printing Techniques.

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    20.500.12530/87858Extra-articular deformity is that located proximal to the femoral epicondyles or distal to the neck of the fibula. In patients with gonarthrosis associated with extra-articular deformity, a different evaluation and approach will be necessary at the time of planning the arthroplasty. 3D planning and printing techniques have had a major impact on pre-operative planning, allowing the production of custom guides at low cost and in an accessible way. To our knowledge, this is the first report of combined 3D-guided extra-articular femoral osteotomy and total knee arthroplasty (TKA) for the treatment of extra-articular deformity and knee osteoarthritis. We present the case of a 48-year-old caucasian male with gonarthrosis and a history of supracondylar femoral fracture with vicious consolidation. The pre-operative scan images were used for planning in collaboration with the engineers of the 3D planning and printing unit of our hospital. Two guides were designed and printed using biocompatible resin. The first one has a cannulated cylinder attached to a template of the patient's distal femoral surface to locate the entry point to the intramedullary canal. The second one fits the anterior cortex of the femur, over the fracture callus, and has six cannulated cylinders attached; four of them guided K-wires through the plane of the osteotomy and the other two guided position K-wires that would ensure canal alignment in the next step. A fixation and control plate was designed to maintain the corrected alignment until the definitive fixation with a retrograde femoral nail. After corrective osteotomy and fixation, TKA was performed. Six months after surgery, the patient is independent, pain-free, and does not use mechanical aids for walking. X-ray shows consolidation of the osteotomy and restoration of the mechanical axis of the limb. The use of home 3D printers and open-source software, as well as the creation of a multidisciplinary 3D unit with orthopedic surgeons and bioengineers, makes it possible to obtain customized guides or implants with satisfactory clinical results at minimal cost

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