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1.
Arch Bone Jt Surg ; 12(4): 256-263, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38716182

RESUMEN

Objectives: The surgical management of periprosthetic fractures (PPF) and periimplant fractures (PIF) can be challenging. The locking attachment plate (LAP) was proposed in recent years for the osteosynthesis of such fractures. The aim of this study was to assess the experience of a third-level hospital with LAP for the treatment of PPF and PIF, and analyse the clinical outcomes. Methods: Data were prospectively collected and analysed from all patients whose PPF/PIF was treated surgically with LAP in a third-level hospital from June 2018 to June 2022. All fractures were postoperative low-energy femur fractures. The minimum follow-up period was six months. Results: Thirty-eight patients (31 women) met the eligibility criteria. The mean age was 86.3 years. The median time until surgery was 4 days. A mean of 3.61 screws were used for each LAP. The mean femur plate length was 14 holes, and the mean working length 7.1 holes. The median hospital stay was nine days. The mean follow-up was 19.56 months. At one month, 12 patients tolerated partial weight-bearing. Five patients walked independently indoors. One patient had died and seven patients were readmitted. At six months, six more patients had died. Fifteen patients tolerated full weight-bearing (FWB). Nine patients walked independently indoors, six outdoors. Twenty-five patients reached fracture consolidation without malalignment. Nine patients were readmitted. At 12 months, another patient had died. Seventeen patients tolerated FWB. Eleven patients walked independently indoors, six outdoors. Twenty-five patients achieved fracture consolidation without malalignment. Five patients were readmitted. Fourteen patients crossed the two-year postoperative threshold. All achieved fracture consolidation. Two patients passed the 4-year postoperative milestone. Conclusion: The clinical results of patients whose PPF or PIF was treated with the LAP are promising. This fixation method is a viable option to be considered when planning surgery for such fractures.

3.
J Neurointerv Surg ; 2024 Apr 25.
Artículo en Inglés | MEDLINE | ID: mdl-38663997

RESUMEN

BACKGROUND: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE. METHODS: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality. RESULTS: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively. CONCLUSION: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.

4.
Epidemiologia (Basel) ; 5(2): 167-186, 2024 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-38651389

RESUMEN

Our goal was to determine the cellular immune response (CIR) in a sample of the Borriana COVID-19 cohort (Spain) to identify associated factors and their relationship with infection, reinfection and sequelae. We conducted a nested case-control study using a randomly selected sample of 225 individuals aged 18 and older, including 36 individuals naïve to the SARS-CoV-2 infection and 189 infected patients. We employed flow-cytometry-based immunoassays for intracellular cytokine staining, using Wuhan and BA.2 antigens, and chemiluminescence microparticle immunoassay to detect SARS-CoV-2 antibodies. Logistic regression models were applied. A total of 215 (95.6%) participants exhibited T-cell response (TCR) to at least one antigen. Positive responses of CD4+ and CD8+ T cells were 89.8% and 85.3%, respectively. No difference in CIR was found between naïve and infected patients. Patients who experienced sequelae exhibited a higher CIR than those without. A positive correlation was observed between TCR and anti-spike IgG levels. Factors positively associated with the TCR included blood group A, number of SARS-CoV-2 vaccine doses received, and anti-N IgM; factors inversely related were the time elapsed since the last vaccine dose or infection, and blood group B. These findings contribute valuable insights into the nuanced immune landscape shaped by SARS-CoV-2 infection and vaccination.

5.
Biol Sex Differ ; 15(1): 34, 2024 Apr 08.
Artículo en Inglés | MEDLINE | ID: mdl-38589872

RESUMEN

BACKGROUND: Children with pregnancy-associated plasma protein-A2 (PAPP-A2) mutations resulting in low levels of bioactive insulin-like growth factor-1 (IGF1) and progressive postnatal growth retardation have improved growth velocity and height following recombinant human (rh)IGF1 treatment. The present study aimed to evaluate whether Pappa2 deficiency and pharmacological manipulation of GH/IGF1 system are associated with sex-specific differences in growth-related signaling pathways. METHODS: Plasma, hypothalamus, pituitary gland and liver of Pappa2ko/ko mice of both sexes, showing reduced skeletal growth, and liver of these mice treated with rhGH, rhIGF1 and rhPAPP-A2 from postnatal day (PND) 5 to PND35 were analyzed. RESULTS: Reduced body and femur length of Pappa2ko/ko mice was associated with increases in: (1) components of IGF1 ternary complexes (IGF1, IGFBP5/Igfbp5, Igfbp3, Igfals) in plasma, hypothalamus and/or liver; and (2) key signaling regulators (phosphorylated PI3K, AKT, mTOR, GSK3ß, ERK1/2 and AMPKα) in hypothalamus, pituitary gland and/or liver, with Pappa2ko/ko females having a more prominent effect. Compared to rhGH and rhIGF1, rhPAPP-A2 specifically induced: (1) increased body and femur length, and reduced plasma total IGF1 and IGFBP5 concentrations in Pappa2ko/ko females; and (2) increased Igf1 and Igf1r levels and decreased Ghr, Igfbp3 and Igfals levels in the liver of Pappa2ko/ko females. These changes were accompanied by lower phospho-STAT5, phospho-AKT and phospho-ERK2 levels and higher phospho-AMPK levels in the liver of Pappa2ko/ko females. CONCLUSIONS: Sex-specific differences in IGF1 system and signaling pathways are associated with Pappa2 deficiency, pointing to rhPAPP-A2 as a promising drug to alleviate postnatal growth retardation underlying low IGF1 bioavailability in a female-specific manner.


Understanding the physiological role of pregnancy-associated plasma protein-A2 (PAPP-A2), a proteinase involved in the insulin-like growth factor-1 (IGF1) availability to regulate growth, could provide insight into new treatments for patients with short stature and skeletal abnormalities. Although progressive postnatal growth retardation in patients with PAPP-A2 mutations can differ between males and females, we do not know the underlying differences in IGF1 system and signaling, and their response to treatment that contribute to growth improvement. The present study examines whether Pappa2 deficiency and pharmacological administration of rhGH, rhIGF1 and rhPAPP-A2 are associated with sex-specific differences in IGF1 ternary complexes and IGF1 signaling pathways. Reduced body and femur length of Pappa2-deficient mice was associated with sex- and tissue-specific alteration of IGF ternary/binary complexes and IGF1 signaling pathways. rhPAPP-A2 treatment induced female-specific increase in body and femur length and reduction in IGF ternary/binary complexes through STAT5-AKT-ERK2-AMPK signaling pathways in liver. The involvement of PAPP-A2 in sex-based growth physiology supports the use of promising drugs to alleviate postnatal growth retardation underlying low IGF1 bioavailability in a female-specific manner.


Asunto(s)
Piperazinas , Proteína Plasmática A Asociada al Embarazo , Proteínas Proto-Oncogénicas c-akt , Humanos , Masculino , Niño , Ratones , Femenino , Animales , Proteína Plasmática A Asociada al Embarazo/genética , Proteína Plasmática A Asociada al Embarazo/metabolismo , Trastornos del Crecimiento/metabolismo
6.
World Neurosurg ; 2024 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-38580091

RESUMEN

BACKGROUND: Pilocytic astrocytomas (PA) are the most common gliomas in children/adolescents but are less common and poorly studied in adults. Here, we describe the clinical presentation, surgical management, and outcomes of surgically treated adult patients with intraventricular (IV) PA and review the literature. METHODS: Consecutive adult patients treated for IV brain tumors at a tertiary academic center over 25 years (1997-2023) were identified. Clinical data were reviewed retrospectively for adult IV PA patients. A systematic literature review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. RESULTS: Eight patients with IV PA were included. Median age was 25 years (range, 18-69 years), and 4 (50%) were female. The most common tumor location was the lateral ventricle (5, 63%), followed by the fourth ventricle (3, 37%). Subtotal and near total resection were the most common surgical outcomes (6 patients, 75%), followed by gross total resection in 2 (25%). Progression or recurrence occurred in 3 patients (37%), requiring repeat resection in 2 patients. The 5-year overall survival and progression-free survival were 67% and 40%, respectively. In addition, 42 cases were identified in the literature. CONCLUSIONS: PAs in adults are rare and an IV location is even more uncommon. The findings demonstrate the challenges in caring for these patients, with overall- and progression-free survival outcomes being poorer than the general adult PA population. Findings support the employment of surgical techniques and approaches that favor gross total resection when possible. Further studies are needed to better characterize this unique presentation.

7.
Toxics ; 12(3)2024 Feb 29.
Artículo en Inglés | MEDLINE | ID: mdl-38535924

RESUMEN

Alcohol use disorder (AUD) is a major component in the etiology of cognitive decline and dementia. Underlying mechanisms by which long-term alcohol abuse causes cognitive dysfunction include excessive oxidative stress and inflammation in the brain, activated by increased reactive oxygen/nitrogen species (ROS/RNS), advanced glycation end-products (AGEs) and high-mobility group box 1 protein (HMGB1). In a pilot study, we examine the potential clinical value of circulating biomarkers of oxidative stress including ROS/RNS, HMGB1, the soluble receptor for AGE (sRAGE), the brain biomarker of aging apolipoprotein D (ApoD), and the antioxidant regulator nuclear factor erythroid 2-related factor 2 (NRF2) as predictive indices for cognitive impairment (CI) in abstinent patients with AUD (n = 25) compared to patients with established Alzheimer's disease (AD, n = 26) and control subjects (n = 25). Plasma concentrations of sRAGE were evaluated with immunoblotting; ROS/RNS with a fluorometric kit; and HMGB1, ApoD, and NRF2 by ELISA. Abstinent AUD patients had higher sRAGE, ROS/RNS (p < 0.05), and ApoD (p < 0.01) concentrations, similar to those of AD patients, and lower NRF2 (p < 0.01) concentrations, compared to controls. These changes were remarkable in AUD patients with CI. HMGB1, and sRAGE correlated positively with duration of alcohol use (rho = 0.398, p = 0.022; rho = 0.404, p = 0.018), whereas sRAGE correlated negatively with periods of alcohol abstinence (rho = -0.340, p = 0.045). A predictive model including ROS/RNS, HMGB1, sRAGE, alcohol use duration, and alcohol abstinence periods was able to differentiate AUD patients with CI (92.3% of correct predictions, ROC-AUC= 0.90) from those without CI. In conclusion, we propose ROS/RNS, HMGB1, and sRAGE as stress biomarkers capable of predicting cognitive impairment in AUD patients.

8.
J Neurointerv Surg ; 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-38429099

RESUMEN

BACKGROUND: Endovascular therapy (EVT) stands as an established and effective intervention for acute ischemic stroke in patients harboring tandem lesions (TLs). However, the optimal anesthetic strategy for EVT in TL patients remains unclear. This study aims to evaluate the impact of distinct anesthetic techniques on outcomes in acute ischemic stroke patients presenting with TLs. METHODS: Patient-level data, encompassing cases from 16 diverse centers, were aggregated for individuals with anterior circulation TLs treated between January 2015 and December 2020. A stratification based on anesthetic technique was conducted to distinguish between general anesthesia (GA) and procedural sedation (PS). Multivariable logistic regression models were built to discern the association between anesthetic approach and outcomes, including the favorable functional outcome defined as 90-day modified Rankin Score (mRS) of 0-2, ordinal shift in mRS, symptomatic intracranial hemorrhage (sICH), any hemorrhage, successful recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) score ≥2b), excellent recanalization (mTICI 3), first pass effect (FPE), early neurological improvement (ENI), door-to-groin and recanalization times, intrahospital mortality, and 90-day mortality. RESULTS: Among 691 patients from 16 centers, 595 patients (GA 38.7%, PS 61.3%) were included in the final analysis. There were no significant differences noted in the door-to-groin time (80 (46-117.5) mins vs 54 (21-100), P=0.607) and groin to recanalization time (59 (39.5-85.5) mins vs 54 (38-81), P=0.836) among the groups. The odds of a favorable functional outcome (36.6% vs 52.6%; adjusted OR (aOR) 0.56, 95% CI 0.38 to 0.84, P=0.005) and a favorable shift in the 90-day mRS (aOR 0.71, 95% CI 0.51 to 0.99, P=0.041) were lower in the GA group. No differences were noted for sICH (3.9% vs 4.7%, P=0.38), successful recanalization (89.1% vs 86.5%, P=0.13), excellent recanalization (48.5% vs 50.3%, P=0.462), FPE (53.6% vs 63.4%, P=0.05), ENI (38.9% vs 38.8%, P=0.138), and 90-day mortality (20.3% vs 16.3%, P=0.525). An interaction was noted for favorable functional outcome between the type of anesthesia and the baseline Alberta Stroke Program Early CT Score (ASPECTS) (P=0.033), degree of internal carotid artery (ICA) stenosis (P<0.001), and ICA stenting (P<0.001), and intraparenchymal hematoma between the type of anesthesia and intravenous thrombolysis (P=0.019). In a subgroup analysis, PS showed better functional outcomes in patients with age ≤70 years, National Institutes of Health Stroke Scale (NIHSS) score <15, and acute ICA stenting. CONCLUSIONS: Our findings suggest that the preference for PS not only aligns with comparable procedural safety but is also associated with superior functional outcomes. These results prompt a re-evaluation of current anesthesia practices in EVT, urging clinicians to consider patient-specific characteristics when determining the optimal anesthetic strategy for this patient population.

9.
Artículo en Inglés | MEDLINE | ID: mdl-38459359

RESUMEN

Age estimation is a major challenge in anthropology and forensic odontology laboratories, as well as in judicial settings, as one of the tools used in human identification. The aim of this study was to evaluate the usefulness of age estimation methods based on the accurate measurement of tooth color changes. A systematic review was carried out following the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and in compliance with Cochrane criteria recommendations (PROSPERO registration number CRD 42022343371). An electronic search was performed in the following databases: Pubmed, Web of Science, Medline, Current Contents Connect, SciELO, KCI-Korean Journal Database, Derwent Innovations Index and Russian Citation Index. The search strategy yielded a total of 18 articles. A randomized meta-analysis model of the results for the CIE L*a*b* color variables stratified by age (less than 30 years, 30-60 years, 60 years and older) was performed with 9 of the 18 studies included in this systematic review. According to our results, sex and location of color measurement are the most influential factors in color estimation. All studies were carried out in healthy anterior teeth by spectrophotometry as the most commonly used method for color measurement, with CIE L*a*b* being the most commonly analyzed parameters. Studies based on age as a dependent variable showed R2 values between 0.28 and 0.56, being higher in ex vivo teeth. Studies based on age as an independent variable showed R2 values ranging from 0.10 to 0.48. The random model showed high heterogeneity for the L*, a* and b* parameters in all age groups, which is explained by discrepancies in age range and non-standardized conditions for color measurement. This systematic review highlights the need to protocolize age estimation studies that measure tooth color, in order to apply this method in different forensic settings.

10.
Eur Stroke J ; : 23969873241234713, 2024 Feb 25.
Artículo en Inglés | MEDLINE | ID: mdl-38403924

RESUMEN

INTRODUCTION: Recent randomized controlled trials demonstrated superiority of mechanical thrombectomy compared to medical therapy in acute basilar artery occlusions, however, little data is available to guide clinicians in functional prognosis and risk stratification. PATIENTS AND METHODS: Data from the retrospectively established PC-SEARCH Thrombectomy registry, which included patients with basilar artery occlusion from eight sites from January 2015 to December 2021, was interrogated. Outcomes were dichotomized into 90-day favorable (mRS ⩽ 3) and unfavorable (mRS > 3). Multivariate logistic regression analysis was performed with respect to the outcome groups and were adjusted for potential confounding baseline characteristics. RESULTS: Four-hundred-forty-four patients were included in this analysis. Mean age was 66 [SD 15], with 56% male, and comprised of 76% Caucasian. Patients presented with an initial median NIHSS of 18 and 199 patients (44.8%) achieved favorable 90-day functional outcomes. Independent predictors of favorable outcomes included younger age, pc-ASPECTS > 8 (OR 2.30 p < 0.001), and TICI ⩾ 2b (OR 7.56 p < 0.001). Unfavorable outcomes were associated with increasing number of passes (OR 1.29 p = 0.004) and sICH (OR 4.19 p = 0.015). IA-tPA was an independent risk factor for sICH (OR 7.15 p = 0.002) without improving favorable functional outcomes. CONCLUSION AND DISCUSSION: PC-ASPECTS > 8, successful recanalization (TICI ⩾ 2b), first-pass recanalization, and younger age are independent predictors of favorable 90-day functional outcome in thrombectomy treated patients with acute basilar artery occlusion. Conversely, sICH were independent predictors of unfavorable outcomes. IA-tPA and unsuccessful recanalization are independently associated with sICH.

11.
Neurosurg Rev ; 47(1): 75, 2024 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-38319484

RESUMEN

Intramedullary spinal cord metastasis (ISCM), though rare, represents a potentially debilitating manifestation of systemic cancer. With emerging advances in cancer care, ISCMs are increasingly being encountered in clinical practice. Herein, we describe one of the larger retrospective single institutional case series on ISCMs, analyze survival and treatment outcomes, and review the literature. All surgically evaluated ISCMs at our institution between 2005 and 2023 were retrospectively reviewed. Demographics, tumor features, treatment, and clinical outcome characteristics were collected. Neurological function was quantified via the Frankel grade and the McCormick score (MCS). The pre- and post-operative Karnofsky performance scores (KPS) were used to assess functional status. Descriptive statistics, univariate analysis, log-rank test, and the Kaplan-Meier survival analysis were performed. A total of 9 patients were included (median age 67 years (range, 26-71); 6 were male). Thoracic and cervical spinal segments were most affected (4 patients each). Six patients (75%) underwent surgical management (1 biopsy and 5 resections), and 3 cases underwent chemoradiation only. Post-operatively, 2 patients had an improvement in their neurological exam with one patient becoming ambulatory after surgery; three patients maintained their neurological exam, and 1 had a decline. There was no statistically significant difference in the pre- and post-operative MCS and median KPS scores in surgically treated patients. Median OS after ISCM diagnosis was 7 months. Absence of brain metastasis, tumor histology (renal and melanoma), cervical/thoracic location, and post-op KPS ≥ 70 showed a trend toward improved overall survival. The incidence of ISCM is increasing, and earlier diagnosis and treatment are considered key for the preservation of neurological function. When patient characteristics are favorable, surgical resection of ISCM can be considered in patients with rapidly progressive neurological deficits. Surgical treatment was not associated with an improvement in overall survival in patients with ISCMs.


Asunto(s)
Neoplasias Encefálicas , Neoplasias de la Médula Espinal , Neoplasias de la Columna Vertebral , Humanos , Masculino , Anciano , Femenino , Estudios Retrospectivos , Neoplasias de la Columna Vertebral/cirugía , Neoplasias de la Médula Espinal/cirugía , Biopsia
12.
Front Neurol ; 15: 1352310, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38343711

RESUMEN

Importance: Stroke-to-recanalization time is a strong predictor of outcomes in anterior circulation large-vessel occlusion (LVO). The authors aimed to evaluate functional outcomes in early (<6 h) vs. late (6-24 h) time windows for thrombectomy-treated basilar artery occlusions. Methods: Patients were derived from the Posterior Circulation Ischemic Stroke Evaluation: Analyzing Radiographic and Intra-procedural Predictors of Mechanical Thrombectomy (PC-SEARCH) Registry and retrospectively analyzed early and late basilar artery thrombectomy time windows cohorts. Patients were dichotomized based on the last known well and correlated to 90-day functional outcomes (mRS 0-3). A multiple logistic regression analysis was performed. Results: A total of 405 patients were included in this study: 216 and 189 patients in the early and late time windows, respectively. Baseline demographic, stroke, radiographic, and intraprocedural characteristics were similar between the groups. A total of 99 (46%) and 79 (42%) patients in the early and late time windows, respectively, achieved favorable functional outcomes at 90 days (p = 0.41), and multiple logistic regression analysis did not reveal differences between cohorts (OR: 0.74; 95% CI: 0.46-1.19; p = 0.22). Symptomatic hemorrhage (7% vs. 5%; p = 0.69) and neurological complications (8% vs. 9%; p = 0.83) were similar between the groups; however, hospital complications were more common in the early time window cohort (22% vs. 13%; p = 0.01). Conclusion: The early and late thrombectomy time windows can achieve similar rates of 90-day favorable functional outcomes. However, timely thrombectomy influences the likelihood of achieving excellent functional outcomes (mRS ≤ 2) within the early time window.

13.
Int J Mol Sci ; 25(4)2024 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-38396643

RESUMEN

Paracetamol, or acetaminophen (N-acetyl-para-aminophenol, APAP), is an analgesic and antipyretic drug that is commonly used worldwide, implicated in numerous intoxications due to overdose, and causes serious liver damage. APAP can cross the blood-brain barrier and affects brain function in numerous ways, including pain signals, temperature regulation, neuroimmune response, and emotional behavior; however, its effect on adult neurogenesis has not been thoroughly investigated. We analyze, in a mouse model of hepatotoxicity, the effect of APAP overdose (750 mg/kg/day) for 3 and 4 consecutive days and after the cessation of APAP administration for 6 and 15 days on cell proliferation and survival in two relevant neurogenic zones: the subgranular zone of the dentate gyrus and the hypothalamus. The involvement of liver damage (plasma transaminases), neuronal activity (c-Fos), and astroglia (glial fibrillar acidic protein, GFAP) were also evaluated. Our results indicated that repeated APAP overdoses are associated with the inhibition of adult neurogenesis in the context of elevated liver transaminase levels, neuronal hyperactivity, and astrogliosis. These effects were partially reversed after the cessation of APAP administration for 6 and 15 days. In conclusion, these results suggest that APAP overdose impairs adult neurogenesis in the hippocampus and hypothalamus, a fact that may contribute to the effects of APAP on brain function.


Asunto(s)
Enfermedad Hepática Inducida por Sustancias y Drogas , Sobredosis de Droga , Ratones , Masculino , Animales , Acetaminofén/farmacología , Enfermedad Hepática Inducida por Sustancias y Drogas/metabolismo , Transaminasas/metabolismo , Neurogénesis , Hígado/metabolismo , Ratones Endogámicos C57BL
14.
EFSA J ; 22(1): e8517, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38213415

RESUMEN

The qualified presumption of safety (QPS) process was developed to provide a safety assessment approach for microorganisms intended for use in food or feed chains. The QPS approach is based on an assessment of published data for each taxonomic unit (TU), with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a TU are, where possible, confirmed at the species/strain or product level and reflected by 'qualifications'. In the period covered by this Statement, no new information was found that would change the status of previously recommended QPS TUs. Of 71 microorganisms notified to EFSA between April and September 2023 (30 as feed additives, 22 as food enzymes or additives, 7 as novel foods and 12 from plant protection products [PPP]), 61 were not evaluated because: 26 were filamentous fungi, 1 was Enterococcus faecium, 5 were Escherichia coli, 1 was a bacteriophage (all excluded from the QPS evaluation) and 28 were TUs that already have a QPS status. The other 10 notifications belonged to 9 TUs which were evaluated for a possible QPS status: Ensifer adhaerens and Heyndrickxia faecalis did not get the QPS recommendation due to the limited body of knowledge about their occurrence in the food and/or feed chains and Burkholderia ubonensis also due to its ability to generate biologically active compounds with antimicrobial activity; Klebsiella pneumoniae, Serratia marcescens and Pseudomonas putida due to safety concerns. K. pneumoniae is excluded from future QPS evaluations. Chlamydomonas reinhardtii is recommended for QPS status with the qualification 'for production purposes only'; Clostridium tyrobutyricum is recommended for QPS status with the qualification 'absence of genetic determinants for toxigenic activity'; Candida oleophila has been added as a synonym of Yarrowia lipolytica. The Panel clarifies the extension of the QPS status for genetically modified strains.

16.
Interv Neuroradiol ; : 15910199231223538, 2024 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-38166487

RESUMEN

BACKGROUND: The potentially higher risk of hemorrhagic complications is of concern in stent-assisted coiling (SAC) of ruptured wide-necked intracranial aneurysms (IAs). The Woven EndoBridge (WEB) is considered an appealing alternative since antiplatelet therapy is not required. Herein, we aimed to compare the safety and effectiveness of WEB vs. SAC for the treatment of ruptured wide-necked IAs. METHODS: This was an international cross-sectional study of consecutive patients treated for ruptured wide-neck IAs with WEB or SAC at four high-volume neurovascular centers between 2019 and 2022. Primary and secondary efficacy outcomes were radiographic aneurysm occlusion at follow-up and functional status at last follow-up. Safety outcomes included periprocedural hemorrhagic/ischemia-related complications. RESULTS: One hundred five patients treated with WEB and 112 patients treated with SAC were included. The median procedure duration of endovascular treatment was shorter for WEB than for SAC (69 vs. 76 min; p = 0.04). There were no significant differences in complete aneurysm occlusion rates (SAC: 64.5% vs. WEB: 60.9%; adjusted OR [aOR] = 0.70; 95%CI 0.34-1.43; p = 0.328). SAC had a significantly higher risk of complications (23.2% vs. 9.5%, p = 0.009), ischemic events (17% vs. 6.7%, p = 0.024), and EVD hemorrhage (16% vs. 0%, p = 0.008). The probability of procedure-related complications across procedure time was significantly lower with WEB compared with SAC (aOR = 0.40; 95%CI 0.20-1.13; p = 0.03). CONCLUSION: WEB and SAC demonstrated similar obliteration rates at follow-up when used for embolization of ruptured wide-necked IAs. However, SAC showed higher rates of procedure-related complications primarily driven by ischemic events and higher rates of EVD hemorrhage. The overall treatment duration was shorter for WEB than for SAC.

17.
Int J Spine Surg ; 18(1): 32-36, 2024 Mar 04.
Artículo en Inglés | MEDLINE | ID: mdl-37903540

RESUMEN

INTRODUCTION: Lumbosacral traumatic spondylolisthesis L5-S1 is a rare clinical entity that compromises the stability of the L5 vertebra by displacing it anteriorly, laterally, or posteriorly on the S1 vertebral body secondary to osteotendinous and/or articular compromise of this segment due to trauma. This pathology is difficult to classify and manage; although surgical management remains the gold standard, short- and long-term results in the literature are scarce and highly variable. PATIENT PRESENTATION: We present the case of a 53-year-old patient with lumbar trauma due to a free fall from a height of 6 meters. The fall resulted in cauda equina syndrome secondary to lumbosacral traumatic spondylolisthesis L5-S1, which required immediate surgical management. INTERVENTION AND OUTCOME: For surgical management, we used a posterior approach for L5-S1 transpedicular screw fixation, spinal decompression, bilateral root foraminotomy of L5, and L5-S1 open transforaminal lumbar interbody fusion with open reduction. After the operation, the patient reported immediate improvement of postoperative lower extremities pain and was discharged on the third postoperative day after achieving clinical improvement with physical therapy and bladder rehabilitation exercises. CONCLUSION: Lumbosacral traumatic spondylolisthesis L5-S1 is an unusual pathology that requires further study as there is currently no standardized classification. Surgical management is the gold standard and includes open reduction with short transpedicular screw fixation in segment L5-S1 and other surgical interventions such as extension to the pelvis with iliac screws, screws to the L4 vertebral body, and use of lumbar interbody fusion cages.

18.
World Neurosurg ; 182: 99, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38030075

RESUMEN

Augmented reality (AR) is an emerging technology in medicine that is underexplored in the endovascular neurosurgery arena. We describe a novel technique integrating the Hololens 2 head-mounted AR (HMAR) system for navigation of the intracranial circulation and simple coiling of an aneurysm silicone model. Computed tomography angiographies (CTAs) of the silicone models were obtained, simulating the preprocedural CTA obtained for patient treatments. CTA was imported into the 3-dimensional (3D) HMAR system, and a 3D hologram of the circulation was created. Using the right common carotid artery run (performed in the silicon model) as a landmark, the AR hologram was superimposed on the angiography screen (Video 1). A 5-French sheath, intermediate catheter, 0.012-inch microcatheter, and microwire were used for the purely navigational model. The same process was repeated with the aneurysm model, which was navigated with a 0.58 intermediate catheter, 0.17 microcatheter, 0.014 microwire, and 6 × 15 3D-shaped soft coil. The proximal and distal vessels of the flow model were successfully navigated using the AR hologram, which replaced the conventional roadmap. No contrast ¨puffs¨ were needed because the hologram replaced the roadmap from proximal to distal vasculature. The silicon navigational model and aneurysm model were successfully navigated using only the AR 3D model. A coil was deployed in the aneurysm model. Finally, a 3D-360-degree examination of the aneurysmal anatomy was possible during the procedure. The concept of HMAR-assisted cerebral angiography is feasible. We were able to perform the whole intracranial navigation using only the preoperative CTA. Additional refinements and fine-tuning of the registration and alignment of the hologram to the silicon model or anatomy of the patient are needed before this technology can be incorporated into clinical practice. In the meantime, the use of this tool for the training and development of endovascular skills offers valuable educational opportunities. Further advances in this direction aiming to create real 3D roadmaps are needed to decrease contrast use, radiation exposure, and navigation times.


Asunto(s)
Aneurisma , Realidad Aumentada , Neurocirugia , Humanos , Silicio , Angiografía Cerebral , Siliconas
20.
J Cerebrovasc Endovasc Neurosurg ; 26(1): 23-29, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-37813698

RESUMEN

OBJECTIVE: Flow diverting stents (FDS) are increasingly used for the treatment of intracranial aneurysms. While FDS can provide flow diversion of parent vessels, their high metal surface coverage can cause thromboembolism. Transcranial Doppler (TCD) emboli monitoring can be used to identify subclinical embolic phenomena after neurovascular procedures. Limited data exists regarding the use of TCDs for emboli monitoring in the periprocedural period after FDS placement. We evaluated the rate of positive TCDs microembolic signals and stroke after FDS deployment at our institution. METHODS: We retrospectively evaluated 105 patients who underwent FDS treatment between 2012 and 2016 using the Pipeline stent (Medtronic, Minneapolis, MN, USA). Patients were pretreated with aspirin and clopidogrel. All patients were therapeutic on clopidogrel pre-operatively. TCD emboli monitoring was performed immediately after the procedure. Microembolic signals (mES) were classified as "positive" (<15 mES/hour) and "strongly positive" (>15 mES/hour). Clinical stroke rates were determined at 2-week and 6-month post-operatively. RESULTS: A total of 132 intracranial aneurysms were treated in 105 patients. TCD emboli monitoring was "positive" in 11.4% (n=12) post-operatively and "strongly positive" in 4.8% (n=5). These positive cases were treated with heparin drips or modification of the antiplatelet regimen, and TCDs were repeated. Following medical management modifications, normalization of mES was achieved in 92% of cases. The overall stroke rates at 2-week and 6-months were 3.8% and 4.8%, respectively. CONCLUSIONS: TCD emboli monitoring may help early in the identification of thromboembolic events after flow diversion stenting. This allows for modification of medical therapy and, potentially, preventionf of escalation into post-operative strokes.

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