BACKGROUND:In most cases, routine neuropathological analysis can clearly distinguish between methylated and unmethylated MGMT promoters in glioblastoma (GBM). However, some GBMs display weak MGMT promoter methylation. This study aimed to evaluate its impact on disease progression and survival compared with fully methylated and unmethylated cases. METHODS:A quantitative analysis of MGMT promoter methylation was performed on 140 of 190 samples from a cohort of adult patients with newly diagnosed GBM. The MGMT promoter was stratified into three subgroups based on methylation status: unmethylated, weakly methylated (9-28%), and methylated (29-100%). These cut-off values were selected based on previously published data demonstrating significant differences in progression-free survival (PFS) and overall survival (OS) among patients with these categories. Clinical characteristics, treatment regimens, and survival outcomes were analyzed and compared. Cox proportional hazards regression was used to evaluate the impact of MGMT methylation status on progression-free interval (PFI) and overall survival (OS). RESULTS:The MGMT promoter was unmethylated in 57 (40.7%) samples, methylated in 66 (47.1%) samples, and weakly methylated in 17 (12.1%) samples. Compared to patients with methylated and unmethylated MGMT promoters, the PFI of patients with weak MGMT methylation was comparable (P=0.53) and the OS was slightly longer (P=0.08). After stratification following chemoradiotherapy consisting of TMZ, patients with weakly methylated MGMT have a longer PFI. The Cox proportional hazards regression model revealed that a weakly methylated MGMT promoter was a significant risk factor for longer OS (P=0.02), while older age remained an unfavorable prognostic factor for survival (P<0.001). CONCLUSIONS:Weak MGMT promoter methylation may offer clinical benefits comparable to full methylation, including longer PFI and improved OS compared to unmethylated cases. This positive effect on PFI appears more pronounced in patients receiving concurrent chemoradiotherapy with TMZ. Advanced age continues to be associated with a less favorable prognosis.
BACKGROUND:Despite wide variation in the outcomes and costs of lumbar fusion, few studies have integrated these domains together within a single metric to assess "value" (outcomes achieved per dollar spent). In this review, we sought to 1) characterize existing metrics of cost-effectiveness for lumbar fusion, 2) evaluate all applications of time-driven activity-based costing (TDABC) in spine surgery, and 3) outline the conceptual foundation for a standardized Operative Value Index (OVI). METHODS:Two PRISMA-concordant systematic reviews were performed on PubMed and Scopus databases. The first review examined all studies which reported a cost-effectiveness metric for lumbar fusion. The second review examined all applications of TDBAC in spine surgery. RESULTS:Among 366 screened studies, 40 (21 for cost-effectiveness in lumbar fusion, 19 for TDABC in spine surgery) fulfilled inclusion criteria. The incremental cost-effectiveness ratio (ICER) was the most common metric, followed by OVI. Costs were frequently defined as reimbursement or charges; few studies assessed actual costs or TDABC. TDABC studies consistently demonstrated that costs were driven primarily by surgeon-level and procedure-specific factors, not patient characteristics. OVI studies uniformly used TDABC costs combined with disease-specific outcomes, but were limited to short-term follow-up and primarily intraoperative costs. CONCLUSIONS:Current value assessments in lumbar fusion are limited by heterogeneous outcomes and imprecise costing. A standardized framework integrating pathology-specific outcomes with episode-level costing (not charges or reimbursement) may enable more generalizable and accurate comparisons of operative value.
BACKGROUND:This review aims to review the efficacy and toxicity of anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in the management of glioblastoma. METHODS:A systematic review was completed utilizing PubMed, Cochrane, and Embase databases up to February 2025. Boolean operators and the MeSH term "glioma" were used, along with relevant keywords related to EGFR. RESULTS:First- and second-generation EGFR-focused TKIs performed poorly in patients with GBM. The use of erlotinib in combination with radiotherapy, alkylating agents, and anti-angiogenic agents yielded the best outcomes in patients with newly diagnosed GBM. CONCLUSIONS:EGFR-focused TKIs were largely disappointing as a treatment for GBM. Longstanding issues, including treatment resistance, tumor heterogeneity, and blood-brain barrier penetration persist. Future efforts must focus on tackling these issues, and prioritizing patient selection via biomarkers.
BACKGROUND:A precise understanding of the national neurosurgical workforce is essential for effective healthcare planning and ensuring the long-term sustainability of the specialty. In Italy, the number of newly trained neurosurgeons is strictly limited by a competitive national residency entrance system, making accurate forecasting of workforce needs critical. Recent evidence suggests an aging neurosurgical population, highlighting the urgency of estimating retirements and training requirements to maintain adequate staffing levels. However, updated and comprehensive data on the national neurosurgical workforce have long been lacking. The Società Italiana di Neurochirurgia (SINCH) therefore promoted a national census to provide an accurate overview of all active neurosurgeons during the biennium 2022-2023. METHODS:A national cross-sectional descriptive study was conducted between 2022 and 2023 to characterize the demographics and distribution of neurosurgeons within the Italian Public Health System and affiliated facilities. Three principal investigators and one supervisor coordinated the project under SINCH supervision. Data were collected through: 1) consolidation of the SINCH-PROGETKA database; 2) direct verification via personalized e-mails to all 113 neurosurgical unit directors (112 complete replies); 3) systematic web-based searches across 17 medical directory platforms; and 4) cross-matching with official medical organizations (FNOMCEO). Data were analyzed by institution type, geographic area, gender, age, and leadership role. RESULTS:A total of 1489 active neurosurgeons were identified, with 1055 (74.1%) confirmed as SINCH members. Most professionals worked in public institutions (AOSSN 51.1%, AOU 17.2%, IRCCS 9.7%, AOU-IRCCS 5.4%), while 235 (15.9%) operated primarily in the private sector. Workforce distribution showed marked regional disparities: Northern and Central Italy accounted for 71% of neurosurgeons, whereas the South and Islands hosted only 29%. The national average was 1 neurosurgeon per 39,523 inhabitants, one of the highest ratios in Europe. Women represented 24.1% of active neurosurgeons but only <4% of unit directors. The mean age of directors was 59 years, reflecting an aging leadership cohort. CONCLUSIONS:This updated census provides the most comprehensive profile to date of Italian neurosurgeons. Despite adequate overall numbers, regional and gender imbalances persist, and leadership renewal remains limited. When compared with the previous ICoNe2 study, these data confirm Italy's exceptionally high neurosurgical density and underscore the need for coordinated workforce planning, optimization of training programs, and rational redistribution of resources to ensure sustainable and equitable neurosurgical care nationwide.
BACKGROUND:This meta-analysis aimed to compare intraoperative metrics and postoperative outcomes of sacroiliac joint fusions (SIJF) performed under robotic versus non-robotic navigation. METHODS:Studies of adults undergoing SIJF with intraoperative navigation that reported ≥1 relevant outcome were included. PubMed, Scopus, and Web of Science were searched for studies published between September 14th, 2015, and September 14th, 2025. Before data analysis, patients were split into robotic and non-robotic fusion groups, and the non-robotic group was further split into fluoroscopic (F), virtual surgical planning (2D), and stereotactic (3D) navigation subgroups. Risk of bias was assessed using the revised Graphical Appraisal Tool for Epidemiological Studies (GATE). Datasets were analyzed using MedCalc and Stata. RESULTS:Twenty papers describing 1581 SIJFs were analyzed for visual analogue scale (VAS) pain, Oswestry Disability Index (ODI), and postoperative complications. ODI and VAS showed postoperative improvement across all groups, with a steeper VAS reduction in the robotic group. Postoperative complication rates were lowest in the non-robotic (2D) subgroup, and lower in the robotic group than in the non-robotic (3D) subgroup. The non-robotic (F) subgroup had the lowest rate of new pain, whereas the robotic group had the highest. The robotic group showed the lowest rate of hematomas. Qualitative analysis of reported data suggests that robotic navigation demonstrates the highest accuracy rate, whereas fluoroscopy demonstrates the lowest. The results, although consistent, were not statistically significant, likely due to substantial heterogeneity among studies. CONCLUSIONS:Findings indicate a reduction in postoperative pain and favorable outcomes across both navigation modalities. Additionally, robotic approaches provide an added benefit of reducing intraoperative radiation exposure. Further prospective comparative studies with larger sample sizes are needed to obtain statistically significant comparative data between the groups and to reach definitive conclusions.
The management of postoperative pain after brain surgery is challenging due to the vulnerability of neuroanatomic structures and differences in the perception of pain among different individuals. Pain management is essential for the patient's quick recovery. The main aim of the review is to assess the various pharmacological and non-pharmacological techniques for managing pain in patients after brain surgery, highlighting the potential benefits and safety. This is a focused narrative review of literature published between 2016 and 2024. A targeted search of major databases: PubMed/MEDLINE, EMBASE, Scopus, Web of Science, Cochrane CENTRAL and Google Scholar was performed using terms for postoperative pain, craniotomy, neurosurgery, scalp block, multimodal analgesia, gabapentinoids, dexmedetomidine, cognitive behavioral therapy, Transcutaneous Electrical Nerve Stimulation and related concepts. The present review purposively selected randomized controlled trials, systematic reviews, meta-analyses and high-quality observational studies that evaluated analgesic strategies for major intracranial procedures. Non-English reports, narrative reviews lacking primary data, and studies with inadequate outcome reporting were excluded. Data synthesis is solely narrative and focused on comparative effectiveness and safety. The evidence supports opioid-sparing, multimodal strategies after major intracranial procedures. NSAIDs and acetaminophen show modest reductions in pain up to 12-24 hours. Local anesthetic scalp blocks and wound infiltration such as ropivacaine provide short-term benefit. Gabapentinoids reduce opioid consumption but increase dizziness and somnolence. Dexmedetomidine can delay rescue analgesia intraoperatively but is not consistently superior to alternatives. Non-pharmacologic approaches including, cognitive behavioral therapy, Transcutaneous Electrical Nerve Stimulation, Repetitive transcranial magnetic stimulation or, transcranial magnetic stimulation acupuncture show promise for longer-term or neuropathic symptoms, but evidence is limited and heterogeneous. Multimodal, opioid-sparing regimens, combining systemic non-opioid analgesics, targeted local or regional techniques, and selected adjuvants appear most effective for early postoperative pain after intracranial surgery. Non-pharmacologic therapies and neuromodulation may have adjunctive roles, but higher-quality comparative trials with standardized outcomes are needed to define optimal protocols and long-term effects.
INTRODUCTION:Healthcare costs in the USA have increased without corresponding improvements in patient outcomes, prompting calls for value-based reimbursement models. Accurate cost measurement per episode of care is essential to this approach. Traditional methods, such as cost-to-charge ratio (CCR), lack precision. Time-driven activity-based costing (TDABC), which assigns costs based on time spent per activity, offers a more accurate alternative. This review evaluates TDABC use in spine surgery and its potential to enhance cost transparency and efficiency. EVIDENCE ACQUISITION:This systematic review followed PRISMA guidelines. A literature search was performed for studies published between 1996 and 2025 using terms related to costing strategies and spine surgery. Included studies applied TDABC in cost analysis; non-English and commentary articles were excluded. Extracted data included costing methodologies, cost categories, and study purpose. Bias was assessed using the Newcastle-Ottawa scale. EVIDENCE SYNTHESIS:Twelve studies including 6143 patients were analyzed, covering procedures such as ACDF, lumbar laminectomy, and microdiscectomy. Reported costs for single-level ACDF ranged from $ 6776 to $ 27,558. Most studies focused on intraoperative costs, though some included full care episodes. TDABC identified cost differences tied to factors such as surgeon experience and BMI. Personnel time, hospital stay, and postoperative visits were common cost drivers. CONCLUSIONS:TDABC offers a more granular and accurate method for analyzing spine surgery costs. However, variation in methodology across studies limits comparability. Standardized protocols and direct comparisons with traditional costing methods are needed to fully leverage TDABC's potential for improving cost management and care efficiency.
INTRODUCTION:Aneurysmal subarachnoid hemorrhage commonly requires external ventricular drain (EVD) insertion. The effect of rapid versus gradual weaning on infection rates, hospital stay, and requirement for ventriculoperitoneal shunt (VPS) is not known. We aimed to compare rapid and gradual weaning strategies with measurable outcomes. EVIDENCE ACQUISITION:A PRISMA compliant systematic review and meta-analysis was conducted (PROSPERO ID 1144244). Articles published in MEDLINE, Embase, and Cochrane Library between inception and July 2025 were included. Weaning definitions, infection rates, hospital stay, and VPS insertion rates were identified. Binary and continuous outcomes were calculated using random effects meta-analysis models. EVIDENCE SYNTHESIS:In total, six studies (1802 patients) were included. The mean age of the included patients was 56.3 years, and 35% of the population were male. Clinical severity of aSAH was high: 54% presenting with WFNS IV-V and 37% with WFNS I-II. The most common definition of rapid weaning was immediate clamping (83.3%, N.=5/6). Rapid weaning was not associated with increased VPS requirement (RR=0.94, 95% CI 0.57-1.54, P=0.7547), or Infection rates (RR=0.99, 95% CI 0.55-1.76, P=0.9462). Rapid weaning was associated with reduced length of stay in hospital (five studies, 25.6 vs. 29.5 days, mean difference -4.3 [95% CI: -5.7, -3.0], P<0.001). CONCLUSIONS:Rapid weaning does not appear to be associated with reduced VPS dependence, or infection. Further studies are required to establish the ideal EVD weaning protocol to minimize infection, failure rates and hospital stay.
BACKGROUND:Selective dorsal rhizotomy (SDR) is used to treat spastic cerebral palsy (CP), but its effectiveness remains debated due to heterogeneous, predominantly non-randomized evidence. METHODS:This systematic review and single-arm meta-analysis was prospectively registered in PROSPERO (CRD420251132796) and conducted in accordance with PRISMA 2020 and the Cochrane Handbook. PubMed, Embase, and Web of Science were searched for studies evaluating SDR in pediatric CP. Eligible designs included case series, retrospective or prospective cohorts, and randomized trials reporting motor or spasticity outcomes. The primary endpoints were Gross Motor Function Measure-66 (GMFM-66) and Modified Ashworth Scale (MAS). Risk of bias was assessed using the ROBINS-I tool. Mean change values with 95% confidence intervals (CI) were pooled using random-effects models (REML). Statistical heterogeneity was evaluated with the I2 statistic, and sensitivity analyses (including leave-one-out and varying correlation coefficients for missing SDs) were performed. RESULTS:Sixteen studies including 756 children were analyzed. SDR was associated with significant improvements in GMFM-66 at the shortest (mean change 3.29; 95% CI 1.54-5.03; I2=71%) and longest (mean change 3.71; 95% CI 2.00-5.42; I2=72%) available follow-up. Spasticity was significantly reduced, with a pooled mean change in MAS of -1.98 (95% CI -3.26 to -0.70; I2=99%). Sensitivity analyses confirmed the stability of results across assumptions, and leave-one-out analyses did not materially alter effect estimates. All included studies were judged to have a moderate risk of bias. CONCLUSIONS:SDR is associated with clinically meaningful and durable improvements in gross motor function and reductions in spasticity in children with spastic CP.
BACKGROUND:Large language models (LLMs) are increasingly being explored in healthcare, particularly for enhancing patient education. In spine surgery, LLMs have the potential to enhance communication and support patients through perioperative care. However, concerns remain regarding the accuracy, readability, and overall reliability of these tools in delivering patient-facing information. This review aimed to understand the current use of LLMs in answering patient questions in spine surgery. METHODS:A structured search of PubMed and Google Scholar was conducted using terms focused on LLMs and neurosurgery. Studies were only included if they tested LLMs' ability in answering patient questions related to spine surgery. Exclusion criteria included non-peer-reviewed articles, studies that did not evaluate chatbot performance, or those using LLMs for non-educational purposes. RESULTS:LLMs were tested across a variety of spine-related topics, including scoliosis, lumbar and cervical fusion, endoscopic procedures, and spinal cord stimulation. Studies consistently reported moderate to high accuracy ratings. Readability scores remained a limitation, with most responses written at a college reading level. Empathy and clarity varied by model and condition, with some studies showing improved ratings when assessed by non-medical reviewers. Methodological variability across studies introduced inconsistencies and limited comparability. CONCLUSIONS:LLMs show promising utility for patient education in spine surgery for addressing frequently asked questions. However, challenges in readability, accuracy, and standardization limit their current clinical adoption. Moving forward, studies must incorporate standardized evaluation tools, address high rate of content hallucination, and focus on chatbot performance in personalized scenarios. Cross-disciplinary collaboration is essential to ensure safe, accessible integration into neurosurgical care pathways.
BACKGROUND:Intracranial arteriovenous malformations (AVMs) are a major cause of intracranial hemorrhage (ICH) in children, often leading to significant neurological deficits or mortality. The primary aim of this study was to analyze the management strategies and long-term outcomes of pediatric AVMs treated at Santobono-Pausilipon Children's Hospital over the past 15 years with a particular focus on hemorrhagic presentation. METHODS:A retrospective review was conducted on pediatric patients (0-18 years) diagnosed with intracranial AVMs between July 2008 and December 2024. Data on demographics, clinical presentation, imaging findings, Spetzler-Martin and Supplemented Spetzler-Martin grading, treatment modalities, complications, and outcomes were collected. Treatment approaches included microsurgical resection, endovascular embolization, stereotactic radiosurgery (SRS), and multimodal management were evaluated. RESULTS:A total of 48 pediatric AVM cases were identified (24 males, 24 females; mean age: 8.8 years). The majority (N.=41, 85.4%)) presented with intracranial hemorrhage. Treatment strategies included microsurgical resection (17 cases), embolization (6 cases), SRS (9 cases), and multimodal therapy (14 cases). Mean follow-up was 5 years. Residual AVMs were detected in 13% of cases, with three rebleeding events. The postoperative modified Rankin Scale (mRS) showed favorable outcomes (mRS 0-2) in 37 patients. One patient died due to major hemorrhage. CONCLUSIONS:Pediatric AVMs exhibit diverse clinical presentations and require individualized management strategies. While surgical resection remains the most definitive treatment, multimodal approaches may be necessary for high-grade or deep-seated AVMs. Long-term follow-up is crucial due to the risk of AVM recurrence and rebleeding. Advancements in molecular and genetic research may further refine therapeutic strategies for pediatric AVMs in the future.
BACKGROUND:Spetzler-Martin (SM) grade III brain arteriovenous malformations (AVMs) present a therapeutic challenge due to their risk profile. This systematic review and meta-analysis aimed to evaluate the safety and efficacy of endovascular treatment (EVT) as first-line therapy for these lesions. METHODS:We searched PubMed, Embase, Cochrane CENTRAL, and Web of Science from inception to January 2025. Eligible studies were observational, enrolled patients with SM grade III AVMs undergoing EVT, and reported clinical or radiological outcomes. Primary endpoints included obliteration rate, functional outcome, and adverse events. Random-effects models were used to calculate pooled proportions with 95% confidence intervals (CI). Heterogeneity was assessed with I2. Statistical analysis was conducted in R® version 4.4.0. RESULTS:Nineteen studies (N.=1105; SM grade III: N.=588) were included. EVT achieved complete immediate obliteration in 51% (95% CI: 30-72%; I2=95%), while residual nidus persisted in 39% (95% CI: 19-60%). Functional independence (mRS 0-2) was reached in 96% (95% CI: 90%-99%; I2=32%), whereas poor functional outcome (mRS ≥3) occurred in 5% of patients (95% CI: 1-11%). Permanent neurological deficits were reported in 5% (95% CI: 1-12%), and procedural complications occurred in 14% (95% CI: 7-22%). Mortality and recurrence rates were both 0%. Adjunctive therapies were required in 49% of cases (95% CI: 26-73%). Rebleeding during follow-up occurred in 7% (95% CI: 2-15%). CONCLUSIONS:EVT as first-line therapy for SM grade III AVMs is associated with high functional independence, moderate obliteration rates, low permanent morbidity, and negligible mortality, although nearly half of patients require adjunctive treatment.
BACKGROUND:Spontaneous intracerebral hemorrhage (ICH) is associated with high mortality and disability. This study aimed to develop and validate machine learning models based on preoperative multimodal data to predict the risk of intraoperative rebleeding (IOR) and postoperative functional recovery in ICH patients, thereby providing support for precision treatment decisions. METHODS:This multicenter prospective cohort study included 498 primary ICH patients who underwent surgical treatment at three tertiary hospitals in China between January 2018 and December 2023. Preoperative clinical characteristics, laboratory tests, and imaging parameters were collected. The primary endpoint was IOR (defined as obvious arterial bleeding requiring additional hemostatic measures during surgery, or residual/new hematoma increased by ≥5 mL on CT within 24 hours after surgery compared to preoperative assessment). The secondary endpoint was good functional outcome (modified Rankin Scale [mRS] ≤2) at 6 months postoperatively. Machine learning algorithms were used to construct prediction models, which were evaluated through temporal validation and external multicenter validation cohorts. RESULTS:Among the included patients, the incidence of IOR was 14.7% (73/498), and the rate of good outcome at 6 months was 42.6% (212/498). After rigorous cross-validation and hyperparameter optimization, the deep neural network model performed best in predicting IOR (AUC 0.892, 95%CI: 0.851-0.933), with accuracy of 83.7%, sensitivity of 84.6%, and specificity of 83.5%. The XGBoost model was optimal for predicting functional recovery (AUC 0.875, 95%CI: 0.831-0.919), with accuracy of 81.9%, sensitivity of 82.1%, and specificity of 81.8%. In the external validation cohort (N.=156), the two models achieved AUCs of 0.842 (95%CI: 0.768-0.916) and 0.831 (95%CI: 0.758-0.904), respectively. Multivariate analysis showed that hematoma volume (OR=1.35, 95%CI: 1.21-1.51, per 10 mL increase), admission INR (OR=3.17, 95%CI: 2.04-4.93, >1.4 vs. ≤1.4), midline shift (OR=1.28, 95%CI: 1.13-1.44, per 1 mm increase), and preoperative platelet count (OR=0.83, 95%CI: 0.76-0.91, per decrease of 20×109/L) were independent risk factors for IOR. Decision curve analysis demonstrated that machine learning models provided higher net clinical benefit than traditional ICH and FUNC scores. CONCLUSIONS:Machine learning prediction models validated across multiple centers can accurately assess the risk of IOR and postoperative functional recovery in ICH patients, thereby guiding individualized treatment decisions and potentially improving patient outcomes.
BACKGROUND:Posterior fossa approaches are commonly used during routine neurosurgery. Cerebrospinal fluid (CSF) leakage is one of the most important posterior fossa surgery-related complications. CSF leakage can manifest as both pseudomeningocele and external leakage. If craniotomy or craniectomy is performed, the skull defect can be repaired using heterologous polymethylmethacrylate (PMMA) cranioplasty. The aim of this study was to evaluate the clinical results of the O-ring technique in terms of postoperative complications. METHODS:Patients treated using the retrosigmoid (RS), key-hole RS, or cerebellar hemispheric approach with O-ring PMMA cranioplasty were selected. Data analysis considered age, sex, pathology, surgical approach, presence of preoperative hydrocephalus, wound closure problems, and CSF-related complications postoperatively and at one- and three-month follow-ups. RESULTS:Thirty-three patients were selected, and meningioma was the most common disease. The majority of patients (60.6%) were treated with the standard RS approach. No patient presented with surgical complications in terms of pseudomeningocele or external CSF leakage, neither postoperatively nor at the one-month follow-up. On three-month follow-up MRI, subcutaneous fluid collection was observed in two patients (6.1%). CONCLUSIONS:Our study shows promising results that the O-ring technique could represent a valid option to reduce postoperative CSF leakage in posterior fossa surgery.
BACKGROUND:Polyethylene glycol (PEG) hydrogel dural sealants (DuraSeal, Adherus) reinforce dural closure, but case reports describe cerebrospinal fluid (CSF) leak, infection, and swelling-related neurologic injury. We characterized post-market safety in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, comparing structured problem codes with negation-aware narrative review. METHODS:MAUDE reports from January 1, 2015, to June 30, 2024, mentioning either device were extracted and deduplicated by unique identifiers (MDR_REPORT_KEY, REPORT_NUMBER). Structured FDA patient and device problem codes were mapped to clinical categories (CSF leak, infection, wound dehiscence, neurologic deficit, swelling/mass effect, polymerization/application issue, adhesion, reoperation/hospitalization). Narratives underwent deterministic, negation-aware screening for the same categories, and for each device we calculated event proportions. RESULTS:After deduplication, 279 reports were analyzed (256 DuraSeal, 23 Adherus). Most were coded as injury or malfunction; deaths were rare. CSF leak was the most frequent signal (DuraSeal 26.2% structured vs. 27.0% narrative; Adherus 52.2% vs. 47.8%). For DuraSeal, narrative review nearly doubled infection reports (8.2% vs. 19.9%) and identified swelling/mass effect (9.4%), neurologic deficit (4.3%), and reoperation/hospitalization (7.8%) largely absent from structured codes. For Adherus, narrative review identified isolated reports of infection, swelling/mass effect, and reoperation. CONCLUSIONS:PEG hydrogel dural sealants show post-market safety patterns dominated by CSF leak, suspected infection, and swelling-related neurologic events. Exclusive reliance on structured MAUDE codes underestimates key complications. Integrating structured fields with negation-aware narrative review yields a more complete safety profile and supports cautious use in constrained intracranial spaces.
BACKGROUND:Recent studies have documented a rising incidence of intracranial complications of sinusitis and otitis (ICSO) in the post-COVID-19 era, particularly in pediatric patients. The aim of this study is to analyze this trend in our institution and compare it with recent literature, with a specific focus on decompressive craniectomy as critical part of the surgical management. METHODS:We retrospectively reviewed all patients under 18 years of age admitted to Bambino Gesù Children's Hospital with a discharge diagnosis of ICSO, between January 2017 and December 2024. We analyzed patients' demographic data, pathogen characteristics, type of primary infection and intracranial complications, and signs and symptoms at presentation. Management of the infection and cerebral venous sinus thrombosis (CVST) rate were also reported, along with clinical and radiological outcomes. RESULTS:A total of 26 patients were included with an estimated increase of 1.07 patients per year (β=1.07, 95% CI [0.23, 1.91], P=0.018). 3 patients were managed exclusively with antibiotic therapy, 2 underwent sinus endoscopic surgical treatment, 11 underwent neurosurgical intervention, and 10 required a combined approach. Six patients underwent decompressive craniectomy. Venous sinus thrombosis was identified in 10 patients. Overall, 19 patients had a clinical complete recovery, while 5 presented residual deficits at follow-up. 2 patients had a fatal progression of the infection. CONCLUSIONS:This single-center study highlights a significant increase in ICSO in the post-COVID-19 era in the pediatric population, with a high proportion of venous sinus thrombosis (40%) and decompressive craniectomy (29%). High vigilance for ICSO in children, particularly in the context of evolving post-pandemic infectious disease patterns is recommended.
