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Pedram Emami, Patrick Czorlich, Friederike S. Fritzsche, Manfred Westphal, Johannes M. Rueger, Rolf Lefering, and Michael Hoffmann

OBJECTIVE

Prediction of death and functional outcome is essential for determining treatment strategies and allocation of resources for patients with severe traumatic brain injury (TBI). The aim of this study was to evaluate, by using pupillary status and Glasgow Coma Scale (GCS) score, if patients with severe TBI who are ≤ 15 years old have a lower mortality rate and better outcome than adults with severe TBI.

METHODS

A retrospective cohort analysis of patients suffering from severe TBI registered in the Trauma Registry of the German Society for Trauma Surgery between 2002 and 2013 was undertaken. Severe TBI was defined as an Abbreviated Injury Scale of the head (AIShead) score of ≥ 3 and an AIS score for any other part of the body that does not exceed the AIShead score. Only patients with complete data (GCS score, age, and pupil parameters) were included. To assess the impact of GCS score and pupil parameters, the authors also used the recently introduced Eppendorf-Cologne Scale and divided the study population into 2 groups: children (0–15 years old) and adults (16–55 years old). Each patient's outcome was measured at discharge from the trauma center by using the Glasgow Outcome Scale.

RESULTS

A total of 9959 patients fulfilled the study inclusion criteria; 888 (8.9%) patients were ≤ 15 years old (median 10 years). The overall mortality rate and the mortality rate for patients with a GCS of 3 and bilaterally fixed and dilated pupils (19.9% and 16.3%, respectively) were higher for the adults than for the pediatric patients (85% vs 80.9%, respectively), although cardiopulmonary resuscitation rates were significantly higher in the pediatric patients (5.6% vs 8.8%, respectively). In the multivariate logistic regression analysis, no motor response (OR 3.490, 95% CI 2.240–5.435) and fixed pupils (OR 4.197, 95% CI 3.271–5.386) and bilateral dilated pupils (OR 2.848, 95% CI 2.282–3.556) were associated with a higher mortality rate. Patients ≤ 15 years old had a statistically lower mortality rate (OR 0.536, 95% CI 0.421–0.814; p = 0.001). The rate of good functional outcomes (Glasgow Outcome Scale Score 4 or 5) was higher in pediatric patients than in the adults (72.2% vs 63.1%, respectively).

CONCLUSIONS

This study found that severe TBI in children aged ≤ 15 years is associated with a lower mortality rate and superior functional outcome than in adults. Also, children admitted with a missing motor response or fixed and bilaterally dilated pupils also have a lower mortality rate and higher functional outcome than adults with the same initial presentation. Therefore, patients suffering from severe TBI, especially pediatric patients, could benefit from early and aggressive treatment.

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Michael Hoffmann, Christian Koelsche, Marcel Seiz-Rosenhagen, Sabine Mai, Frank Lohr, David Reuss, Frederik Wenz, Christoffer Gebhardt, and Frank A. Giordano

Meningeal melanocytomas are rare tumors. They are derived from leptomeningeal melanocytes and predominantly occur along the spine and the posterior fossa. Here, the authors report a case of intramedullary melanocytoma of intermediate grade in a 58-year-old female patient who was initially misdiagnosed with malignant melanoma until mutational analyses of a panel of genes associated with melanotic tumors led to reclassification.

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Robert Herrmann, Maureen Dreher, Andrew Farb, Michael Hoffmann, Christopher M. Loftus, Nina Mezu-Nwaba, Vivek Pinto, Xiaolin Zheng, and Carlos Peña

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.

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Oliver Dudeck, Olivier Jordan, Karl-Titus Hoffmann, Kai Tesmer, Tibor Kreuzer-Nagy, Petr Podrabsky, Michael Heise, Rudolf Meyer, Ali Fuat Okuducu, Harald Bruhn, Jöns Hilborn, Daniel A. Rüfenacht, Eric Doelker, and Roland Felix

Object

To evaluate iodine-containing polyvinyl alcohol (I-PVA) as a precipitating liquid embolic agent, implant characteristics—including radiopacity, setting behavior, and biocompatibility—were studied in an aneurysm model in swine.

Methods

Twelve broad-based carotid artery (CA) sidewall aneurysms were surgically constructed in six pigs. Iodine-containing polyvinyl alcohol dissolved in dimethyl sulfoxide (DMSO) was injected during temporary balloon occlusion bridging the aneurysm neck. Control angiography as well as multidetector row computerized tomography (CT) angiography was performed after 4 weeks. Harvested aneurysms were investigated histopathologically and by 3-tesla high-field magnetic resonance (MR) imaging. The mean degree of aneurysm occlusion achieved was 96%. In two aneurysms a minimal protrusion of I-PVA into the CA lumen was observed. During one embolization, leakage of the liquid embolic agent due to DMSO-induced damage of the microcatheter resulted in CA occlusion. Aneurysms embolized with I-PVA could be discriminated clearly from the parent artery on CT angiograms because there was no beam-hardening artifact. High-field MR imaging allowed a detailed depiction of the liquid embolic distribution within the aneurysm. Histologically, a mild to moderate inflammatory response was found in successfully embolized aneurysms, and the polymer mass was frequently covered by a membrane of fibroblasts and endothelial cells.

Conclusions

Iodine-containing polyvinyl alcohol is a ready-to-use liquid embolic agent clearly visible under fluoroscopy; additives are not required. The setting behavior allows for controlled delivery in aneurysm cavities. Histological studies performed 4 weeks after embolization revealed no sign of toxic tissue response to the liquid embolic agent. Overall, I-PVA exhibits interesting implant characteristics in that radiopaque admixtures are not necessary, thus allowing for artifact-free evaluation of treated aneurysms by using CT and MR angiography.

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Thomas Datzmann, Thomas Kapapa, Angelika Scheuerle, Oscar McCook, Tamara Merz, Sarah Unmuth, Andrea Hoffmann, René Mathieu, Simon Mayer, Uwe Max Mauer, Stefan Röhrer, Deniz Yilmazer-Hanke, Peter Möller, Benedikt Lukas Nussbaum, Enrico Calzia, Michael Gröger, Clair Hartmann, Peter Radermacher, and Martin Wepler

OBJECTIVE

Acute subdural hematoma (ASDH) is a leading entity in brain injury. Rodent models mostly lack standard intensive care, while large animal models frequently are only short term. Therefore, the authors developed a long-term, resuscitated porcine model of ASDH-induced brain injury and report their findings.

METHODS

Anesthetized, mechanically ventilated, and instrumented pigs with human-like coagulation underwent subdural injection of 20 mL of autologous blood and subsequent observation for 54 hours. Continuous bilateral multimodal brain monitoring (intracranial pressure [ICP], cerebral perfusion pressure [CPP], partial pressure of oxygen in brain tissue [PbtO2], and brain temperature) was combined with intermittent neurological assessment (veterinary modified Glasgow Coma Scale [MGCS]), microdialysis, and measurement of plasma protein S100β, GFAP, neuron-specific enolase [NSE], nitrite+nitrate, and isoprostanes. Fluid resuscitation and continuous intravenous norepinephrine were targeted to maintain CPP at pre-ASDH levels. Immediately postmortem, the brains were taken for macroscopic and histological evaluation, immunohistochemical analysis for nitrotyrosine formation, albumin extravasation, NADPH oxidase 2 (NOX2) and GFAP expression, and quantification of tissue mitochondrial respiration.

RESULTS

Nine of 11 pigs survived the complete observation period. While ICP significantly increased after ASDH induction, CPP, PbtO2, and the MGCS score remained unaffected. Blood S100β levels significantly fell over time, whereas GFAP, NSE, nitrite+nitrate, and isoprostane concentrations were unaltered. Immunohistochemistry showed nitrotyrosine formation, albumin extravasation, NOX2 expression, fibrillary astrogliosis, and microglial activation.

CONCLUSIONS

The authors describe a clinically relevant, long-term, resuscitated porcine model of ASDH-induced brain injury. Despite the morphological injury, maintaining CPP and PbtO2 prevented serious neurological dysfunction. This model is suitable for studying therapeutic interventions during hemorrhage-induced acute brain injury with standard brain-targeted intensive care.