Safety of lacto-N-tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on lacto-N-tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed by LNT, but also containing D-lactose and other oligosaccharides such as para-lacto-N-hexaose-2 (para-LNH-2), lacto-N-triose II and a small fraction of other carbohydrates. It is produced by fermentation with a genetically modified strain of Escherichia coli K-12. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. The intake of LNT from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring LNT in breastfed infants on a body weight basis. The intake of other carbohydrate-type compounds structurally related to LNT is considered of no safety concern. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations. (c) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Immediate, but Not Delayed, Microsurgical Skull Reconstruction Exacerbates Brain Damage in Experimental Traumatic Brain Injury Model

Moderate to severe traumatic brain injury (TBI) often results in malformations to the skull. Aesthetic surgical maneuvers may offer normalized skull structure, but inconsistent surgical closure of the skull area accompanies TBI. We examined whether wound closure by replacement of skull flap and bone wax would allow aesthetic reconstruction of the TBI-induced skull damage without causing any detrimental effects to the cortical tissue. Adult male Sprague-Dawley rats were subjected to TBI using the controlled cortical impact (CCI) injury model. Immediately after the TBI surgery, animals were randomly assigned to skull flap replacement with or without bone wax or no bone reconstruction, then were euthanized at five days post-TBI for pathological analyses. The skull reconstruction provided normalized gross bone architecture, but 2,3,5-triphenyltetrazolium chloride and hematoxylin and eosin staining results revealed larger cortical damage in these animals compared to those that underwent no surgical maneuver at all. Brain swelling accompanied TBI, especially the severe model, that could have relieved the intracranial pressure in those animals with no skull reconstruction. In contrast, the immediate skull reconstruction produced an upregulation of the edema marker aquaporin-4 staining, which likely prevented the therapeutic benefits of brain swelling and resulted in larger cortical infarcts. Interestingly, TBI animals introduced to a delay in skull reconstruction (i.e., 2 days post-TBI) showed significantly reduced edema and infarcts compared to those exposed to immediate skull reconstruction. That immediate, but not delayed, skull reconstruction may exacerbate TBI-induced cortical tissue damage warrants a careful consideration of aesthetic repair of the skull in TBI

Posterior Clinoidectomy: Dural Tailoring Technique and Clinical Application

The posterior clinoid process, a bony prominence at the superolateral aspect of the dorsum sellae, has a strategic importance in a transcavernous approach to basilar tip aneurysms. To further optimize this microsurgical technique during posterior clinoidectomy, we performed a cadaveric study of this regional anatomy, describe a technique called dural tailoring, and report initial results in the surgical treatment of upper basilar artery (BA) aneurysm. After 10 adult cadaver heads (silicone-injected) were prepared for dissection, a posterior clinoidectomy with dural tailoring was performed. The dura overlying the upper clivus was coagulated with bipolar electrocoagulation and incised. Stripping dura off the clivus and lateral reflection then exposed the ipsilateral posterior clinoid process and dorsum sellae, thus creating a dural flap. Posterior clinoidectomy with dural tailoring was then used in seven patients with upper BA aneurysms. Our stepwise modification of the posterior clinoidectomy with dural tailoring created a flap that afforded protection of the cavernous sinus and oculomotor nerve. During surgery, there were no recorded intraoperative injuries to neurovascular structures. One patient died postoperatively from morbidity related to severe-grade subarachnoid hemorrhage. Postoperative oculomotor nerve palsy occurred in 3 patients (43%). In all cases, the nerve was anatomically preserved and partial to complete recovery was recorded during the first postoperative year. This technique effectively provided exposure of retrosellar upper basilar aneurysms in seven patients (basilar tip 43% and superior cerebellar artery aneurysms 57%). Outcomes and safety are at least equivalent to or better than basilar aneurysm surgery performed without surgical adjuncts, presumably a less complex subset

The One–Piece Orbitopterional Approach

The orbitopterional approach is an anterior skull base extension of the pterional approach that provides greater exposure to the anterior cranial fossa, supra– and parasellar regions, and anterior communicating artery complex. We describe the surgical technique in a stepwise manner to create a one–piece orbitopterional craniotomy flap; keyholes for the bone cuts are the MacCarty burr–hole and the anterolateral portion of the inferior orbital fissure. This one–piece technique is less complicated than the two–piece orbitopterional craniotomy and eliminates the need for complex reconstruction of cosmetically important areas (i.e., the orbit and forehead)

Subtonsillar approach to the foramen of Luschka: an anatomic and clinical study.

OBJECTIVE: Conventional approaches to tumors of the foramen of Luschka are limited because the foramen is viewed from either the fourth ventricle laterally (transvermian approach) or the cerebellopontine angle medially (suboccipital approach). The definitive approach is subtonsillar, because the foramen of Luschka is actually the end of the natural cleavage plane between the cerebellar tonsil and the medulla. We describe the microsurgical anatomic features of the foramen of Luschka region and the operative technique for the subtonsillar approach to this region. METHODS: In the anatomic study, five formalin-fixed, silicone-injected, cadaveric heads were used. In the clinical study, the records for five patients treated via the subtonsillar approach were examined; several illustrative cases are presented. RESULTS: The foramen of Luschka is formed by the tela choroidea and the rhomboid lip and exists at the lateral end of the cerebellomedullary fissure, which is a natural cleavage plane between the cerebellar tonsil and the medulla. The subtonsillar approach is performed via a suboccipital craniotomy; the patient is positioned in the lateral decubitus position, with the tumor side down. After the cerebellar tonsil is freed from arachnoid adhesions, it can be retracted rostrodorsally from the medulla, to expose the cerebellomedullary fissure. Clinically, the tela choroidea and rhomboid lip are significantly attenuated by tumor expansion. Therefore, by dissecting in a subtonsillar manner around the tumor, one can reach the foramen of Luschka without traversing any neural tissue. CONCLUSION: The subtonsillar approach yields a panoramic view to the foramen of Luschka laterally and up to the middle cerebellar peduncle superiorly. This approach minimizes the distance between the tumor and the surgeon, while maximizing neural preservation. We think this is the definitive approach to this difficult region of the posterior fossa