Postoperative complications in cranial and spine neurosurgery: a prospective observational study.

BACKGROUND: Postoperative complications do occur in all neurosurgical departments, but the way they are defined, and their true incidence vary a lot. The aim of the present study was to objectively assess the morbidity and mortality related to all neurosurgical procedures performed in our department and provide insight on their main causes and identify key factors to reduce their incidence. METHODS: Data were retrieved from a prospectively maintained database regarding all patients undergoing a cranial or spinal neurosurgical procedure between November 2016 and April 2016 in the neurosurgical department in Timone University Hospital (APHM- Marseille). Patients undergoing a functional, pediatric, or interventional neuroradiological procedures were not included. RESULTS: The medical records of a total number of 963 patients were analyzed. A postoperative complication occurred in 208 patients (21.6%) including 115 (26.6%) in the cranial surgery group and 93 (17.5%) in the spinal surgery group. A complication occurred 1.5 more frequently in the cranial than in the spinal surgery group. Cranial surgery is 1.5 times more at risk of complications than spinal surgery (P=0.007). Preoperative comorbidities (ASA Score >3 to 4) were significantly associated with the occurrence of complications (P<0.001). In the cranial group, procedures performed in an emergency setting were 1.8 times more at risk of complications than scheduled surgeries (P<0.001). Conversely, in the spine group, scheduled surgeries were 1.4 times less at risk than emergency procedures (P=0.04). The main complication in both groups was found to be postoperative infection, with an incidence of 9.3% and 11.1% for cranial and spinal surgery respectively. Postoperative mortality reached 4.9% and 1.7% and the average length of stay was 12 and 11 days respectively. CONCLUSIONS: The incidence of complication in our series was found to be relatively high with predominantly infection as the main cause of postoperative complications. Reinforcing good practice measures at every step should help to significantly decrease our complication rate.

Role of 3D volume growth rate for drug activity evaluation in meningioma clinical trials: the example of the CEVOREM study.

BACKGROUND: We aimed to improve the assessment of the drug activity in meningioma clinical trials based on the study of the 3D volume growth rate (3DVGR) in a series of aggressive meningiomas. We secondarily aimed to correlate 3DVGR study with patient outcome. METHODS: We performed a post hoc analysis based on volume data and 3DVGR extracted from CEVOREM study including 18 patients with 32 recurrent high-grade meningiomas and treated with everolimus and octreotide. The joint latent class model was used to classify tumor 3DVGR undertreatment. RESULTS: Class 1 includes lesions responding to treatment with decrease in volume in the first 3 months, and then a stabilization thereafter (9.5% of tumors) (mean pretreatment 3DVGR = 6.13%/month; mean undertreatment 3DVGR = -18.7%/month within 3 first months and -0.14%/month after the 3 first months). Class 2 includes lesions considered as stable or with a slight increase in volume undertreatment (65.5%) (mean pretreatment 3DVGR = 6.09%/month; undertreatment 3DVGR = -0.09% within the first 3 months). Class 3 includes lesions without 3DVGR decrease (25%) (mean pretreatment 3DVGR = 46.9%/month; mean undertreatment 3DVGR = 19.2%/month within the first 3 months). Patients with class 3 lesions had a significantly worse progression-free survival (PFS) rate than class 1 and 2 ones. CONCLUSIONS: Tumor 3DVGR could be helpful to detect early signal of drugs antitumoral activity or nonactivity. This volume response classification could help in the assessment of drug activity in tumors with mostly volume stabilization and rare response as aggressive meningiomas even with a low number of patients in complement to 6 months PFS.

Everolimus and Octreotide for Patients with Recurrent Meningioma: Results from the Phase II CEVOREM Trial.

PURPOSE: Aggressive meningiomas that progress after surgery/radiotherapy represent an unmet medical need. Strong and constant expression of SSTR2A receptors and activation of the Pi3K/Akt/mTOR pathway have been demonstrated in meningiomas. The combination of everolimus, an mTOR inhibitor, and octreotide, a somatostatin agonist, has shown additive antitumor effect in vitro. The phase II CEVOREM trial investigated the efficacy of this combination on recurrent meningiomas. PATIENTS AND METHODS: Patients with documented recurrent tumor progression ineligible for further surgery/radiotherapy were eligible to receive octreotide (30 mg/d, day 1) and everolimus (10 mg/d, days 1-28). The primary endpoint was the 6-month progression-free survival rate (PFS6). The secondary endpoints were overall survival, response rate, tumor growth rate according to central review, and safety. RESULTS: A total of 20 patients were enrolled, including 2 with World Health Organization (WHO) grade I tumors, 10 with WHO grade II tumors, and 8 with WHO grade III tumors; furthermore, 4 patients harbored NF2 germline mutation. The overall PFS6 was 55% [95% confidence interval (CI), 31.3%-73.5%], and overall 6- and 12-month survival rates were 90% (95% CI, 65.6%-97.4%) and 75% (95% CI, 50.0%-88.7%), respectively. A major decrease (>50%) was observed in the growth rate at 3 months in 78% of tumors. The median tumor growth rate decreased from 16.6%/3 months before inclusion to 0.02%/3 months at 3 months (P < 0.0002) and 0.48%/3 months at 6 months after treatment (P < 0.0003). CONCLUSIONS: The combination of everolimus and octreotide was associated with clinical and radiological activity in aggressive meningiomas and warrants further studies. Decrease in the tumor volume growth rate should be considered a complementary and sensitive endpoint to select potentially effective drugs for recurrent meningiomas.

The epidural approach to the Meckel's cave: a how I do it.

BACKGROUND: Meckel's cave (MC) is a meningeal cleft lying in the middle fossa laterally to the cavernous sinus. Tumours that develop inside the MC may require a surgical resection. The authors describe the surgical technique of the intracranial epidural approach to the MC. METHODS: Based upon anatomical dissection showing the relevant surgical anatomy, and illustrated by the video of an operated case, the authors detail the surgical procedure. The key point is to shave the floor of the middle fossa and skeletonize the superior orbital fissure, rotundum and ovale foramen in order to delineate the plane of dural elevation and expose the lateral wall of the MC. The rules of exposure and resection of the tumour are then shown. Variations and limitations of the approach are discussed. CONCLUSION: Conducted in a stepwise manner and following relevant landmarks, the epidural anterolateral approach offers a safe and reliable exposure to the diseases that develop within the MC.