Safety and Performance of a New Burr Hole Covering Device: Results of the Multicenter COVER Registry.

BACKGROUND: Burr hole covering in brain surgical procedures can avoid complications and unaesthetic results. The aim of this registry was to assess the safety and performance of a new polymeric burr hole covering device (Cranial COVER, NEOS Surgery). METHODS: A multicenter, prospective, clinical registry design was used for the study. All the patients who fulfilled the inclusion criteria were included in the study and followed up for 6 months. Baseline clinical parameters, surgical variables (technical success of the implantation, surgeon satisfaction), postoperative variables (aesthetic and functional results, neuroimaging artifacts), and adverse events were evaluated. RESULTS: Forty-three Cranial COVER devices were implanted in 30 patients. Most of them were implanted in frontal locations (53.5%). After implantation, 97.7% of the devices completely covered the burr hole, and 100% perfectly adapted to the skull surface. All surgeons ranked their satisfaction with the implantation procedure as very high or high. No artifacts were detected in any of the neuroimaging studies performed and no adverse events related with the device or its implantation were reported during the follow-up. There were significantly more scalp depressions associated with uncovered than with Cranial COVER-covered burr holes (p = 0.040). Patient satisfaction with covered burr holes located in the frontal and parietal areas was 9.0 ± 1.4 over 10. CONCLUSION: Cranial COVER is a safe and reliable burr hole covering system that offers excellent cosmetic results and high satisfaction rates for both surgeons and patients. Cranial COVER is highly adaptable to the skull surface, and it was predominantly used in frontal locations due to their cosmetic importance.

Long-Term Results of Deep Brain Stimulation for Treatment-Resistant Depression: Outcome Analysis and Correlation With Lead Position and Electrical Parameters.

BACKGROUND: Long-term efficacy and mechanisms of action of deep brain stimulation (DBS) for treatment-resistant depression (TRD) are under investigation. OBJECTIVE: To compare long-term outcomes with active electrode's coordinates and its electrical parameters in patients with TRD treated with DBS in the subgenual cingulate gyrus (SCG-DBS). METHODS: Seventeen patients with TRD underwent SCG-DBS. Demographic and baseline characteristics were recorded. The 17-item Hamilton Depression Rating Scale was used to measure the response to the therapy. The anterior commissure-posterior commissure coordinates of the active contacts and the total electrical energy delivered were calculated and correlated with clinical outcomes. Patient-specific tractographic analysis was performed to identify the modulated pathways in responders. RESULTS: Twelve women (70.6%) and 5 men (29.4%) with a median age of 48 yr (34-70 years) were included. Along the 5-year follow-up, 3 main clinical trajectories were observed according to symptom's improvement: great responders (≥80%), medium responders (≥50%-79%), and poor responders (<50%). Active contacts' coordinates and total electrical energy delivered showed no correlation with clinical outcomes. Brodmann area 10 medial was the most frequently stimulated area and the forceps minor, the most frequently modulated tract. CONCLUSION: SCG-DBS for TRD is clearly effective in some patients. Active contacts' coordinates were highly variable within the region and, like electrical parameters, did not seem to correlate with clinical outcomes. In the current series, Brodmann area 10 medial and the forceps minor were the most frequently targeted area and modulated pathway, respectively.

Neuronavigated Ultrasound in Neuro-Oncology: A True Real-Time Intraoperative Image.

OBJECTIVE: Ultrasound is considered a real-time imaging method in neuro-oncology because of its highly rapid image acquisition time. However, to our knowledge, there are no studies that analyze the additional surgical time that it requires. METHODS: A prospective study of 100 patients who underwent intra-axial brain tumor resection with navigated intraoperative ultrasound. The primary outcomes were lesion visibility grade on ultrasound and concordance with preoperative magnetic resonance imaging (MRI) scan, intraoperative ultrasound usage time, and percentage of tumor resection on ultrasound and comparison with postoperative MRI scan. RESULTS: The breakdown of patients included the following: 53 high-grade gliomas, 26 metastases, 14 low-grade gliomas, and 7 others. Ninety-six percent of lesions were clearly visualized. The tumor border was clearly delimited in 71%. Concordance with preoperative MRI scan was 78% (P < 0.001). The mean time ± SD for sterile covering of the probe was 2.16 ± 0.5 minutes, and the mean image acquisition time was 2.49 ± 1.26 minutes. Insular tumor location, low-grade glioma, awake surgery, and recurrent tumor were statistically associated with an increased ultrasound usage time. Ultrasound had a sensitivity of 94.4% and a specificity of 100% for residual tumor detection. CONCLUSIONS: Neuronavigated ultrasound can be considered a truly real-time intraoperative imaging method because it does not increase surgical time significantly and provides optimal visualization of intra-axial brain lesions and residual tumor.

Occipital nerve stimulation and deep brain stimulation for refractory cluster headache: a prospective analysis of efficacy over time.

OBJECTIVE: Occipital nerve stimulation (ONS) and deep brain stimulation (DBS) are widely used surgical treatments for chronic refractory cluster headache (CH). However, there is little literature regarding long-term follow-up of these treatments. METHODS: The authors describe two prospective cohorts of patients with refractory CH treated with ONS and DBS and compare preoperative to postoperative status at 6 and 12 months after the surgery and at final follow-up. Efficacy analysis using objective and subjective variables is reported, as well as medication reduction and complications. RESULTS: The ONS group consisted of 13 men and 4 women, with a median age of 44 years (range 31-61 years). The median number of attacks per week (NAw) before surgery was 28 (range 7-70), and the median follow-up duration was 48 months. The DBS group comprised 5 men and 2 women, with a median age of 50 years (range 29-64 years). The median NAw before surgery was 56 (range 14-140), and the median follow-up was 36 months. The NAw and visual analog scale score were significantly reduced for the ONS and DBS groups after surgery. However, while all the patients from the DBS group were considered responders at final follow-up, with more than 85% being satisfied with the treatment, approximately 29% of initial responders to ONS became resistant by the final follow-up (p = 0.0253). CONCLUSIONS: ONS is initially effective as a treatment for refractory CH, although a trend toward loss of efficacy was observed. No clear predictors of good clinical response were found in the present study. Conversely, DBS appears to be effective and provide a more stable clinical response over time with an acceptable rate of surgical complications.

Long-Term Safety and Performance of a Polymeric Clamplike Cranial Fixation System.

OBJECTIVE: After a craniotomy procedure to access the brain, neurosurgeons have several options to fix the bone flap to the skull. The aim of this study was to assess if a polymeric clamplike fixation system (Cranial LOOP) is a safe and reliable system that maintains over time an appropriate alignment of the bone flap. METHODS: This is an observational, retrospective, case series study of 60 patients who underwent a craniotomy and were subject to cranial bone flap fixation with the Cranial LOOP fixation system. Baseline clinical parameters, surgical variables, medical records, and all postoperative medical images available were reviewed to assess the bone flap alignment and potential adverse events. RESULTS: A total of 182 Cranial LOOPs were implanted in the 60 patients (56.01 ± 20.21 years, 55% women) included in the study. The cranial fixation system maintained a good bone flap alignment in 95% of the patients studied immediately after surgery and in up to 96.7% of them at the end of follow-up. No intraoperative complications were reported. An ulcer potentially related to a device was detected, which was solved without the need for device removal. No artifacts were observed in any of the 219 medical images analyzed. CONCLUSIONS: Cranial LOOP is a safe and reliable postoperative long-term cranial bone flap fixation system. This device can fix the bone flap after a wide range of craniotomy procedures, performed in multiple locations, and provides good bone flap alignment. Cranial LOOP does not interfere in patient follow-up through medical imaging.

Efficacy of Sphenopalatine Ganglion Radiofrequency in Refractory Chronic Cluster Headache.

BACKGROUND: In the literature, there are only short series of radiofrequency of the sphenopalatine ganglion (SPG) to treat chronic refractory cluster headache (CCHr) with variable results. Furthermore, there is no consensus on which methodology to use: radiofrequency ablation (RFA) or pulsed radiofrequency (PRF). METHODS: We conducted a prospective analysis of 37 patients with CCHr who underwent RFA or PRF of the SPG in our center between 2004 and 2015. RESULTS: The mean age of the patients was 40 years (range, 26-59 years). PRF was performed in 24 patients, and RFA was performed in 13 patients. A total of 5 patients (13.5%) experienced complete clinical relief of both pain and parasympathetic symptoms, 21 patients (56.8%) had partial and transient relief, and 11 patients (29.7%) did not improve. There was no evidence of significant superiority of one radiofrequency modality over the other (P = 0.48). There were no complications associated with the technique. The passage of time tended to decrease the efficacy of both techniques (P < 0.001). The mean follow-up was 68.1 months (range, 15-148 months). To our knowledge, this is the series with the largest number of patients and the longest follow-up period published in the literature. CONCLUSIONS: Radiofrequency of the SPG is a safe, fast, and partially effective method for the treatment of CCHr. Given its low rate of complications and its low economic cost, we think it should be one of the first invasive treatment options, prior to techniques with greater morbidity and mortality, such as neuromodulation.

Extradural anterior clinoidectomy in the management of parasellar meningiomas: Analysis of 13 years of experience and literature review. / Clinoidectomía anterior extradural en el manejo de meningiomas paraselares: análisis de 13 años de experiencia y revisión de la literatura.

BACKGROUND AND AIM: The extradural anterior clinoidectomy (EAC) is a key microsurgical technique that facilitates the resection of tumors located in the parasellar region. There is currently no consensus regarding the execution of the procedure via extradural or intradural nor scientific evidence that supports its routine use. The purpose of this article is to expose our experience in performing EAC as part of the management of the parasellar meningiomas. MATERIALS AND METHODS: A retrospective analysis of the EAC for parasellar meningioma resection performed in our center between 2003 and 2015 was done. A total of 53 patients were recorded. We analized our series focusing on visual outcomes, resection rates and complications. Through an extensive bibliographic research, we discussed the advantages and disadvantages of the EAC, technical considerations, comparison with the intradural clinoidectomy and its visual impact. RESULTS: The most frequent tumors were anterior clinoidal meningiomas (33.9%). The most common initial symptoms were decreased visual acuity (45.3%) and headache (22.6%). A gross total resection was achieved in 67.9%, being subtotal in the remaining 32.1%. Regarding the visual deficits 67.9% of the patients presented clinical stability, 22.6% improvement and 9.4% worsening. The degree of tumor resection did not significantly influence post-surgical visual outcomes, either visual acuity (P=.71) or campimetric alterations (P=.53). 24.5% of the patients experienced iiinerve transient paresis and 1.9% permanent. The postoperative cerebrospinal fluid leak rate was 3.8%. Mortality rate was 0%. The mean follow-up was 82.3 months. CONCLUSIONS: In our experience, EAC is a safe technique that facilitates the resection of the meningiomas located in the parasellar area, helps to achieve early tumor devascularization, reduces the need for retraction of the cerebral parenchyma and could play a positive role in the preservation of visual function and the appearance of tumor recurrences in the anterior clinoid process (ACP).

[Isocitrate dehydrogenase type I mutation as a prognostic factor in glioblastoma and a literature review]. / Importancia de la mutación de la isocitrato deshidrogenasa tipo I como factor pronóstico en pacientes con glioblastomas y revisión de la literatura.

OBJECTIVE: Treatment response and prognosis in glioblastoma (GBM) tumours can differ among patients, highlighting the growing relevance of genetic biomarkers to differentiate glioblastoma sub-types. The biomarker isocitrate dehydrogenase (IDH1) is currently receiving considerable attention. The objective of this work was to analyse the clinical and prognostic differences between glioblastomas with and without the IDH1 mutation. METHODS: A retrospective study was performed on patients with GBM who underwent surgery between 2007 and 2012. The inclusion criteria were: patient age between 18-85 years who underwent surgery for the first time with complete macroscopic resection, complete adjuvant treatment with chemotherapy and radiotherapy, and a Karnofsky performance score>70. RESULTS: A total of 61 patients (36 males/25 famales) were included and with a mean age of 62.3 years. An IDH1mutation was found in 14 patients (23%). Median survival in patients with the IDH1 mutation (IDH1-m) was 23.6 months compared with 11.9 months in those with the wild type IDH1 (IDH1-wt) (P=.028). Disease onset in IDH1-m patients tended to be at a younger age, 58.7 vs. 63.4 years, but this difference was not statistically significant. CONCLUSION: Glioblastomas with IDH1-m should be considered a different entity from the IDH1-wt, as their natural history and prognosis differ. In the near future we should be classified glioblastomas based on the presence of the IDH1 mutation.