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Alireza Mansouri, Benjamin Cooper, Samuel M. Shin and Douglas Kondziolka

OBJECT

Randomized-controlled trials (RCTs) are advocated to provide high-level medical evidence. However, in neurosurgery, there are barriers to conducting RCTs. The authors of this study sought to analyze the quality of neurosurgical RCTs since 2000 to determine the adequacy of their design and reporting.

METHODS

A search of the MEDLINE and EMBASE databases (2000–2014) was conducted. The medical subject heading (MeSH) terms used in the search included: “neurosurgery” OR “neurosurgical procedure,” “brain neoplasms,” “infarction” and “decompression,” “carotid stenosis,” “cerebral hemorrhage,” and “spinal fusion.” These studies were limited to RCTs, in humans, and in the English language. The Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scales were used to assess the quality of RCT design and reporting. The standardized median times cited (median citations divided by years since publication) were used to assess impact. A pragmatic-explanatory continuum indicator summary-based scale was used to assess the design of the studies as primarily pragmatic or explanatory.

RESULTS

Sixty-one articles were identified, and the following subspecialties were the most common: vascular (23, 37%), followed by functional neurosurgery and neurooncology (both 13, 21%). The following nations were the primary leaders in RCTs: US (25 studies, 41%), Germany (8 studies, 13%), and the United Kingdom (7 studies, 11%). Median sample size was 100 (interquartile range [IQR] 41.5–279). The majority of the studies (40, 66%) had pragmatic objectives. The median number of times cited overall was 69 (IQR 20.5–193). The combined median CONSORT score was 36 (IQR 27.5–39). Blinding was most deficiently reported. Other areas with a relatively low quality of reporting were sample size calculation (34.2% of surgical, 38.5% of drug, and 20% of device studies), allocation concealment (28.9% of surgical, 23.1% of drug, and 50% of device studies), and protocol implementation (18.4% of surgical, 23% of drug, and 20% of device studies). The quality of reporting did not correlate with the study impact. All studies had a median Jadad score ≤ 3. Thirty-three pragmatic studies (83%) and 5 explanatory studies (25%) met the design objectives. All pragmatic studies based on drug and device trials met their objectives, while 74% of pragmatic surgical trials met their objectives.

CONCLUSIONS

The prevalence of neurosurgical RCTs is low. The quality of RCT design and reporting in neurosurgery is also low. Many study designs are not compatible with stated objectives. Pragmatic studies were more likely to meet design objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting.

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Samuel S. Shin, C. Edward Dixon, David O. Okonkwo and R. Mark Richardson

Traumatic brain injury (TBI) remains a significant public health problem and is a leading cause of death and disability in many countries. Durable treatments for neurological function deficits following TBI have been elusive, as there are currently no FDA-approved therapeutic modalities for mitigating the consequences of TBI. Neurostimulation strategies using various forms of electrical stimulation have recently been applied to treat functional deficits in animal models and clinical stroke trials. The results from these studies suggest that neurostimulation may augment improvements in both motor and cognitive deficits after brain injury. Several studies have taken this approach in animal models of TBI, showing both behavioral enhancement and biological evidence of recovery. There have been only a few studies using deep brain stimulation (DBS) in human TBI patients, and future studies are warranted to validate the feasibility of this technique in the clinical treatment of TBI. In this review, the authors summarize insights from studies employing neurostimulation techniques in the setting of brain injury. Moreover, they relate these findings to the future prospect of using DBS to ameliorate motor and cognitive deficits following TBI.

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Dong Ah Shin, Ryoong Huh, Sang Sup Chung, Jack Rock and Samuel Ryu

Object

Stereotactic radiosurgery (SRS) has become an important treatment alternative to surgery for a variety of spinal lesions. However, the use of SRS in the management of intradural intramedullary (IDIM) metastasis remains controversial. The aim of this study was to determine the clinical efficacy and safety of SRS for treatment of IDIM metastasis.

Methods

Nine patients with 11 IDIM metastases treated with SRS at Henry Ford Hospital were retrospectively reviewed. The mean age at presentation was 50 years, with a range of 14–71 years. There were 4 intradural extramedullary and 7 intramedullary lesions. The radiosurgery procedure used techniques of image-guided and intensitymodulated radiation. The mean treatment dose was 13.8 Gy, with a range of 10–16 Gy. All patients had clinical follow-up (except in 1 lesion), with an emphasis on initial symptoms and ambulatory status, and 8 patients (9 lesions) had imaging studies. The median follow-up duration was 10 months.

Results

The presenting symptoms were improved in 8 (80%) of 10 evaluable lesions, unchanged in 1 case, and worsened in 1 case. Radiographic responses were seen as follows: complete response in 2 (22%) of 9; partial response in 3 (33%) of 9; stable disease in 3 (33%) of 9; and progressive disease in 1 (11%) of 9. After radiosurgery, 7 patients (78%) remained ambulatory until the last follow-up visit. The overall median survival time after SRS was 8 months, with a range of 2–19 months. No radiation toxicity was detected clinically during the follow-up period.

Conclusions

Despite the fact that this was a small series of patients with IDIM metastasis who had limited treatment options, SRS appears to be an effective and safe method of treating patients with these lesions.

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Jason Sheehan, Dale Ding and Robert M. Starke

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Jun Jae Shin, Sang Hyun Kim, Yong Eun Cho, Samuel H. Cheshier and Jon Park

Object

Several controversial issues arise in the management of unstable hangman's fractures. Some surgeons perform external reduction and immobilize the patient's neck in a halo vest, while others perform surgical reduction and internal fixation. The nonsurgical treatments with rigid collar or halo vest immobilization present problems, including nonunion, pseudarthrosis, skull fracture, and scalp laceration and may also fail to achieve anatomical realignment of the local C2–3 kyphosis. With recent advances in surgical technique and technology, surgical intervention is increasingly performed as the primary treatment in high cervical fractures. The outcomes of such surgeries are often superior to those of conservative treatment. The authors propose that surgical intervention as a primary management for hangman's fracture may avoid risks inherent in conservative management when severe circumferential discoligamentous instability is present and may reduce the risk of catastrophic results at the fracture site.

The purposes of this study were to assess fracture healing following expedient reduction and surgical fixation and to propose a guideline for treatment of unstable hangman's fractures.

Methods

From April 2006 to December 2011, the authors treated 105 patients with high cervical fractures. This study included 23 (21.9%) of these patients (15 men and 8 women; mean age 46.4 years) with Type II, IIa, and III hangman's fractures according to the Levine and Edwards classification. The patient's age, sex, mechanism of injury, associated injuries, neurological status, and complications were ascertained. The authors retrospectively assessed the clinical outcome (Neck Disability Index), radiological findings (disc height, translation, and angulation), and bony healing.

Results

The average follow-up period was 28.9 months (range 12–63.2 months). The overall average Neck Disability Index score at the time of this study was 6.6 ± 2.3. The average duration of hospitalization was 20.3 days, and fusion was achieved in all cases by 14.8 ± 1.6 weeks after surgery, as demonstrated on dynamic radiographs and cervical 3D CT scans.

The mean pretreatment translation was 6.9 ± 3.2 mm, and the mean postoperative translation was 1.6 ± 1.8 mm (mean reduction 5.2 ± 3.1 mm). The initial angulation was 4.7° ± 5.3° and the postoperative angulation was 2.5° ± 1.8° (mean reduction 6.1° ± 5.3°). The preoperative and postoperative values for translation and angulation differed significantly (p < 0.05). The overall C2–3 disc height was 6.7 ± 1.2 mm preoperatively, whereas 3 months after surgery it was 6.4 ± 1.1 mm. These values did not differ significantly (p = 0.0963).

Conclusions

The authors observed effective reduction and bony healing in cases of unstable hangman's fractures after fixation, and all patients experienced favorable clinical outcomes with neck pain improvement. The protocols allowed for physiological reconstruction of the fractured deformities and avoided external fixation. The authors suggest that posterior reduction and screw fixation should be used as a primary treatment to promote stability of hangman's fracture in the presence of discoligamentous instability or combined fractures.

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Oren Sagher and Hemant A. Parmar

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Nathan T. Zwagerman, Eric W. Wang, Samuel S. Shin, Yue-Fang Chang, Juan C. Fernandez-Miranda, Carl H. Snyderman and Paul A. Gardner

OBJECTIVE

Based on a null hypothesis that the use of short-term lumbar drainage (LD) after endoscopic endonasal surgery (EES) for intradural pathology does not prevent postoperative CSF leaks, a trial was conducted to assess the effect of postoperative LD on postoperative CSF leak following standard reconstruction.

METHODS

A prospective, randomized controlled trial of lumbar drain placement after endoscopic endonasal skull base surgery was performed from February 2011 to March 2015. All patients had 3-month follow-up data. Surgeons were blinded to which patients would or would not receive the drain until after closure was completed. An a priori power analysis calculation assuming 80% of power, 5% postoperative CSF leak rate in the no-LD group, and 16% in the LD group determined a planned sample size of 186 patients. A routine data and safety check was performed with every 50 patients being recruited to ensure the efficacy of randomization and safety. These interim tests were run by a statistician who was not blinded to the arms they were evaluating. This study accrued 230 consecutive adult patients with skull base pathology who were eligible for endoscopic endonasal resection. Inclusion criteria (high-flow leak) were dural defect greater than 1 cm2 (mandatory), extensive arachnoid dissection, and/or dissection into a ventricle or cistern. Sixty patients were excluded because they did not meet the inclusion criteria. One hundred seventy patients were randomized to either receive or not receive a lumbar drain.

RESULTS

One hundred seventy patients were randomized, with a mean age of 51.6 years (range 19–86 years) and 38% were male. The mean BMI for the entire cohort was 28.1 kg/m2. The experimental cohort with postoperative LD had an 8.2% rate of CSF leak compared to a 21.2% rate in the control group (odds ratio 3.0, 95% confidence interval 1.2–7.6, p = 0.017). In 106 patients in whom defect size was measured intraoperatively, a larger defect was associated with postoperative CSF leak (6.2 vs 2.9 cm2, p = 0.03). No significant difference was identified in BMI between those with (mean 28.4 ± 4.3 kg/m2) and without (mean 28.1 ± 5.6 kg/m2) postoperative CSF leak (p = 0.79). Furthermore, when patients were grouped based on BMI < 25, 25–29.9, and > 30 kg/m2, no difference was noted in the rates of CSF fistula (p = 0.97).

CONCLUSIONS

Among patients undergoing intradural EES judged to be at high risk for CSF leak as defined by the study’s inclusion criteria, perioperative LD used in the context of vascularized nasoseptal flap closure significantly reduced the rate of postoperative CSF leaks.

Clinical trial registration no.: NCT03163134 (clinicaltrials.gov).

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Samuel S. Shin, Geoffrey Murdoch, Ronald L. Hamilton, Amir H. Faraji, Hideyuki Kano, Nathan T. Zwagerman, Paul A. Gardner, L. Dade Lunsford and Robert M. Friedlander

OBJECT

Stereotactic radiosurgery (SRS) is a therapeutic option for repeatedly hemorrhagic cavernous malformations (CMs) located in areas deemed to be high risk for resection. During the latency period of 2 or more years after SRS, recurrent hemorrhage remains a persistent risk until the obliterative process has finished. The pathological response to SRS has been studied in relatively few patients. The authors of the present study aimed to gain insight into the effect of SRS on CM and to propose possible mechanisms leading to recurrent hemorrhages following SRS.

METHODS

During a 13-year interval between 2001 and 2013, bleeding recurred in 9 patients with CMs that had been treated using Gamma Knife surgery at the authors' institution. Microsurgical removal was subsequently performed in 5 of these patients, who had recurrent hemorrhages between 4 months and 7 years after SRS. Specimens from 4 patients were available for analysis and used for this report.

RESULTS

Histopathological analysis demonstrated that vascular sclerosis develops as early as 4 months after SRS. In the samples from 2 to 7 years after SRS, sclerotic vessels were prominent, but there were also vessels with incomplete sclerosis as well as some foci of neovascularization.

CONCLUSIONS

Recurrent bleeding after SRS for CM could be related to incomplete sclerosis of the vessels, but neovascularization may also play a role.

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Alexandre Paim Diaz, Marcelo Liborio Schwarzbold, Ricardo Guarnieri, Maria Emilia Rodrigues de Oliveira Thais, Fernando Cini Freitas, Fernando Zanela da Silva Areas, Marcelo Neves Linhares and Roger Walz

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Amir H. Faraji, Kumar Abhinav, Kevin Jarbo, Fang-Cheng Yeh, Samuel S. Shin, Sudhir Pathak, Barry E. Hirsch, Walter Schneider, Juan C. Fernandez-Miranda and Robert M. Friedlander

OBJECT

Brainstem cavernous malformations (CMs) are challenging due to a higher symptomatic hemorrhage rate and potential morbidity associated with their resection. The authors aimed to preoperatively define the relationship of CMs to the perilesional corticospinal tracts (CSTs) by obtaining qualitative and quantitative data using high-definition fiber tractography. These data were examined postoperatively by using longitudinal scans and in relation to patients’ symptomatology. The extent of involvement of the CST was further evaluated longitudinally using the automated “diffusion connectometry” analysis.

METHODS

Fiber tractography was performed with DSI Studio using a quantitative anisotropy (QA)-based generalized deterministic tracking algorithm. Qualitatively, CST was classified as being “disrupted” and/or “displaced.” Quantitative analysis involved obtaining mean QA values for the CST and its perilesional and nonperilesional segments. The contralateral CST was used for comparison. Diffusion connectometry analysis included comparison of patients’ data with a template from 90 normal subjects.

RESULTS

Three patients (mean age 22 years) with symptomatic pontomesencephalic hemorrhagic CMs and varying degrees of hemiparesis were identified. The mean follow-up period was 37.3 months. Qualitatively, CST was partially disrupted and displaced in all. Direction of the displacement was different in each case and progressively improved corresponding with the patient’s neurological status. No patient experienced neurological decline related to the resection. The perilesional mean QA percentage decreases supported tract disruption and decreased further over the follow-up period (Case 1, 26%–49%; Case 2, 35%–66%; and Case 3, 63%–78%). Diffusion connectometry demonstrated rostrocaudal involvement of the CST consistent with the quantitative data.

CONCLUSIONS

Hemorrhagic brainstem CMs can disrupt and displace perilesional white matter tracts with the latter occurring in unpredictable directions. This requires the use of tractography to accurately define their orientation to optimize surgical entry point, minimize morbidity, and enhance neurological outcomes. Observed anisotropy decreases in the perilesional segments are consistent with neural injury following hemorrhagic insults. A model using these values in different CST segments can be used to longitudinally monitor its craniocaudal integrity. Diffusion connectometry is a complementary approach providing longitudinal information on the rostrocaudal involvement of the CST.