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Gonzague Guillaumet, Nozar Aghakhani, Silvia Morar, Razvan Copaciu, Fabrice Parker, and Steven Knafo

OBJECTIVE

Surgical treatment for nonforaminal syringomyelia related to spinal arachnoiditis is still controversial. The authors sought to assess respective outcomes and rates of reintervention for shunting and spinal cord untethering (arachnolysis) in spinal arachnoiditis with syringomyelia.

METHODS

This retrospective cohort study was conducted at a single reference center for syringomyelia. Patients undergoing arachnolysis and/or shunting interventions for nonforaminal syringomyelia were screened.

RESULTS

The study included 75 patients undergoing 130 interventions. Arachnolysis without shunting was performed in 48 patients, while 27 patients underwent shunting. The mean follow-up between the first surgery and the last outpatient visit was 65.0 months (range 12–379 months, median 53 months). At the last follow-up, the modified McCormick score was improved or stabilized in 83.4% of patients after arachnolysis versus 66.7% after shunting. Thirty-one (41.3%) patients underwent reintervention during follow-up, with a mean delay of 33.2 months. The rate of reintervention was 29.2% in the arachnolysis group versus 63.0% in the shunting group (chi-square = 8.1, p = 0.007). However, this difference was largely driven by the extension of the arachnoiditis: in patients with focal arachnoiditis (≤ 2 spinal segments), the reintervention rate was 21.6% for arachnolysis versus 57.1% for shunting; in patients with extensive arachnoiditis, it was 54.5% versus 65.0%, respectively. Survival analysis assessing the time to the first reintervention demonstrated a better outcome in both the arachnolysis (p = 0.03) and the focal arachnoiditis (p = 0.04) groups.

CONCLUSIONS

Arachnolysis led to fewer reinterventions than shunting in patients with nonforaminal syringomyelia. There was a high risk of reintervention for patients with extensive arachnopathies, irrespective of the surgical technique.

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Risheng Xu, Lydia Gregg, Sheng-fu Larry Lo, and Philippe Gailloud

Low-flow spinal extradural arteriovenous fistulas (SEAVFs) are frequently misdiagnosed as spinal dural arteriovenous fistulas (SDAVFs), and their true prevalence is unknown. The principal feature distinguishing low-flow SEAVFs from SDAVFs is the location of the shunt, which involves a pouch of epidural plexus in SEAVFs and a radiculomedullary vein (RMV) in SDAVFs. A venous hypertensive myelopathy comparable to the one observed with SDAVFs develops when the arterialized venous pouch of an SEAVF is connected to an RMV. Depending on the size of the epidural pouch, a low-flow SEAVF may uncommonly drain into multiple RMVs. The authors present an observation of a low-flow SEAVF whose double radiculomedullary drainage was revealed only after intraoperative digital subtraction angiography, and they discuss the surgical implications of this anatomical configuration.

Open access

Daisuke Sakai, Jordy Schol, Akihiko Hiyama, Hiroyuki Katoh, Masahiro Tanaka, Masato Sato, and Masahiko Watanabe

OBJECTIVE

The objectives of this study were to apply the simultaneous translation on two rods (ST2R) maneuver involving rods contoured with a convexity at the desired thoracic kyphosis (TK) apex level and to assess the effects on the ability to support triplanar deformity corrections, including TK apex improvement, in patients with hypokyphotic adolescent idiopathic scoliosis (AIS).

METHODS

Using retrospective analysis, the authors examined the digital records that included 2- to 4-week, 1-year, and 2-year postoperative radiographic follow-up data of female hypokyphotic (TK < 20°) AIS patients (Lenke type 1–3) treated with ST2R. The authors assessed the corrections of triplanar deformities by examining the main Cobb angle, TK, rib hump, apical vertebral rotation, Scoliosis Research Society 22-item questionnaire scores, and TK apex translocation. In order to better grasp the potential of ST2R, the outcomes were compared with those of a historical matched case-control cohort treated with a standard rod rotation (RR) maneuver.

RESULTS

Data were analyzed for 25 AIS patients treated with ST2R and 27 patients treated with RR. The ST2R group had significant improvements in the main Cobb angle and TK, reduction in the rib hump size at each time point, and a final correction rate of 72%. ST2R treatment significantly increased the kyphosis apex by an average of 2.2 levels. The correction rate was higher at each time point in the ST2R group than in the RR group. ST2R engendered favorable TK corrections, although the differences were nonsignificant, at 2 years compared with the RR group (p = 0.056). The TK apex location was significantly improved in the ST2R cohort (p < 0.001). At the 1-month follow-up, hypokyphosis was resolved in 92% of the ST2R cohort compared with 30% of the RR cohort.

CONCLUSIONS

Resolving hypokyphotic AIS remains challenging. The ST2R technique supported significant triplanar corrections, including TK apex translocation and restoration of hypokyphosis in most patients. Comparisons with the RR cohort require caution because of differences in the implant profile. However, ST2R significantly improved the coronal and sagittal corrections. It also allowed for distribution of correctional forces over two rod implants instead of one, which should decrease the risk of screw pullout and rod flattening. It is hoped that the description here of commercially available reducers used with the authors’ surgical technique will encourage other clinicians to consider using the ST2R technique.

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Akiyoshi Ogino, L. Dade Lunsford, Hao Long, Stephen Johnson, Andrew Faramand, Ajay Niranjan, John C. Flickinger, and Hideyuki Kano

OBJECTIVE

This report evaluates the outcomes of stereotactic radiosurgery (SRS) as the first-line treatment of intracanalicular vestibular schwannomas (VSs).

METHODS

Between 1987 and 2017, the authors identified 209 patients who underwent SRS as the primary intervention for a unilateral intracanalicular VS. The median patient age was 54 years (range 22–85 years); 94 patients were male and 115 were female. Three patients had facial neuropathy at the time of SRS. One hundred fifty-five patients (74%) had serviceable hearing (Gardner-Robertson [GR] grades I and II) at the time of SRS. The median tumor volume was 0.17 cm3 (range 0.015–0.63 cm3). The median margin dose was 12.5 Gy (range 11.0–25.0 Gy). The median maximum dose was 24.0 Gy (range 15.7–50.0 Gy).

RESULTS

The progression-free survival rates of all patients with intracanalicular VS were 97.5% at 3 years, 95.6% at 5 years, and 92.1% at 10 years. The rates of freedom from the need for any additional intervention were 99.4% at 3 years, 98.3% at 5 years, and 98.3% at 10 years. The serviceable hearing preservation rates in GR grade I and II patients at the time of SRS were 76.6% at 3 years, 63.5% at 5 years, and 27.3% at 10 years. In univariate analysis, younger age (< 55 years, p = 0.011), better initial hearing (GR grade I, p < 0.001), and smaller tumor volumes (< 0.14 cm3, p = 0.016) were significantly associated with improved hearing preservation. In multivariate analysis, better hearing (GR grade I, p = 0.001, HR 2.869, 95% CI 1.569–5.248) and smaller tumor volumes (< 0.14 cm3, p = 0.033, HR 2.071, 95% CI 1.059–4.047) at the time of SRS were significantly associated with improved hearing preservation. The hearing preservation rates of patients with GR grade I VS were 88.1% at 3 years, 77.9% at 5 years, and 38.1% at 10 years. The hearing preservation rates of patients with VSs smaller than 0.14 cm3 were 85.5% at 3 years, 77.7% at 5 years, and 42.6% at 10 years. Facial neuropathy developed in 1.4% from 6 to 156 months after SRS.

CONCLUSIONS

SRS provided sustained tumor control in more than 90% of patients with intracanalicular VS at 10 years and freedom from the need for additional intervention in more than 98% at 10 years. Patients with initially better hearing and smaller VSs had enhanced serviceable hearing preservation during an observation interval up to 10 years after SRS.

Open access

Kee D. Kim, K. Stuart Lee, Domagoj Coric, Jason J. Chang, James S. Harrop, Nicholas Theodore, and Richard M. Toselli

OBJECTIVE

The aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.

METHODS

This was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.

RESULTS

Nineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.

CONCLUSIONS

In this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.

Clinical trial registration no.: NCT02138110 (clinicaltrials.gov)

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Chelsea Shope, Mohammed Alshareef, Thomas Larrew, Christopher Bolling, Justin Reagan, Milad Yazdani, Maria Spampinato, and Ramin Eskandari

OBJECTIVE

Traumatic brain injury (TBI) is a prevalent pediatric pathology in the modern emergency department. Computed tomography (CT) is utilized for detection of TBI and can result in cumulatively high radiation exposure. Recently, a fast brain magnetic resonance imaging (fbMRI) protocol has been employed for rapid imaging of hydrocephalus in pediatric patients. The authors investigate the utility of a modified trauma-focused fbMRI (t-fbMRI) protocol as an alternative to surveillance CT in the setting of acute TBI in pediatric patients, thus reducing radiation exposure while improving diagnostic yield.

METHODS

A retrospective review was performed at the authors’ institution for all pediatric patients who had undergone t-fbMRI within 72 hours of an initial CT scan, using a 1.5- or 3-T MR scanner for trauma indications. Forty patients met the study inclusion criteria. The authors performed a comparison of findings on the reads of CT and fbMRI, and a board-certified neuroradiologist conducted an independent review of both modalities.

RESULTS

T-fbMRI outperformed CT in specificity, sensitivity, and negative predictive value for all injury pathologies measured, except for skull fractures. T-fbMRI demonstrated a sensitivity of 100% in the detection of extraaxial bleed, intraventricular hemorrhage, and subarachnoid hemorrhage and had a sensitivity of 78% or greater for epidural hematoma, subdural hematoma, and intraparenchymal hemorrhage. T-fbMRI yielded a specificity of 100% for all types of intracranial hemorrhages, with a corresponding negative predictive value that exceeded that for CT.

CONCLUSIONS

In pediatric populations, the t-fbMRI protocol provides a valid alternative to CT in the surveillance of TBI and intracranial hemorrhage. Although not as sensitive in the detection of isolated skull fractures, t-fbMRI can be used to monitor pathologies implicated in TBI patients while minimizing radiation exposure from traditional surveillance imaging.

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Badih J. Daou, Siri Sahib S. Khalsa, Sharath Kumar Anand, Craig A. Williamson, Noah S. Cutler, Bryan L. Aaron, Sudharsan Srinivasan, Venkatakrishna Rajajee, Kyle Sheehan, and Aditya S. Pandey

OBJECTIVE

Hydrocephalus and seizures greatly impact outcomes of patients with aneurysmal subarachnoid hemorrhage (aSAH); however, reliable tools to predict these outcomes are lacking. The authors used a volumetric quantitative analysis tool to evaluate the association of total aSAH volume with the outcomes of shunt-dependent hydrocephalus and seizures.

METHODS

Total hemorrhage volume following aneurysm rupture was retrospectively analyzed on presentation CT imaging using a custom semiautomated computer program developed in MATLAB that employs intensity-based k-means clustering to automatically separate blood voxels from other tissues. Volume data were added to a prospectively maintained aSAH database. The association of hemorrhage volume with shunted hydrocephalus and seizures was evaluated through logistic regression analysis and the diagnostic accuracy through analysis of the area under the receiver operating characteristic curve (AUC).

RESULTS

The study population comprised 288 consecutive patients with aSAH. The mean total hemorrhage volume was 74.9 ml. Thirty-eight patients (13.2%) developed seizures. The mean hemorrhage volume in patients who developed seizures was significantly higher than that in patients with no seizures (mean difference 17.3 ml, p = 0.01). In multivariate analysis, larger hemorrhage volume on initial CT scan and hemorrhage volume > 50 ml (OR 2.81, p = 0.047, 95% CI 1.03–7.80) were predictive of seizures. Forty-eight patients (17%) developed shunt-dependent hydrocephalus. The mean hemorrhage volume in patients who developed shunt-dependent hydrocephalus was significantly higher than that in patients who did not (mean difference 17.2 ml, p = 0.006). Larger hemorrhage volume and hemorrhage volume > 50 ml (OR 2.45, p = 0.03, 95% CI 1.08–5.54) were predictive of shunt-dependent hydrocephalus. Hemorrhage volume had adequate discrimination for the development of seizures (AUC 0.635) and shunted hydrocephalus (AUC 0.629).

CONCLUSIONS

Hemorrhage volume is an independent predictor of seizures and shunt-dependent hydrocephalus in patients with aSAH. Further evaluation of aSAH quantitative volumetric analysis may complement existing scales used in clinical practice and assist in patient prognostication and management.

Free access

Marjorie C. Wang and Mohammed Y. T. AlGhamdi

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Anouk Borg, Ciaran Scott Hill, Besnik Nurboja, Giles Critchley, and David Choi

OBJECTIVE

Lumbar spinal stenosis (LSS) is a common and debilitating condition that is increasing in prevalence in the world population. Surgical decompression is often standard treatment when conservative measures have failed. Interspinous distractor devices (IDDs) have been proposed as a safe alternative; however, the associated cost and early reports of high failure rates have brought their use into question. The primary objective of this study was to determine the cost-effectiveness and long-term quality-of-life (QOL) outcomes after treatment of LSS with the X-Stop IDD compared with surgical decompression by laminectomy.

METHODS

A multicenter, open-label randomized controlled trial of 47 patients with LSS was conducted; 21 patients underwent insertion of the X-Stop device and 26 underwent laminectomy. The primary outcomes were monetary cost and QOL measured using the EQ-5D questionnaire administered at 6-, 12-, and 24-month time points.

RESULTS

The mean monetary cost for the laminectomy group was £2712 ($3316 [USD]), and the mean cost for the X-Stop group was £5148 ($6295): £1799 ($2199) procedural cost plus £3349 mean device cost (£2605 additional cost per device). Using an intention-to-treat analysis, the authors found that the mean quality-adjusted life-year (QALY) gain for the laminectomy group was 0.92 and that for the X-Stop group was 0.81. The incremental cost-effectiveness ratio was −£22,145 (−$27,078). The revision rate for the X-Stop group was 19%. Five patients crossed over to the laminectomy arm after being in the X-Stop group.

CONCLUSIONS

Laminectomy was more cost-effective than the X-Stop for the treatment of LSS, primarily due to device cost. The X-Stop device led to an improvement in QOL, but it was less than that in the laminectomy group. The use of the X-Stop IDD should be reserved for cases in which a less-invasive procedure is required. There is no justification for its regular use as an alternative to decompressive surgery.

Clinical trial registration no.: ISRCTN88702314 (www.isrctn.com)

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Victor M. Lu, Ashish H. Shah, Frederic A. Vallejo, Daniel G. Eichberg, Evan M. Luther, Sumedh S. Shah, Ricardo J. Komotar, and Michael E. Ivan

OBJECTIVE

Adult glioblastoma (GBM) has proven refractory to decades of innovation. Oncolytic viral therapy represents a novel therapy that uses viral vectors as both a delivery and therapeutic mechanism to target GBM cells. Despite the growing body of basic science data supporting the feasibility of viral therapy to treat GBM, the reporting of clinical trial results is heterogeneous. Correspondingly, the aim of this study was to present a contemporary summary of the progress all clinical trials have made to date.

METHODS

The ClinicalTrials.gov database was reviewed in August 2020 for all possible interventional clinical trials involving viral vector–based therapy to treat adult GBM. These were then screened against selection criteria to identify pertinent clinical trials.

RESULTS

A total of 29 oncolytic viral therapy trials treating adult GBM were identified. The median start and expected completion years were 2014 and 2020, respectively. At the time of this writing, 10 (35%) trials were reported to have completed recruitment, whereas 7 (24%) were actively recruiting. The median target enrollment number was 36 (range 13–108), with the majority of trials being phase I (n = 18, 62%), and involving secondary GBM among other malignant glioma (n = 19, 66%). A total of 10 unique viral vectors were used across all trials, with the most common being adenovirus (n = 16, 55%). Only 2 (7%) phase I trials to date have reported outcomes on the ClinicalTrials.gov portal. Results of 12 additional clinical trials were found in academic publications, with median progression-free and overall survival times of 3 and 15 months, respectively, after the first viral dose at recurrence. The coordination of the large majority of trials originated from the US (n = 21, 72%), and the median number of testing sites per trial was 1 (range 1–15), via industry funding (n = 18 trials, 62%).

CONCLUSIONS

There are multiple early-stage oncolytic viral therapy clinical trials for adult GBM currently active. To date, limited results and outcomes are promising but scarce. The authors expect this to change in the near future because many trials are scheduled to have either nearly or actually reached their expected recruitment completion time. How exactly oncolytic viral therapy will fit into the current treatment paradigms for primary and secondary GBM remains to be seen, and will not be known until safety and toxicity profiles are established by these clinical trials.