Intra-arterial thrombolysis with tenecteplase for the treatment of cervical spinal cord ischemia: Technical case report.

BACKGROUND: In recent years, there have anecdotal reports of intra-arterial thrombolysis (IAT) for the treatment of spinal cord ischemia (SCI) with encouraging results. We describe a patient with acute cervical SCI who underwent IAT with Tenecteplase at our institution. CASE PRESENTATION: A 20-year-old man presented to the emergency department with a 12-hour history of progressive onset upper and lower extremity numbness, weakness, and urinary incontinence after sustaining a fall. MRI of cervical spine demonstrated T2 and STIR hyperintensity in the ventral aspect of the spinal cord spanning the C3, C4, and C5 levels suggestive of SCI. He demonstrated progression of neurologic deficits to C4 ASIA B spinal cord injury with complete loss of motor function, diminished sensation, and absent rectal tone. Emergent angiography was performed with prominent anterior spinal supply via the left ascending cervical artery. A total of 30 mg of Tenecteplase was administered intra-arterially in the bilateral vertebral arteries, bilateral ascending cervical arteries, and bilateral inferior thyroid arteries. Two-week post-intervention neurologic examination demonstrated improvement in injury level and severity. The patient was C6 ASIA C SCI, with 2/5 strength in the distal upper and lower extremities and improved sensation. CONCLUSION: IAT with Tenecteplase may be a feasible option for the treatment of acute spinal cord ischemia in carefully selected patients.

The role of bone mineral density in adult spinal deformity patients undergoing corrective surgery: a matched analysis.

STUDY DESIGN: Retrospective cohort. BACKGROUND: Over 44 million adults are estimated to have either osteoporosis or osteopenia. Adult spinal deformity (ASD) is estimated to affect between 32 and 68% of the elderly population. OBJECTIVE: Retrospective investigation comparing rates of postoperative complications following thoracolumbar scoliosis surgery in patients with normal bone mineral density (BMD) to those with osteopenia or osteoporosis in addition to analyzing the effects of pretreatment with anti-osteoporotic medications in patients with low BMD. METHODS: Using administrative database of Humana beneficiaries, ICD-9 and ICD-10 diagnosis codes were used to identify ASD patients undergoing multilevel thoracolumbar fusions between 2007 and 2017. RESULTS: The propensity matched population analyzed in this study contained 1044 patients equally represented by those with a history of osteopenia, osteoporosis, or normal BMD. Osteopenia and osteoporosis were associated with increased odds of revision surgery (OR 2.01 95% CI 1.36-2.96 and OR 1.57, 95% CI 1.05-2.35), respectively. Similarly, there was an almost twofold increased odds of proximal and distal junctional kyphosis in patients with osteopenia and osteoporosis (OR 1.95, 95% CI 1.40-2.74 and OR 1.88, 95% CI 1.34-2.64), respectively. A total of 258 (37.1%) patients with osteoporosis were pretreated with anti-osteoporotic medications and there was no statistically significant decrease in odds of proximal or distal junctional kyphosis or revision surgery in these patients. CONCLUSION: Patients with ASD undergoing multilevel thoracolumbar fusion surgery have significantly higher rates of postoperative pseudarthrosis, proximal and distal junctional kyphosis, and revision surgery rates compared to patients with normal BMD.

Pediatric primary high-grade spinal glioma: a National Cancer Database analysis of current patterns in treatment and outcomes.

PURPOSE: Pediatric primary high-grade spinal glioma (p-HGSG) is an extremely rare disease process, with little data within the current literature. Akin to primary high-grade gliomas, this cancer has been exemplified by dismal prognosis and poor response to modern treatment paradigms. This study seeks to investigate the current trends affecting overall survival using the National Cancer Database (NCDB). METHODS: The NCDB was queried for p-HGSG between 2004 and 2016, by utilizing the designated diagnosis codes. Kaplan-Meier curves were generated, and log-rank testing was performed to analyze factors affecting overall survival. In addition, a Cox proportional-hazards model was used to perform multivariate regression analysis of survival outcomes. RESULTS: A cohort of 97 patients was identified with a histologically confirmed p-HGSG. The overall incidence of p-HGSG in all pediatric spinal cord tumors is 7.5%, with a mean survival time of 25.3 months (SD, 21.0) and 5-year overall survival of 17.0%. The majority of patients underwent surgery (n = 87, 89.7%), radiotherapy (n = 73, 75.3%), and chemotherapy (n = 60, 61.9%). Univariate, multivariate, and Kaplan-Meier log-rank testing failed to demonstrate an association between performing surgery, extent of resection, radiotherapy, or chemotherapy with improved survival outcomes. CONCLUSIONS: The current study constitutes the largest retrospective analysis of p-HGSGs to date, finding that current treatment options of surgery, radiotherapy, and chemotherapy have unclear benefit. This disease process has a poor prognosis without a current modality of treatment that conclusively alters survival. The risks and side effects of these treatment modalities must be carefully considered in such a highly aggressive disease process, especially given potentially limited survival benefits.

Adult primary high-grade spinal glioma: a nationwide analysis of current trends in treatment and outcomes.

PURPOSE: High-grade spinal glioma (HGSG) is an extremely rare, malignant neoplasm insufficiently described in the literature. We sought to investigate the effect of epidemiological risk factors and treatment strategies on the prognosis of HGSGs using the National Cancer Database (NCDB). METHODS: Patients with diagnosis codes specific for HGSG were queried from the NCDB during the years 2004-2016. Kaplan-Meier curves were generated with log-rank testing performed to assess factors affecting survival. Univariate and multivariate Cox regression analysis was also performed to investigate overall survival. RESULTS: 396 patients were identified with a histologically-confirmed diagnosis of HGSG between 2004-2016. The mean survival time for all patients was 24.5 months (SD: 20.3). Multivariate Cox proportional-hazards regression analysis revealed that tumor size of 26-50 mm (HR 4.96, 95% CI 1.76-13.98, p < 0.01) and greater than 50 mm (HR 4.67, 95% CI 1.43-15.23, p = 0.01) were associated with worsened overall survival in comparison to lesions less than 26 mm. While quality of life was not investigated, both Kaplan-Meier log-rank testing and regression analysis failed to demonstrate an association of survival outcomes with extent of resection, radiotherapy, or chemotherapy. CONCLUSION: The current study represents the largest retrospective analysis of adult primary high-grade spinal glioma to date. Our analysis found no relationship between the extent of surgical resection and survival outcomes. In addition, we failed to show any statistically significant survival benefit with radiotherapy or chemotherapy. This disease process has a poor prognosis without a current modality of treatment that improves survival.

Association of osteopenia and osteoporosis with higher rates of pseudarthrosis and revision surgery in adult patients undergoing single-level lumbar fusion.

OBJECTIVE: Patients with osteopenia or osteoporosis who require surgery for symptomatic degenerative spondylolisthesis may have higher rates of postoperative pseudarthrosis and need for revision surgery than patients with normal bone mineral densities (BMDs). To this end, the authors compared rates of postoperative pseudarthrosis and need for revision surgery following single-level lumbar fusion in patients with normal BMD with those in patients with osteopenia or osteoporosis. The secondary outcome was to investigate the effects of pretreatment with medications that prevent bone loss (e.g., teriparatide, bisphosphonates, and denosumab) on these adverse outcomes in this patient cohort. METHODS: Patients undergoing single-level lumbar fusion between 2007 and 2017 were identified. Based on 1:1 propensity matching for baseline demographic characteristics and comorbidities, 3 patient groups were created: osteopenia (n = 1723, 33.3%), osteoporosis (n = 1723, 33.3%), and normal BMD (n = 1723, 33.3%). The rates of postoperative pseudarthrosis and revision surgery were compared between groups. RESULTS: The matched populations analyzed in this study included a total of 5169 patients in 3 groups balanced at baseline, with equal numbers (n = 1723, 33.3%) in each group: patients with a history of osteopenia, those with a history of osteoporosis, and a control group of patients with no history of osteopenia or osteoporosis and with normal BMD. A total of 597 complications were recorded within a 2-year follow-up period, with pseudarthrosis (n = 321, 6.2%) being slightly more common than revision surgery (n = 276, 5.3%). The odds of pseudarthrosis and revision surgery in patients with osteopenia were almost 2-fold (OR 1.7, 95% CI 1.26-2.30) and 3-fold (OR 2.73, 95% CI 1.89-3.94) higher, respectively, than those in patients in the control group. Similarly, the odds of pseudarthrosis and revision surgery in patients with osteoporosis were almost 2-fold (OR 1.92, 95% CI 1.43-2.59) and > 3-fold (OR 3.25, 95% CI 2.27-4.65) higher, respectively, than those in patients in the control group. Pretreatment with medications to prevent bone loss prior to surgery was associated with lower pseudarthrosis and revision surgery rates, although the differences did not reach statistical significance. CONCLUSIONS: Postoperative pseudarthrosis and revision surgery rates following single-level lumbar spinal fusion are significantly higher in patients with osteopenia and osteoporosis than in patients with normal BMD. Pretreatment with medications to prevent bone loss prior to surgery decreased these complication rates, although the observed differences did not reach statistical significance.

Atypical Teratoid/Rhabdoid Tumor of the Conus Medullaris.

INTRODUCTION: Atypical teratoid/rhabdoid tumor (AT/RT) is a rare tumor of the central nervous system, especially when involving the spinal column or spinal cord. CASE PRESENTATION: We present a case of a 5-year-old girl with progressive bilateral lower extremity pain found to have a discrete nodular lesion of the conus with mild heterogeneous enhancement. Surgical decompression and resection demonstrated a pathologic tumor consistent with AT/RT with loss of INI1 protein on immunohistochemistry. DISCUSSION AND CONCLUSION: AT/RT lesions of the conus medullaris are exceedingly rare and associated with extensive disease. We report a rare case of AT/RT with selective involvement of the conus medullaris, as well as describe the surgical, radiographic, and pathologic findings of this tumor.

COVID-19 Vaccine Related Cervical Radiculitis and Parsonage-Turner Syndrome: Case Report and Review of the Literature.

Parsonage-Turner Syndrome, or neuralgic amyotrophy, is an acute-onset upper limb and shoulder girdle palsy that can occur in a post-viral, post-surgical or idiopathic setting. There have also been some reported cases of the syndrome occurring following vaccinations. The pathophysiology of neuralgic amyotrophy is not completely understood and many of the commonly used diagnostic imaging modalities we use to try and diagnose this syndrome are inaccurate and misleading. We present the case of a 40-year-old gentleman who presented with acute onset burning pain and fasciculations in his right upper extremity following vaccination with the second dose of the Pfizer-BioNTech COVID-19 vaccine. His symptoms progressed to weakness in isolated muscle groups with electromyographic evidence of decreased nerve conduction. MRI of the cervical spine demonstrated multilevel central and foraminal stenosis, suggesting a diagnosis of cervical radiculopathy. The patient underwent a C4-5/C5-6 and C6-7 laminoforaminotomy and tolerated the procedure well. Post-operatively, the patient has experienced gradual symptom improvement with residual right triceps and pectoralis muscle weakness as well as paresthesias of the right elbow and forearm. Parsonage-Turner Syndrome is a brachial plexus palsy that can affect one or multiple branches of the brachial plexus. It causes acute-onset pain and weakness, and the diagnosis can be difficult to make with the commonly used diagnostic imaging methods. We reviewed other case reports about neuralgic amyotrophy following vaccinations as well as the current literature on more accurate diagnostic imaging modalities that may help our diagnosis and understanding of the pathophysiology of this condition.

Impact of post-procedure stenosis on outcomes of patients with severe intracranial stenosis treated with intracranial stent placement.

BACKGROUND: The optimal target post-procedure stenosis after percutaneous angioplasty and stent placement (PTAS) for intracranial stenosis is unknown. We determined the effect of post-procedure stenosis after intracranial PTAS on subsequent clinical events in patients with severe symptomatic intracranial stenosis. METHODS: We categorized the severity of post-procedure stenosis as '<30%', '30-49%', and '≥50%' among 207 patients who underwent PTAS in a multicenter randomized clinical trial. Outcomes included stroke or death within 72 hours and within 30 days, ipsilateral stroke beyond 30 days of treatment, and stroke or death within 30 days or stroke in the qualifying artery beyond 30 days (primary endpoint of the trial). Cox proportional hazards analysis was performed with adjustments for age, initial severity of stenosis, location of stenosis, and qualifying event. Kaplan-Meier curves were generated for the primary endpoint stratified by post-procedure stenosis with log-rank analysis. RESULTS: The severity of post-procedure stenosis was categorized as <30%, 30-49%, and ≥50% in 112, 73, and 22 patients, respectively. Compared with patients with post-procedure stenosis <30%, there was no difference in the risk of primary endpoint among patients with post-procedure stenoses of 30-49% (hazards ratio (HR) 0.85, 95% confidence interval (95% CI) 0.64 to 1.15) or those with ≥50% (HR 0.91, 95% CI 0.57 to 1.43). Log-rank analysis did not demonstrate a difference in rates of primary endpoint between groups stratified by post-procedure stenosis (P=0.70). CONCLUSION: In the absence of any benefit on short- and long-term outcomes, strategies to achieve a low severity of post-procedure stenosis among patients with severe intracranial stenosis may not be warranted.

Incidence, Management, and Outcomes of Adult Spinal Chordoma Patients in the United States.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Spinal chordomas are rare primary malignant neoplasms of the primitive notochord. They are slow growing but locally aggressive lesions that have high rates of recurrence and metastasis after treatment. Gold standard treatment remains en-bloc surgical resection with questionable efficacy of adjuvant therapies such as radiation and chemotherapy. Here we provide a comprehensive analysis of prognostic factors, treatment modalities, and survival outcomes in patients with spinal chordoma. METHODS: Patients with diagnosis codes specific for chordoma of spine, sacrum, and coccyx were queried from the National Cancer Database (NCDB) during the years 2004-2016. Outcomes were investigated using Cox univariate and multivariate regression analyses, and survival curves were generated for comparative visualization. RESULTS: 1,548 individuals were identified with a diagnosis of chordoma, 60.9% of which were at the sacrum or coccyx and 39.1% at the spine. The mean overall survival of patients in our cohort was 8.2 years. Increased age, larger tumor size, and presence of metastases were associated with worsened overall survival. 71.2% of patients received surgical intervention and both partial and radical resection were associated with significantly improved overall survival (P < 0.001). Neither radiotherapy nor chemotherapy administration improved overall survival; however, amongst patients who received radiation, those who received proton-based radiation had significantly improved overall survival compared to traditional radiation. CONCLUSION: Surgical resection significantly improves overall survival in patients with spinal chordoma. In those patients receiving radiation, those who receive proton-based modalities have improved overall survival. Further studies into proton radiotherapy doses are required.

Risk of new cerebral ischemic events in patients with symptomatic internal carotid artery stenosis while awaiting carotid stent placement.

BACKGROUND AND PURPOSE: Although there is an emphasis on performing carotid artery stent (CAS) placement within 2 weeks after index event of transient ischemic attack (TIA) or minor stroke in patients with significant extracranial internal carotid artery (ICA) stenosis, the risks and characteristics of recurrent cerebral ischemic event while waiting for CAS placement are not well defined. METHOD: We analyzed patients admitted to our institution over a 45-month period with symptomatic extracranial ICA stenosis. We identified any new cerebral ischemic events that occurred between index cerebral or retinal ischemic event and CAS placement and categorized them as TIA and minor or major ischemic strokes. We calculated the risk of new ipsilateral cerebral ischemic events between index cerebral or retinal ischemic event and CAS placement. RESULTS: The mean age of 131 patients analyzed was 67 years (range: 47-94 years; 92 were men), and 94 and 37 patients had 70%-99% and 50%-69% severity of stenosis, respectively. The mean and median time intervals between index cerebral or retinal ischemic event and CAS performance were 28 (standard deviation [SD] 30) and 7 (interquartile range 33) days, respectively. A total of 9 of 131 patients (6.9%, 95% confidence interval 2.5%-11.2%) experienced new cerebral ischemic events over 3637 patient days of observation. The risk of new ipsilateral cerebral ischemic events was 2.5 per 1000 patient days of observation. CONCLUSION: We estimated the risk of new ipsilateral cerebral ischemic events in patients with ICA stenosis ≥50% in severity while waiting for CAS placement to guide appropriate timing of procedure.

The Risk of Adverse Events in Smokers Undergoing Spinal Fusion: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: Determine if tobacco use is associated with increased risk of postoperative adverse events within 90 days in patients undergoing spinal fusion surgery. METHODS: Databases were queried to identify cohort studies that directly compared smokers with non-smokers and provided the absolute number of adverse events and the population at risk. Data quality was evaluated using the Quality in Prognosis Studies tool. Risk ratios (RR) and 95% confidence intervals were calculated and compared between studies. The grading of recommendation, assessment, development and evaluation (GRADE) criteria were used to assess the strength of the evidence. RESULTS: Seventeen studies assessing 37 897 participants met the inclusion criteria. Of these, 10 031 (26.5%) were smokers and 27 866 (73.5%) were nonsmokers. The mean age for the study population was 58 years, and 45% were males. Smoking was not associated with increased risk of one or more major adverse events within 90 days following spine surgery (seven studies, pooled RR 1.13, 95% CI [.75-1.71], I2 = 41%). However, smoking was significantly associated with one or more major adverse events in ≤2 level fusion (three studies, pooled RR 2.46, 95% CI [1.18-5.12], I2 = 0%), but not in fusions of ≥3 levels (four studies, pooled RR .87, 95% CI [.70-1.08], I2 = 0%). Additionally, there was no statistically significant association between smoking and any adverse event, nor increased reoperation risk due to adverse events. CONCLUSIONS: In this meta-analysis, tobacco use was not associated with a statistically significant increased risk of adverse events within 90 days in patients undergoing spinal fusion surgery. Our results are limited by the variable reporting methodology for both complication rates as well as smoking incidence between the included individual studies.

Thirty-Day Outcomes of Resolute Onyx Stent for Symptomatic Intracranial Stenosis: A Multicenter Propensity Score-Matched Comparison With Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.

BACKGROUND: Symptomatic intracranial atherosclerotic disease (sICAD) is estimated to cause 10% of strokes annually in the United States. However, treatment remains a challenge with several different stenting options studied in the past with unfavorable results. OBJECTIVE: To report the 30-day stroke and/or death rate associated with intracranial stent placement for sICAD using Resolute Onyx Zotarolimus-Eluting Stent (RO-ZES) and provide a comparison with the results of Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. METHODS: Prospectively maintained databases across 8 stroke centers were used to identify adult patients treated with RO-ZES for sICAD between January 2019 and December 2021. Primary end point was composite of 30-day stroke, intracerebral hemorrhage, and/or death. Propensity score matching was performed using age, hypertension, lipid disorder, cigarette smoking, and symptomatic target vessel to create a matched group for comparison between RO-ZES and the SAMMPRIS medical management and treatment groups (SAMMPRIS percutaneous angioplasty and stenting [S-PTAS]). RESULTS: A total of 132 patients met the inclusion criteria for analysis (mean age: 64.2 years). Mean severity of stenosis was 81.4% (±11.4%). A total of 4 (3.03%) stroke and/or deaths were reported within 30 days of treatment in the RO-ZES group compared with 6.6% in the SAMMPRIS medical management group (OR [odds ratio] 2.26, 95% CI 0.7-9.56, P = .22) and 15.6% in the S-PTAS group (OR 5.9, 95% CI 2.04-23.4, P < .001). Propensity score match analysis of 115 patients in each group demonstrated 30-day stroke and/or death rate of 2.6% in the RO-ZES group and 15.6% in the S-PTAS group (OR 6.88, 95% CI 1.92-37.54, P < .001). CONCLUSION: Patients treated with RO-ZES had a relatively low 30-day stroke and/or death rate compared with the S-PTAS group. Further large-scale prospective studies are warranted to evaluate the safety and efficacy of RO-ZES for the treatment of sICAD.

The Impact of Asymptomatic Human Immunodeficiency Virus-Positive Disease Status on Inpatient Complications Following Spine Surgery: A Propensity Score-Matched Analysis.

In the United States, nearly 1.2 million people > 12 years old have human immunodeficiency virus (HIV), which is associated with postoperative complications following orthopedic procedures. Little is known about how asymptomatic HIV (AHIV) patients fare postoperatively. This study compares complications after common spine surgeries between patients with and without AHIV. The Nationwide Inpatient Sample (NIS) was retrospectively reviewed from 2005-2013, identifying patients aged > 18 years who underwent 2-3-level anterior cervical discectomy and fusion (ACDF), ≥4-level thoracolumbar fusion (TLF), or 2-3-level lumbar fusion (LF). Patients with AHIV and without HIV were 1:1 propensity score-matched. Univariate analysis and multivariable binary logistic regression were performed to assess associations between HIV status and outcomes by cohort. 2-3-level ACDF (n = 594 total patients) and ≥4-level TLF (n = 86 total patients) cohorts demonstrated comparable length of stay (LOS), rates of wound-related, implant-related, medical, surgical, and overall complications between AHIV and controls. 2-3-level LF (n = 570 total patients) cohorts had comparable LOS, implant-related, medical, surgical, and overall complications. AHIV patients experienced higher postoperative respiratory complications (4.3% vs. 0.4%,). AHIV was not associated with higher risks of medical, surgical, or overall inpatient postoperative complications following most spine surgical procedures. The results suggest the postoperative course may be improved in patients with baseline control of HIV infection.

Transotic Approach for Resection of Expansile Endolymphatic Sac Tumor.

Objectives and Design Endolymphatic sac tumors (ELSTs) are rare and indolent tumors that arise from the endolymphatic sac in the posterior petrous ridge. We present a video case report illustrating the use of a transotic approach for resection of an expansile ELST. Setting and Participants A 25-year-old male presented with a multiyear history of worsening left-sided hearing loss, vertigo, and headaches. Otoscopy revealed a red mass behind an intact tympanic membrane. Computed tomography revealed a large, locally aggressive mass centered in the posterior petrous temporal bone. Magnetic resonance imaging demonstrated a heterogeneously enhancing 2.4 × 3.1 × 2.4 cm tumor that exerted mass effect on the cerebellar surface with extension into the jugular foramen, tympanic cavity, internal auditory canal, and cistern of the cerebellopontine angle. A transotic approach was planned to obtain the necessary generous exposure. Main Outcome Measures and Results Preoperative angiography revealed arterial supply via the ascending pharyngeal and tumor embolization with Onyx was performed. Surgical resection began with a blind-sac closure created from the external auditory canal. The tympanic membrane and malleus were removed and the incustapedial joint was transected. A subtotal petrosectomy was performed for partial tumor exposure. The facial canal and sigmoid sinus were carefully skeletonized and a labrynthectomy was performed. The tumor was resected using a combination of bipolar cautery and blunt and sharp dissection. For closure, an abdominal fat graft was secured with overlying resorbable mesh followed by sequential closure of all skin layers. Histopathologic analysis revealed an ELST. Conclusion The transotic approach offers wide exposure and facilitates large, complex tumor removal. The link to the video can be found at https://youtu.be/YvhyN8iVi44 .

The Role of Parenteral Dantrolene in the Contemporary Management of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage: A Systematic Review.

OBJECTIVE: Cerebral vasospasm remains a significant source of morbidity and mortality in patients with aneurysmal subarachnoid hemorrhage. Dantrolene has shown promise in several animal studies in the treatment of cerebral vasospasm. The present study seeks to critically review the evidence of its use in human subjects, aiming to 1) describe the forms and dosages used, 2) describe its safety profile, and 3) describe its effectiveness in treating cerebral vasospasm. METHODS: A systematic review of intra-arterial dantrolene use in cerebral vasospasm was performed. A total of 86 articles were identified across all databases, 6 of which were ultimately included in the present study. Primary outcomes included a description of the form and dosage of dantrolene prescribed, the incidence of adverse effects after dantrolene use, and its efficacy for the treatment of cerebral vasospasm. RESULTS: Study designs included 2 randomized controlled trials (33.3%), 2 case series (33.3%), and 2 case reports (33.3%). Both the intra-arterial and intravenous administration of dantrolene has been performed with varying dose regimens. Although there exists limited clinical information regarding side effects, a case of liver toxicity was reported. All existing studies reported benefit in vasospasm measured either by transcranial Doppler or digital subtraction angiography. The level of evidence was low, consisting largely of retrospective studies that had a high likelihood of bias. CONCLUSIONS: Dantrolene is a promising new therapeutic agent in the treatment of cerebral vasospasm. Although existing reports of its use are encouraging, high-quality prospective randomized trials are necessary for recommendations pertaining to dose, route, indications, and efficacy.

Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials.

OBJECTIVE: The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials. METHODS: The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation. RESULTS: A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity. CONCLUSIONS: The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

Gender Disparities in Outpatient Management of Postlaminectomy Syndrome.

INTRODUCTION: Postlaminectomy syndrome (PLS), also known as failed back surgery syndrome, is the persistence of radicular pain in the face of surgical intervention. Despite its prevalence in 10 to 40% of spine surgery patients, outpatient pharmacologic and interventional management remains poorly characterized. METHODS: The 2007 to 2016 National Ambulatory Medical Care Survey (NAMCS) was utilized to include all outpatients diagnosed with PLS. For each visit, documented pain medications (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], neuropathic agents, etc) as well as patient demographics and comorbidities (sex, age, race, insurance coverage, and medical history) were recorded. The association between medication class and rate of prescription relative to sex was assessed in the population-weighted cohort, using propensity score matching to control for potential confounders. RESULTS: A total of 70,343 PLS patients were identified, including 36,313 (51.6%) women. After accounting for baseline demographics and comorbidity differences between male and female patients, men were 2 to 3 times more likely to be prescribed opioids (OR: 2.38; 95%CI: 2.30-2.46) and procedural interventions for PLS compared to the female cohort, while women utilized neuropathic agents (OR: 0.53; 95%CI: 0.51-0.55) and NSAIDs (OR: 0.68; 95%CI: 0.65-0.70) more frequently. CONCLUSION: Pain management in outpatients presenting with PLS-related pain consisted of higher opioid utilization for men and higher neuropathic agents and NSAIDs utilization for the female patients. CLINICAL RELEVANCE: This article is the first to shed light on disparities in pain management among patients with post-laminectomy syndrome.

Bone Morphogenetic Protein in Anterior Lumbar Interbody Fusions: A Propensity-Matched Medicare Outcome Analysis.

BACKGROUND: Bone morphogenetic protein (BMP) is a costly agent commonly used in spine surgery. Its effectiveness and complication profile have never been studied in a large, propensity-matched population following its approval by the Food and Drug Administration for use in single-level anterior lumbar interbody fusion (ALIF) surgeries. OBJECTIVE: To investigate the rate of symptomatic pseudarthrosis or need for revision surgery after single-level stand-alone ALIFs with and without the use of BMP. METHODS: Medicare Standard Analytic files derived from Medicare parts A and B were used to identify adult patients who underwent single-level ALIF procedures with and without use of BMP between 2004 and 2014. Patients were propensity matched based on their age, gender, and history of diabetes mellitus, hypertension, chronic kidney disease, body mass index greater than 30 kg/m2, smoking, rheumatoid arthritis, and osteoporosis. Sensitivity analysis using adjusted multivariate logistic regression models was also performed. The primary outcomes were the rates of symptomatic pseudarthrosis or need for revision surgery. RESULTS: The propensity-matched population analyzed in this study contained 22,380 patients undergoing single-level ALIF (8971 [40.6%] with BMP and 13,139 [59.4%] without BMP). Both patient groups were balanced at baseline. The rate of symptomatic pseudarthrosis in the propensity-matched analysis was higher in the BMP group (1.9% vs 1.4%, P < 0.05). BMP use during single-level ALIFs was associated with 44% increased odds of developing pseudarthrosis (OR 1.44, 95% CI 1.16-1.76). However, there was no statistically significant difference in the rate of revision surgery between groups (3.7% vs 3.5%, P = 0.49). CONCLUSIONS: BMP use in single-level ALIFs may be associated with increased risk of symptomatic pseudarthrosis. Large prospective pragmatic trials are needed to corroborate our findings.

Current Trends and Socioeconomic Disparities in the Utilization of Spine Augmentation for Patients With Osteoporotic Vertebral Compression Fracture: A Nationwide Inpatient Sample Analysis From 2012 to 2016.

INTRODUCTION: Osteoporotic vertebral compression fracture (OVCF) is a growing health care problem in today's aging population. Since the advent of kyphoplasty and vertebroplasty, these interventions have been commonly utilized in the treatment of symptomatic OVCF. However, the use of these interventions varies because there is not a standard of care for the management of OVCF. There remain disparities in the use of these procedures as treatment for OVCFs in the United States. METHODS: The 2012 to 2016 Nationwide Inpatient Sample was queried for all patients admitted for OVCF. These patients were then grouped based on whether they received conservative vs surgical (kyphoplasty/vertebroplasty) management and compared with respect to various socioeconomic factors including race, insurance coverage, income quartile, hospital control, and geography. Propensity score matching was utilized to control for potential baseline confounders as well as the influence of other endpoints. RESULTS: The search criteria identified 35,199 patients admitted with OVCF, of whom 7900 (22.4%) received spine augmentation. Blacks/African Americans (risk ratios [RR] = 0.79, P < 0.001), Hispanics/Latinos (RR = 0.82, P < 0.001), Asians/Pacific Islanders (RR = 0.81, P = 0.048), and unknown/other races (RR = 0.88, P = 0.037) were less likely to receive surgical management than whites/Caucasians. When compared with Medicare patients, those with Medicaid (RR = 0.76, P < 0.001) were less likely to receive surgery while privately insured patients were more likely (RR = 1.06, P = 0.42). Patients in the West (RR = 0.90, P < 0.001) were less likely to receive surgery for OVCF than those in the Northeast. CONCLUSIONS: A wide variety of socioeconomic disparities exists in the use of spinal augmentation for the management of OVCF in the United States, limiting patient access to a potentially beneficial procedure. CLINICAL RELEVANCE: Retrospective Analysis.