Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.

Importance: Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. Objective: To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. Design, Setting, and Participants: Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. Interventions: Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. Main Outcomes and Measures: The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. Results: Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). Conclusions and Relevance: Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.

Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel.

OBJECTIVE: To determine whether patients who learned the views of an expert surgeons' panel's assessment of equipoise between 2 alternative operative treatments had increased likelihood of consenting to randomization. BACKGROUND: Difficulty obtaining patient consent to randomization is an important barrier to conducting surgical randomized clinical trials, the gold standard for generating clinical evidence. METHODS: Observational study of the rate of patient acceptance of randomization within a 5-center randomized clinical trial comparing lumbar spinal decompression versus lumbar spinal decompression plus instrumented fusion for patients with symptomatic grade I degenerative lumbar spondylolisthesis with spinal stenosis. Eligible patients were enrolled in the trial and then asked to accept randomization. A panel of 10 expert spine surgeons was formed to review clinical information and images for individual patients to provide an assessment of suitability for randomization. The expert panel vote was disclosed to the patient by the patient's surgeon before the patient decided whether to accept randomization or not. RESULTS: Randomization acceptance among eligible patients without expert panel review was 40% (19/48) compared with 81% (47/58) among patients undergoing expert panel review (P < 0.001). Among expert-reviewed patients, randomization acceptance was 95% when all experts or all except 1 voted for randomization, 75% when 2 experts voted against randomization, and 20% with 3 or 4 votes against (P < 0.001 for trend). CONCLUSIONS: Patients provided with an expert panel's assessment of their own suitability for randomization were twice as likely to agree to randomization compared with patients receiving only their own surgeon's recommendation.

International classification of disease clinical modification 9 modeling of a patient comorbidity score predicts incidence of perioperative complications in a nationwide inpatient sample assessment of complications in spine surgery.

OF BACKGROUND DATA: A patient comorbidity score (RCS) was developed from a prospective study of complications occurring in spine surgery patients. OBJECTIVE: To validate the RCS, we present an International Classification of Disease Clinical Modification (ICD-CM)-9 model of the score and correlate the score with complication incidence in a group of patients from the Nationwide Inpatient Sample database. We compare the predictive value of the score with the Charlson index. STUDY DESIGN: We conducted a retrospective assessment of Nationwide Inpatient Sample patients undergoing cervical or thoracolumbar spine surgery for degenerative pathology from 2002 to 2009. METHODS: We generated an ICD-9-CM coding-based model of our prospectively derived RCS, categorizing diagnostic codes to represent relevant comorbidities. Multivariate models were constructed to eliminate the least significant variables. ICD-9-CM coding was also used to calculate a Charlson comorbidity score for each patient. The accuracy of the RCS was compared with the Charlson index through the use of a receiver-operating curve. RESULTS: A total of 352,535 patients undergoing 369,454 spine procedures for degenerative disease were gathered. Hypertension and hyperlipidemia were the most common comorbidities. Cervical procedures resulted in 8286 complications (4.50%), whereas thoracolumbar procedures produced 25,118 complications (13.55%). Increasing RCS correlated linearly with increasing complication incidence (odds ratio [OR] 1.11; 95% confidence interval [CI], 1.10-1.13; P<0.0001). Logistic regression revealed that neurological deficit, cardiac conditions, and drug or alcohol use had greatest association with complication occurrence. The Charlson index also correlated with complication occurrence in both cervical (OR 1.25; 95% CI, 1.23-1.27) and thoracolumbar (OR 1.11; 95% CI, 1.10-1.12) patient groups. Receiver-operating curve analysis allowed a comparison of accuracy of the indices by comparing predictive values. The RCS performed as well as the Charlson index in predicting complication occurrence in both cervical and thoracic spine patients. CONCLUSIONS: ICD-9-based modeling validated that RCS correlates with complication occurrence. The RCS performed as well as the Charlson index in predicting risk of complication in spine patients.

Variations in cost calculations in spine surgery cost-effectiveness research.

OBJECT: Cost-effectiveness research in spine surgery has been a prominent focus over the last decade. However, there has yet to be a standardized method developed for calculation of costs in such studies. This lack of a standardized costing methodology may lead to conflicting conclusions on the cost-effectiveness of an intervention for a specific diagnosis. The primary objective of this study was to systematically review all cost-effectiveness studies published on spine surgery and compare and contrast various costing methodologies used. METHODS: The authors performed a systematic review of the cost-effectiveness literature related to spine surgery. All cost-effectiveness analyses pertaining to spine surgery were identified using the cost-effectiveness analysis registry database of the Tufts Medical Center Institute for Clinical Research and Health Policy, and the MEDLINE database. Each article was reviewed to determine the study subject, methodology, and results. Data were collected from each study, including costs, interventions, cost calculation method, perspective of cost calculation, and definitions of direct and indirect costs if available. RESULTS: Thirty-seven cost-effectiveness studies on spine surgery were included in the present study. Twenty-seven (73%) of the studies involved the lumbar spine and the remaining 10 (27%) involved the cervical spine. Of the 37 studies, 13 (35%) used Medicare reimbursements, 12 (32%) used a case-costing database, 3 (8%) used cost-to-charge ratios (CCRs), 2 (5%) used a combination of Medicare reimbursements and CCRs, 3 (8%) used the United Kingdom National Health Service reimbursement system, 2 (5%) used a Dutch reimbursement system, 1 (3%) used the United Kingdom Department of Health data, and 1 (3%) used the Tricare Military Reimbursement system. Nineteen (51%) studies completed their cost analysis from the societal perspective, 11 (30%) from the hospital perspective, and 7 (19%) from the payer perspective. Of those studies with a societal perspective, 14 (38%) reported actual indirect costs. CONCLUSIONS: Changes in cost have a direct impact on the value equation for concluding whether an intervention is cost-effective. It is essential to develop a standardized, accurate means of calculating costs. Comparability and transparency are essential, such that studies can be compared properly and policy makers can be appropriately informed when making decisions for our health care system based on the results of these studies.

Cost-effectiveness of lumbar discectomy and single-level fusion for spondylolisthesis: experience with the NeuroPoint-SD registry.

OBJECT: There is significant practice variation and uncertainty as to the value of surgical treatments for lumbar spine disorders. The authors' aim was to establish a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures by using prospectively collected outcomes. METHODS: An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level fusion for spondylolisthesis or single-level lumbar discectomy were included. The 36-Item Short Form Health Survey (SF-36) and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: lumbar disc (125 patients) and lumbar listhesis (35 patients). The quality-adjusted life year (QALY) data were calculated using 6-dimension utility index scores. Direct costs and complication costs were estimated using Medicare reimbursement values from 2011, and indirect costs were estimated using the human capital approach with the 2011 US national wage index. Total costs equaled $14,980 for lumbar discectomy and $43,852 for surgery for lumbar spondylolisthesis. RESULTS: There were 198 patients enrolled over 1 year. The mean age was 46 years (49% female) for lumbar discectomy (n = 148) and 58.1 years (60% female) for lumbar spondylolisthesis (n = 50). Ten patients with disc herniation (6.8%) and 1 with listhesis (2%) required repeat operation at 1 year. The overall 1-year follow-up rate was 88%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, visual analog scale, and SF-36 scores (p = 0.0002), which persisted at the 1-year evaluation (p < 0.0001). By 1 year, more than 80% of patients in each cohort who were working preoperatively had returned to work. Lumbar discectomy was associated with a gain of 0.225 QALYs over the 1-year study period ($66,578/QALY gained). Lumbar spinal fusion for Grade I listhesis was associated with a gain of 0.195 QALYs over the 1-year study period ($224,420/QALY gained). CONCLUSIONS: This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. These data are useful for demonstrating return to work and cost-effectiveness following surgical treatment of single-level lumbar disc herniation or spondylolisthesis. One-year cost per QALY was obtained, and this cost per QALY is expected to improve further by 2 years. This work sets the stage for real-world analysis of the value of health interventions.

Impact of Depression and Anxiety on Patient Reported Outcomes Measures after Lumbar Fusion.

BACKGROUND: Depression and anxiety are common in patients undergoing spinal surgery and might negatively impact outcomes. This study investigates the possible effect of these diagnoses on patient reported outcomes following lumbar fusion. METHODS: Retrospective review of a registry containing prospectively collected data of lumbar fusion procedures at a single institution was performed from May 23, 2012 to June 15, 2022. Patients with a minimum of two year follow-up were included. Demographic information, diagnoses, medications, patient-reported outcomes measures (PROMs), and complications data at preoperative, three months, six months, 1 year, and two years postoperative were collected. Statistical analysis was performed using Student's t-tests, χ2, binomial correlation, odds ratios, logistic regression, and mean clinically important difference. RESULTS: A total of 156 patients were included (60 males, 96 females) with mean age 62.6 ± 11.1 years at surgery. Thirty-nine (25%) had depression and/or anxiety (DA). Baseline Oswestry Disability Index (ODI) and EuroQol Group 5D questionnaire (EQ5D) scores were significantly worse in the DA cohort compared to controls (ODI 51.1 ± 18.3 vs. 42.9 ± 15.8; P = 0.010, EQ5D 0.46 ± 0.21 vs. 0.57 ± 0.21; P = 0.005). Both cohorts experienced similar relative improvement at two years (delta ODI -18.2 ± 27.9 vs. -17.8 ± 22.1; P = 0.924, EQ5D 6.8 ± 33.8 vs. 8.1 ± 32.9; P = 0.830). Absolute outcome scores were worse in the DA cohort at all intervals. DA were not independently predictive of changes in PROMs (delta ODI mean difference 4.49, r2 = 0.36, P = 0.924). CONCLUSIONS: The present study showed similar improvement in PROMs following lumbar fusion for patients with anxiety and depression compared to healthy controls. These data suggest these patients are no less likely to benefit from appropriately planned lumbar fusion.

Patients May Return to Work Sooner After Laminoplasty: Occupational Outcomes of the Cervical Spondylotic Myelopathy Surgical Trial.

BACKGROUND AND OBJECTIVES: Return-to-work (RTW) is an important outcome for employed patients considering surgery for cervical spondylotic myelopathy (CSM). We conducted a post hoc analysis of patients as-treated in the Cervical Spondylotic Myelopathy Surgical Trial, a prospective, randomized trial comparing surgical approaches for CSM to evaluate factors associated with RTW. METHODS: In the trial, patients were randomized (2:3) to either anterior surgery (anterior cervical decompression/fusion [ACDF]) or posterior surgery (laminoplasty [LP], or posterior cervical decompression/fusion [PCDF], at surgeon's discretion). Work status was recorded at 1, 3, 6, and 12 months postoperatively. For patients working full-time or part-time on enrollment, time to RTW was compared across as-treated surgical groups using discrete-time survival analysis. Multivariate logistic regression was used to assess predictors of RTW. Clinical outcomes were compared using a linear mixed-effects model. RESULTS: A total of 68 (42%) of 163 patients were working preoperatively and were analyzed. In total, 27 patients underwent ACDF, 29 underwent PCDF, and 12 underwent LP. 45 (66%) of 68 patients returned to work by 12 months. Median time to RTW differed by surgical approach (LP = 1 month, ACDF = 3 months, PCDF = 6 months; P = .02). Patients with longer length-of-stay were less likely to be working at 1 month (odds ratio 0.51; 95% CI, 0.29-0.91; P = .022) and 3 months (odds ratio 0.39; 95% CI, 0.16-0.96; P = .04). At 3 months, PCDF was associated with lower Short-Form 36 physical component summary scores than ACDF (estimated mean difference [EMD]: 6.42; 95% CI, 1.4-11.4; P = .007) and LP (EMD: 7.98; 95% CI, 2.7-13.3; P = .003), and higher Neck Disability Index scores than ACDF (EMD: 12.48; 95% CI, 2.3-22.7; P = .01) and LP (EMD: 15.22; 95% CI, 2.3-28.1; P = .014), indicating worse perceived physical functioning and greater disability, respectively. CONCLUSION: Most employed patients returned to work within 1 year. LP patients resumed employment earliest, while PCDF patients returned to work latest, with greater disability at follow-up, suggesting that choice of surgical intervention may influence occupational outcomes.

Implementation of a spine triage program and its effect on outpatient radiology utilization.

OBJECTIVE: Clinical care pathways designed to triage spinal disorders have been shown to reduce wait times and improve patient satisfaction. The goal of this study was to perform an analysis of outpatient radiology costs before and after the implementation of a spine care triage pathway. METHODS: All imaging orders and surgical procedures were captured in a prospective spine registry for patients referred to the department of neurosurgery within a single academic center between July 1, 2017, and November 3, 2020. A spine triage algorithm was developed and implemented January 1, 2018. Healthcare utilization was recorded for 1 year after the first appointment in the department of neurosurgery. Imaging costs were estimated using publicly available data from the Centers for Medicare and Medicaid Services. Statistical analysis consisted of an independent sample t-test or randomization test for continuous variables and a chi-square test for categorical variables. RESULTS: A total of 3854 patients were included in this study. The mean age was 60 years (50.8% female) and 89.8% had undergone advanced imaging before being referred to the department of neurosurgery. In total, 12.6% of patients were referred with a specific surgical diagnosis (i.e., spinal stenosis, lumbar spondylolisthesis, etc.). During the pretriage phase 1810 patients were enrolled, and there were 2044 patients enrolled after the triage algorithm was implemented. Advanced imaging (CT or MRI) was ordered more frequently by providers before the triage program was initiated, with imaging ordered in 34% (617/1810) of patients pretriage versus 14.8% (302/2044) after the triage pathway was implemented (p < 0.001). The authors calculated a significant reduction in cost associated with reduced radiology utilization. Before triage, the cost of radiology utilization was $85,475/1000 patients compared with $40,107/1000 patients afterward (p < 0.001). The triage program did not change the utilization of surgery (14.6% before, 13.6% after). CONCLUSIONS: Among patients treated after a spinal triage program was implemented in a single neurosurgery department, there was a substantial reduction in the use of advanced imaging and a 50% reduction in cost associated with outpatient radiology utilization. The triage program did not change the rate of spine surgery being performed.

The New England Neurosurgical Society: growth and evolution over 70 years.

The New England Neurosurgical Society (NENS) was founded in 1951 under the leadership of its first President (Dr. William Beecher Scoville) and Secretary-Treasurer (Dr. Henry Thomas Ballantine). The purpose of creating the NENS was to unite local neurosurgeons in the New England area; it was one of the first regional neurosurgical societies in America. Although regional neurosurgical societies are important supplements to national organizations, they have often been overshadowed in the available literature. Now in its 70th year, the NENS continues to serve as a platform to represent the needs of New England neurosurgeons, foster connections and networks with colleagues, and provide research and educational opportunities for trainees. Additionally, regional societies enable discussion of issues uniquely relevant to the region, improve referral patterns, and allow for easier attendance with geographic proximity. In this paper, the authors describe the history of the NENS and provide a roadmap for its future. The first section portrays the founders who led the first meetings and establishment of the NENS. The second section describes the early years of the NENS and profiles key leaders. The third section discusses subsequent neurosurgeons who steered the NENS and partnerships with other societies. In the fourth section, the modern era of the NENS and its current activities are highlighted.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Cost-effectiveness of confirmatory techniques for the placement of lumbar pedicle screws.

OBJECT: There is considerable variation in the use of adjunctive technologies to confirm pedicle screw placement. Although there is literature to support the use of both neurophysiological monitoring and isocentric fluoroscopy to confirm pedicle screw positioning, there are no studies examining the cost-effectiveness of these technologies. This study compares the cost-effectiveness and efficacy of isocentric O-arm fluoroscopy, neurophysiological monitoring, and postoperative CT scanning after multilevel instrumented fusion for degenerative lumbar disease. METHODS: Retrospective data were collected from 4 spine surgeons who used 3 different strategies for monitoring of pedicle screw placement in multilevel lumbar degenerative disease. A decision analysis model was developed to analyze costs and outcomes of the 3 different monitoring strategies. A total of 448 surgeries performed between 2005 and 2010 were included, with 4 cases requiring repeat operation for malpositioned screws. A sample of 64 of these patients was chosen for structured interviews in which the EuroQol-5D questionnaire was used. Expected costs and quality-adjusted life years were calculated based on the incidence of repeat operation and its negative effect on quality of life and costs. RESULTS: The decision analysis model demonstrated that the O-arm monitoring strategy is significantly (p < 0.001) less costly than the strategy of postoperative CT scanning following intraoperative uniplanar fluoroscopy, which in turn is significantly (p < 0.001) less costly than neurophysiological monitoring. The differences in effectiveness of the different monitoring strategies are not significant (p = 0.92). CONCLUSIONS: Use of the O-arm for confirming pedicle screw placement is the least costly and therefore most cost-effective strategy of the 3 techniques analyzed.

Spine Instrumented Surgery on a Budget-Tools for Lowering Cost Without Changing Outcome.

STUDY DESIGN: Review article. OBJECTIVES: There have been substantial increases in the utilization of complex spinal surgery in the last 20 years. Spinal instrumented surgery is associated with high costs as well as significant variation in approach and care. The objective of this manuscript is to identify and review drivers of instrumented spine surgery cost and explain how surgeons can reduce costs without compromising outcome. METHODS: A literature search was conducted using PubMed. The literature review returned 217 citations. 27 publications were found to meet the inclusion criteria. The relevant literature on drivers of spine instrumented surgery cost is reviewed. RESULTS: The drivers of cost in instrumented spine surgery are varied and include implant costs, complications, readmissions, facility-based costs, surgeon-driven preferences, and patient comorbidities. Each major cost driver represents an opportunity for potential reductions in cost. With high resource utilization and often uncertain outcomes, spinal surgery has been heavily scrutinized by payers and hospital systems, with efforts to reduce costs and standardize surgical approach and care pathways. CONCLUSIONS: Education about cost and commitment to standardization would be useful strategies to reduce cost without compromising patient-reported outcomes after instrumented spinal fusion.

Age, body mass index, and osteoporosis are more predictive than imaging for adjacent-segment reoperation after lumbar fusion.

BACKGROUND: Adjacent-segment disease (ASD) is a well-described long-term complication after lumbar fusion. There is a lack of consensus about the risk factors for development of ASD, but identifying them could improve surgical outcomes. Our goal was to analyze the effect of patient characteristics and radiographic parameters on the development of symptomatic ASD requiring revision surgery after posterior lumbar fusion. METHODS: In this retrospective cohort study, we identified patients who underwent lumbar fusion surgery and revision surgery from May 2012 to November 2018 using an institutional lumbar fusion registry. Patients having both pre- and post-operative upright radiographs were included in the study. Revision surgeries for which the index operation was performed at an outside hospital were excluded from analysis. Univariate analysis was conducted on candidate variables, and variables with P< 0.2 were selected for multivariate logistic regression. RESULTS: Of the 106 patients identified, 21 required reoperation (29 months average follow-up). Age >65 years (OR 4.14, 95% CI 1.46-11.76, P= 0.008), body mass index (BMI) >34 (OR 1.13, 95% CI 1.04-1.23, P = 0.004), and osteoporosis (OR 14, 95% CI 1.38-142.42, P = 0.03) were independent predictors of reoperation in the multivariate analysis. Increased facet diastasis at fusion levels (OR 0.60, 95% CI 0.42-0.85, P = 0.004) was associated with reduced reoperation rates. Change in segmental LL at the index operation level, rostral and caudal facet diastasis, vacuum discs, and T2 hyperintensity in the facets were not predictors of reoperation. CONCLUSION: Age >65, BMI >34, and osteoporosis were independent predictors of adjacent-segment reoperation after lumbar spinal fusion.

Opioid Use, Risk Factors, and Outcome in Lumbar Fusion Surgery.

OBJECTIVE: Inappropriate opioid use resulted in 68% of all U.S. drug overdoses in 2017-nearly 75% of all opioid deaths-costing $80 billion per year. It is imperative to understand the impact of opioid use on outcome from surgery for lower back pain disorders. METHODS: A retrospective review of lumbar spinal fusion registry data at a single center from 2015-2018 was performed. A novel algorithm was used to extract opioid utilization from the electronic health record. Number of levels fused, fusion type, and minimally invasive surgery status were collected from the registry, as were depression status, European Quality of Life 5 level score, and Oswestry Disability Index at 6 months to 1 year postoperatively. RESULTS: We included 294 patients (mean age 62 years, 48% male). Patients younger than 65 years trended toward more opioid use before surgery and significantly higher opioid use after surgery (P < 0.0001). Depression trended toward increasing opioid use after surgery (P = 0.08). Fusions of 4 or more levels were associated with overall greater opioid use after surgery (P = 0.03). Higher rate of opioid use before and after surgery is associated with worse European Quality of Life 5 level scores after surgery (P = 0.01 and P = 0.04) and worse Oswestry Disability Index scores after surgery (P = 0.006 and P = 0.002). CONCLUSIONS: This registry finds that younger age and lower functional status scores are associated with higher opioid use before surgery. Opioid use before surgery, younger age, and >4 levels of fusion are associated with higher opioid use after surgery. Overall, opioid use is associated with worse functional outcome and may serve as a marker of disease progression.

Magnetic resonance perfusion-weighted imaging defines angiogenic subtypes of oligodendroglioma according to 1p19q and EGFR status.

1p19q LOH has been shown to predict radio- and chemosensitivity and prolonged survival in oligodendrogliomas (OLs). We have recently shown that magnetic resonance perfusion-weighted imaging (MR-PWI) may be useful in predicting the histopathological grade or cytogenetic type of oligodendroglial neoplasms. MR-PWI allows noninvasive determination of relative tumor blood volume (rTBV), which may reflect the degree of neoplastic angiogenesis and metabolism. The present study was aimed to correlate rTBV to the angiogenic markers and EGFR expression in oligodendroglial tumors with 1p/19q LOH or 1p LOH (Group 1) and 1p19q intact alleles or 19q LOH (Group 2), respectively. In WHO grade II neoplasms, Group 1 showed significantly greater rTBV than Group 2 (P = 0.013). However, the differences between Group 1 and Group 2 were not significant in grade III tumors. Probe-based real-time RT-PCR analyses showed that 12% of Group 2 high-grade tumors with intact 1p19q exhibited dramatic EGFR overexpression (designated EGFR-high). Grade III neoplasms showed a significantly higher rTBV than grade II neoplasms. Group 1 tumors showed significantly higher rTBV than Group 2 tumors, independent of the EGFR-high subtype. Real-time RT-PCR analyses showed increased expression of VEGF, CD31 and CD105 in Group 1 tumors as compared to Group 2 tumors, excluding the EGFR-high subtype. Multivariable linear regression analysis showed a significant association of rTBV with 1p19q LOH, and expression of EGFR and VEGF. Therefore, the combined use of extensive molecular profiling and advanced MR imaging modalities may improve the accuracy of tumor grading, provide prognostic information, and has the potential to influence treatment decisions.

Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

BACKGROUND: Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported. DESIGN AND METHODS: This is a historically controlled post-market multicenter study to determine the safety and efficacy of the Barricaid device when used in addition to primary lumbar discectomy in a US population. A total of 75 patients with large annular defects will receive the Barricaid device following lumbar discectomy at up to 25 sites in the US and will return for clinical and imaging follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by a data safety monitoring board and imaging studies will be read by an independent imaging core laboratory. Patients treated with the Barricaid device in a previous European randomized trial with comparable eligibility criteria, surgical procedures, and outcome measures will serve as historical controls. Main outcomes will include back pain severity, leg pain severity, Oswestry Disability Index, health utility on the EuroQol-5 Dimension questionnaire, complications, symptomatic reherniation, and reoperation. Propensity score adjustment using inverse probability of treatment weighting will be used to adjust for differences in baseline patient characteristics between the US trial participants and European historical controls. ETHICS AND DISSEMINATION: This study was approved by a central institutional review board. The study results of this trial will be widely disseminated at conference proceedings and published in peer-reviewed journals. The outcomes of this study will have important clinical and economic implications for all stakeholders involved in treating patients with lumbar discectomy in the US. STUDY REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580. LEVEL OF EVIDENCE: 3.

Tension pneumocephalus after endoscopic sinus surgery: case report of repair and management in absence of obvious skull base defect.

Tension pneumocephalus is a rare complication of functional endoscopic sinus surgery that may lead to rapid neurologic deterioration. Patients typically display symptoms within hours after the operation, and computed tomography reveals the presence of a skull base defect. We report a unique case of subacute tension pneumocephalus with no obvious skull base defect, which was associated with a pupil-involving third-nerve palsy. We discuss management of this complication and preventive measures for avoiding pneumocephalus after functional endoscopic sinus surgery.

Prediction of oligodendroglial tumor subtype and grade using perfusion weighted magnetic resonance imaging.

OBJECT: Treatment of patients with oligodendrogliomas relies on histopathological grade and characteristic cytogenetic deletions of 1p and 19q, shown to predict radio- and chemosensitivity and prolonged survival. Perfusion weighted magnetic resonance (MR) imaging allows for noninvasive determination of relative tumor blood volume (rTBV) and has been used to predict the grade of astrocytic neoplasms. The aim of this study was to use perfusion weighted MR imaging to predict tumor grade and cytogenetic profile in oligodendroglial neoplasms. METHODS: Thirty patients with oligodendroglial neoplasms who underwent preoperative perfusion MR imaging were retrospectively identified. Tumors were classified by histopathological grade and stratified into two cytogenetic groups: 1p or 1p and 19q loss of heterozygosity (LOH) (Group 1), and 19q LOH only on intact alleles (Group 2). Tumor blood volume was calculated in relation to contralateral white matter. Multivariate logistic regression analysis was used to develop predictive models of cytogenetic profile and tumor grade. RESULTS: In World Health Organization Grade II neoplasms, the rTBV was significantly greater (p < 0.05) in Group 1 (mean 2.44, range 0.96-3.28; seven patients) compared with Group 2 (mean 1.69, range 1.27-2.08; seven patients). In Grade III neoplasms, the differences between Group 1 (mean 3.38, range 1.59-6.26; four patients) and Group 2 (mean 2.83, range 1.81-3.76; 12 patients) were not significant. The rTBV was significantly greater (p < 0.05) in Grade III neoplasms (mean 2.97, range 1.59-6.26; 16 patients) compared with Grade II neoplasms (mean 2.07, range 0.96-3.28; 14 patients). The models integrating rTBV with cytogenetic profile and grade showed prediction accuracies of 68 and 73%, respectively. CONCLUSIONS: Oligodendroglial classification models derived from advanced imaging will improve the accuracy of tumor grading, provide prognostic information, and have potential to influence treatment decisions.