National 22-year epilepsy surgery landscape shows increasing open and minimally invasive pediatric epilepsy surgery.

OBJECTIVES: A surgical "treatment gap" in pediatric epilepsy persists despite the demonstrated safety and effectiveness of surgery. For this reason, the national surgical landscape should be investigated such that an updated assessment may more appropriately guide health care efforts. METHODS: In our retrospective cross-sectional observational study, the National Inpatient Sample (NIS) database was queried for individuals 0 to <18 years of age who had an International Classification of Diseases (ICD) code for drug-resistant epilepsy (DRE). This cohort was then split into a medical group and a surgical group. The former was defined by ICD codes for -DRE without an accompanying surgical code, and the latter was defined by DRE and one of the following epilepsy surgeries: any open surgery; laser interstitial thermal therapy (LITT); vagus nerve stimulation; or responsive neurostimulation (RNS) from 1998 to 2020. Demographic variables of age, gender, race, insurance type, hospital charge, and hospital characteristics were analyzed between surgical options. Continuous variables were analyzed with weight-adjusted quantile regression analysis, and categorical variables were analyzed by weight-adjusted counts with percentages and compared with weight-adjusted chi-square test results. RESULTS: These data indicate an increase in epilepsy surgeries over a 22-year period, primarily due to a statistically significant increase in open surgery and a non-significant increase in minimally invasive techniques, such as LITT and RNS. There are significant differences in age, race, gender, insurance type, median household income, Elixhauser index, hospital setting, and size between the medical and surgical groups, as well as the procedure performed. SIGNIFICANCE: An increase in open surgery and minimally invasive surgeries (LITT and RNS) account for the overall rise in pediatric epilepsy surgery over the last 22 years. A positive inflection point in open surgery is seen in 2005. Socioeconomic disparities exist between medical and surgical groups. Patient and hospital sociodemographics show significant differences between the procedure performed. Further efforts are required to close the surgical "treatment gap."

Recovery of walking in nonambulatory children with chronic spinal cord injuries: Case series.

The immature central nervous system is recognized as having substantial neuroplastic capacity. In this study, we explored the hypothesis that rehabilitation can exploit that potential and elicit reciprocal walking in nonambulatory children with chronic, severe (i.e., lower extremity motor score < 10/50) spinal cord injuries (SCIs). Seven male subjects (3-12 years of age) who were at least 1-year post-SCI and incapable of discrete leg movements believed to be required for walking, enrolled in activity-based locomotor training (ABLT; clinicaltrials.gov NCT00488280). Six children completed the study. Following a minimum of 49 sessions of ABLT, three of the six children achieved walking with reverse rolling walkers. Stepping development, however, was not accompanied by improvement in discrete leg movements as underscored by the persistence of synergistic movements and little change in lower extremity motor scores. Interestingly, acoustic startle responses exhibited by the three responding children suggested preserved reticulospinal inputs to circuitry below the level of injury capable of mediating leg movements. On the other hand, no indication of corticospinal integrity was obtained with transcranial magnetic stimulation evoked responses in the same individuals. These findings suggest some children who are not predicted to improve motor and locomotor function may have a reserve of adaptive plasticity that can emerge in response to rehabilitative strategies such as ABLT. Further studies are warranted to determine whether a critical need exists to re-examine rehabilitation approaches for pediatric SCI with poor prognosis for any ambulatory recovery.

Risk of developing glioblastoma following non-CNS primary cancer: a SEER analysis between 2000 and 2018.

BACKGROUND: Patients with a prior malignancy are at elevated risk of developing subsequent primary malignancies (SPMs). However, the risk of developing subsequent primary glioblastoma (SPGBM) in patients with a prior cancer history is poorly understood. METHODS: We used the Surveillance, Epidemiology, and End Results (SEER) database and identified patients diagnosed with non-CNS malignancy between 2000 and 2018. We calculated a modified standardized incidence ratio (M-SIR), defined as the ratio of the incidence of SPGBM among patients with initial non-CNS malignancy to the incidence of GBM in the general population, stratified by sex latency, and initial tumor location. RESULTS: Of the 5,326,172 patients diagnosed with a primary non-CNS malignancy, 3559 patients developed SPGBM (0.07%). Among patients with SPGBM, 2312 (65.0%) were men, compared to 2,706,933 (50.8%) men in the total primary non-CNS malignancy cohort. The median age at diagnosis of SPGBM was 65 years. The mean latency between a prior non-CNS malignancy and developing a SPGBM was 67.3 months (interquartile range [IQR] 27-100). Overall, patients with a primary non-CNS malignancy had a significantly elevated M-SIR (1.13, 95% CI 1.09-1.16), with a 13% increased incidence of SPGBM when compared to the incidence of developing GBM in the age-matched general population. When stratified by non-CNS tumor location, patients diagnosed with primary melanoma, lymphoma, prostate, breast, renal, or endocrine malignancies had a higher M-SIR (M-SIR ranges: 1.09-2.15). Patients with lung cancers (M-SIR 0.82, 95% CI 0.68-0.99), or stomach cancers (M-SIR 0.47, 95% CI 0.24-0.82) demonstrated a lower M-SIR. CONCLUSION: Patients with a history of prior non-CNS malignancy are at an overall increased risk of developing SPGBM relative to the incidence of developing GBM in the general population. However, the incidence of SPGBM after prior non-CNS malignancy varies by primary tumor location, with some non-CNS malignancies demonstrating either increased or decreased predisposition for SPGBM depending on tumor origin. These findings merit future investigation into whether these relationships represent treatment effects or a previously unknown shared predisposition for glioblastoma and non-CNS malignancy.

Safety and Feasibility of Cervical and Thoracic Transcutaneous Spinal Cord Stimulation to Improve Hand Motor Function in Children With Chronic Spinal Cord Injury.

OBJECTIVE: In adults with cervical spinal cord injury (SCI), transcutaneous spinal stimulation (scTS) has improved upper extremity strength and control. This novel noninvasive neurotherapeutic approach combined with training may modulate the inherent developmental plasticity of children with SCI, providing even greater improvements than training or stimulation alone. Because children with SCI represent a vulnerable population, we first must establish the safety and feasibility of any potential novel therapeutic approach. The objectives of this pilot study were to determine the safety, feasibility, and proof of principle of cervical and thoracic scTS for short-term effect on upper extremity strength in children with SCI. MATERIALS AND METHODS: In this nonrandomized, within-subject repeated measure design, seven participants with chronic cervical SCI performed upper extremity motor tasks without and with cervical (C3-C4 and C6-C7) and thoracic (T10-T11) site scTS. Safety and feasibility of using cervical and thoracic sites scTS were determined by the frequency count of anticipated and unanticipated risks (eg, pain, numbness). Proof-of-principle concept was tested via change in force production during hand motor tasks. RESULTS: All seven participants tolerated cervical and thoracic scTS across the three days, with a wide range of stimulation intensities (cervical sites = 20-70 mA and thoracic site = 25-190 mA). Skin redness at the stimulation sites was observed in four of 21 assessments (19%) and dissipated in a few hours. No episode of autonomic dysreflexia was observed or reported. Hemodynamic parameters (systolic blood pressure and heart rate) remained within stable limits (p > 0.05) throughout the assessment time points at baseline, with scTS, and after the experiment. Hand-grip and wrist-extension strength increased (p < 0.05) with scTS. CONCLUSIONS: We indicated that short-term application of scTS via two cervical and one thoracic site is safe and feasible in children with SCI and resulted in immediate improvements in hand-grip and wrist-extension strength in the presence of scTS. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT04032990.

Is intraoperative MRI use in malignant brain tumor surgery a health care burden? A matched analysis of MarketScan Database.

BACKGROUND: Intraoperative magnetic resonance imaging (iMRI) is a useful adjunct for resection of primary malignant brain tumors (MBTs). The aim of our study is to investigate the impact of iMRI on health care utilization in patients who underwent craniotomy for resection of MBTs. MATERIALS AND METHODS: MarketScan database were queried using the ICD-9/10 and CPT 4th edition, from 2008 to 2020. We included patients ≥ 18 years of age who underwent a craniotomy with at-least one year follow-up. Outcomes were length of stay (LOS), discharge disposition, hospital/emergency room (ER) re-admissions, outpatient services, medication refills and corresponding payments. RESULTS: Of 6,640 patients who underwent craniotomy for MBTs, 465 patients (7%) had iMRI used during the procedure with 0.7% per year increase in iMRI use during the study period. Patients without iMRI use had higher complications at index hospitalization compared to those with iMRI use (19% vs. 14%, p = 0.04). There was no difference in the ER admission rates among the patients who underwent surgery with and without iMRI use at 6-months and 1-year after the index procedure. In terms of post-discharge payments, no significant differences were noted among the patients without and with iMRI use at 6-months ($81,107 vs. $ 81,458, p = 0.26) and 1-year ($132,657 vs. $ 118,113, p = 0.12). CONCLUSION: iMRI use during craniotomy for MBT gradually increased during the study period. iMRI did not result in higher payments at index hospitalization, 6-months, and 1-year after the index procedure.

Spinal cord imaging markers and recovery of standing with epidural stimulation in individuals with clinically motor complete spinal cord injury.

Spinal cord epidural stimulation (scES) is an intervention to restore motor function in those with severe spinal cord injury (SCI). Spinal cord lesion characteristics assessed via magnetic resonance imaging (MRI) may contribute to understand motor recovery. This study assessed relationships between standing ability with scES and spared spinal cord tissue characteristics at the lesion site. We hypothesized that the amount of lateral spared cord tissue would be related to independent extension in the ipsilateral lower limb. Eleven individuals with chronic, clinically motor complete SCI underwent spinal cord MRI, and were subsequently implanted with scES. Standing ability and lower limb activation patterns were assessed during an overground standing experiment with scES. This assessment occurred prior to any activity-based intervention with scES. Lesion hyperintensity was segmented from T2 axial images, and template-based analysis was used to estimate spared tissue in anterior, posterior, right, and left spinal cord regions. Regression analysis was used to assess relationships between imaging and standing outcomes. Total volume of spared tissue was related to left (p = 0.007), right (p = 0.005), and bilateral (p = 0.011) lower limb extension. Spared tissue in the left cord region was related to left lower limb extension (p = 0.019). A positive trend (p = 0.138) was also observed between right spared cord tissue and right lower limb extension. In this study, MRI measures of spared spinal cord tissue were significantly related to standing outcomes with scES. These preliminary results warrant future investigation of roles of supraspinal input and MRI-detected spared spinal cord tissue on lower limb motor responsiveness to scES.

Predictors of volitional motor recovery with epidural stimulation in individuals with chronic spinal cord injury.

Spinal cord epidural stimulation (scES) has enabled volitional lower extremity movements in individuals with chronic and clinically motor complete spinal cord injury and no clinically detectable brain influence. The aim of this study was to understand whether the individuals' neuroanatomical characteristics or positioning of the scES electrode were important factors influencing the extent of initial recovery of lower limb voluntary movements in those with clinically motor complete paralysis. We hypothesized that there would be significant correlations between the number of joints moved during attempts with scES prior to any training interventions and the amount of cervical cord atrophy above the injury, length of post-traumatic myelomalacia and the amount of volume coverage of lumbosacral enlargement by the stimulation electrode array. The clinical and imaging records of 20 individuals with chronic and clinically motor complete spinal cord injury who underwent scES implantation were reviewed and analysed using MRI and X-ray integration, image segmentation and spinal cord volumetric reconstruction techniques. All individuals that participated in the scES study (n = 20) achieved, to some extent, lower extremity voluntary movements post scES implant and prior to any locomotor, voluntary movement or cardiovascular training. The correlation results showed that neither the cross-section area of spinal cord at C3 (n = 19, r = 0.33, P = 0.16) nor the length of severe myelomalacia (n = 18, r = -0.02, P = 0.93) correlated significantly with volitional lower limb movement ability. However, there was a significant, moderate correlation (n = 20, r = 0.59, P = 0.006) between the estimated percentage of the lumbosacral enlargement coverage by the paddle electrode as well as the position of the paddle relative to the maximal lumbosacral enlargement and the conus tip (n = 20, r = 0.50, P = 0.026) with the number of joints moved volitionally. These results suggest that greater coverage of the lumbosacral enlargement by scES may improve motor recovery prior to any training, possibly because of direct modulatory effects on the spinal networks that control lower extremity movements indicating the significant role of motor control at the level of the spinal cord.

Retrospective trends in length of stay and bowel management at discharge from inpatient rehabilitation among individuals with spinal cord injury.

STUDY DESIGN: Retrospective observational cohort study. OBJECTIVES: To describe the trend in length of stay (LOS) and its association with the rate of individuals needing total assistance with bowel management upon discharge from inpatient spinal cord injury (SCI) rehabilitation facilities. SETTING: Participants enrolled in the National Spinal Cord Injury Model Systems (NSCIMS) database. METHODS: The NSCIMS database was used to obtain bowel management characteristics from individuals (n = 15,975) aged 15 years or older discharged from inpatient rehabilitation facilities between 1988 and 2016 with known demographic factors and LOS. Levels of bowel management were defined from the functional independence measure (FIM) based on the level of assistance required to complete a bowel program. To control for changes in participant population and injury characteristics over the study period, the inverse probability of treatment weight (IPTW) technique was used. Linear and logistic regressions and the Spearman correlation coefficient were used for statistical analyses. RESULTS: The LOS significantly decreased more than ¾ of a day on average each year from 1988 (LOS: 83.16 days) to 2016 (LOS: 50.53 days). Concurrently, the odds of needing total assistance in bowel management at discharge increased 4.1% each year. The correlation between these trends was moderate (-0.63). Association analyses yielded that a 1-day decrease in average LOS was associated with a 0.53% increase in those needing total assistance for bowel management at discharge. CONCLUSION: Over the years, as inpatient rehabilitation LOS decreased, rates of those needing total assistance for bowel management at discharge increased.

Clinical Trial Designs for Neuromodulation in Chronic Spinal Cord Injury Using Epidural Stimulation.

STUDY DESIGN: This is a narrative review focused on specific challenges related to adequate controls that arise in neuromodulation clinical trials involving perceptible stimulation and physiological effects of stimulation activation. OBJECTIVES: 1) To present the strengths and limitations of available clinical trial research designs for the testing of epidural stimulation to improve recovery after spinal cord injury. 2) To describe how studies can control for the placebo effects that arise due to surgical implantation, the physical presence of the battery, generator, control interfaces, and rehabilitative activity aimed to promote use-dependent plasticity. 3) To mitigate Hawthorne effects that may occur in clinical trials with intensive supervised participation, including rehabilitation. MATERIALS AND METHODS: Focused literature review of neuromodulation clinical trials with integration to the specific context of epidural stimulation for persons with chronic spinal cord injury. CONCLUSIONS: Standard of care control groups fail to control for the multiple effects of knowledge of having undergone surgical procedures, having implanted stimulation systems, and being observed in a clinical trial. The irreducible effects that have been identified as "placebo" require sham controls or comparison groups in which both are implanted with potentially active devices and undergo similar rehabilitative training.

Epidural stimulation for cardiovascular function increases lower limb lean mass in individuals with chronic motor complete spinal cord injury.

NEW FINDINGS: What is the central question of this study? Spinal cord injury results in paralysis and deleterious neuromuscular and autonomic adaptations. Lumbosacral epidural stimulation can modulate motor and/or autonomic functions. Does long-term epidural stimulation for normalizing cardiovascular function affect leg muscle properties? What is the main finding and its importance? Leg lean mass increased after long-term epidural stimulation for cardiovascular function, which was applied in the sitting position and did not activate the leg muscles. Leg muscle strength and fatigue resistance, assessed in a subgroup of individuals, also increased. These adaptations might support interventions for motor recovery and warrant further mechanistic investigation. ABSTRACT: Chronic motor complete spinal cord injury (SCI) results in paralysis and deleterious neuromuscular and autonomic adaptations. Paralysed muscles demonstrate atrophy, loss of force and increased fatigability. Also, SCI-induced autonomic impairment results in persistently low resting blood pressure and heart rate, among other features. We previously reported that spinal cord epidural stimulation (scES) optimized for cardiovascular (CV) function (CV-scES), which is applied in sitting position and does not activate the leg muscles, can maintain systolic blood pressure within a normotensive range during quiet sitting and during orthostatic stress. In the present study, dual-energy X-ray absorptiometry collected from six individuals with chronic clinically motor complete SCI demonstrated that 88 ± 11 sessions of CV-scES (7 days week-1 ; 2 h day-1 in four individuals and 5 h day-1 in two individuals) over a period of ∼6 months significantly increased lower limb lean mass (by 0.67 ± 0.39 kg or 9.4 ± 8.1%; P < 0.001). Additionally, muscle strength and fatigability data elicited by neuromuscular electrical stimulation in three of these individuals demonstrated a general increase (57 ± 117%) in maximal torque output (between 2 and 44 N m in 14 of the 17 muscle groups tested overall) and torque-time integral during intermittent, fatiguing contractions (63 ± 71%; between 7 and 230% in 16 of the 17 muscle groups tested overall). In contrast, whole-body mass and composition did not change significantly. In conclusion, long-term use of CV-scES can have a significant impact on lower limb muscle properties after chronic motor complete SCI.

Economics of the Management of Craniospinal Chordoma and Chondrosarcoma and the feasibility of the bundled payment model.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) created a new reimbursement model "Bundled Payment for Care Improvement (BPCI)" which reimburses providers a predetermined payment in advance to cover all possible services rendered within a certain time window. Chordoma and Chondrosarcoma are locally aggressive malignant primary bony tumors. Treatment includes surgical resection and radiotherapy with substantial risk for recurrence which necessitates monitoring and further treatment. We assessed the feasibility of the BPCI model in these neurosurgical diseases. METHODS: We selected patients with chordoma/chondrosarcoma from inpatient admission table using the International Classification of Disease, 9th (ICD-9), and 10th (ICD-10) revision codes. We collected the patients' demographics and insurance type at the index hospitalization. We recorded the following outcomes length of stay, total payment, discharge disposition, and complications for the index hospitalization. For post-discharge, we collected the 30 days and 3/6/12 months inpatient admission, outpatient service, and medication refills. Continuous variables were summarized by means with standard deviations, median with interquartile and full ranges (minimum-maximum); Continuous outcomes were compared by nonparametric Wilcoxson rank-sum test. All tests were 2-sided with a significance level of 0.05. Statistical data analysis was performed in SAS 9.4 (SAS Institute, Inc, Cary, NC). RESULTS: The population size was 2041 patients which included 1412 patients with cranial (group1), 343 patients with a mobile spine (group 2), and 286 patients with sacrococcygeal (group 3) chordoma and chondrosarcoma. For index hospitalization, the median length of stay (days) was 4, 6, and 7 for groups 1, 2, and 3 respectively (P<.001). The mean payments were ($58,130), ($84,854), and ($82,440), for groups 1, 2, and 3 respectively (P=.02). The complication rates were 30%, 35%, and 43% for groups 1, 2, and 3 respectively (P<.001). Twelve months post-discharge, the hospital readmission rates were 44%, 53%, and 65% for groups 1, 2, and 3, respectively (P<.001). The median payments for this period were ($72,294), ($76,827), and ($101,474), for groups 1, 2, and 3, respectively (P <.001). CONCLUSION: The management of craniospinal chordoma and chondrosarcoma is costly and may extend over a prolonged period. The success of BPCI requires a joint effort between insurers and hospitals. Also, it should consider patients' comorbidities, the complexity of the disease. Finally, the adoptionof quality improvement programs by hospitals can help with cost reduction.

Inverse national trends of laser interstitial thermal therapy and open surgical procedures for refractory epilepsy: a Nationwide Inpatient Sample-based propensity score matching analysis.

OBJECTIVE: Surgery for medically refractory epilepsy (RE) is an underutilized treatment modality, despite its efficacy. Laser interstitial thermal therapy (LITT), which is minimally invasive, is increasingly being utilized for a variety of brain lesions and offers comparable seizure outcomes. The aim of this study was to report the national trends of open surgical procedures for RE with the advent of LITT. METHODS: Data were extracted using the ICD-9/10 codes from the Nationwide Inpatient Sample (NIS, 2012-2016) in this retrospective study. Patients with a primary diagnosis of RE who underwent either open surgeries (lobectomy, partial lobectomy, and amygdalohippocampectomy) or LITT were included. Patient demographics, complications, hospital length of stay (LOS), discharge disposition, and index hospitalization costs were analyzed. Propensity score matching (PSM) was used to analyze outcomes. RESULTS: A cohort of 128,525 in-hospital patients with RE was included and 5.5% (n = 7045) of these patients underwent either open surgical procedures (94.3%) or LITT (5.7%). LITT is increasingly being performed at a rate of 1.09 per 1000 epilepsy admissions/year, while open surgical procedures are decreasing at a rate of 10.4/1000 cases/year. The majority of procedures were elective (92%) and were performed at large-bed-size hospitals (86%). All LITT procedures were performed at teaching facilities and the majority were performed in the South (37%) and West (30%) regions. The median LOS was 1 day for the LITT cohort and 4 days for the open cohort. Index hospitalization charges were significantly lower following LITT compared to open procedures ($108,332 for LITT vs $124,012 for open surgery, p < 0.0001). LITT was associated with shorter median LOS, high likelihood of discharge home, and lower median index hospitalization charges compared to open procedures for RE on PSM analysis. CONCLUSIONS: LITT is increasingly being performed in favor of open surgical procedures. LITT is associated with a shorter LOS, a higher likelihood of being discharged home, and lower index hospitalization charges compared to open procedures. LITT is a safe treatment modality in carefully selected patients with RE and offers an opportunity to increase the utilization of surgical treatment in patients who may be opposed to open surgery or have contraindications that preclude open surgery.

Estimation of average treatment effects among multiple treatment groups by using an ensemble approach.

In observational studies, generalized propensity score (GPS)-based statistical methods, such as inverse probability weighting (IPW) and doubly robust (DR) method, have been proposed to estimate the average treatment effect (ATE) among multiple treatment groups. In this article, we investigate the GPS-based statistical methods to estimate treatment effects from two aspects. The first aspect of our investigation is to obtain an optimal GPS estimation method among four competing GPS estimation methods by using a rank aggregation approach. We further examine whether the optimal GPS-based IPW and DR methods would improve the performance for estimating ATE. It is well known that the DR method is consistent if either the GPS or the outcome models are correctly specified. The second aspect of our investigation is to examine whether the DR method could be improved if we ensemble outcome models. To that end, bootstrap method and rank aggregation method are used to obtain the ensemble optimal outcome model from several competing outcome models, and the resulting outcome model is incorporated into the DR method, resulting in an ensemble DR (enDR) method. Extensive simulation results indicate that the enDR method provides the best performance in estimating the ATE regardless of the method used for estimating GPS. We illustrate our methods using the MarketScan healthcare insurance claims database to examine the treatment effects among three different bones and substitutes used for spinal fusion surgeries. We draw conclusions based on the estimates from the enDR method coupled with the optimal GPS estimation method.

Insights into complication rates, reoperation rates, and healthcare utilization associated with use of recombinant human bone morphogenetic protein-2 in patients with spine infections.

OBJECTIVEUse of recombinant human bone morphogenetic protein-2 (rhBMP-2) in patients with spine infections is controversial. The purpose of this study was to identify long-term complications, reoperations, and healthcare utilization associated with rhBMP-2 use in patients with spine infections.METHODSThis retrospective study extracted data using ICD-9/10 and CPT codes from MarketScan (2000-2016). Patients were dichotomized into 2 groups (rhBMP-2, no rhBMP-2) based on whether rhBMP-2 was used during fusion surgery for spinal infections. Outcomes of interest were reoperation rates (index level, other levels), readmission rates, discharge disposition, length of stay, complications, and healthcare resource utilization at the index hospitalization and 1, 3, 6, 12, and 24 months following discharge. Outcomes were compared using nonparametric 2-group tests and generalized linear regression models.RESULTSThe database search identified 2762 patients with > 24 months' follow-up; rhBMP-2 was used in 8.4% of their cases. The patients' median age was 53 years, 52.43% were female, and 15.11% had an Elixhauser Comorbidity Index ≥ 3. Patients in the rhBMP-2 group had higher comorbidity indices, incurred higher costs at index hospitalization, were discharged home in most cases, and had lower complication rates than those in the no-rhBMP-2 group. There was no statistically significant between-groups difference in complication rates 1 month following discharge or in reoperation rates at 3, 6, 12, and 24 months following the procedure. Patients in the no-rhBMP-2 group incurred higher utilization of outpatient services and medication refill costs at 1, 3, 6, 12, and 24 months following surgery.CONCLUSIONSIn patients undergoing surgery for spine infection, rhBMP-2 use was associated with lower complication rates and higher median payments during index hospitalization compared to cases in which rhBMP-2 was not used. There was no significant between-groups difference in reoperation rates (index and other levels) at 3, 6, 12, and 24 months after the index operation. Patients treated with rhBMP-2 incurred lower utilization of outpatient services and overall payments. These results indicate that rhBMP-2 can be used safely in patients with spine infections with cost-effective utilization of healthcare resources and without an increase in complications or reoperation rates.

Outcomes of decompression and fusion for treatment of spinal infection

Objective: Spine infection including vertebral osteomyelitis, discitis, paraspinal musculoskeletal infection, and spinal abscess refractory to medical management poses significant challenges to the treating physician. Surgical management is often required in patients suffering neurological deficits or spinal deformity with significant pain. To date, best practices have not been elucidated for the optimization of health outcomes and resource utilization in the setting of surgical intervention for spinal infection. The authors conducted the present study to assess the magnitude of reoperation rates in both fusion and nonfusion groups as well as overall health resource utilization following surgical decompression for spine infection. Methods: The authors performed an analysis using MarketScan (2001­2015) to identify health outcomes and healthcare utilization metrics of spine infection following surgical intervention with decompression alone or combined with fusion. Adult patients underwent surgical management for primary or secondary spinal infection and were followed up for at least 12 months postoperatively. Assessed outcomes included reoperation, healthcare utilization and payment at the index hospitalization and within 12 months after discharge, postoperative complications, and infection recurrence. Results: A total of 2662 patients in the database were eligible for inclusion in this study. Rehospitalization for infection was observed in 3.99% of patients who had undergone fusion and in 11.25% of those treated with decompression alone. Reoperation was needed in 12.7% of the patients without fusion and 8.16% of those with fusion. Complications within 30 days were more common in the nonfusion group (24.64%) than in the fusion group (16.49%). Overall postoperative payments after 12 months totaled $33,137 for the nonfusion group and $23,426 for the fusion group. Conclusions: In this large cohort study with a 12-month follow-up, the recurrence of infection, reoperation rates, and complications were higher in patients treated with decompression alone than in those treated with decompression plus fusion. These findings along with imaging characteristics, disease severity, extent of bony resection, and the presence of instability may help surgeons decide whether to include fusion at the time of initial surgery. Further studies that control for selection bias in appropriately matched cohorts are necessary to determine the additive benefits of fusion in spinal infection management.

National trends in cerebral bypass for unruptured intracranial aneurysms: a National (Nationwide) Inpatient Sample analysis of 1998-2015.

OBJECTIVEThe development and recent widespread dissemination of flow diverters may have reduced the utilization of surgical bypass procedures to treat complex or giant unruptured intracranial aneurysms (UIAs). The aim of this retrospective cohort study was to observe trends in cerebral revascularization procedures for UIAs in the United States before and after the introduction of flow diverters by using the National (Nationwide) Inpatient Sample (NIS).METHODSThe authors extracted data from the NIS database for the years 1998-2015 using the ICD-9/10 diagnostic and procedure codes. Patients with a primary diagnosis of UIA with a concurrent bypass procedure were included in the study. Outcomes and hospital charges were analyzed.RESULTSA total of 216,212 patients had a primary diagnosis of UIA during the study period. The number of patients diagnosed with a UIA increased by 128% from 1998 (n = 7718) to 2015 (n = 17,600). Only 1328 of the UIA patients (0.6%) underwent cerebral bypass. The percentage of patients who underwent bypass in the flow diverter era (2010-2015) remained stable at 0.4%. Most patients who underwent bypass were white (51%), were female (62%), had a median household income in the 3rd or 4th quartiles (57%), and had private insurance (51%). The West (33%) and Midwest/North Central regions (30%) had the highest volume of bypasses, whereas the Northeast region had the lowest (15%). Compared to the period 1998-2011, bypass procedures for UIAs in 2012-2015 shifted entirely to urban teaching hospitals (100%) and to an elective basis (77%). The median hospital stay (9 vs 3 days, p < 0.0001), median hospital charges ($186,746 vs $66,361, p < 0.0001), and rate of any complication (51% vs 17%, p < 0.0001) were approximately threefold higher for the UIA patients with bypass than for those without bypass.CONCLUSIONSDespite a significant increase in the diagnosis of UIAs over the 17-year study period, the proportion of bypass procedures performed as part of their treatment has remained stable. Therefore, advances in endovascular aneurysm therapy do not appear to have affected the volume of bypass procedures performed in the UIA population. The authors' findings suggest a potentially ongoing niche for bypass procedures in the contemporary treatment of UIAs.

Interim Results of a Phase II Study of Hypofractionated Radiotherapy with Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients over 70 Years Old with Newly Diagnosed Glioblastoma.

OBJECTIVE: In this phase II study, we investigate clinical outcomes and tolerability of hypofractionated radiotherapy (HRT) combined with temozolomide (TMZ) to treat elderly patients with glioblastoma (GBM). METHODS: Patients 70 years of age or older with newly diagnosed GBM received HRT to a dose of 34 Gy given in ten fractions over 2 weeks, delivered with concurrent and adjuvant TMZ. RESULTS: In this interim analysis, ten patients were enrolled on trial from 12/1/2015 to 4/5/2017. With a median follow-up of 9 months (range 3-12 months), median progression-free survival (PFS) was 6 months. The median overall survival (OS) has not been reached. Estimated 1-year OS and PFS rates were 53.3 and 44.4%, respectively. All patients completed the full course of RT, with no patients developing grade 3 or higher adverse events from treatment. CONCLUSIONS: The preliminary results of our phase II trial suggest HRT delivered over 2 weeks with concurrent and adjuvant TMZ is well tolerated in elderly patients with GBM without compromising clinical outcomes.

Health care utilization and overall costs based on opioid dependence in patients undergoing surgery for degenerative spondylolisthesis.

OBJECTIVE Opioid abuse is highly prevalent in patients with back pain. The aim of this study was to identify health care utilization and overall costs associated with opioid dependence in patients undergoing surgery for degenerative spondylolisthesis (DS). METHODS The authors queried the MarketScan database using ICD-9 and CPT-4 codes from 2000 to 2012. Opioid dependency was defined as having a diagnosis of opioid use disorder, having a prescription for opioid use disorder, or having 10 or more opioid prescriptions. Opioid dependency was evaluated in 12-month period leading to surgery and in the period 3-15 months following the procedure. Patients were segregated into 4 groups based on opioid dependence before and after surgery: group NDND (prior nondependent who remain nondependent), group NDD (prior nondependent who become dependent), group DND (prior dependent who become nondependent), and group DD (prior dependent who remain dependent). The outcomes of interest were discharge disposition, hospital length of stay (LOS), complications, and health care resource costs. The 4 groups were compared using the Kruskal-Wallis test and linear contrasts built from generalized regression models. RESULTS A total of 10,708 patients were identified, with 81.57%, 3.58%, 8.54%, and 6.32% of patients in groups NDND, NDD, DND, and DD, respectively. In group DD, 96.31% of patients had decompression with fusion, compared with 93.59% in group NDND. Patients in group NDD, DND, and DD had longer hospital LOS compared with those in group NDND. Patients in group DD were less likely to be discharged home compared with those in group NDND (odds ratio 0.639, 95% confidence interval 0.52-0.785). At 3-15 months postdischarge, patients in group DD incurred 21% higher hospital readmission costs compared with those in group NDND. However, patients in groups NDD and DD were likely to incur 2.8 times the overall costs compared with patients in group NDND (p < 0.001) at 3-15 months after surgery (median overall payments: group NDD $20,033 and group DD $19,654, vs group NDND $7994). CONCLUSIONS Patients who continued to be opioid dependent or became opioid dependent following surgery for DS incurred significantly higher health care utilization and costs within 3 months and in the period 3-15 months after discharge from surgery.

Variability in the utility of predictive models in predicting patient-reported outcomes following spine surgery for degenerative conditions: a systematic review.

OBJECTIVEThere is increasing emphasis on patient-reported outcomes (PROs) to quantitatively evaluate quality outcomes from degenerative spine surgery. However, accurate prediction of PROs is challenging due to heterogeneity in outcome measures, patient characteristics, treatment characteristics, and methodological characteristics. The purpose of this study was to evaluate the current landscape of independently validated predictive models for PROs in elective degenerative spinal surgery with respect to study design and model generation, training, accuracy, reliability, variance, and utility.METHODSThe authors analyzed the current predictive models in PROs by performing a search of the PubMed and Ovid databases using PRISMA guidelines and a PICOS (participants, intervention, comparison, outcomes, study design) model. They assessed the common outcomes and variables used across models as well as the study design and internal validation methods.RESULTSA total of 7 articles met the inclusion criteria, including a total of 17 validated predictive models of PROs after adult degenerative spine surgery. National registry databases were used in 4 of the studies. Validation cohorts were used in 2 studies for model verification and 5 studies used other methods, including random sample bootstrapping techniques. Reported c-index values ranged from 0.47 to 0.79. Two studies report the area under the curve (0.71-0.83) and one reports a misclassification rate (9.9%). Several positive predictors, including high baseline pain intensity and disability, demonstrated high likelihood of favorable PROs.CONCLUSIONSA limited but effective cohort of validated predictive models of spine surgical outcomes had proven good predictability for PROs. Instruments with predictive accuracy can enhance shared decision-making, improve rehabilitation, and inform best practices in the setting of heterogeneous patient characteristics and surgical factors.