Publications by authors named "Tej D Azad"

86 Publications

A Comprehensive Circulating Tumor DNA Assay for Detection of Translocation and Copy-Number Changes in Pediatric Sarcomas.

Mol Cancer Ther 2021 10 5;20(10):2016-2025. Epub 2021 Aug 5.

Division of Hematology/Oncology, Department of Pediatrics, University of California San Francisco, San Fransisco, California.

Most circulating tumor DNA (ctDNA) assays are designed to detect recurrent mutations. Pediatric sarcomas share few recurrent mutations but rather are characterized by translocations and copy-number changes. We applied Cancer Personalized Profiling by deep Sequencing (CAPP-Seq) for detection of translocations found in the most common pediatric sarcomas. We also applied ichorCNA to the combined off-target reads from our hybrid capture to simultaneously detect copy-number alterations (CNA). We analyzed 64 prospectively collected plasma samples from 17 patients with pediatric sarcoma. Translocations were detected in the pretreatment plasma of 13 patients and were confirmed by tumor sequencing in 12 patients. Two of these patients had evidence of complex chromosomal rearrangements in their ctDNA. We also detected copy-number changes in the pretreatment plasma of 7 patients. We found that ctDNA levels correlated with metastatic status and clinical response. Furthermore, we detected rising ctDNA levels before relapse was clinically apparent, demonstrating the high sensitivity of our assay. This assay can be utilized for simultaneous detection of translocations and CNAs in the plasma of patients with pediatric sarcoma. While we describe our experience in pediatric sarcomas, this approach can be applied to other tumors that are driven by structural variants.
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http://dx.doi.org/10.1158/1535-7163.MCT-20-0987DOI Listing
October 2021

Defining and describing treatment heterogeneity in new-onset idiopathic lower back and extremity pain through reconstruction of longitudinal care sequences.

Spine J 2021 May 23. Epub 2021 May 23.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA 94305, USA. Electronic address:

Background Context: Despite established guidelines, long-term management of surgically-treated low back pain (LBP) and lower extremity pain (LEP) remains heterogeneous. Understanding care heterogeneity could inform future approaches for standardization of practices.

Purpose: To describe treatment heterogeneity in surgically-managed LBP and LEP.

Study Design/setting: Retrospective study of a nationwide commercial database spanning inpatient and outpatient encounters for enrollees of eligible employer-supplied healthcare plans (2007-2016).

Patient Sample: A population-based sample of opioid-naïve adult patients with newly-diagnosed LBP or LEP were identified. Inclusion required at least 12-months of pre-diagnosis and post-diagnosis continuous follow-up.

Exposure: Included treatments/evaluations include conservative management (chiropractic manipulative therapy, physical therapy, epidural steroid injections), imaging (x-ray, MRI, CT), pharmaceuticals (opioids, benzodiazepines), and spine surgery (decompression, fusion).

Outcome Measures: Primary outcomes-of-interest were 12-month net healthcare expenditures (inpatient and outpatient) and 12-month opioid usage.

Methods: Analyses include interrogation of care sequence heterogeneity and temporal trends in sequence-initiating services. Comparisons were conducted in the framework of sequence-specific treatment sequences, which reflect the personalized order of healthcare services pursued by each patient. Outlier sequences characterized by high opioid use and costs were identified from frequently observed surgical treatment sequences using Mahalanobis distance.

Results: A total of 2,496,908 opioid-naïve adult patients with newly-diagnosed LBP or LEP were included (29,519 surgical). In the matched setting, increased care sequence heterogeneity was observed in surgical patients (0.51 vs. 0.12 previously-unused interventions/studies pursued per month). Early opioid and MRI use has decreased between 2008 and 2015 but is matched by increases in early benzodiazepine and x-ray use. Outlier sequences, characterized by increased opioid use and costs, were found in 5.8% of surgical patients. Use of imaging prior to conservative management was common in patients pursuing outlier sequences compared to non-outlier sequences (96.5% vs. 63.8%, p<.001). Non-outlier sequences were more frequently characterized by early conservative interventions (31.9% vs. 7.4%, p<.001).

Conclusions: Surgically-managed LBP and LEP care sequences demonstrate high heterogeneity despite established practice guidelines. Outlier sequences associated with high opioid usage and costs can be identified and are characterized by increased early imaging and decreased early conservative management. Elements that may portend suboptimal longitudinal management could provide opportunities for standardization of patient care.
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http://dx.doi.org/10.1016/j.spinee.2021.05.019DOI Listing
May 2021

Prediction Models in Degenerative Spine Surgery: A Systematic Review.

Global Spine J 2021 Apr;11(1_suppl):79S-88S

1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Study Design: Systematic review.

Objectives: To review the existing literature of prediction models in degenerative spinal surgery.

Methods: Review of PubMed/Medline and Embase databases was conducted to identify articles between January 1, 2000 and March 1, 2020 that reported prediction model performance for outcomes following elective degenerative spine surgery.

Results: Thirty-one articles were included. Twenty studies were of thoracolumbar, 5 were of cervical, and 6 included all spine patients. Five studies were externally validated. Prediction models were developed using machine learning (42%) and logistic regression (42%) as well as other techniques. Web-based calculators were included in 45% of published articles. Various outcomes were investigated, including complications, infection, length of stay, discharge disposition, reoperation, readmission, disability score, back pain, leg pain, return to work, and opioid dependence.

Conclusions: Significant heterogeneity exists in methods used to develop prediction models of postoperative outcomes after degenerative spine surgery. Most internally validate their scores, but a few have been externally validated. Areas under the curve for most models range from 0.6 to 0.9. Techniques for development are becoming increasingly sophisticated with different machine learning tools. With further external validation, these models can be deployed online for patient, physician, and administrative use, and have the potential to optimize outcomes and maximize value in spine surgery.
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http://dx.doi.org/10.1177/2192568220959037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076813PMC
April 2021

Coronavirus Disease 2019 Policy Restricting Family Presence May Have Delayed End-of-Life Decisions for Critically Ill Patients.

Crit Care Med 2021 10;49(10):e1037-e1039

Johns Hopkins University, Baltimore, MD.

Objectives: To determine if a restrictive visitor policy inadvertently lengthened the decision-making process for dying inpatients without coronavirus disease 2019.

Design: Regression discontinuity and time-to-event analysis.

Setting: Two large academic hospitals in a unified health system.

Patients Or Subjects: Adult decedents who received greater than or equal to 1 day of ICU care during their terminal admission over a 12-month period.

Interventions: Implementation of a visit restriction policy.

Measurements And Main Results: We identified 940 adult decedents without coronavirus disease 2019 during the study period. For these patients, ICU length of stay was 0.8 days longer following policy implementation, although this effect was not statistically significant (95% CI, -2.3 to 3.8; p = 0.63). After excluding patients admitted before the policy but who died after implementation, we observed that ICU length of stay was 2.9 days longer post-policy (95% CI, 0.27-5.6; p = 0.03). A time-to-event analysis revealed that admission after policy implementation was associated with a significantly longer time to first do not resuscitate/do not intubate/comfort care order (adjusted hazard ratio, 2.2; 95% CI, 1.6-3.1; p < 0.0001).

Conclusions: Policies restricting family presence may lead to longer ICU stays and delay decisions to limit treatment prior to death. Further policy evaluation and programs enabling access to family-centered care and palliative care during the ongoing coronavirus disease 2019 pandemic are imperative.
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http://dx.doi.org/10.1097/CCM.0000000000005044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8439643PMC
October 2021

Single-suture craniosynostosis and the epigenome: current evidence and a review of epigenetic principles.

Neurosurg Focus 2021 04;50(4):E10

2Department of Neurosurgery, Johns Hopkins Hospital, Baltimore, Maryland.

Craniosynostosis (CS) is a congenital disease that arises due to premature ossification of single or multiple sutures, which results in skull deformities. The surgical management of single-suture CS continues to evolve and is driven by a robust body of clinical research; however, the molecular underpinnings of CS remain poorly understood. Despite long-standing hypotheses regarding the interaction of genetic predisposition and environmental factors, formal investigation of the epigenetic underpinnings of CS has been limited. In an effort to catalyze further investigation into the epigenetic basis of CS, the authors review the fundamentals of epigenetics, discuss recent studies that shed light on this emerging field, and offer hypotheses regarding the role of epigenetic mechanisms in the development of single-suture CS.
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http://dx.doi.org/10.3171/2021.1.FOCUS201008DOI Listing
April 2021

Opinion & Special Articles: Shared Decision-Making During the COVID-19 Pandemic: Three Bullets in 3 Hemispheres.

Authors:
Tej D Azad

Neurology 2021 05 10;96(20):e2558-e2560. Epub 2021 Mar 10.

From the Department of Neurosurgery, Johns Hopkins Hospital, Baltimore, MD.

Patients with traumatic brain injury may be dependent on the decision-making of their families. Restrictive visitation policies implemented during the coronavirus disease 2019 (COVID-19) pandemic disproportionately affect these patients and their families. This narrative aims to illustrate this phenomenon and catalyze discussions regarding the need for careful evaluation of restrictive family visitation policies and exceptions that may be required for patients with brain injuries.
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http://dx.doi.org/10.1212/WNL.0000000000011811DOI Listing
May 2021

Association of Race with Early Outcomes of Elective Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: Propensity-Matched and Subgroup Analysis.

World Neurosurg 2021 06 5;150:e176-e181. Epub 2021 Mar 5.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. Electronic address:

Objective: To investigate the impact of race on 30-day postoperative complication rates of elective posterior spinal fusions (PSF) for adolescent idiopathic scoliosis (AIS).

Methods: Patients who underwent PSF between 2012 and 2018 were reviewed from the American College of Surgeons National Surgical Quality Improvement Program pediatric database. Propensity score matching was utilized to evaluate whether patient race (i.e., black vs. white) was correlated with postoperative complications.

Results: A total of 4051 PSF for AIS cases met criteria for inclusion. Of these, 3221 (79.5%) patients were white and 830 (20.5%) were black. Several baseline characteristics significantly differed between cohorts. Patients in the black cohort had a significantly higher body mass index, a greater proportion of female patients, higher ASA scores, preoperative diagnosis of asthma or cardiac risk factors, and prior use of steroids. The total number of vertebral segments fused was also greater in the black cohort. After controlling for differences in baseline characteristics with propensity score matching analysis, the only significant difference in morbidity and mortality identified was a higher incidence of venous thromboembolism among the black cohort (2.8% vs. 0.1%; P < 0.001).

Conclusions: In contrast to prior literature, our analysis did not identify black race as an independent risk factor for higher perioperative morbidity or mortality in patients of young age group undergoing elective PSF for AIS, except the higher incidence of venous thromboembolism. The findings of the present study suggest that previously reported perioperative morbidity and mortality outcomes in black patients may be secondary to baseline health characteristics, and not due to race itself.
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http://dx.doi.org/10.1016/j.wneu.2021.02.113DOI Listing
June 2021

Utility of prediction model score: a proposed tool to standardize the performance and generalizability of clinical predictive models based on systematic review.

J Neurosurg Spine 2021 Feb 26:1-9. Epub 2021 Feb 26.

1Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Objective: The objective of this study was to evaluate the characteristics and performance of current prediction models in the fields of spine metastasis and degenerative spine disease to create a scoring system that allows direct comparison of the prediction models.

Methods: A systematic search of PubMed and Embase was performed to identify relevant studies that included either the proposal of a prediction model or an external validation of a previously proposed prediction model with 1-year outcomes. Characteristics of the original study and discriminative performance of external validations were then assigned points based on thresholds from the overall cohort.

Results: Nine prediction models were included in the spine metastasis category, while 6 prediction models were included in the degenerative spine category. After assigning the proposed utility of prediction model score to the spine metastasis prediction models, only 1 reached the grade of excellent, while 2 were graded as good, 3 as fair, and 3 as poor. Of the 6 included degenerative spine models, 1 reached the excellent grade, while 3 studies were graded as good, 1 as fair, and 1 as poor.

Conclusions: As interest in utilizing predictive analytics in spine surgery increases, there is a concomitant increase in the number of published prediction models that differ in methodology and performance. Prior to applying these models to patient care, these models must be evaluated. To begin addressing this issue, the authors proposed a grading system that compares these models based on various metrics related to their original design as well as internal and external validation. Ultimately, this may hopefully aid clinicians in determining the relative validity and usability of a given model.
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http://dx.doi.org/10.3171/2020.8.SPINE20963DOI Listing
February 2021

Fostering reproducibility and generalizability in machine learning for clinical prediction modeling in spine surgery.

Spine J 2021 10 13;21(10):1610-1616. Epub 2020 Oct 13.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA, USA. Electronic address:

As the use of machine learning algorithms in the development of clinical prediction models has increased, researchers are becoming more aware of the deleterious effects that stem from the lack of reporting standards. One of the most obvious consequences is the insufficient reproducibility found in current prediction models. In an attempt to characterize methods to improve reproducibility and to allow for better clinical performance, we utilize a previously proposed taxonomy that separates reproducibility into 3 components: technical, statistical, and conceptual reproducibility. By following this framework, we discuss common errors that lead to poor reproducibility, highlight the importance of generalizability when evaluating a ML model's performance, and provide suggestions to optimize generalizability to ensure adequate performance. These efforts are a necessity before such models are applied to patient care.
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http://dx.doi.org/10.1016/j.spinee.2020.10.006DOI Listing
October 2021

Timing of Adjuvant Radiation Therapy and Risk of Wound-Related Complications Among Patients With Spinal Metastatic Disease.

Global Spine J 2021 Jan 22;11(1):44-49. Epub 2019 Nov 22.

6429Stanford University School of Medicine, Stanford, CA, USA.

Study Design: This was an epidemiological study using national administrative data from the MarketScan database.

Objective: To investigate the impact of early versus delayed adjuvant radiotherapy (RT) on wound healing following surgical resection for spinal metastatic disease.

Methods: We queried the MarketScan database (2007-2016), identifying patients with a diagnosis of spinal metastasis who also underwent RT within 8 weeks of surgery. Patients were categorized into "Early RT" if they received RT within 4 weeks of surgery and as "Late RT" if they received RT between 4 and 8 weeks after surgery. Descriptive statistics and hypothesis testing were used to compare baseline characteristics and wound complication outcomes.

Results: A total of 540 patients met the inclusion criteria: 307 (56.9%) received RT within 4 weeks (Early RT) and 233 (43.1%) received RT within 4 to 8 weeks (Late RT) of surgery. Mean days to RT for the Early RT cohort was 18.5 (SD, 6.9) and 39.7 (SD, 7.6) for the Late RT cohort. In a 90-day surveillance period, n = 9 (2.9%) of Early RT and n = 8 (3.4%) of Late RT patients developed wound complications ( = .574).

Conclusions: When comparing patients who received RT early versus delayed following surgery, there were no significant differences in the rates of wound complications. Further prospective studies should aim to identify optimal patient criteria for early postoperative RT for spinal metastases.
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http://dx.doi.org/10.1177/2192568219889363DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734271PMC
January 2021

Opioid Prescribing Patterns for Low Back Pain Among Commercially Insured Children.

Spine (Phila Pa 1976) 2020 Nov;45(21):E1365-E1366

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA.

: Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003657DOI Listing
November 2020

Robotic Spine Surgery: Current State in Minimally Invasive Surgery.

Global Spine J 2020 Apr 28;10(2 Suppl):34S-40S. Epub 2020 May 28.

Johns Hopkins School of Medicine, Baltimore, MD, USA.

Study Design: Narrative review.

Objectives: Robotic systems in spinal surgery may offer potential benefits for both patients and surgeons. In this article, the authors explore the future prospects and current limitations of robotic systems in minimally invasive spine surgery.

Methods: We describe recent developments in robotic spine surgery and minimally invasive spine surgery. Institutional review board approval was not needed.

Results: Although robotic application in spine surgery has been gradual, the past decade has seen the arrival of several novel robotic systems for spinal procedures, suggesting the evolution of technology capable of augmenting surgical ability.

Conclusion: Spine surgery is well positioned to benefit from robotic assistance and automation. Paired with enhanced navigation technologies, robotic systems have tremendous potential to supplement the skills of spine surgeons, improving patient safety and outcomes while limiting complications and costs.
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http://dx.doi.org/10.1177/2192568219878131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263345PMC
April 2020

A predictive-modeling based screening tool for prolonged opioid use after surgical management of low back and lower extremity pain.

Spine J 2020 08 20;20(8):1184-1195. Epub 2020 May 20.

Department of Neurosurgery, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA 94305, USA. Electronic address:

Background Context: Outpatient postoperative pain management in spine patients, specifically involving the use of opioids, demonstrates significant variability.

Purpose: Using preoperative risk factors and 30-day postoperative opioid prescribing patterns, we developed models for predicting long-term opioid use in patients after elective spine surgery.

Study Design/setting: This retrospective cohort study utilizes inpatient, outpatient, and pharmaceutical data from MarketScan databases (Truven Health).

Patient Sample: In all, 19,317 patients who were newly diagnosed with low back or lower extremity pain (LBP or LEP) between 2008 and 2015 and underwent thoracic or lumbar surgery within 1 year after diagnosis were enrolled. Some patients initiated opioids after diagnosis but all patients were opioid-naïve before the diagnosis.

Outcome Measures: Long-term opioid use was defined as filling ≥180 days of opioids within one year after surgery.

Methods: Using demographic variables, medical and psychiatric comorbidities, preoperative opioid use, and 30-day postoperative opioid use, we generated seven models on 80% of the dataset and tested the models on the remaining 20%. We used three regression-based models (full logistic regression, stepwise logistic regression, least absolute shrinkage and selection operator), support vector machine, two tree-based models (random forest, stochastic gradient boosting), and time-varying convolutional neural network. Area under the curve (AUC), Brier index, sensitivity, and calibration curves were used to assess the discrimination and calibration of the models.

Results: We identified 903 (4.6%) of patients who met criteria for long-term opioid use. The regression-based models demonstrated the highest AUC, ranging from 0.835 to 0.847, and relatively high sensitivities, predicting between 74.9% and 76.5% of the long-term opioid use patients in the test dataset. The three strongest positive predictors of long-term opioid use were high preoperative opioid use (OR 2.70; 95% confidence interval [CI] 2.27-3.22), number of days with active opioid prescription between postoperative days 15 to 30 (OR 1.10; 95%CI 1.07-1.12), and number of dosage increases between postoperative day 15 to 30 (OR 1.71, 95%CI 1.41-2.08). The strongest negative predictors were number of dosage decreases in the 30-day postoperative period.

Conclusions: We evaluated several predictive models for postoperative long-term opioid use in a large cohort of patients with LBP or LEP who underwent surgery. A regression-based model with high sensitivity and AUC is provided online to screen patients for high risk of long-term opioid use based on preoperative risk factors and opioid prescription patterns in the first 30 days after surgery. It is hoped that this work will improve identification of patients at high risk of prolonged opioid use and enable early intervention and counseling.
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http://dx.doi.org/10.1016/j.spinee.2020.05.098DOI Listing
August 2020

Integrating genomic features for non-invasive early lung cancer detection.

Nature 2020 04 25;580(7802):245-251. Epub 2020 Mar 25.

Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.

Radiologic screening of high-risk adults reduces lung-cancer-related mortality; however, a small minority of eligible individuals undergo such screening in the United States. The availability of blood-based tests could increase screening uptake. Here we introduce improvements to cancer personalized profiling by deep sequencing (CAPP-Seq), a method for the analysis of circulating tumour DNA (ctDNA), to better facilitate screening applications. We show that, although levels are very low in early-stage lung cancers, ctDNA is present prior to treatment in most patients and its presence is strongly prognostic. We also find that the majority of somatic mutations in the cell-free DNA (cfDNA) of patients with lung cancer and of risk-matched controls reflect clonal haematopoiesis and are non-recurrent. Compared with tumour-derived mutations, clonal haematopoiesis mutations occur on longer cfDNA fragments and lack mutational signatures that are associated with tobacco smoking. Integrating these findings with other molecular features, we develop and prospectively validate a machine-learning method termed 'lung cancer likelihood in plasma' (Lung-CLiP), which can robustly discriminate early-stage lung cancer patients from risk-matched controls. This approach achieves performance similar to that of tumour-informed ctDNA detection and enables tuning of assay specificity in order to facilitate distinct clinical applications. Our findings establish the potential of cfDNA for lung cancer screening and highlight the importance of risk-matching cases and controls in cfDNA-based screening studies.
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http://dx.doi.org/10.1038/s41586-020-2140-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8230734PMC
April 2020

Neurosurgical Randomized Trials in Low- and Middle-Income Countries.

Neurosurgery 2020 09;87(3):476-483

NIHR Global Health Research Group on Neurotrauma, University of Cambridge, Cambridge, United Kingdom.

Background: The setting of a randomized trial can determine whether its findings are generalizable and can therefore apply to different settings. The contribution of low- and middle-income countries (LMICs) to neurosurgical randomized trials has not been systematically described before.

Objective: To perform a systematic analysis of design characteristics and methodology, funding source, and interventions studied between trials led by and/or conducted in high-income countries (HICs) vs LMICs.

Methods: From January 2003 to July 2016, English-language trials with >5 patients assessing any one neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. Income classification for each country was assessed using the World Bank Atlas method.

Results: A total of 73.3% of the 397 studies that met inclusion criteria were led by HICs, whereas 26.7% were led by LMICs. Of the 106 LMIC-led studies, 71 were led by China. If China is excluded, only 8.8% were led by LMICs. HIC-led trials enrolled a median of 92 patients vs a median of 65 patients in LMIC-led trials. HIC-led trials enrolled from 7.6 sites vs 1.8 sites in LMIC-led studies. Over half of LMIC-led trials were institutionally funded (54.7%). The majority of both HIC- and LMIC-led trials evaluated spinal neurosurgery, 68% and 71.7%, respectively.

Conclusion: We have established that there is a substantial disparity between HICs and LMICs in the number of published neurosurgical trials. A concerted effort to invest in research capacity building in LMICs is an essential step towards ensuring context- and resource-specific high-quality evidence is generated.
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http://dx.doi.org/10.1093/neuros/nyaa049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426187PMC
September 2020

Patterns of Care and Age-Specific Impact of Extent of Resection and Adjuvant Radiotherapy in Pediatric Pineoblastoma.

Neurosurgery 2020 05;86(5):E426-E435

Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.

Background: Pediatric pineoblastomas are highly aggressive tumors that portend poor outcomes despite multimodal management. Controversy remains regarding optimal disease management.

Objective: To evaluate patterns of care and optimal clinical management of pediatric pineoblastoma.

Methods: A total of 211 pediatric (age 0-17 yr) histologically confirmed pineoblastoma patients diagnosed between 2004 and 2015 were queried from the National Cancer Database. Wilcoxon rank-sum statistics and chi-squared analyses were used to compare continuous and categorical variables, respectively. Univariable and multivariable Cox regressions were used to evaluate prognostic impact of covariates. Propensity-score matching was used to balance baseline characteristics.

Results: Older patients (age ≥ 4 yr) experienced improved overall survival compared to younger patients (age < 4 yr) (hazard ratio [HR] = 0.41; 95% CI 0.25-0.66). Older patients (adjusted odds ratio [aOR] = 5.21; 95% CI 2.61-10.78) and those residing in high-income regions (aOR = 3.16; 95% CI 1.21-8.61) received radiotherapy more frequently. Radiotherapy was independently associated with improved survival in older (adjusted HR [aHR] = 0.31; 95% CI 0.12-0.87) but not younger (aHR = 0.64; 95% CI 0.20-1.90) patients. The benefits of radiotherapy were more pronounced in patients receiving surgery than in those not receiving surgery (aHR [surgical patients] = 0.23; 95% CI 0.08-0.65; aHR [nonsurgical patients] = 0.46; 95% CI 0.22-0.97). Older patients experienced improved outcomes associated with aggressive resection (P = .041); extent of resection was not associated with survival in younger patients (P = .880).

Conclusion: Aggressive tumor resection was associated with improved survival only in older pediatric patients. Radiotherapy was more effective in patients receiving surgery. Age-stratified approaches might allow for improved disease management of pediatric pineoblastoma.
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http://dx.doi.org/10.1093/neuros/nyaa023DOI Listing
May 2020

Adult Spinal Deformity Surgery in Patients With Movement Disorders: A Propensity-matched Analysis of Outcomes and Cost.

Spine (Phila Pa 1976) 2020 Mar;45(5):E288-E295

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA.

Study Design: This was a retrospective study using national administrative data from the MarketScan database.

Objective: To investigate the complication rates, quality outcomes, and costs in a nationwide cohort of patients with movement disorders (MD) who undergo spinal deformity surgery.

Summary Of Background Data: Patients with MD often present with spinal deformities, but their tolerance for surgical intervention is unknown.

Methods: The MarketScan administrative claims database was queried to identify adult patients with MD who underwent spinal deformity surgery. A propensity-score match was conducted to create two uniform cohorts and mitigate interpopulation confounders. Perioperative complication rates, 90-day postoperative outcomes, and total costs were compared between patients with MD and controls.

Results: A total of 316 patients with MD (1.7%) were identified from the 18,970 undergoing spinal deformity surgery. The complication rate for MD patients was 44.6% and for the controls 35.6% (P = 0.009). The two most common perioperative complications were more likely to occur in MD patients, acute-posthemorrhagic anemia (26.9% vs. 20.8%, P < 0.05) and deficiency anemia (15.5% vs. 8.5%, P < 0.05). At 90 days, MD patients were more likely to be readmitted (17.4% vs. 13.2%, P < 0.05) and have a higher total cost ($94,672 vs. $85,190, P < 0.05). After propensity-score match, the overall complication rate remained higher in the MD group (44.6% vs. 37.6%, P < 0.05). 90-day readmissions and costs also remained significantly higher in the MD cohort. Multivariate modeling revealed MD was an independent predictor of postoperative complication and inpatient readmission. Subgroup analysis revealed that Parkinson disease was an independent predictor of inpatient readmission, reoperation, and increased length of stay.

Conclusion: Patients with MD who undergo spinal deformity surgery may be at risk of higher rate of perioperative complications and 90-day readmissions compared with patients without these disorders.

Level Of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003251DOI Listing
March 2020

Limitations of functional neuroimaging for patient selection and surgical planning in glioma surgery.

Neurosurg Focus 2020 02;48(2):E12

2Department of Neurosurgery, Hôpital Gui de Chauliac, Montpellier, France.

The optimal surgical management of gliomas requires a balance between surgical cytoreduction and preservation of neurological function. Preoperative functional neuroimaging, such as functional MRI (fMRI) and diffusion tensor imaging (DTI), has emerged as a possible tool to inform patient selection and surgical planning. However, evidence that preoperative fMRI or DTI improves extent of resection, limits neurological morbidity, and broadens surgical indications in classically eloquent areas is lacking. In this review, the authors describe facets of functional neuroimaging techniques that may limit their impact on neurosurgical oncology and critically evaluate the evidence supporting fMRI and DTI for patient selection and operative planning in glioma surgery. The authors also propose alternative applications for functional neuroimaging in the care of glioma patients.
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http://dx.doi.org/10.3171/2019.11.FOCUS19769DOI Listing
February 2020

Evaluating Shunt Survival Following Ventriculoperitoneal Shunting with and without Stereotactic Navigation in Previously Shunt-Naïve Patients.

World Neurosurg 2020 Apr 26;136:e671-e682. Epub 2020 Jan 26.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, California. Electronic address:

Background: Ventriculoperitoneal shunts are used to alleviate elevated intracranial pressure due to either hydrocephalus or idiopathic intracranial hypertension; however, shunt failure is a significant neurosurgical problem. Despite increases in intraoperative stereotactic navigation usage over the past decade, its effect on shunt survival remains unclear.

Methods: Shunt-naïve pediatric and adult patients receiving ventriculoperitoneal shunting between 2007 and 2015 were identified in a national administrative database. Multivariable logistic and Cox regressions were used to evaluate factors affecting stereotaxy usage and shunt survival. Matched cohorts were generated by propensity score balancing.

Results: Of 9677 patients identified, 932 received image-guided shunt placement. Total shunt failure rate was not associated with stereotaxy use (20.3% with stereotaxy vs. 19.4% without, P = 0.4602). In the matched setting, shunt survival was not extended by use of image guidance during placement (hazard ratio = 1.134, 95% confidence interval 0.923-1.393). Late shunt failures (defined as failures occurring at least 30 days after shunt placement) caused by infection occurred more frequently in the stereotaxy cohort (hazard ratio = 2.207, 95% confidence interval 1.115-4.366), whereas late shunt failures attributable to mechanical shunt failure were more common in the nonstereotaxy cohort (hazard ratio = 1.406, 95% confidence interval 1.002-1.973).

Conclusions: Our findings suggest stereotaxy use during ventriculoperitoneal shunt placement does not affect shunt survival. Late shunt failures caused by infection occurred more frequently in the stereotaxy cohort, whereas late failures caused by mechanical shunt malfunction were more commonly encountered in the nonstereotaxy cohort.
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http://dx.doi.org/10.1016/j.wneu.2020.01.138DOI Listing
April 2020

Liquid biopsy for pediatric diffuse midline glioma: a review of circulating tumor DNA and cerebrospinal fluid tumor DNA.

Neurosurg Focus 2020 01;48(1):E9

1Department of Neurosurgery, Johns Hopkins Hospital, Baltimore, Maryland; and.

Diffuse midline glioma (DMG) is a highly malignant childhood tumor with an exceedingly poor prognosis and limited treatment options. The majority of these tumors harbor somatic mutations in genes encoding histone variants. These recurrent mutations correlate with treatment response and are forming the basis for molecularly guided clinical trials. The ability to detect these mutations, either in circulating tumor DNA (ctDNA) or cerebrospinal fluid tumor DNA (CSF-tDNA), may enable noninvasive molecular profiling and earlier prediction of treatment response. Here, the authors review ctDNA and CSF-tDNA detection methods, detail recent studies that have explored detection of ctDNA and CSF-tDNA in patients with DMG, and discuss the implications of liquid biopsies for patients with DMG.
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http://dx.doi.org/10.3171/2019.9.FOCUS19699DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340556PMC
January 2020

Randomized Controlled Trials in Functional Neurosurgery-Association of Device Approval Status and Trial Quality.

Neuromodulation 2020 Jun 11;23(4):496-501. Epub 2019 Dec 11.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA, USA.

Introduction: Randomized controlled trials (RCTs) have been critical in evaluating the safety and efficacy of functional neurosurgery interventions. Given this, we sought to systematically assess the quality of functional neurosurgery RCTs.

Methods: We used a database of neurosurgical RCTs (trials published from 1961 to 2016) to identify studies of functional neurosurgical procedures (N = 48). We extracted data on the design and quality of these RCTs and quantified the quality of trials using Jadad scores. We categorized RCTs based on the device approval status at the time of the trial and tested the association of device approval status with trial design and quality parameters.

Results: Of the 48 analyzed functional neurosurgery RCTs, the median trial size was 34.5 patients with a median age of 51. The most common indications were Parkinson's disease (N = 20), epilepsy (N = 10), obsessive-compulsive disorder (N = 4), and pain (N = 4). Most trials reported inclusion and exclusion criteria (95.8%), sample size per arm (97.9%), and baseline characteristics of the patients being studied (97.9%). However, reporting of allocation concealment (29.2%), randomization mode (66.7%), and power calculations (54.2%) were markedly less common. We observed that trial quality has improved over time (Spearman r, 0.49). We observed that trials studying devices with humanitarian device exemption (HDE) and experimental indications (EI) tended to be of higher quality than trials of FDA-approved devices (p = 0.011). A key distinguishing quality characteristic was the proportion of HDE and EI trials that were double-blinded, compared to trials of FDA-approved devices (HDE, 83.3%; EI, 69.2%; FDA-approved, 35.3%). Although more than one-third of functional neurosurgery RCTs reported funding from industry, no significant association was identified between funding source and trial quality or outcome.

Conclusion: The quality of RCTs in functional neurosurgery has improved over time but reporting of specific metrics such as power calculations and allocation concealment requires further improvement. Device approval status but not funding source was associated with trial quality.
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http://dx.doi.org/10.1111/ner.13083DOI Listing
June 2020

Genomic Landscape of Intramedullary Spinal Cord Gliomas.

Sci Rep 2019 12 10;9(1):18722. Epub 2019 Dec 10.

Ludwig Center for Cancer Genetics, Sidney Kimmel Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.

Intramedullary spinal cord tumors (IMSCTs) are rare neoplasms that have limited treatment options and are associated with high rates of morbidity and mortality. To better understand the genetic basis of these tumors we performed whole exome sequencing on 45 tumors and matched germline DNA, including twenty-nine spinal cord ependymomas and sixteen astrocytomas. Though recurrent somatic mutations in IMSCTs were rare, we identified NF2 mutations in 15.7% of tumors (ependymoma, N = 7; astrocytoma, N = 1), RP1 mutations in 5.9% of tumors (ependymoma, N = 3), and ESX1 mutations in 5.9% of tumors (ependymoma, N = 3). We further identified copy number amplifications in CTU1 in 25% of myxopapillary ependymomas. Given the paucity of somatic driver mutations, we further performed whole-genome sequencing of 12 tumors (ependymoma, N = 9; astrocytoma, N = 3). Overall, we observed that IMSCTs with intracranial histologic counterparts (e.g. glioblastoma) did not harbor the canonical mutations associated with their intracranial counterparts. Our findings suggest that the origin of IMSCTs may be distinct from tumors arising within other compartments of the central nervous system and provides the framework to begin more biologically based therapeutic strategies.
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http://dx.doi.org/10.1038/s41598-019-54286-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6904446PMC
December 2019

Patterns of Opioid and Benzodiazepine Use in Opioid-Naïve Patients with Newly Diagnosed Low Back and Lower Extremity Pain.

J Gen Intern Med 2020 01 12;35(1):291-297. Epub 2019 Nov 12.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA, USA.

Background: The morbidity and mortality associated with opioid and benzodiazepine co-prescription is a pressing national concern. Little is known about patterns of opioid and benzodiazepine use in patients with acute low back pain or lower extremity pain.

Objective: To characterize patterns of opioid and benzodiazepine prescribing among opioid-naïve, newly diagnosed low back pain (LBP) or lower extremity pain (LEP) patients and to investigate the relationship between benzodiazepine prescribing and long-term opioid use.

Design/setting: We performed a retrospective analysis of a commercial database containing claims for more than 75 million enrollees in the USA.

Participants: Participants were adult patients newly diagnosed with LBP or LEP between 2008 and 2015 who did not have a red flag diagnosis, had not received an opioid prescription in the 6 months prior to diagnosis, and had 12 months of continuous enrollment after diagnosis.

Main Outcomes And Measures: Among patients receiving at least one opioid prescription within 12 months of diagnosis, we defined discrete patterns of benzodiazepine prescribing-continued use, new use, stopped use, and never use. We tested the association of these prescription patterns with long-term opioid use, defined as six or more fills within 12 months.

Results: We identified 2,497,653 opioid-naïve patients with newly diagnosed LBP or LEP. Between 2008 and 2015, 31.9% and 11.5% of these patients received opioid and benzodiazepine prescriptions, respectively, within 12 months of diagnosis. Rates of opioid prescription decreased from 34.8% in 2008 to 27.0% in 2015 (P < 0.001); however, prescribing of benzodiazepines only decreased from 11.6% in 2008 to 10.8% in 2015. Patients with continued or new benzodiazepine use consistently used more opioids than patients who never used or stopped using benzodiazepines during the study period (one-way ANOVA, P < 0.001). For patients with continued and new benzodiazepine use, the odds ratio of long-term opioid use compared with those never prescribed a benzodiazepine was 2.99 (95% CI, 2.89-3.08) and 2.68 (95% CI, 2.62-2.75), respectively.

Limitations: This study used administrative claims analyses, which rely on accuracy and completeness of diagnostic, procedural, and prescription codes.

Conclusion: Overall opioid prescribing for low back pain or lower extremity pain decreased substantially during the study period, indicating a shift in management within the medical community. Rates of benzodiazepine prescribing, however, remained at approximately 11%. Concurrent prescriptions of benzodiazepines and opioids after LBP or LEP diagnosis were associated with increased risk of long-term opioid use.
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http://dx.doi.org/10.1007/s11606-019-05549-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6957597PMC
January 2020

Circulating Tumor DNA Analysis for Detection of Minimal Residual Disease After Chemoradiotherapy for Localized Esophageal Cancer.

Gastroenterology 2020 02 9;158(3):494-505.e6. Epub 2019 Nov 9.

Department of Radiation Oncology, Stanford University, Stanford, California; Stanford Cancer Institute, Stanford University, Stanford, California; Institute for Stem Cell Biology and Regenerative Medicine, Stanford University, Stanford, California. Electronic address:

Background & Aims: Biomarkers are needed to risk stratify after chemoradiotherapy for localized esophageal cancer. These could improve identification of patients at risk for cancer progression and selection of additional therapy.

Methods: We performed deep sequencing (CAncer Personalized Profiling by deep Sequencing, [CAPP-Seq]) analyses of plasma cell-free DNA collected from 45 patients before and after chemoradiotherapy for esophageal cancer, as well as DNA from leukocytes and fixed esophageal tumor biopsy samples collected during esophagogastroduodenoscopy. Patients were treated from May 2010 through October 2015; 23 patients subsequently underwent esophagectomy, and 22 did not undergo surgery. We also sequenced DNA from blood samples from 40 healthy control individuals. We analyzed 802 regions of 607 genes for single-nucleotide variants previously associated with esophageal adenocarcinoma or squamous cell carcinoma. Patients underwent imaging analyses 6-8 weeks after chemoradiotherapy and were followed for 5 years. Our primary aim was to determine whether detection of circulating tumor DNA (ctDNA) after chemoradiotherapy is associated with risk of tumor progression (growth of local, regional, or distant tumors, detected by imaging or biopsy).

Results: The median proportion of tumor-derived DNA in total cell-free DNA before treatment was 0.07%, indicating that ultrasensitive assays are needed for quantification and analysis of ctDNA from localized esophageal tumors. Detection of ctDNA after chemoradiotherapy was associated with tumor progression (hazard ratio, 18.7; P < .0001), formation of distant metastases (hazard ratio, 32.1; P < .0001), and shorter disease-specific survival times (hazard ratio, 23.1; P < .0001). A higher proportion of patients with tumor progression had new mutations detected in plasma samples collected after chemoradiotherapy than patients without progression (P = .03). Detection of ctDNA after chemoradiotherapy preceded radiographic evidence of tumor progression by an average of 2.8 months. Among patients who received chemoradiotherapy without surgery, combined ctDNA and metabolic imaging analysis predicted progression in 100% of patients with tumor progression, compared with 71% for only ctDNA detection and 57% for only metabolic imaging analysis (P < .001 for comparison of either technique to combined analysis).

Conclusions: In an analysis of cell-free DNA in blood samples from patients who underwent chemoradiotherapy for esophageal cancer, detection of ctDNA was associated with tumor progression, metastasis, and disease-specific survival. Analysis of ctDNA might be used to identify patients at highest risk for tumor progression.
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http://dx.doi.org/10.1053/j.gastro.2019.10.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010551PMC
February 2020

New spinal robotic technologies.

Front Med 2019 Dec 31;13(6):723-729. Epub 2019 Oct 31.

Department of Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD, 21287, USA.

Robotic systems in surgery have developed rapidly. Installations of the da Vinci Surgical System® (Intuitive Surgical, Sunnyvale, CA, USA), widely used in urological and gynecological procedures, have nearly doubled in the United States from 2010 to 2017. Robotics systems in spine surgery have been adopted more slowly; however, users are enthusiastic about their applications in this subspecialty. Spinal surgery often requires fine manipulation of vital structures that must be accessed via limited surgical corridors and can require repetitive tasks over lengthy periods of time - issues for which robotic assistance is well-positioned to complement human ability. To date, the United States Food and Drug Administration (FDA) has approved 7 robotic systems across 4 companies for use in spinal surgery. The available clinical data evaluating their efficacy have generally demonstrated these systems to be accurate and safe. A critical next step in the broader adoption of surgical robotics in spine surgery is the design and implementation of rigorous comparative studies to interrogate the utility of robotic assistance. Here we discuss current applications of robotics in spine surgery, review robotic systems FDA-approved for use in spine surgery, summarize randomized controlled trials involving robotics in spine surgery, and comment on prospects of robotic-assisted spine surgery.
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http://dx.doi.org/10.1007/s11684-019-0716-6DOI Listing
December 2019

Trends in Anterior Lumbar Interbody Fusion in the United States: A MarketScan Study From 2007 to 2014.

Clin Spine Surg 2020 06;33(5):E226-E230

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA.

Background: Although the incidence of spinal fusions has increased significantly in the United States over the last quarter century, national trends of anterior lumbar interbody fusion (ALIF) utilization are not known.

Purpose: The objective of this study was to characterize trends, clinical characteristics, risk factors associated with, and outcomes of ALIF in the United States.

Study Design: This was an epidemiological study using national administrative data from the MarketScan database.

Methods: Using a large administrative database, we identified adults who underwent ALIF in the United States from 2007 to 2014. The incidence of ALIF was studied longitudinally over time and across geographic regions in the United States. Data related to postoperative complications, length of stay, readmission, and cost were collected.

Results: We identified 49,945 patients that underwent ALIF in the United States between 2007 and 2014. The total number of ALIF procedures increased from 3650 in 2007 to 6151 in 2014, accounting for an average increase of 24.07% annually. The Southern United States performed the highest number of ALIFs. The most common conditions treated were degenerative disc disease and spondylolisthesis. Over one third of patients (34.6%) underwent multilevel fusion. The most common complications were iron deficiency anemia, urinary tract infections, and pulmonary complications. Hospital and physician pay increased significantly during the study period.

Conclusions: For the first time in our knowledge, we identified national trends in ALIF utilization, outcomes, and cost using a large administrative database. Our study reaffirms prior work that has demonstrated low rates of complications, mortality, and readmission following ALIF.

Level Of Evidence: Level III.
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http://dx.doi.org/10.1097/BSD.0000000000000904DOI Listing
June 2020

TO THE EDITOR.

Spine (Phila Pa 1976) 2019 09;44(18):E1109-E1110

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA.

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http://dx.doi.org/10.1097/BRS.0000000000003143DOI Listing
September 2019

Laminectomy Versus Corpectomy for Spinal Metastatic Disease-Complications, Costs, and Quality Outcomes.

World Neurosurg 2019 Nov 9;131:e468-e473. Epub 2019 Aug 9.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, California, USA. Electronic address:

Background: The landmark Patchell trial established surgical decompression followed by adjuvant radiotherapy as standard-of-care for patients with spinal cord compression caused by metastatic cancer. However, little comparative evidence exists with regard to the choice of specific surgical approaches for these patients. We sought to conduct a comparative analysis of outcomes of surgical options for spinal metastatic disease.

Methods: This was an epidemiologic study using national administrative data from the MarketScan database. We queried the MarketScan database (2007-2016), identifying patients with a diagnosis of spinal metastasis treated with surgical decompression (N = 1054). We used descriptive statistics and hypothesis testing to compare baseline characteristics, complications, quality metrics, and costs.

Results: We identified patients with spinal metastases undergoing laminectomy (N = 760), corpectomy (N = 193), or both combined procedures (laminectomy and corpectomy, N = 101). No significant differences in baseline demographics, follow-up time, or primary tumor histology were observed. We found a greater 30-day postoperative complication rate among patients undergoing corpectomy (P < 0.0001), driven by increased rate of postoperative anemia and pulmonary complications. Length of stay and 30-day readmission rates did not vary between surgical approaches. Total index hospitalization and 30-day payments were greatest among patients undergoing combined procedures and lowest for patients undergoing laminectomy alone.

Conclusions: Our findings highlight distinct complication profiles and quality outcomes associated with selection of surgical approach for patients with spinal metastases. These findings must be interpreted with a clear understanding of the limitations.
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http://dx.doi.org/10.1016/j.wneu.2019.07.206DOI Listing
November 2019

A Descriptive Analysis of Spinal Cord Arteriovenous Malformations: Clinical Features, Outcomes, and Trends in Management.

World Neurosurg 2019 Nov 9;131:e579-e585. Epub 2019 Aug 9.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, California, USA. Electronic address:

Background: Spinal arteriovenous malformations (AVM) are an abnormal interconnection of vasculature in the spine than can lead to significant neurologic deficit if left untreated.

Objective: The objective of this study was to characterize how patients with spinal AVM initially presented, what treatment options were used, and their overall outcomes on a national scale.

Methods: The MarketScan database was queried to identify adult patients diagnosed with a spinal AVM from 2007 to 2015. Trends in management, postoperative complication rates, and costs were determined.

Results: In total, 976 patients were identified with having a diagnosis of a spinal AVM. Patients were more commonly treated with an open incision than an embolization (40.1% vs. 15.4%). The overall complication rate was 33.61%. Spinal AVM admissions have been stable over the past decade, and mean cost of hospitalization has risen from of $48,700 in 2007 to $71,292 in 2015. Patients who underwent open surgery had a greater complication rate than those treated with embolization (31.15% vs. 18.25%, P < 0.005); however, this may be strongly influenced by complexity of spinal AVM pathology and not treatment modality.

Conclusions: Costs of spinal AVM management continue to rise, even when treatment modalities have reduced length of stay significantly. Open surgery may lead to more postoperative complications and a greater length of stay than endovascular approaches. Further studies should look to identify the efficacy of endovascular approaches for spinal cord AVMs, particularly in complex spinal AVM traditionally treated with open surgery and to isolate factors leading to the elevated hospitalization costs.
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http://dx.doi.org/10.1016/j.wneu.2019.08.010DOI Listing
November 2019

Molecular foundations of primary spinal tumors-implications for surgical management.

Ann Transl Med 2019 May;7(10):222

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Primary spinal tumors are rare lesions that require careful clinical management due to their intimate relationship with critical neurovascular structures and the significant associated risk of morbidity. While the advent of molecular and genomic profiling is beginning to impact the management of the cranial counterparts, translation for spinal tumors has lagged behind. Maximal safe surgical resection remains the mainstay of patients with primary spinal tumors, with extent of resection and histology the only consistently identified independent predictors of survival. Adjuvant therapy has had limited impact. To develop targeted neoadjuvant and adjuvant therapies, improve prognostication, and enhance patient selection in spinal oncology, a thorough understanding of the current molecular and genomic landscape of spinal tumors is required. In this review, we detail the epidemiology, current standard-of-care, and molecular features of the most commonly encountered intramedullary spinal cord tumors (IMSCT), intradural extramedullary (IDEM) tumors, and primary spinal column malignancies (PSCM). We further discuss current efforts and future opportunities for integrating molecular advances in spinal oncology with clinical management.
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http://dx.doi.org/10.21037/atm.2019.04.46DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6595199PMC
May 2019
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