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Catherine Miller and Daniel Guillaume

OBJECT

External ventricular drains (EVDs) are regularly used in pediatric neurosurgery for diagnostic and therapeutic purposes. Hemorrhage caused by placing an EVD is a common complication noted in the adult literature. In the pediatric literature, on the other hand, only a few articles have assessed the risk of hemorrhage with placement, and none have reported the occurrence of hemorrhage with removal of an EVD. The authors investigated the incidence of hemorrhage with both placement and removal of the EVD in a pediatric population.

METHODS

After obtaining institutional review board approval, a comprehensive database was created to include all pediatric patients who required EVD placement between March 2008 and June 2014 at the authors’ institution. A retrospective chart review was completed, and all imaging was reviewed for evidence of hemorrhage with placement and removal of the EVD.

RESULTS

During the designated time period, 73 EVDs were placed in 63 patients (ages 2 weeks–17 years). Indications for EVD placement were as follows: shunt infection/malfunction (21), tumor (12), hydrocephalus (18), hemorrhage (12), edema (4), trauma (1), and other (5). Hemorrhage with placement was noted in 5 of the 50 patients who underwent imaging, with a volume ranging from 0.48 cm3 to 7.7 cm3. Thirty-two patients had imaging after EVD removal, and 7 of these patients were noted to have hemorrhage (volume range 0.012 cm3 to 81.5 cm3).

CONCLUSIONS

The authors found the incidence of hemorrhage at EVD placement to be 10%, and the incidence of hemorrhage on EVD removal to be 21.9% in those patients who underwent imaging after each event. Although none of the hemorrhages were of obvious clinical significance, these data can be useful in decision making, and in discussing the risks of EVDs with the patient’s family.

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Catherine Miller, Daniel Guillaume, Kathryn Dusenbery, H. Brent Clark and Christopher Moertel

Brain tumors are the most common solid tumor in childhood, and astrocytomas account for the largest proportion of these tumors. Increasing sophistication in genetic testing has allowed for the detection of specific mutations within tumor subtypes that may represent targets for individualized tumor treatment. The mitogen-activating protein kinase (MAPK) pathway and, more specifically, BRAF mutations have been shown to be prevalent in pediatric pilocytic astrocytomas and may represent one such area to target. Herein, the authors describe 2 cases of inoperable, chemotherapy-resistant pediatric pilocytic astrocytomas with a documented response to trametinib, an MAPK pathway inhibitor. While these cases were not treated in the setting of a clinical trial, their data support further ongoing clinical trial investigation to evaluate the safety and efficacy of this agent in pediatric low-grade gliomas.

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Charles A. Miller, Jason H. Boulter, Daniel J. Coughlin, Michael K. Rosner, Chris J. Neal and Michael S. Dirks

OBJECTIVE

Symptomatic cervical spondylosis with or without radiculopathy can ground an active-duty military pilot if left untreated. Surgically treated cervical spondylosis may be a waiverable condition and allow return to flying status, but a waiver is based on expert opinion and not on recent published data. Previous studies on rates of return to active duty status following anterior cervical spine surgery have not differentiated these rates among military specialty occupations. No studies to date have documented the successful return of US military active-duty pilots who have undergone anterior cervical spine surgery with cervical fusion, disc replacement, or a combination of the two. The aim of this study was to identify the rate of return to an active duty flight status among US military pilots who had undergone anterior cervical discectomy and fusion (ACDF) or total disc replacement (TDR) for symptomatic cervical spondylosis.

METHODS

The authors performed a single-center retrospective review of all active duty pilots who had undergone either ACDF or TDR at a military hospital between January 2010 and June 2017. Descriptive statistics were calculated for both groups to evaluate demographics with specific attention to preoperative flight stats, days to recommended clearance by neurosurgery, and days to return to active duty flight status.

RESULTS

Authors identified a total of 812 cases of anterior cervical surgery performed between January 1, 2010, and June 1, 2017, among active duty, reserves, dependents, and Department of Defense/Veterans Affairs patients. There were 581 ACDFs and 231 TDRs. After screening for military occupation and active duty status, there were a total of 22 active duty pilots, among whom were 4 ACDFs, 17 TDRs, and 2 hybrid constructs. One patient required a second surgery. Six (27.3%) of the 22 pilots were nearing the end of their career and electively retired within a year of surgery. Of the remaining 16 pilots, 11 (68.8%) returned to active duty flying status. The average time to be released by the neurosurgeon was 128 days, and the time to return to flying was 287 days. The average follow-up period was 12.3 months.

CONCLUSIONS

Adhering to military service-specific waiver guidelines, military pilots may return to active duty flight status after undergoing ACDF or TDR for symptomatic cervical spondylosis.

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Matthew D. Alvin, Jacob A. Miller, Daniel Lubelski, Benjamin P. Rosenbaum, Kalil G. Abdullah, Robert G. Whitmore, Edward C. Benzel and Thomas E. Mroz

Object

Cost-effectiveness research in spine surgery has been a prominent focus over the last decade. However, there has yet to be a standardized method developed for calculation of costs in such studies. This lack of a standardized costing methodology may lead to conflicting conclusions on the cost-effectiveness of an intervention for a specific diagnosis. The primary objective of this study was to systematically review all cost-effectiveness studies published on spine surgery and compare and contrast various costing methodologies used.

Methods

The authors performed a systematic review of the cost-effectiveness literature related to spine surgery. All cost-effectiveness analyses pertaining to spine surgery were identified using the cost-effectiveness analysis registry database of the Tufts Medical Center Institute for Clinical Research and Health Policy, and the MEDLINE database. Each article was reviewed to determine the study subject, methodology, and results. Data were collected from each study, including costs, interventions, cost calculation method, perspective of cost calculation, and definitions of direct and indirect costs if available.

Results

Thirty-seven cost-effectiveness studies on spine surgery were included in the present study. Twenty-seven (73%) of the studies involved the lumbar spine and the remaining 10 (27%) involved the cervical spine. Of the 37 studies, 13 (35%) used Medicare reimbursements, 12 (32%) used a case-costing database, 3 (8%) used cost-to-charge ratios (CCRs), 2 (5%) used a combination of Medicare reimbursements and CCRs, 3 (8%) used the United Kingdom National Health Service reimbursement system, 2 (5%) used a Dutch reimbursement system, 1 (3%) used the United Kingdom Department of Health data, and 1 (3%) used the Tricare Military Reimbursement system. Nineteen (51%) studies completed their cost analysis from the societal perspective, 11 (30%) from the hospital perspective, and 7 (19%) from the payer perspective. Of those studies with a societal perspective, 14 (38%) reported actual indirect costs.

Conclusions

Changes in cost have a direct impact on the value equation for concluding whether an intervention is cost-effective. It is essential to develop a standardized, accurate means of calculating costs. Comparability and transparency are essential, such that studies can be compared properly and policy makers can be appropriately informed when making decisions for our health care system based on the results of these studies.

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Roy Xiao, Jacob A. Miller, Navin C. Sabharwal, Daniel Lubelski, Vincent J. Alentado, Andrew T. Healy, Thomas E. Mroz and Edward C. Benzel

OBJECTIVE

Improvements in imaging technology have steadily advanced surgical approaches. Within the field of spine surgery, assistance from the O-arm Multidimensional Surgical Imaging System has been established to yield superior accuracy of pedicle screw insertion compared with freehand and fluoroscopic approaches. Despite this evidence, no studies have investigated the clinical relevance associated with increased accuracy. Accordingly, the objective of this study was to investigate the clinical outcomes following thoracolumbar spinal fusion associated with O-arm–assisted navigation. The authors hypothesized that increased accuracy achieved with O-arm–assisted navigation decreases the rate of reoperation secondary to reduced hardware failure and screw misplacement.

METHODS

A consecutive retrospective review of all patients who underwent open thoracolumbar spinal fusion at a single tertiary-care institution between December 2012 and December 2014 was conducted. Outcomes assessed included operative time, length of hospital stay, and rates of readmission and reoperation. Mixed-effects Cox proportional hazards modeling, with surgeon as a random effect, was used to investigate the association between O-arm–assisted navigation and postoperative outcomes.

RESULTS

Among 1208 procedures, 614 were performed with O-arm–assisted navigation, 356 using freehand techniques, and 238 using fluoroscopic guidance. The most common indication for surgery was spondylolisthesis (56.2%), and most patients underwent a posterolateral fusion only (59.4%). Although O-arm procedures involved more vertebral levels compared with the combined freehand/fluoroscopy cohort (4.79 vs 4.26 vertebral levels; p < 0.01), no significant differences in operative time were observed (4.40 vs 4.30 hours; p = 0.38). Patients who underwent an O-arm procedure experienced shorter hospital stays (4.72 vs 5.43 days; p < 0.01). O-arm–assisted navigation trended toward predicting decreased risk of spine-related readmission (0.8% vs 2.2%, risk ratio [RR] 0.37; p = 0.05) and overall readmissions (4.9% vs 7.4%, RR 0.66; p = 0.07). The O-arm was significantly associated with decreased risk of reoperation for hardware failure (2.9% vs 5.9%, RR 0.50; p = 0.01), screw misplacement (1.6% vs 4.2%, RR 0.39; p < 0.01), and all-cause reoperation (5.2% vs 10.9%, RR 0.48; p < 0.01). Mixed-effects Cox proportional hazards modeling revealed that O-arm–assisted navigation was a significant predictor of decreased risk of reoperation (HR 0.49; p < 0.01). The protective effect of O-arm–assisted navigation against reoperation was durable in subset analysis of procedures involving < 5 vertebral levels (HR 0.44; p = 0.01) and ≥ 5 levels (HR 0.48; p = 0.03). Further subset analysis demonstrated that O-arm–assisted navigation predicted decreased risk of reoperation among patients undergoing posterolateral fusion only (HR 0.39; p < 0.01) and anterior lumbar interbody fusion (HR 0.22; p = 0.03), but not posterior/transforaminal lumbar interbody fusion.

CONCLUSIONS

To the authors' knowledge, the present study is the first to investigate clinical outcomes associated with O-arm–assisted navigation following thoracolumbar spinal fusion. O-arm–assisted navigation decreased the risk of reoperation to less than half the risk associated with freehand and fluoroscopic approaches. Future randomized controlled trials to corroborate the findings of the present study are warranted.

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Rafael De la Garza Ramos, C. Rory Goodwin, Nancy Abu-Bonsrah, Amit Jain, Emily K. Miller, Nicole Huang, Khaled M. Kebaish, Paul D. Sponseller and Daniel M. Sciubba

OBJECTIVE

The aim of this study was to investigate the incidence of and factors associated with complications following idiopathic scoliosis surgery in adolescents.

METHODS

The Nationwide Inpatient Sample database was used to identify patients 10–18 years of age who had undergone spinal fusion for adolescent idiopathic scoliosis (AIS) from 2002 to 2011. Twenty-three unique in-hospital postoperative complications, including death, were examined. A series of logistic regressions was used to determine if any demographic, comorbid, or surgical parameter was associated with complication development. Results of multiple logistic regression analyses were reported as odds ratios with 95% confidence intervals. All analyses were performed after the application of discharge weights to produce national estimates.

RESULTS

A total of 36,335 patients met the study inclusion criteria, 7.6% of whom (95% CI 6.3%–8.9%) developed at least one in-hospital complication. The 3 most common complications were respiratory failure (3.47%), reintubation (1.27%), and implant related (1.14%). Major complications such as death, pancreatitis, disseminated intravascular coagulation, visual loss, spinal cord injury, cardiac arrest, sepsis, nerve root injury, deep vein thrombosis, pulmonary embolism, shock, malignant hyperthermia, myocardial infarction, and iatrogenic stroke each had an incidence ≤ 0.2%. On multiple logistic regression analysis, an increasing age (OR 0.80) was associated with significantly lower odds of complication development; patients who were male (OR 1.80) or who had anemia (OR 2.10), hypertension (OR 2.51), or hypothyroidism (OR 2.27) or underwent revision procedures (OR 5.55) were at a significantly increased risk for complication development. The rates of postoperative complications for posterior, anterior, and combined approaches were 6.7%, 10.0%, and 19.8%, respectively (p < 0.001). Length of fusion (< 8 vs ≥ 8 levels) was not associated with complication development (p = 0.311).

CONCLUSIONS

Analysis of 36,335 patients who had undergone surgery for AIS revealed that younger patients, male patients, patients with a history of anemia, hypertension, or hypothyroidism, as well as those undergoing revision or anterior or combined approaches may have higher rates of postoperative complications. However, the overall complication rate was low (7.6%), and major complications had a rate ≤ 0.2% for each event. These findings suggest that surgery for AIS remains relatively safe, and future prospective investigations may further help to decrease the postoperative morbidity rate.

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Vejay N. Vakharia, Rachel Sparks, Roman Rodionov, Sjoerd B. Vos, Christian Dorfer, Jonathan Miller, Daniel Nilsson, Martin Tisdall, Stefan Wolfsberger, Andrew W. McEvoy, Anna Miserocchi, Gavin P. Winston, Aidan G. O’Keeffe, Sebastien Ourselin and John S. Duncan

OBJECTIVE

One-third of cases of focal epilepsy are drug refractory, and surgery might provide a cure. Seizure-free outcome after surgery depends on the correct identification and resection of the epileptogenic zone. In patients with no visible abnormality on MRI, or in cases in which presurgical evaluation yields discordant data, invasive stereoelectroencephalography (SEEG) recordings might be necessary. SEEG is a procedure in which multiple electrodes are placed stereotactically in key targets within the brain to record interictal and ictal electrophysiological activity. Correlating this activity with seizure semiology enables identification of the seizure-onset zone and key structures within the ictal network. The main risk related to electrode placement is hemorrhage, which occurs in 1% of patients who undergo the procedure. Planning safe electrode placement for SEEG requires meticulous adherence to the following: 1) maximize the distance from cerebral vasculature, 2) avoid crossing sulcal pial boundaries (sulci), 3) maximize gray matter sampling, 4) minimize electrode length, 5) drill at an angle orthogonal to the skull, and 6) avoid critical neurological structures. The authors provide a validation of surgical strategizing and planning with EpiNav, a multimodal platform that enables automated computer-assisted planning (CAP) for electrode placement with user-defined regions of interest.

METHODS

Thirteen consecutive patients who underwent implantation of a total 116 electrodes over a 15-month period were studied retrospectively. Models of the cortex, gray matter, and sulci were generated from patient-specific whole-brain parcellation, and vascular segmentation was performed on the basis of preoperative MR venography. Then, the multidisciplinary implantation strategy and precise trajectory planning were reconstructed using CAP and compared with the implemented manually determined plans. Paired results for safety metric comparisons were available for 104 electrodes. External validity of the suitability and safety of electrode entry points, trajectories, and target-point feasibility was sought from 5 independent, blinded experts from outside institutions.

RESULTS

CAP-generated electrode trajectories resulted in a statistically significant improvement in electrode length, drilling angle, gray matter–sampling ratio, minimum distance from segmented vasculature, and risk (p < 0.05). The blinded external raters had various opinions of trajectory feasibility that were not statistically significant, and they considered a mean of 69.4% of manually determined trajectories and 62.2% of CAP-generated trajectories feasible; 19.4% of the CAP-generated electrode-placement plans were deemed feasible when the manually determined plans were not, whereas 26.5% of the manually determined electrode-placement plans were rated feasible when CAP-determined plans were not (no significant difference).

CONCLUSIONS

CAP generates clinically feasible electrode-placement plans and results in statistically improved safety metrics. CAP is a useful tool for automating the placement of electrodes for SEEG; however, it requires the operating surgeon to review the results before implantation, because only 62% of electrode-placement plans were rated feasible, compared with 69% of the manually determined placement plans, mainly because of proximity of the electrodes to unsegmented vasculature. Improved vascular segmentation and sulcal modeling could lead to further improvements in the feasibility of CAP-generated trajectories.

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Emily K. Miller, Brian J. Neuman, Amit Jain, Alan H. Daniels, Tamir Ailon, Daniel M. Sciubba, Khaled M. Kebaish, Virginie Lafage, Justin K. Scheer, Justin S. Smith, Shay Bess, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

The goal of this study was to analyze the value of an adult spinal deformity frailty index (ASD-FI) in preoperative risk stratification. Preoperative risk assessment is imperative before procedures known to have high complication rates, such as ASD surgery. Frailty has been associated with risk of complications in trauma surgery, and preoperative frailty assessments could improve the accuracy of risk stratification by providing a comprehensive analysis of patient factors that contribute to an increased risk of complications.

METHODS

Using 40 variables, the authors calculated frailty scores with a validated method for 417 patients (enrolled between 2010 and 2014) with a minimum 2-year follow-up in an ASD database. On the basis of these scores, the authors categorized patients as not frail (NF) (< 0.3 points), frail (0.3–0.5 points), or severely frail (SF) (> 0.5 points). The correlation between frailty category and incidence of complications was analyzed.

RESULTS

The overall mean ASD-FI score was 0.33 (range 0.0–0.8). Compared with NF patients (n = 183), frail patients (n = 158) and SF patients (n = 109) had longer mean hospital stays (1.2 and 1.6 times longer, respectively; p < 0.001). The adjusted odds of experiencing a major intraoperative or postoperative complication were higher for frail patients (OR 2.8) and SF patients ( 4.1) compared with NF patients (p < 0.01). For frail and SF patients, respectively, the adjusted odds of developing proximal junctional kyphosis (OR 2.8 and 3.1) were higher than those for NF patients. The SF patients had higher odds of developing pseudarthrosis (OR 13.0), deep wound infection (OR 8.0), and wound dehiscence (OR 13.4) than NF patients (p < 0.05), and they had 2.1 times greater odds of reoperation (p < 0.05).

CONCLUSIONS

Greater patient frailty, as measured by the ASD-FI, was associated with worse outcome in many common quality and value metrics, including greater risk of major complications, proximal junctional kyphosis, pseudarthrosis, deep wound infection, wound dehiscence, reoperation, and longer hospital stay.

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Micheal Raad, Brian J. Neuman, Amit Jain, Hamid Hassanzadeh, Peter G. Passias, Eric Klineberg, Gregory M. Mundis Jr., Themistocles S. Protopsaltis, Emily K. Miller, Justin S. Smith, Virginie Lafage, D. Kojo Hamilton, Shay Bess, Khaled M. Kebaish, Daniel M. Sciubba and the International Spine Study Group

OBJECTIVE

Given the recent shift in health care toward quality reporting requirements and a greater emphasis on a cost-quality approach, patient stratification with respect to long-term outcomes and the use of health care resources is of increasing value. Stratification tools may be effective if they are simple and evidence based. The authors hypothesize that preoperative patient-reported activity levels might independently predict postoperative outcomes in patients with adult spinal deformity.

METHODS

This is a retrospective cohort. A total of 575 patients in a prospective adult spinal deformity surgical database were identified with complete data regarding the preoperative level of activity. Answers to question 5 of the Scoliosis Research Society-22r Patient Questionnaire (SRS-22r) were used to stratify patients into active and inactive groups. Outcomes were length of hospital stay (LOS), level of activity, and reaching the minimum clinically important difference (MCID) for SRS-22r domains and the Physical Component Summary (PCS) of the SF-36 at 2 years postoperatively. The 2 groups were compared with respect to several potential confounders. Covariates with p < 0.1 were controlled for. The impact of activity on LOS was assessed using multivariate negative binomial regression analysis. Multivariate logistic regression models additionally controlling for the respective baseline health-related quality of life (HRQOL) scores were used to assess the association between preoperative activity levels and reaching the MCID at 2 years postoperatively.

RESULTS

A total of 420 (73%) of the 575 patients who met the inclusion criteria had complete data at 2 years postoperatively. The inactive group was more likely to be significantly older, have a higher Charlson Comorbidity Index, worse baseline radiographic deformity, and greater correction of most radiographic parameters. After controlling for possible confounders, the active group had a significantly shorter LOS (incidence risk ratio 0.91, p = 0.043). After adding respective baseline HRQOL scores to the models, active patients were significantly more likely to reach the MCID for the SRS-22r pain domain (OR 1.72, p = 0.026) and PCS (OR 1.94, p = 0.013). Active patients were also significantly more likely to be active at 2 years postoperatively on multivariate analysis (OR 8.94, p < 0.001).

CONCLUSIONS

The authors’ results show that patients who belong to the inactive group are likely to have a longer LOS and lower odds of reaching the MCID in HRQOL or being active at 2 years postoperatively. Inquiring about patients’ preoperative activity levels might be a reliable and simple stratification tool in terms of long- and short-term outcomes in ASD patients.

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Vejay N. Vakharia, Rachel Sparks, Roman Rodionov, Sjoerd B. Vos, Christian Dorfer, Jonathan Miller, Daniel Nilsson, Martin Tisdall, Stefan Wolfsberger, Andrew W. McEvoy, Anna Miserocchi, Gavin P. Winston, Aidan G. O’Keeffe, Sebastien Ourselin and John S. Duncan

OBJECTIVE

One-third of cases of focal epilepsy are drug refractory, and surgery might provide a cure. Seizure-free outcome after surgery depends on the correct identification and resection of the epileptogenic zone. In patients with no visible abnormality on MRI, or in cases in which presurgical evaluation yields discordant data, invasive stereoelectroencephalography (SEEG) recordings might be necessary. SEEG is a procedure in which multiple electrodes are placed stereotactically in key targets within the brain to record interictal and ictal electrophysiological activity. Correlating this activity with seizure semiology enables identification of the seizure-onset zone and key structures within the ictal network. The main risk related to electrode placement is hemorrhage, which occurs in 1% of patients who undergo the procedure. Planning safe electrode placement for SEEG requires meticulous adherence to the following: 1) maximize the distance from cerebral vasculature, 2) avoid crossing sulcal pial boundaries (sulci), 3) maximize gray matter sampling, 4) minimize electrode length, 5) drill at an angle orthogonal to the skull, and 6) avoid critical neurological structures. The authors provide a validation of surgical strategizing and planning with EpiNav, a multimodal platform that enables automated computer-assisted planning (CAP) for electrode placement with user-defined regions of interest.

METHODS

Thirteen consecutive patients who underwent implantation of a total 116 electrodes over a 15-month period were studied retrospectively. Models of the cortex, gray matter, and sulci were generated from patient-specific whole-brain parcellation, and vascular segmentation was performed on the basis of preoperative MR venography. Then, the multidisciplinary implantation strategy and precise trajectory planning were reconstructed using CAP and compared with the implemented manually determined plans. Paired results for safety metric comparisons were available for 104 electrodes. External validity of the suitability and safety of electrode entry points, trajectories, and target-point feasibility was sought from 5 independent, blinded experts from outside institutions.

RESULTS

CAP-generated electrode trajectories resulted in a statistically significant improvement in electrode length, drilling angle, gray matter–sampling ratio, minimum distance from segmented vasculature, and risk (p < 0.05). The blinded external raters had various opinions of trajectory feasibility that were not statistically significant, and they considered a mean of 69.4% of manually determined trajectories and 62.2% of CAP-generated trajectories feasible; 19.4% of the CAP-generated electrode-placement plans were deemed feasible when the manually determined plans were not, whereas 26.5% of the manually determined electrode-placement plans were rated feasible when CAP-determined plans were not (no significant difference).

CONCLUSIONS

CAP generates clinically feasible electrode-placement plans and results in statistically improved safety metrics. CAP is a useful tool for automating the placement of electrodes for SEEG; however, it requires the operating surgeon to review the results before implantation, because only 62% of electrode-placement plans were rated feasible, compared with 69% of the manually determined placement plans, mainly because of proximity of the electrodes to unsegmented vasculature. Improved vascular segmentation and sulcal modeling could lead to further improvements in the feasibility of CAP-generated trajectories.