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R. Lewis Wright and John F. Burke

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Anthony T. Lee, John F. Burke, Pranathi Chunduru, Annette M. Molinaro, Robert Knowlton and Edward F. Chang

OBJECTIVE

Recent trials for temporal lobe epilepsy (TLE) highlight the challenges of investigating surgical outcomes using randomized controlled trials (RCTs). Although several reviews have examined seizure-freedom outcomes from existing data, there is a need for an overall seizure-freedom rate estimated from level I data as investigators consider other methods besides RCTs to study outcomes related to new surgical interventions.

METHODS

The authors performed a systematic review and meta-analysis of the 3 RCTs of TLE in adults and report an overall surgical seizure-freedom rate (Engel class I) composed of level I data. An overall seizure-freedom rate was also collected from level II data (prospective cohort studies) for validation. Eligible studies were identified by filtering a published Cochrane meta-analysis of epilepsy surgery for RCTs and prospective studies, and supplemented by searching indexed terms in MEDLINE (January 1, 2012–April 1, 2018). Retrospective studies were excluded to minimize heterogeneity in patient selection and reporting bias. Data extraction was independently reverified and pooled using a fixed-effects model. The primary outcome was overall seizure freedom following surgery. The historical benchmark was applied in a noninferiority study design to compare its power to a single-study cohort.

RESULTS

The overall rate of seizure freedom from level I data was 72.4% (55/76 patients, 3 RCTs), which was nearly identical to the overall seizure-freedom rate of 71.7% (1325/1849 patients, 18 studies) from prospective cohorts (z = 0.134, p = 0.89; z-test). Seizure-freedom rates from level I and II studies were consistent over the years of publication (R2 < 0.01, p = 0.73). Surgery resulted in markedly improved seizure-free outcomes compared to medical management (RR 10.82, 95% CI 3.93–29.84, p < 0.01; 2 RCTs). Noninferiority study designs in which the historical benchmark was used had significantly higher power at all difference margins compared to using a single cohort alone (p < 0.001, Bonferroni’s multiple comparison test).

CONCLUSIONS

The overall rate of seizure freedom for temporal lobe surgery is approximately 70% for medically refractory epilepsy. The small sample size of the RCT cohort underscores the need to move beyond standard RCTs for epilepsy surgery. This historical seizure-freedom rate may serve as a useful benchmark to guide future study designs for new surgical treatments for refractory TLE.

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John F. Burke, Jayesh P. Thawani, Ian Berger, Nikhil R. Nayak, James H. Stephen, Tunde Farkas, Hovik John Aschyan, John Pierce, Suhail Kanchwala, Donlin M. Long and William C. Welch

OBJECTIVE

Tarlov cysts (TCs) occur most commonly on extradural components of the sacral and coccygeal nerve roots. These lesions are often found incidentally, with an estimated prevalence of 4%–9%. Given the low estimated rates of symptomatic TC and the fact that symptoms can overlap with other common causes of low-back pain, optimal management of this entity is a matter of ongoing debate. Here, the authors investigate the effects of surgical intervention on symptomatic TCs and aim to solidify the surgical criteria for this disease process.

METHODS

The authors performed a retrospective review of data from consecutive patients who were surgically treated for symptomatic TCs from September 2011 to March 2013. Clinical evaluations and results from surveying pain and overall health were used. Univariate statistical analyses were performed.

RESULTS

Twenty-three adults (4 males, 19 females) who had been symptomatic for a mean of 47.4 months were treated with laminectomy, microsurgical exposure and/or imbrication, and paraspinous muscle flap closure. Eighteen patients (78.3%) had undergone prior interventions without sustained improvement. Thirteen patients (56.5%) underwent lumbar drainage for an average of 8.7 days following surgery. The mean follow-up was 14.4 months. Univariate analyses demonstrated that an advanced age (p = 0.045), the number of noted perineural cysts on preoperative imaging (p = 0.02), and the duration of preoperative symptoms (p = 0.03) were associated with a poor postoperative outcome. Although 47.8% of the patients were able to return to normal activities, 93.8% of those surveyed reported that they would undergo the operation again if given the choice.

CONCLUSIONS

This is one of the largest published studies on patients with TCs treated microsurgically. The data suggest that patients with symptomatic TCs may benefit from open microsurgical treatment. Although outcomes seem related to patient age, duration of symptoms, and extent of disease demonstrated on imaging, further study is warranted and underway.

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Ethan A. Winkler, John K. Yue, John F. Burke, Andrew K. Chan, Sanjay S. Dhall, Mitchel S. Berger, Geoffrey T. Manley and Phiroz E. Tarapore

OBJECTIVE

Sports-related traumatic brain injury (TBI) is an important public health concern estimated to affect 300,000 to 3.8 million people annually in the United States. Although injuries to professional athletes dominate the media, this group represents only a small proportion of the overall population. Here, the authors characterize the demographics of sports-related TBI in adults from a community-based trauma population and identify predictors of prolonged hospitalization and increased morbidity and mortality rates.

METHODS

Utilizing the National Sample Program of the National Trauma Data Bank (NTDB), the authors retrospectively analyzed sports-related TBI data from adults (age ≥ 18 years) across 5 sporting categories—fall or interpersonal contact (FIC), roller sports, skiing/snowboarding, equestrian sports, and aquatic sports. Multivariable regression analysis was used to identify predictors of prolonged hospital length of stay (LOS), medical complications, inpatient mortality rates, and hospital discharge disposition. Statistical significance was assessed at α < 0.05, and the Bonferroni correction for multiple comparisons was applied for each outcome analysis.

RESULTS

From 2003 to 2012, in total, 4788 adult sports-related TBIs were documented in the NTDB, which represented 18,310 incidents nationally. Equestrian sports were the greatest contributors to sports-related TBI (45.2%). Mild TBI represented nearly 86% of injuries overall. Mean (± SEM) LOSs in the hospital or intensive care unit (ICU) were 4.25 ± 0.09 days and 1.60 ± 0.06 days, respectively. The mortality rate was 3.0% across all patients, but was statistically higher in TBI from roller sports (4.1%) and aquatic sports (7.7%). Age, hypotension on admission to the emergency department (ED), and the severity of head and extracranial injuries were statistically significant predictors of prolonged hospital and ICU LOSs, medical complications, failure to discharge to home, and death. Traumatic brain injury during aquatic sports was similarly associated with prolonged ICU and hospital LOSs, medical complications, and failure to be discharged to home.

CONCLUSIONS

Age, hypotension on ED admission, severity of head and extracranial injuries, and sports mechanism of injury are important prognostic variables in adult sports-related TBI. Increasing TBI awareness and helmet use—particularly in equestrian and roller sports—are critical elements for decreasing sports-related TBI events in adults.

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John K. Yue, Ethan A. Winkler, John F. Burke, Andrew K. Chan, Sanjay S. Dhall, Mitchel S. Berger, Geoffrey T. Manley and Phiroz E. Tarapore

OBJECTIVE

Traumatic brain injury (TBI) in children is a significant public health concern estimated to result in over 500,000 emergency department (ED) visits and more than 60,000 hospitalizations in the United States annually. Sports activities are one important mechanism leading to pediatric TBI. In this study, the authors characterize the demographics of sports-related TBI in the pediatric population and identify predictors of prolonged hospitalization and of increased morbidity and mortality rates.

METHODS

Utilizing the National Sample Program of the National Trauma Data Bank (NTDB), the authors retrospectively analyzed sports-related TBI data from children (age 0–17 years) across 5 sports categories: fall or interpersonal contact (FIC), roller sports, skiing/snowboarding, equestrian sports, and aquatic sports. Multivariable regression analysis was used to identify predictors of prolonged length of stay (LOS) in the hospital or intensive care unit (ICU), medical complications, inpatient mortality rates, and hospital discharge disposition. Statistical significance was assessed at α < 0.05, and the Bonferroni correction (set at significance threshold p = 0.01) for multiple comparisons was applied in each outcome analysis.

RESULTS

From 2003 to 2012, in total 3046 pediatric sports-related TBIs were recorded in the NTDB, and these injuries represented 11,614 incidents nationally after sample weighting. Fall or interpersonal contact events were the greatest contributors to sports-related TBI (47.4%). Mild TBI represented 87.1% of the injuries overall. Mean (± SEM) LOSs in the hospital and ICU were 2.68 ± 0.07 days and 2.73 ± 0.12 days, respectively. The overall mortality rate was 0.8%, and the prevalence of medical complications was 2.1% across all patients. Severities of head and extracranial injuries were significant predictors of prolonged hospital and ICU LOSs, medical complications, failure to discharge to home, and death. Hypotension on admission to the ED was a significant predictor of failure to discharge to home (OR 0.05, 95% CI 0.03–0.07, p < 0.001). Traumatic brain injury incurred during roller sports was independently associated with prolonged hospital LOS compared with FIC events (mean increase 0.54 ± 0.15 days, p < 0.001).

CONCLUSIONS

In pediatric sports-related TBI, the severities of head and extracranial traumas are important predictors of patients developing acute medical complications, prolonged hospital and ICU LOSs, in-hospital mortality rates, and failure to discharge to home. Acute hypotension after a TBI event decreases the probability of successful discharge to home. Increasing TBI awareness and use of head-protective gear, particularly in high-velocity sports in older age groups, is necessary to prevent pediatric sports-related TBI or to improve outcomes after a TBI.

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John F. Burke, Andrew K. Chan, Rory R. Mayer, Joseph H. Garcia, Brenton Pennicooke, Michael Mann, Sigurd H. Berven, Dean Chou and Praveen V. Mummaneni

The clamshell thoracotomy is often used to access both hemithoraxes and the mediastinum simultaneously for cardiothoracic pathology, but this technique is rarely used for the excision of spinal tumors. We describe the use of a clamshell thoracotomy for en bloc excision of a 3-level upper thoracic chordoma in a 20-year-old patient. The lesion involved T2, T3, and T4, and it invaded both chest cavities and indented the mediastinum. After 2 biopsies to confirm the diagnosis, the patient underwent a posterior spinal fusion followed by bilateral clamshell thoracotomy for 3-level en bloc resection with simultaneous access to both chest cavities and the mediastinum. To demonstrate how the clamshell thoracotomy was used to facilitate the tumor resection, an operative video and illustrations are provided, which show in detail how the clamshell thoracotomy can be used to access both hemithoraxes and the mediastinum.

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Praveen V. Mummaneni, John F. Burke, Andrew K. Chan, Julie Ann Sosa, Errol P. Lobo, Valli P. Mummaneni, Sheila Antrum, Sigurd H. Berven, Michael S. Conte, Sarah B. Doernberg, Andrew N. Goldberg, Christopher P. Hess, Steven W. Hetts, S. Andrew Josephson, Maureen P. Kohi, C. Benjamin Ma, Vaikom S. Mahadevan, Annette M. Molinaro, Andrew H. Murr, Sirisha Narayana, John P. Roberts, Marshall L. Stoller, Philip V. Theodosopoulos, Thomas P. Vail, Sandra Wienholz, Michael A. Gropper, Adrienne Green and Mitchel S. Berger

OBJECTIVE

During the COVID-19 pandemic, quaternary-care facilities continue to provide care for patients in need of urgent and emergent invasive procedures. Perioperative protocols are needed to streamline care for these patients notwithstanding capacity and resource constraints.

METHODS

A multidisciplinary panel was assembled at the University of California, San Francisco, with 26 leaders across 10 academic departments, including 7 department chairpersons, the chief medical officer, the chief operating officer, infection control officers, nursing leaders, and resident house staff champions. An epidemiologist, an ethicist, and a statistician were also consulted. A modified two-round, blinded Delphi method based on 18 agree/disagree statements was used to build consensus. Significant disagreement for each statement was tested using a one-sided exact binomial test against an expected outcome of 95% consensus using a significance threshold of p < 0.05. Final triage protocols were developed with unblinded group-level discussion.

RESULTS

Overall, 15 of 18 statements achieved consensus in the first round of the Delphi method; the 3 statements with significant disagreement (p < 0.01) were modified and iteratively resubmitted to the expert panel to achieve consensus. Consensus-based protocols were developed using unblinded multidisciplinary panel discussions. The final algorithms 1) quantified outbreak level, 2) triaged patients based on acuity, 3) provided a checklist for urgent/emergent invasive procedures, and 4) created a novel scoring system for the allocation of personal protective equipment. In particular, the authors modified the American College of Surgeons three-tiered triage system to incorporate more urgent cases, as are often encountered in neurosurgery and spine surgery.

CONCLUSIONS

Urgent and emergent invasive procedures need to be performed during the COVID-19 pandemic. The consensus-based protocols in this study may assist healthcare providers to optimize perioperative care during the pandemic.

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Rachel E. Tsolinas, John F. Burke, Anthony M. DiGiorgio, Leigh H. Thomas, Xuan Duong-Fernandez, Mark H. Harris, John K. Yue, Ethan A. Winkler, Catherine G. Suen, Lisa U. Pascual, Adam R. Ferguson, J. Russell Huie, Jonathan Z. Pan, Debra D. Hemmerle, Vineeta Singh, Abel Torres-Espin, Cleopa Omondi, Nikos Kyritsis, Jenny Haefeli, Philip R. Weinstein, Carlos A. de Almeida Neto, Yu-Hung Kuo, Derek Taggard, Jason F. Talbott, William D. Whetstone, Geoffrey T. Manley, Jacqueline C. Bresnahan, Michael S. Beattie and Sanjay S. Dhall

OBJECTIVE

Traumatic spinal cord injury (SCI) is a dreaded condition that can lead to paralysis and severe disability. With few treatment options available for patients who have suffered from SCI, it is important to develop prospective databases to standardize data collection in order to develop new therapeutic approaches and guidelines. Here, the authors present an overview of their multicenter, prospective, observational patient registry, Transforming Research and Clinical Knowledge in SCI (TRACK-SCI).

METHODS

Data were collected using the National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs). Highly granular clinical information, in addition to standardized imaging, biospecimen, and follow-up data, were included in the registry. Surgical approaches were determined by the surgeon treating each patient; however, they were carefully documented and compared within and across study sites. Follow-up visits were scheduled for 6 and 12 months after injury.

RESULTS

One hundred sixty patients were enrolled in the TRACK-SCI study. In this overview, basic clinical, imaging, neurological severity, and follow-up data on these patients are presented. Overall, 78.8% of the patients were determined to be surgical candidates and underwent spinal decompression and/or stabilization. Follow-up rates to date at 6 and 12 months are 45% and 36.3%, respectively. Overall resources required for clinical research coordination are also discussed.

CONCLUSIONS

The authors established the feasibility of SCI CDE implementation in a multicenter, prospective observational study. Through the application of standardized SCI CDEs and expansion of future multicenter collaborations, they hope to advance SCI research and improve treatment.