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An Update of a Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role and Timing of Decompressive Surgery

Fehlings, Michael G; Tetreault, Lindsay A; Hachem, Laureen; Evaniew, Nathan; Ganau, Mario; McKenna, Stephen L; Neal, Chris J; Nagoshi, Narihito; Rahimi-Movaghar, Vafa; Aarabi, Bizhan; Hofstetter, Christoph P; Wengel, Valerie Ter; Nakashima, Hiroaki; Martin, Allan R; Kirshblum, Steven; Rodrigues Pinto, Ricardo; Marco, Rex A W; Wilson, Jefferson R; Kahn, David E; Newcombe, Virginia F J; Zipser, Carl M; Douglas, Sam; Kurpad, Shekar N; Lu, Yi; Saigal, Rajiv; Samadani, Uzma; Arnold, Paul M; Hawryluk, Gregory W J; Skelly, Andrea C; Kwon, Brian K
STUDY DESIGN/METHODS:Clinical practice guideline development. OBJECTIVES/OBJECTIVE:Acute spinal cord injury (SCI) can result in devastating motor, sensory, and autonomic impairment; loss of independence; and reduced quality of life. Preclinical evidence suggests that early decompression of the spinal cord may help to limit secondary injury, reduce damage to the neural tissue, and improve functional outcomes. Emerging evidence indicates that "early" surgical decompression completed within 24 hours of injury also improves neurological recovery in patients with acute SCI. The objective of this clinical practice guideline (CPG) is to update the 2017 recommendations on the timing of surgical decompression and to evaluate the evidence with respect to ultra-early surgery (in particular, but not limited to, <12 hours after acute SCI). METHODS:A multidisciplinary, international, guideline development group (GDG) was formed that consisted of spine surgeons, neurologists, critical care specialists, emergency medicine doctors, physical medicine and rehabilitation professionals, as well as individuals living with SCI. A systematic review was conducted based on accepted methodological standards to evaluate the impact of early (within 24 hours of acute SCI) or ultra-early (in particular, but not limited to, within 12 hours of acute SCI) surgery on neurological recovery, functional outcomes, administrative outcomes, safety, and cost-effectiveness. The GRADE approach was used to rate the overall strength of evidence across studies for each primary outcome. Using the "evidence-to-recommendation" framework, recommendations were then developed that considered the balance of benefits and harms, financial impact, patient values, acceptability, and feasibility. The guideline was internally appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. RESULTS:The GDG recommended that early surgery (≤24 hours after injury) be offered as the preferred option for adult patients with acute SCI regardless of level. This recommendation was based on moderate evidence suggesting that patients were 2 times more likely to recover by ≥ 2 ASIA Impairment Score (AIS) grades at 6 months (RR: 2.76, 95% CI 1.60 to 4.98) and 12 months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24 hours compared to after 24 hours. Furthermore, patients undergoing early surgery improved by an additional 4.50 (95% 1.70 to 7.29) points on the ASIA Motor Score compared to patients undergoing surgery after 24 hours post-injury. The GDG also agreed that a recommendation for ultra-early surgery could not be made on the basis of the current evidence because of the small sample sizes, variable definitions of what constituted ultra-early in the literature, and the inconsistency of the evidence. CONCLUSIONS:It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24 hours after injury when medically feasible. Future research is required to determine the differential effectiveness of early surgery in different subpopulations and the impact of ultra-early surgery on neurological recovery. Moreover, further work is required to define what constitutes effective spinal cord decompression and to individualize care. It is also recognized that a concerted international effort will be required to translate these recommendations into policy.
PMCID:10964895
PMID: 38526922
ISSN: 2192-5682
CID: 5644492

Advances in Epidural Spinal Cord Stimulation to Restore Function after Spinal Cord Injury: History and Systematic Review

Mansour, Nadine; Peña Pino, Isabela; Freeman, David; Carrabre, Kailey; Venkatesh, Shivani; Darrow, David; Samadani, Uzma; Parr, Ann M
Epidural Spinal Cord Stimulation (eSCS) has been recently recognized as a potential therapy for chronic Spinal Cord Injury (SCI). eSCS has been shown to uncover residual pathways within the damaged spinal cord. The purpose of this review is to summarize the key findings to date regarding the use of eSCS in SCI. Searches were carried out using Medline, EMBASE, and Web of Science database and reference lists of the included articles. A combination of medical subject heading terms and keywords was used to find studies investigating the use of eSCS in SCI patients to facilitate volitional movement and to restore autonomic function. The risk of bias was assessed using Robins-I tool for nonrandomized studies. We were able to include 40 articles that met our eligibility criteria. The studies included a total of 184 patient experiences with incomplete or complete SCI. The majority of the studies used the Medtronic 16 paddle lead. Around half of the studies reported lead placement between T11- L1. We included studies that assessed motor (n=28); autonomic (n=13); and other outcomes (n=10). The majority of the studies reported improvement in outcomes assessed. The wide range of included outcomes demonstrates the effectiveness of eSCS in treating a diverse SCI population. However, the current studies cannot definitively conclude which patients benefit the most from this intervention. Further study in this area is needed to allow improvement of the eSCS technology and allow it to be more widely available for chronic SCI patients.
PMID: 35403432
ISSN: 1557-9042
CID: 5205062

Eye tracking for classification of concussion in adults and pediatrics

Samadani, Uzma; Spinner, Robert J; Dynkowski, Gerard; Kirelik, Susan; Schaaf, Tory; Wall, Stephen P; Huang, Paul
INTRODUCTION/UNASSIGNED:In order to obtain FDA Marketing Authorization for aid in the diagnosis of concussion, an eye tracking study in an intended use population was conducted. METHODS/UNASSIGNED:Potentially concussed subjects recruited in emergency department and concussion clinic settings prospectively underwent eye tracking and a subset of the Sport Concussion Assessment Tool 3 at 6 sites. The results of an eye tracking-based classifier model were then validated against a pre-specified algorithm with a cutoff for concussed vs. non-concussed. The sensitivity and specificity of eye tracking were calculated after plotting of the receiver operating characteristic curve and calculation of the AUC (area under curve). RESULTS/UNASSIGNED:= 282) was 31.6%. CONCLUSION/UNASSIGNED:A pre-specified algorithm and cutoff for diagnosis of concussion vs. non-concussion has a sensitivity and specificity that is useful as a baseline-free aid in diagnosis of concussion. Eye tracking has potential to serve as an objective "gold-standard" for detection of neurophysiologic disruption due to brain injury.
PMCID:9753125
PMID: 36530640
ISSN: 1664-2295
CID: 5394942

Sport-Related Structural Brain Injury and Return to Play: Systematic Review and Expert Insight

Zuckerman, Scott L; Yengo-Kahn, Aaron M; Tang, Alan R; Bailes, Julian E; Beauchamp, Kathryn; Berger, Mitchel S; Bonfield, Christopher M; Camarata, Paul J; Cantu, Robert C; Davis, Gavin A; Ellenbogen, Richard G; Ellis, Michael J; Feuer, Hank; Guazzo, Eric; Harris, Odette A; Heppner, Peter; Honeybul, Stephen; Manley, Geoff; Maroon, Joseph C; Miele, Vincent J; Nahed, Brian V; Okonkwo, David O; Oppenlander, Mark E; Petty, Jerry; Sabin, H Ian; Samadani, Uzma; Sherburn, Eric W; Sheridan, Mark; Tator, Charles H; Theodore, Nicholas; Timmons, Shelly D; Woodworth, Graeme F; Solomon, Gary S; Sills, Allen K
BACKGROUND:Sport-related structural brain injury (SRSBI) is intracranial pathology incurred during sport. Management mirrors that of non-sport-related brain injury. An empirical vacuum exists regarding return to play (RTP) following SRSBI. OBJECTIVE:To provide key insight for operative management and RTP following SRSBI using a (1) focused systematic review and (2) survey of expert opinions. METHODS:A systematic literature review of SRSBI from 2012 to present in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and a cross-sectional survey of RTP in SRSBI by 31 international neurosurgeons was conducted. RESULTS:Of 27 included articles out of 241 systematically reviewed, 9 (33.0%) case reports provided RTP information for 12 athletes. To assess expert opinion, 31 of 32 neurosurgeons (96.9%) provided survey responses. For acute, asymptomatic SRSBI, 12 (38.7%) would not operate. Of the 19 (61.3%) who would operate, midline shift (63.2%) and hemorrhage size > 10 mm (52.6%) were the most common indications. Following SRSBI with resolved hemorrhage, with or without burr holes, the majority of experts (>75%) allowed RTP to high-contact/collision sports at 6 to 12 mo. Approximately 80% of experts did not endorse RTP to high-contact/collision sports for athletes with persistent hemorrhage. Following craniotomy for SRSBI, 40% to 50% of experts considered RTP at 6 to 12 mo. Linear regression revealed that experts allowed earlier RTP at higher levels of play (β = -0.58, 95% CI -0.111, -0.005, P = .033). CONCLUSION/CONCLUSIONS:RTP decisions following structural brain injury in athletes are markedly heterogeneous. While individualized RTP decisions are critical, aggregated expert opinions from 31 international sports neurosurgeons provide key insight. Level of play was found to be an important consideration in RTP determinations.
PMID: 33693899
ISSN: 1524-4040
CID: 4809382

Evaluation of diffusion measurements reveals radial diffusivity indicative of microstructural damage following acute, mild traumatic brain injury

Mahan, Margaret Y; Rafter, Daniel J; Truwit, Charles L; Oswood, Mark; Samadani, Uzma
PURPOSE/OBJECTIVE:Mild TBI, characterized by microstructural damage, often undetectable on conventional imaging techniques, is a pervasive condition that disturbs brain function and can potentially result in long-term deficits. Deciphering the underlying microstructural damage in mild TBI is crucial for establishing a reliable diagnosis and enabling effective therapeutics. Efforts to capture this damage have been extensive, but results have been inconsistent and incomplete. METHODS:To that effect, we set out to examine the shape of the diffusion tensor in mild TBI during the acute phase of injury. We inspected diffusivity and geometric measurements describing the diffusion tensor's shape and compared mild TBI (N = 34, 20.4-66.6 yo) measurements with those from healthy control (N = 42, 20.7-67.2 yo) participants using voxelwise tract-based spatial statistics. Subsequently, to explore associations between the diffusion measurements in mild TBI, we performed nonparametric statistics and machine learning techniques. RESULTS:was also found to be important for discriminating between groups. CONCLUSION/CONCLUSIONS:, in assessing TBI and suggest differentiating diffusion measurements has the potential utility to detect variations in the underlying pathophysiology after injury.
PMID: 33359428
ISSN: 1873-5894
CID: 4731332

Litigation risks despite guideline adherence for acute spinal cord injury: time is spine

Rafter, Daniel; Vasdev, Ranveer; Hurrelbrink, Duncan; Gormley, Mark; Chettupally, Tabitha; Shen, Francis X; Samadani, Uzma
OBJECTIVE:Current guidelines do not specify timing for management of acute spinal cord injury (aSCI) due to lack of high-quality evidence supporting specific intervals for intervention. Randomized prospective trials may be unethical. Nonetheless, physicians have been sued for delays in diagnosis and intervention. METHODS:The authors reviewed both the medical literature supporting the guidelines and the legal cases reported in the Westlaw and Lexis Advance databases from 1972 to 2018 resulting in awards or settlements, to identify whether surgeons are vulnerable to litigation despite the existence of guidelines not mandating specific timing of care. RESULTS:Timing of intervention was related to claims in 59 (36%) of 163 cases involving SCI. All 22 trauma cases identified cited timing of intervention, sometimes related to delayed diagnosis, as a reason for the lawsuit. The mean award of 10 cases in which the plaintiffs' awards were disclosed was $4,294,384. In the majority of cases, award amounts were not disclosed. CONCLUSIONS:Because conduct of a prospective, randomized trial to investigate surgical timing of intervention for aSCI may not be achievable, evidence-based guidelines will be unlikely to mandate specific timing. Nonetheless, surgeons who unreasonably delay intervention for aSCI may be at risk for litigation due to treatment delay. This is increasingly likely in an environment where "complete" SCI is difficult to verify. SCI may at some point be recognized as a surgical emergency, as brain injury generally is, despite a lack of prospective randomized trials supporting this implementation, challenging the feasibility of the US trauma infrastructure to provide care for these patients.
PMID: 33130619
ISSN: 1092-0684
CID: 4655802

Eye Tracking as a Biomarker for Concussion in Children

Bin Zahid, Abdullah; Hubbard, Molly E; Lockyer, Julia; Podolak, Olivia; Dammavalam, Vikalpa M; Grady, Matthew; Nance, Michael; Scheiman, Mitchell; Samadani, Uzma; Master, Christina L
OBJECTIVE:Concussion is the most common type of brain injury in both pediatric and adult populations and can potentially result in persistent postconcussion symptoms. Objective assessment of physiologic "mild" traumatic brain injury in concussion patients remains challenging. This study evaluates an automated eye-tracking algorithm as a biomarker for concussion as defined by its symptoms and the clinical signs of convergence insufficiency and accommodation dysfunction in a pediatric population. DESIGN/METHODS:Cross-sectional case-control study. SETTING/METHODS:Primary care. PATIENTS/METHODS:Concussed children (N = 56; mean age = 13 years), evaluated at a mean of 22-week post-injury, compared with 83 uninjured controls. INDEPENDENT VARIABLES/METHODS:Metrics comparing velocity and conjugacy of eye movements over time were obtained and were compared with the correlation between Acute Concussion Evaluation (ACE) scores, convergence, and accommodation dysfunction. MAIN OUTCOME MEASURES/METHODS:Subjects' eye movements recorded with an automated eye tracker while they watched a 220-second cartoon film clip played continuously while moving within an aperture. RESULTS:Twelve eye-tracking metrics were significantly different between concussed and nonconcussed children. A model to classify concussion as diagnosed by its symptoms assessed using the ACE achieved an area under the curve (AUC) = 0.854 (71.9% sensitivity, 84.4% specificity, a cross-validated AUC = 0.789). An eye-tracking model built to identify near point of convergence (NPC) disability achieved 95.8% specificity and 57.1% sensitivity for an AUC = 0.810. Reduced binocular amplitude of accommodation had a Spearman correlation of 0.752(P value <0.001) with NPC. CONCLUSION/CONCLUSIONS:Eye tracking correlated with concussion symptoms and detected convergence and accommodative abnormalities associated with concussion in the pediatric population. It demonstrates utility as a rapid, objective, noninvasive aid in the diagnosis of concussion.
PMID: 30095503
ISSN: 1536-3724
CID: 3236452

A retrospective descriptive study of cranioplasty failure rates and contributing factors in novel 3D printed calcium phosphate implants compared to traditional materials

Koller, Michael; Rafter, Daniel; Shok, Gillian; Murphy, Sean; Kiaei, Sheena; Samadani, Uzma
BACKGROUND:Failure rates with cranioplasty procedures have driven efforts to improve graft material and reduce reoperation. One promising allograft source is a 3D-printed titanium mesh with calcium phosphate filler. This study evaluated failure rates and pertinent characteristics of these novel 3D-grafts compared to traditional materials. METHODS:Sixty patients were retrospectively identified who underwent a cranioplasty between January 2015-December 2017. Specific data points related to graft failure were collected for all surgical admissions, from the primary injury to their most recent. These included, but were not limited to, initial physical exam findings, vitals, comorbid conditions, surgery length, estimated blood loss, incision type, and need for revision. Failure rates of 3D-printed allografts were compared to traditional grafts. RESULTS:A total of 60 subjects were identified who underwent 71 unique cranioplasty procedures (3D = 13, Synthetic = 12, Autologous = 46). There were 14 total failures, demonstrating a 19.7% overall failure rate. Specifically, 15.4% (n = 2) of 3D, 19.6% (n = 9) of autologous, and 25.0% (n = 3) of synthetic grafts required revision. Patients receiving 3D-grafts had the shortest overall mean surgery times (200.8 ± 54.3 min) and lowest infection rates (7.7%) compared to autologous (210.5 ± 47.9 min | 25.0%) and synthetic models (217.6 ± 77.3 min | 8.7%), though significance was unable to be determined. Tobacco use and trap-door incisions were associated with increased failure rates relative to straight or curved incisions in autologous grafts. Cranioplasties performed less than 3 months after craniectomy appeared to fail more often than those performed at least three months after craniectomy, for the synthetic group. CONCLUSION/CONCLUSIONS:We concluded that 3D-printed cranioplasty grafts may lead to lower failure rates and shorter surgery times compared to traditional cranioplasty materials in our limited population. 3D-implants hold promise for cranial reconstruction after TBI.
PMID: 32556704
ISSN: 2365-6271
CID: 4485252

Discrepancy between internal and external intracranial pressure transducers: quantification of an old source of error in EVDs?

Darrow, David; Lee-Norris, Alex; Larson, Anthony; Samadani, Uzma; Netoff, Theoden I
BACKGROUND:Intracranial pressure monitoring remains the foundation for prevention of secondary injury after traumatic brain injury and is most commonly performed using an external ventricular drain or intraparenchymal pressure monitor. The Integra Flex ventricular catheter combines an external ventricular catheter with a pressure transducer embedded in the tip of the catheter to allow continuous pressure readings while simultaneously draining cerebrospinal fluid. Discrepancies between measurements from the continuously reported internal pressure transducer and intermittently assessed and externally-transduced ventricular drain prompted an analysis and characterization of pressures transduced from the same ventricular source. METHODS:More than 500 hours of high-resolution (125 Hz) continuous recordings were manually reviewed to identify 73 hours of simultaneous measurements (clamped EVD) from internal and external transducers in patients with traumatic brain injury. RESULTS:A significant positive bias was found in pressure readings obtained from external relative to internal measurements. The two methods of measurement generally correlated poorly with each other and variably. While proportional bias was found with Bland-Altman analysis, coherence revealed rare shifts in the external transducer as a major source of discrepancy. Infrequent changes in the zero-level of the external transducer were found to be the primary source of discrepancy. Relative to the observed differences, no significant trend was observed over time between the two modalities. CONCLUSION/CONCLUSIONS:This study suggests that the internal pressure transducer may be a more reliable estimate of intracranial pressure relative to bedside external transducers due to the inherent behavioral requirement of leveling.
PMID: 31394360
ISSN: 1878-8769
CID: 4033482

tbiExtractor: A framework for extracting traumatic brain injury common data elements from radiology reports

Mahan, Margaret; Rafter, Daniel; Casey, Hannah; Engelking, Marta; Abdallah, Tessneem; Truwit, Charles; Oswood, Mark; Samadani, Uzma
BACKGROUND:The manual extraction of valuable data from electronic medical records is cumbersome, error-prone, and inconsistent. By automating extraction in conjunction with standardized terminology, the quality and consistency of data utilized for research and clinical purposes would be substantially improved. Here, we set out to develop and validate a framework to extract pertinent clinical conditions for traumatic brain injury (TBI) from computed tomography (CT) reports. METHODS:We developed tbiExtractor, which extends pyConTextNLP, a regular expression algorithm using negation detection and contextual features, to create a framework for extracting TBI common data elements from radiology reports. The algorithm inputs radiology reports and outputs a structured summary containing 27 clinical findings with their respective annotations. Development and validation of the algorithm was completed using two physician annotators as the gold standard. RESULTS:tbiExtractor displayed high sensitivity (0.92-0.94) and specificity (0.99) when compared to the gold standard. The algorithm also demonstrated a high equivalence (94.6%) with the annotators. A majority of clinical findings (85%) had minimal errors (F1 Score ≥ 0.80). When compared to annotators, tbiExtractor extracted information in significantly less time (0.3 sec vs 1.7 min per report). CONCLUSION/CONCLUSIONS:tbiExtractor is a validated algorithm for extraction of TBI common data elements from radiology reports. This automation reduces the time spent to extract structured data and improves the consistency of data extracted. Lastly, tbiExtractor can be used to stratify subjects into groups based on visible damage by partitioning the annotations of the pertinent clinical conditions on a radiology report.
PMID: 32609723
ISSN: 1932-6203
CID: 4504402