A Prospective Phase I/II Clinical Trial of High-Dose Proton Therapy for Chordomas and Chondrosarcomas.

Purpose: The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine. Methods: A prospective cohort of 54 patients (42 with chordomas and 12 with chondrosarcomas) was enrolled between 2010 and 2018. The primary endpoints were feasibility and <20% rate of acute grade ≥3 toxicity, and secondary endpoints included cancer-specific outcomes and toxicities. Patients were followed with magnetic resonance imaging or computed tomography at 3-month intervals. Proton beam therapy was delivered with doses up to 79.2 Gy using protons only, combination protons/intensity modulated radiation therapy (IMRT), or IMRT only. Results: Feasibility endpoints were met, with only 2 out of 54 patient radiation therapy plans failing to meet dosimetric constraints with protons, and 4 out of 54 experiencing a delay or treatment break >5 days, none for toxicities related to treatment. There were no grade 4 acute toxicities and 1 grade 3 acute toxicity (sensory neuropathy). The only 2 grade 3 late toxicities recorded, osteoradionecrosis and intranasal carotid blowout (mild and not emergently treated), occurred in a single patient. We report overall survival as 83% at 5 years, with local failure-free survival and progression-free survival rates of 72% and 68%, respectively. Five patients developed distant disease, and among the 9/54 patients who died, 4 deaths were not attributed to treatment or recurrence. Conclusions: Our findings suggest that high-dose proton therapy alone or in combination with IMRT is a safe and effective treatment option for chordomas and chondrosarcomas of the skull base and spine.

Racial disparities in short-term spinal fusion outcomes across 4263 consecutive patients.

OBJECTIVE: Race plays a salient role in access to surgical care. However, few investigations have assessed the impact of race within surgical populations after care has been delivered. The objective of this study was to employ an exact matching protocol to a homogenous population of spine surgery patients in order to isolate the relationships between race and short-term postoperative outcomes. METHODS: In total, 4263 consecutive patients who underwent single-level, posterior-only lumbar fusion at a single multihospital academic medical center were retrospectively enrolled. Of these patients, 3406 patients self-identified as White and 857 patients self-identified as non-White. Outcomes were initially compared across all patients via logistic regression. Subsequently, White patients and non-White patients were exactly matched on the basis of key demographic and health characteristics (1520 matched patients). Outcome disparities were evaluated between the exact-matched cohorts. Primary outcomes were readmissions, emergency department (ED) visits, reoperations, mortality, intraoperative complications, and discharge disposition. RESULTS: Before matching, non-White patients were less likely to be discharged home and more likely to be readmitted, evaluated in the ED, and undergo reoperation. After matching, non-White patients experienced higher rates of nonhome discharge, readmissions, and ED visits. Non-White patients did not have more surgical complications either before or after matching. CONCLUSIONS: Between otherwise similar cohorts of spinal fusion cases, non-White patients experienced unfavorable discharge disposition and higher risk of multiple adverse postoperative outcomes. However, these findings were not accounted for by differences in surgical complications, suggesting that structural factors underlie the observed disparities.

Gender and Sex Differences in Health-related Quality of Life, Clinical Outcomes and Survival after Treatment of Metastatic Spine Disease.

STUDY DESIGN: Retrospective review of prospective, multicenter and international cohort study. OBJECTIVE: To describe the effect of gender on HRQoL, clinical outcomes and survival for patients with spinal metastases treated with either surgery and/or radiation. SUMMARY OF BACKGROUND DATA: Gender differences in health-related outcomes are demonstrated in numerous studies, with women experiencing worse outcomes and receiving lower standards of care than men, however, the influence that gender has on low health-related quality of life (HRQoL) and clinical outcomes after spine surgery remains unclear. METHODS: Patient demographic data, overall survival, treatment details, perioperative complications, and HRQoL measures including EQ-5D, pain NRS, the short form 36 version 2 (SF-36v2) and the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) were reviewed. Patients were stratified by sex, and a separate sensitivity analysis that excluded gender-specific cancers (i.e., breast, prostate, etc.) was performed. RESULTS: The study cohort included 207 female and 183 male patients, with age, smoking status, and site of primary cancer being significantly different between the two cohorts (P<0.001). Both males and females experienced significantly improved SOSGOQ2.0, EQ-5D, and pain NRS scores at all study time points from baseline (P<0.001). Upon sensitivity analysis, (gender-specific cancers removed from analysis), the significant improvement in SOSGOQ physical, mental, and social subdomains and on SF-36 domains disappeared for females. Males experienced higher rates of postoperative complications. Kaplan-Meier survival analysis of both the overall and sensitivity analysis cohorts showed females lived longer than males after treatment (P=0.001 and 0.043, respectively). CONCLUSION: Both males and females experienced significantly improved HRQoL scores after treatment, but females demonstrated longer survival and a lower complication rate. This study suggests that gender may be a prognostic factor in survival and clinical outcomes for patients undergoing treatment for spine metastases and should be taken into consideration when counseling patients accordingly.

Relationship Between Comorbidity Burden and Short-Term Outcomes Across 4680 Consecutive Spinal Fusions.

OBJECTIVE: Preoperative management requires the identification and optimization of modifiable medical comorbidities, though few studies isolate comorbid status from related patient-level variables. This study evaluates Charlson Comorbidity Index (CCI)-an easily derived measure of aggregate medical comorbidity-to predict outcomes from spinal fusion surgery. Coarsened exact matching is employed to control for key patient characteristics and isolate CCI. METHODS: We retrospectively assessed 4680 consecutive patients undergoing single-level, posterior-only lumbar fusion at a single academic center. Logistic regression evaluated the univariate relationship between CCI and patient outcomes. Coarsened exact matching generated exact demographic matches between patients with high comorbid status (CCI >6) or no medical comorbidities (matched n = 524). Patients were matched 1:1 on factors associated with surgical outcomes, and outcomes were compared between matched cohorts. Primary outcomes included surgical complications, discharge status, 30- and 90-day risk of readmission, emergency department (ED) visits, reoperation, and mortality. RESULTS: Univariate regression of increasing CCI was significantly associated with non-home discharge, as well as 30- and 90-day readmission, ED visits, and mortality (all P < 0.05). Subsequent isolation of comorbidity between otherwise exact-matched cohorts found comorbid status did not affect readmissions, reoperations, or mortality; high CCI score was significantly associated with non-home discharge (OR = 2.50, P < 0.001) and 30-day (OR = 2.44, P = 0.02) and 90-day (OR = 2.29, P = 0.008) ED evaluation. CONCLUSIONS: Comorbidity, measured by CCI, did not increase the risk of readmission, reoperation, or mortality. Single-level, posterior lumbar fusions may be safe in appropriately selected patients regardless of comorbid status. Future studies should determine whether CCI can guide discharge planning and postoperative optimization.

Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.

Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.

Human Services and Behavioral Health Integration: A Model for Whole-Person Medicaid Managed Care.

A comprehensive, whole-person approach to individuals' health care can be achieved by aligning, integrating, and coordinating health services with other human services. HealthChoices, Pennsylvania's managed Medicaid program, delegates responsibility for Medicaid-funded behavioral health service management to individual counties or multicounty collaboratives. County administrators' programmatic and fiscal oversight of Medicaid-funded services allows them to create synergies between behavioral health and other human service delivery systems and to set priorities on the basis of local needs. This model supports access to community-based care, integration of general medical and behavioral health services, and programs that address social determinants of health.

Correlation Between the Spinal Instability Neoplastic Score (SINS) and Patient Reported Outcomes.

STUDY DESIGN: International multicenter prospective observational cohort study on patients undergoing radiation +/- surgical intervention for the treatment of symptomatic spinal metastases. OBJECTIVES: To investigate the association between the total Spinal Instability Neoplastic Score (SINS), individual SINS components and PROs. METHODS: Data regarding patient demographics, diagnostics, treatment, and PROs (SF-36, SOSGOQ, EQ-5D) was collected at baseline, 6 weeks, and 12 weeks post-treatment. The SINS was assessed using routine diagnostic imaging. The association between SINS, PRO at baseline and change in PROs was examined with the Spearmans rank test. RESULTS: A total of 307 patients, including 174 patients who underwent surgery+/- radiotherapy and 133 patients who underwent radiotherapy were eligible for analyses. In the surgery+/- radiotherapy group, 18 (10.3%) patients with SINS score between 0-6, 118 (67.8%) with a SINS between 7-12 and 38 (21.8%) with a SINS between 13-18, as compared to 55 (41.4%) SINS 0-6, 71(53.4%) SINS 7-12 and 7 (5.2%) SINS 13-18 in the radiotherapy alone group. At baseline, the total SINS and the presence of mechanical pain was significantly associated with the SOSGOQ pain domain (r = -0.519, P < 0.001) and the NRS pain score (r = 0.445, P < 0.001) for all patients. The presence of mechanical pain demonstrated to be moderately associated with a positive change in PROs at 12 weeks post-treatment. CONCLUSION: Spinal instability, as defined by the SINS, was significantly correlated with PROs at baseline and change in PROs post-treatment. Mechanical pain, as a single SINS component, showed the highest correlations with PROs.

Anticoagulation Holiday: Resumption of Direct Oral Anticoagulants for Atrial Fibrillation in Patients with Index Traumatic Intracranial Hemorrhage.

Background: The optimal time to restart direct oral anticoagulants (DOACs) for nonvalvular atrial fibrillation (NVAF) after traumatic intracranial hemorrhage (tICH) is unknown. Physicians must weigh the risk of recurrent hemorrhage against ischemic stroke. We investigated rates of stroke while holding anticoagulation, hemorrhage after anticoagulation resumption, and factors associated with the decision to restart anticoagulation. Methods: Patients presenting to our level I trauma center for tICH while on a DOAC for NVAF were retrospectively reviewed over 2 years. Age, sex, DOAC use, antiplatelet use, congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease, sex score for stroke risk in NVAF, injury mechanism, bleeding pattern, Injury Severity Score, use of a reversal agent, Glasgow Coma Scale at 24 hours, hemorrhage expansion, neurosurgical intervention, Morse Fall Risk, DOAC restart date, rebleed events, and ischemic stroke were recorded to study rates of recurrent hemorrhage and stroke, and factors that influenced the decision to restart anticoagulation. Results: Twenty-eight patients sustained tICH while on a DOAC. Fall was the most common mechanism (89.3%), and subdural hematoma was the predominant bleeding pattern (60.7%). Of the 25 surviving patients, 16 patients (64%) restarted a DOAC a median 29.5 days after tICH. One patient had recurrent hemorrhage after resuming anticoagulation. One patient had an embolic stroke after 118 days off anticoagulation. Age >80, Injury Severity Score ≥16, and expansion of tICH influenced the decision to indefinitely hold anticoagulation. Conclusion: The low stroke rate observed in this study suggests that holding DOACs for NVAF for 1 month is sufficient to reduce the risk of stroke after tICH. Additional data are required to determine optimal restart timing.

Steroids in the Management of Preoperative Neurological Deficits in Metastatic Spine Disease: Results From the EPOSO Study.

OBJECTIVE: Patients presenting with neurological deficit secondary to metastatic epidural spinal cord compression (MESCC) are often treated with surgery in combination with high-dose corticosteroids. Despite steroids being commonly used, the evidence regarding the effect of corticosteroids on patient outcomes is limited. The objective of this study was to describe the effect of corticosteroid use on preoperative neurological function in patients with MESCC. METHODS: Patients who underwent surgery between August 2013 and February 2017 for the treatment of spinal metastases and received steroids to prevent neurologic deficits were included. Data regarding demographics, diagnosis, treatment, neurological function, adverse events, health-related quality of life, and survival were extracted from an international multicenter prospective cohort. RESULTS: A total of 30 patients treated surgically and receiving steroids at baseline were identified. Patients had a mean age of 58.2 years (standard deviation, 11.2 years) at time of surgery. Preoperatively, 50% of the patients experienced deterioration of neurological function, while in 30% neurological function was stable and 20% improved in neurological function. Lengthier steroid use did not correlate with improved or stabilized neurological function. Postoperative adverse events were observed in 18 patients (60%). Patients that stabilized or improved neurologically after steroid use showed a trend towards improved survival at 3- and 24-month postsurgery. CONCLUSION: This study described the effect of steroids on preoperative neurological function in patients with MESCC. Stabilization or improvement of preoperative neurological function occurred in 50% of the patients.

Association of Venous Thromboembolism Prophylaxis After Neurosurgical Intervention for Traumatic Brain Injury With Thromboembolic Complications, Repeated Neurosurgery, and Mortality.

IMPORTANCE: There is a lack of evidence regarding the effectiveness and safety of pharmacologic venous thromboembolism (VTE) prophylaxis among patients who undergo neurosurgical interventions for traumatic brain injury (TBI). OBJECTIVE: To measure the association between timing of VTE prophylaxis after urgent neurosurgical intervention for TBI and thromboembolic and intracranial complications. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included adult patients (aged ≥16 years) who underwent urgent neurosurgical interventions (craniotomy/craniectomy or intracranial monitor/drain insertion within 24 hours after admission) for TBI at level 1 and 2 trauma centers participating in the American College of Surgeons Trauma Quality Improvement Program between January 1, 2012, and December 31, 2016. Data were analyzed from January to August 2020. EXPOSURES: Timing of pharmacologic VTE prophylaxis initiation after urgent neurosurgical intervention (prophylaxis delay) measured in days (24-hour periods). MAIN OUTCOMES AND MEASURES: The primary outcome was VTE (deep vein thrombosis or pulmonary embolism). Secondary outcomes were repeated neurosurgery (neurosurgical reintervention after initiation of VTE prophylaxis) and mortality. Hierarchical logistic regression models were used to evaluate the association between prophylaxis delay and each outcome at the patient level and were adjusted for patient baseline and injury characteristics. RESULTS: The study included 4951 patients (3676 [74%] male; median age, 50 years [IQR, 31-64 years]) who underwent urgent neurosurgical intervention for TBI at 304 trauma centers. The median prophylaxis delay was 3 days (IQR, 1-5 days). After adjustment for patient baseline and injury characteristics, prophylaxis delay was associated with increased odds of VTE (adjusted odds ratio [aOR], 1.08 per day; 95% CI, 1.04-1.12). Earlier initiation of prophylaxis was associated with increased risk of repeated neurosurgery. During the first 3 days, each additional day of prophylaxis delay was associated with a 28% decrease in odds of repeated neurosurgery (aOR, 0.72 per day; 95% CI, 0.59-0.88). After 3 days, each additional day of prophylaxis delay was associated with an additional 15% decrease in odds of repeated neurosurgery (aOR, 0.85 per day; 95% CI, 0.80-0.90). Earlier prophylaxis was associated with greater mortality among patients who initially underwent intracranial monitor/drain procedures, such that each additional day of prophylaxis delay was associated with decreased odds of death (aOR, 0.94 per day; 95% CI, 0.89-0.99). CONCLUSIONS AND RELEVANCE: In this cohort study of patients who underwent urgent neurosurgical interventions for TBI, early pharmacologic VTE prophylaxis was associated with reduced risk of thromboembolism. However, earlier initiation of prophylaxis was associated with increased risk of repeated neurosurgery. These findings suggest that although timely initiation of prophylaxis should be prioritized, caution should be used particularly during the first 3 days after the index procedure, when this risk appears to be highest.

Use of the LACE+ index to predict readmissions after single-level lumbar fusion.

OBJECTIVE: Spinal fusion is one of the most common neurosurgical procedures. The LACE (length of stay, acuity of admission, Charlson Comorbidity Index [CCI] score, and emergency department [ED] visits within the previous 6 months) index was developed to predict readmission but has not been tested in a large, homogeneous spinal fusion population. The present study evaluated use of the LACE+ score for outcome prediction after lumbar fusion. METHODS: LACE+ scores were calculated for all patients (n = 1598) with complete information who underwent single-level, posterior-only lumbar fusion at a single university medical system. Logistic regression was performed to assess the ability of the LACE+ score as a continuous variable to predict hospital readmissions within 30 days (30D), 30-90 days (30-90D), and 90 days (90D) of the index operation. Secondary outcome measures included ED visits and reoperations. Subsequently, patients with LACE+ scores in the bottom decile were exact matched to the patients with scores in the top 4 deciles to control for sociodemographic and procedural variables. RESULTS: Among all patients, increased LACE+ score significantly predicted higher rates of readmissions in the 30D (p < 0.001), 30-90D (p = 0.001), and 90D (p < 0.001) postoperative windows. LACE+ score also predicted risk of ED visits at all 3 time points and reoperations at 30-90D and 90D. When patients with LACE+ scores in the bottom decile were compared with patients with scores in the top 4 deciles, higher LACE+ score predicted higher risk of readmissions at 30D (p = 0.009) and 90D (p = 0.005). No significant difference in hospital readmissions was observed between the exact-matched cohorts. CONCLUSIONS: The present results suggest that the LACE+ score demonstrates utility in predicting readmissions within 30 and 90 days after single-level lumbar fusion. Future research is warranted that utilizes the LACE+ index to identify strategies to support high-risk patients in a prospective population.

Increased likelihood of psychiatric readmission with Medicaid expansion vs legacy coverage.

OBJECTIVES: To compare patterns of psychiatric hospitalization and readmission within 30 days for Medicaid expansion (expansion) vs previously insured (legacy) samples. STUDY DESIGN: Retrospective analysis using Medicaid behavioral health service claims. METHODS: We identified 24,044 individuals with hospitalizations in calendar years 2017 and 2018 within the network of a behavioral health managed care organization in Pennsylvania. Logistic regression was used to examine factors associated with readmission. RESULTS: Individuals covered under expansion (n = 7747) vs legacy (n = 16,297) were older and more likely to be male and European American, with higher rates of cooccurring mental health (MH) and substance use disorder (SUD) diagnoses, as well as lower rates of MH and SUD services in the 30 days prior and any prior MH hospitalization. A higher proportion of individuals with expansion vs legacy status were readmitted (11.3% vs 9.0%; P < .0001). Controlling for factors associated with readmission, regression showed an increased likelihood of readmission for expansion vs legacy status (adjusted odds ratio [AOR], 1.23; 95% CI, 1.12-1.35; P < .0001). Increased risk for readmission was also found across populations for male patients (AOR, 1.12; 95% CI, 1.02-1.22; P = .0124), those with prior MH hospitalizations (AOR, 1.65; 95% CI, 1.51-1.81; P < .0001) or other behavioral health services (AOR, 1.14; 95% CI, 1.03-1.26; P = .0142), those with longer hospitalization episodes (AOR, 1.01; 95% CI, 1.00-1.01; P < .0001), and those with cooccurring SUD (AOR, 1.58; 95% CI, 1.44-1.74; P < .0001). CONCLUSIONS: Individuals with coverage through Medicaid expansion compared with legacy coverage have an increased risk of psychiatric readmission and may warrant targeted interventions that also address service utilization and cooccurring SUD.

Short-Term Impact of Bracing in Multi-Level Posterior Lumbar Spinal Fusion.

BACKGROUND: Clinical practice in postoperative bracing after posterior lumbar spine fusion (PLF) is inconsistent between providers. This paper attempts to assess the effect of bracing on short-term outcomes related to safety, quality of care, and direct costs. METHODS: Retrospective cohort analysis of consecutive patients undergoing multilevel PLF with or without bracing (2013-2017) was undertaken (n = 980). Patient demographics and comorbidities were analyzed. Outcomes assessed included length of stay (LOS), discharge disposition, quality-adjusted life years (QALY), surgical-site infection (SSI), total cost, readmission within 30 days, and emergency department (ED) evaluation within 30 days. RESULTS: Amongst the study population, 936 were braced and 44 were not braced. There was no difference between the braced and unbraced cohorts regarding LOS (P = .106), discharge disposition (P = .898), 30-day readmission (P = .434), and 30-day ED evaluation (P = 1.000). There was also no difference in total cost (P = .230) or QALY gain (P = .740). The results indicate a significantly lower likelihood of SSI in the braced population (1.50% versus 6.82%, odds ratio = 0.208, 95% confidence interval = 0.057-0.751, P = .037). There was no difference in relevant comorbidities (P = .259-1.000), although the braced cohort was older than the unbraced cohort (63 versus 56 y, P = .003). CONCLUSION: Bracing following multilevel posterior lumbar fixation does not alter short-term postoperative course or reduce the risk for early adverse events. Cost analysis show no difference in direct costs between the 2 treatment approaches. Short-term data suggest that removal of bracing from the postoperative regimen for PLF will not result in increased adverse outcomes.

Use of Thromboelastography in the Evaluation and Management of Patients With Traumatic Brain Injury: A Systematic Review and Meta-Analysis.

Traumatic brain injury is associated with coagulopathy that increases mortality risk. Viscoelastic hemostatic assays such as thromboelastography (Haemonetics SA, Signy, Switzerland) provide rapid coagulopathy assessment and may be particularly useful for goal-directed treatment of traumatic brain injury patients. We conducted a systematic review to assess thromboelastography in the evaluation and management of coagulopathy in traumatic brain injury patients. DATA SOURCES: MEDLINE, PubMed Central, Embase, and CENTRAL. STUDY SELECTION: Clinical studies of adult patients with traumatic brain injury (isolated or polytrauma) who were assessed by either standard thromboelastography or thromboelastography with platelet mapping plus either conventional coagulation assays or platelet function assays from January 1999 to June 2021. DATA EXTRACTION: Demographics, injury mechanism and severity, diagnostic, laboratory data, therapies, and outcome data were extracted for analysis and comparison. DATA SYNTHESIS: Database search revealed 1,169 sources; eight additional articles were identified by the authors. After review, 31 publications were used for qualitative analysis, and of these, 16 were used for quantitative analysis. Qualitative and quantitative analysis found unique patterns of thromboelastography and thromboelastography with platelet mapping parameters in traumatic brain injury patients. Patterns were distinct compared with healthy controls, nontraumatic brain injury trauma patients, and traumatic brain injury subpopulations including those with severe traumatic brain injury or penetrating traumatic brain injury. Abnormal thromboelastography K-time and adenosine diphosphate % inhibition on thromboelastography with platelet mapping are associated with decreased survival after traumatic brain injury. Subgroup meta-analysis of severe traumatic brain injury patients from two randomized controlled trials demonstrated improved survival when using a viscoelastic hemostatic assay-guided resuscitation strategy (odds ratio, 0.39; 95% CI, 0.17-0.91; p = 0.030). CONCLUSIONS: Thromboelastography and thromboelastography with platelet mapping characterize coagulopathy patterns in traumatic brain injury patients. Abnormal thromboelastography profiles are associated with poor outcomes. Conversely, treatment protocols designed to normalize abnormal parameters may be associated with improved traumatic brain injury patient outcomes. Current quality of evidence in this population is low; so future efforts should evaluate viscoelastic hemostatic assay-guided hemostatic resuscitation in larger numbers of traumatic brain injury patients with specific focus on those with traumatic brain injury-associated coagulopathy.

Case Series of Ultrasonic Navigated Osteotomy for the Treatment of Spinal Chordomas.

BACKGROUND: Chordomas present challenges for en bloc surgical resection, which optimally reduces local recurrence and increases patient survival. Navigated ultrasonic osteotomy, also known as piezosurgery, provides a distinct advantage for achieving negative margins after en bloc resection. METHODS: Eight consecutive patients with chordomas (2 cervical, 3 lumbar, and 3 sacral) treated with navigated ultrasonic osteotomy to achieve en bloc resection were identified from our institutional spine tumor database (2016-2019) and retrospectively reviewed. RESULTS: En bloc resection, with negative margins, was achieved in all cases. Two patients (25%) were women, and mean age at surgery was 44 ± 11 years. Median estimated blood loss was 1000 mL (interquartile range: 263-1500 mL). Median length of hospital stay was 10 days (interquartile range: 3-19.5 days). Two patients required a revision procedure. Two patients had complications requiring readmission within the 30-day postoperative window. Mean duration of follow-up for the cohort was 900 ± 554 days. CONCLUSIONS: Navigated ultrasonic osteotomy is an effective surgical technique to achieve en bloc resection of chordomas with negative margins and disease-free survival. To date, this represents the first reported cohort of patients undergoing the procedure as described here. Future studies should include larger sample sizes for more robust clinical outcome data to further elucidate the benefits of piezosurgery for obtaining en bloc chordoma resection.

Role of Race in Short-Term Outcomes for 1700 Consecutive Patients Undergoing Brain Tumor Resection.

BACKGROUND: Access to medical care seems to be impacted by race. However, the effect of race on outcomes, once care has been established, is poorly understood. PURPOSE: This study seeks to assess the influence of race on patient outcomes in a brain tumor surgery population. IMPORTANCE AND RELEVANCE TO HEALTHCARE QUALITY: This study offers insights to if or how quality is impacted based on patient race, after care has been established. Knowledge of disparities may serve as a valuable first step toward risk factor mitigation. METHODS: Patients differing in race, but matched on other outcomes affecting characteristics, were assessed for differences in outcomes subsequent to brain tumor resection. Coarsened exact matching was used to match 1700 supratentorial brain tumor procedures performed over a 6-year period at a single, multihospital academic medical center. Patient outcomes assessed included unplanned readmission, mortality, emergency department (ED) visits, and unanticipated return to surgery. RESULTS: There was no significant difference in readmissions, mortality, ED visits, return to surgery after index admission, or return to surgery within 30 days between the two races. CONCLUSION: This study suggests that race does not independently influence postsurgical outcomes but may instead serve as a proxy for other closely related demographics.

Health related quality of life outcomes following surgery and/or radiation for patients with potentially unstable spinal metastases.

BACKGROUND: Currently there is no prospective pain and health related quality of life (HRQOL) data of patients with potentially unstable spinal metastases who were treated with surgery ± radiation or radiation alone. METHODS: An international prospective cohort multicenter study of patients with potentially unstable spinal metastases, defined by a SINS score 7 to 12, treated with surgery ± radiation or radiotherapy alone was conducted. HRQOL was evaluated with the numeric rating scale (NRS) pain score, the SOSGOQ2.0, the SF-36, and the EQ-5D at baseline and 6, 12, 26, and 52 weeks after treatment. RESULTS: A total of 136 patients were treated with surgery ± radiotherapy and 84 with radiotherapy alone. At baseline, surgically treated patients were more likely to have mechanical pain, a lytic lesion, a greater median Spinal Instability Neoplastic score, vertebral compression fracture, lower performance status, HRQOL, and pain scores. From baseline to 12 weeks post-treatment, surgically treated patients experienced a 3.0-point decrease in NRS pain score (95% CI -4.1 to -1.9, p<.001), and a 12.7-point increase in SOSGOQ2.0 score (95% CI 6.3-19.1, p<.001). Patients treated with radiotherapy alone experienced a 1.4-point decrease in the NRS pain score (95% CI -2.9 to 0.0, p=.046) and a 6.2-point increase in SOSGOQ2.0 score (95% CI -2.0 to 14.5, p=.331). Beyond 12 weeks, significant improvements in pain and HRQOL metrics were maintained up to 52-weeks follow-up in the surgical cohort, as compared with no significant changes in the radiotherapy alone cohort. CONCLUSIONS: Patients treated with surgery demonstrated clinically and statistically significant improvements in pain and HRQOL up to 1-year postsurgery. Treatment with radiotherapy alone resulted in improved pain scores, but these were not sustained beyond 3 months and HRQOL outcomes demonstrated nonsignificant changes over time. Within the SINS potentially unstable group, distinct clinical profiles were observed in patients treated with surgery or radiotherapy alone.

Thoracolumbar Transverse Process Fractures Are More Frequently Associated with Nonspinal Injury than Clinically Significant Spine Fracture.

OBJECTIVE: We studied the risk of associated spinal and nonspinal injuries (NSIs) in the setting of observed thoracolumbar transverse process fracture (TPF) and examined the clinical management of TPF. METHODS: Patients treated at a Level I trauma center over a 5-year period were screened for thoracolumbar TPF. Prevalence of associated spinal fractures and NSIs as well as relationship to level of TPF was explored. Clinical management and follow-up outcomes were reviewed. RESULTS: A total of 252 patients with thoracolumbar TPFs were identified. NSIs were commonly observed (70.6%, n = 178); however, associated spinal fractures were more rarely seen (24.6%, n = 62, P < 0.0001). No patients had neurological deficits attributable to TPFs, and only 3 patients with isolated TPFs were treated with orthosis. Among patients with outpatient follow-up (70.6%, n = 178), none developed delayed-onset neurological deficits or spinal instability. Thoracic TPFs (odds ratio = 3.56, 95% confidence interval = 1.20-10.56) and L1 TPFs (odds ratio = 2.48, 95% confidence interval = 1.41-4.36) were predictive of associated thoracic NSIs. L5 TPF was associated with pelvic fractures (odds ratio = 6.30, 95% confidence interval = 3.26-12.17). There was no difference in rate of NSIs between isolated TPF (70.0%) and TPF with associated clinically relevant spinal fracture (72.6%, P = 0.70). CONCLUSIONS: NSIs are nearly 3 times more common in patients with thoracolumbar TPFs than associated clinically relevant spinal fractures. Spine service consultation for TPF may be unnecessary unless fracture is associated with a clinically relevant spinal injury, which represents a minority of cases. However, detection of TPF should raise suspicion for high likelihood of associated NSIs.

Development of an Intraoperative Pipeline for Holographic Mixed Reality Visualization During Spinal Fusion Surgery.

Objective. Holographic mixed reality (HMR) allows for the superimposition of computer-generated virtual objects onto the operator's view of the world. Innovative solutions can be developed to enable the use of this technology during surgery. The authors developed and iteratively optimized a pipeline to construct, visualize, and register intraoperative holographic models of patient landmarks during spinal fusion surgery. Methods. The study was carried out in two phases. In phase 1, the custom intraoperative pipeline to generate patient-specific holographic models was developed over 7 patients. In phase 2, registration accuracy was optimized iteratively for 6 patients in a real-time operative setting. Results. In phase 1, an intraoperative pipeline was successfully employed to generate and deploy patient-specific holographic models. In phase 2, the registration error with the native hand-gesture registration was 20.2 ± 10.8 mm (n = 7 test points). Custom controller-based registration significantly reduced the mean registration error to 4.18 ± 2.83 mm (n = 24 test points, P < .01). Accuracy improved over time (B = -.69, P < .0001) with the final patient achieving a registration error of 2.30 ± .58 mm. Across both phases, the average model generation time was 18.0 ± 6.1 minutes (n = 6) for isolated spinal hardware and 33.8 ± 8.6 minutes (n = 6) for spinal anatomy. Conclusions. A custom pipeline is described for the generation of intraoperative 3D holographic models during spine surgery. Registration accuracy dramatically improved with iterative optimization of the pipeline and technique. While significant improvements and advancements need to be made to enable clinical utility, HMR demonstrates significant potential as the next frontier of intraoperative visualization.