Aspin: neurosurgical aspirin intervention prognostic study - perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial.

RATIONALE: Aspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events. OBJECTIVE: The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared with the current policy of perioperative discontinuation of aspirin. STUDY DESIGN: A randomized controlled trial with two parallel groups of 277 cases (554 in total). STUDY POPULATION: Patients undergoing low complex lumbar spinal surgery and using aspirin. All patients are aged >18 years. INTERVENTION: Peri-operative continuation of aspirin. STUDY OUTCOMES: Primary study outcome: composite of the following bleeding complications: Neurological deterioration as a result of hemorrhage in the surgical area with cauda and/or nerve root compression. Post-surgical anemia with hemoglobin level lower than 5 mmol/l, requiring transfusion. Subcutaneous hematoma leading to wound leakage and pain higher than NRS=7. Major and/or minor hemorrhage in any other body system according to the definition of the International Society on Thrombosis and Haemostasis bleeding scale. Secondary study outcomes: Each of the individual components of the primary outcome Absolute mean difference in operative blood loss between the study arms Thrombo-embolic-related complications: Myocardial infarction Venous thromboembolism Stroke Arterial thromboembolism FURTHER STUDY OUTCOMES: Anticoagulant treatment satisfaction by the Anti-Clot Treatment Scale (ACTS) and general health by the Patient-Reported Outcomes Measurement Information System (PROMIS Global-10) in the pre- and postoperative phase. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study imposes no additional risk to patients. Currently, there is no consensus on whether or not aspirin should be discontinued before cranial or spinal surgery. Currently, aspirin is typically discontinued in cranial and spinal surgery, because of a potential increased risk of hemorrhagic complication. An argument not based on a clinical trial. However, this policy might delay surgical procedures or carry the risk of resulting in an increase in cardiac and neurologic thrombotic perioperative events. It is unclear if the possibility of an increase in hemorrhage-related complications outweighs the risk of an increase in cardiac and neurologic thrombotic perioperative events. Furthermore, the Data Safety Monitoring Board (DSMB) will be asked for safety analysis by monitoring the study. There are no further disadvantages to participating in this study. Outcome measurements are recorded during admission and regular outpatient visits, and thus, do not require additional visits to the hospital.

Dexamethasone versus Surgery for Chronic Subdural Hematoma.

BACKGROUND: The role of glucocorticoids without surgical evacuation in the treatment of chronic subdural hematoma is unclear. METHODS: In this multicenter, open-label, controlled, noninferiority trial, we randomly assigned symptomatic patients with chronic subdural hematoma in a 1:1 ratio to a 19-day tapering course of dexamethasone or to burr-hole drainage. The primary end point was the functional outcome at 3 months after randomization, as assessed by the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]). Noninferiority was defined by a lower limit of the 95% confidence interval of the odds ratio for a better functional outcome with dexamethasone than with surgery of 0.9 or more. Secondary end points included scores on the Markwalder Grading Scale of symptom severity and on the Extended Glasgow Outcome Scale. RESULTS: From September 2016 through February 2021, we enrolled 252 patients of a planned sample size of 420; 127 were assigned to the dexamethasone group and 125 to the surgery group. The mean age of the patients was 74 years, and 77% were men. The trial was terminated early by the data and safety monitoring board owing to safety and outcome concerns in the dexamethasone group. The adjusted common odds ratio for a lower (better) score on the modified Rankin scale at 3 months with dexamethasone than with surgery was 0.55 (95% confidence interval, 0.34 to 0.90), which failed to show noninferiority of dexamethasone. The scores on the Markwalder Grading Scale and Extended Glasgow Outcome Scale were generally supportive of the results of the primary analysis. Complications occurred in 59% of the patients in the dexamethasone group and 32% of those in the surgery group, and additional surgery was performed in 55% and 6%, respectively. CONCLUSIONS: In a trial that involved patients with chronic subdural hematoma and that was stopped early, dexamethasone treatment was not found to be noninferior to burr-hole drainage with respect to functional outcomes and was associated with more complications and a greater likelihood of later surgery. (Funded by the Netherlands Organization for Health Research and Development and others; DECSA EudraCT number, 2015-001563-39.).

Predicting Motor Outcome and Quality of Life After Subthalamic Deep Brain Stimulation for Parkinson's Disease: The Role of Standard Screening Measures and Wearable-Data.

BACKGROUND: Standardized screening for subthalamic deep brain stimulation (STN DBS) in Parkinson's disease (PD) patients is crucial to determine eligibility, but its utility to predict postoperative outcomes in eligible patients is inconclusive. It is unknown whether wearable data can contribute to this aim. OBJECTIVE: To evaluate the utility of universal components incorporated in the DBS screening, complemented by a wearable sensor, to predict motor outcomes and Quality of life (QoL) one year after STN DBS surgery. METHODS: Consecutive patients were included in the OPTIMIST cohort study from two DBS centers. Standardized assessments included a preoperative Levodopa Challenge Test (LCT), and questionnaires on QoL and non-motor symptoms including cognition, psychiatric symptoms, impulsiveness, autonomic symptoms, and sleeping problems. Moreover, an ambulatory wearable sensor (Parkinson Kinetigraph (PKG)) was used. Postoperative assessments were similar and also included a Stimulation Challenge Test to determine DBS effects on motor function. RESULTS: Eighty-three patients were included (median (interquartile range) age 63 (56-68) years, 36% female). Med-OFF (Stim-OFF) motor severity deteriorated indicating disease progression, but patients significantly improved in terms of Med-ON (Stim-ON) motor function, motor fluctuations, QoL, and most non-motor domains. Motor outcomes were not predicted by preoperative tests, including covariates of either LCT or PKG. Postoperative QoL was predicted by better preoperative QoL, lower age, and more preoperative impulsiveness scores in multivariate models. CONCLUSION: Data from the DBS screening including wearable data do not predict postoperative motor outcome at one year. Post-DBS QoL appears primarily driven by non-motor symptoms, rather than by motor improvement.

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year: The FACET Randomized Clinical Trial.

Importance: The choice between posterior cervical foraminotomy (posterior surgery) and anterior cervical discectomy with fusion (anterior surgery) for cervical foraminal radiculopathy remains controversial. Objective: To investigate the noninferiority of posterior vs anterior surgery in patients with cervical foraminal radiculopathy with regard to clinical outcomes after 1 year. Design, Setting, and Participants: This multicenter investigator-blinded noninferiority randomized clinical trial was conducted from January 2016 to May 2020 with a total follow-up of 2 years. Patients were included from 9 hospitals in the Netherlands. Of 389 adult patients with 1-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomized (132 to posterior and 133 to anterior), 15 were lost to follow-up and 228 were included in the 1-year analysis (110 in posterior and 118 in anterior). Interventions: Patients were randomly assigned 1:1 to posterior foraminotomy or anterior cervical discectomy with fusion. Main Outcomes and Measures: Primary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%). Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with 2-proportion z tests at 1-sided .05 significance levels with Bonferroni corrections. Results: Among 265 included patients, the mean (SD) age was 51.2 (8.3) years; 133 patients (50%) were female and 132 (50%) were male. Patients were randomly assigned to posterior (132) or anterior (133) surgery. The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, -0.11 percentage points; 1-sided 95% CI, -0.01) and the between-group difference in arm pain was -2.8 (1-sided 95% CI, -9.4) at 1-year follow-up, indicating noninferiority of posterior surgery. Decrease in arm pain had a between-group difference of 3.4 (1-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had 2-sided 95% CIs clustered around 0 with small between-group differences. Conclusions and Relevance: In this randomized clinical trial, posterior surgery was noninferior to anterior surgery for patients with cervical radiculopathy regarding success rate and arm pain at 1 year. Decrease in arm pain and secondary outcomes had small between-group differences. These results may be used to enhance shared decision-making. Trial Registration: Netherlands Trial Register Identifier: NTR5536.

Surgery After Primary Dexamethasone Treatment for Patients with Chronic Subdural Hematoma-A Retrospective Study.

BACKGROUND: We aimed to quantify the need for additional surgery in patients with chronic subdural hematoma (CSDH) primarily treated with dexamethasone and to identify patient characteristics associated with additional surgery. METHODS: Data were retrospectively collected from 283 patients with CSDH, primarily treated with dexamethasone, in 3 hospitals from 2008 to 2018. Primary outcome was the need for additional surgery. The association between baseline characteristics and additional surgery was analyzed with univariable and multivariable logistic regression analysis and presented as adjusted odds ratios (aOR). RESULTS: In total, 283 patients with CSDH were included: 146 patients (51.6%) received 1 dexamethasone course (DXM group), 30 patients (10.6%) received 2 dexamethasone courses (DXM-DXM group), and 107 patients (37.8%) received additional surgery (DXM-SURG group). Patients who underwent surgery more often had a Markwalder Grading Scale of 2 (as compared with 1, aOR 2.05; 95% confidence interval [CI] 0.90-4.65), used statins (aOR 2.09; 95% CI 1.01-4.33), had a larger midline shift (aOR 1.10 per mm; 95% CI 1.01-1.21) and had larger hematoma thickness (aOR 1.16 per mm; 95% CI 1.09-1.23), had a bilateral hematoma (aOR 1.85; 95% CI 0.90-3.79), and had a separated hematoma (as compared with homogeneous, aOR 1.77; 95% CI 0.72-4.38). Antithrombotics (aOR 0.45; 95% CI 0.21-0.95) and trabecular hematoma (as compared with homogeneous, aOR 0.31; 95% CI 0.12-0.77) were associated with a lower likelihood of surgery. CONCLUSIONS: More than one-third of patients with CSDH primarily treated with dexamethasone received additional surgery. These patients were more severely affected amongst others with larger hematomas.

National survey on the current practice and attitudes toward the management of chronic subdural hematoma.

BACKGROUND: Chronic subdural hematoma (CSDH) is a frequent pathological entity in daily clinical practice. However, evidence-based CSDH-guidelines are lacking and level I evidence from randomized clinical trials (RCTs) is limited. In order to establish and subsequently implement a guideline, insight into current clinical practice and attitudes toward CSDH-treatment is required. The aim is to explore current practice and attitudes toward CSDH-management in the Netherlands. METHODS: A national online survey was distributed among Dutch neurologists and neurosurgeons, examining variation in current CSDH-management through questions on treatment options, (peri)operative management, willingness to adopt new treatments and by presenting four CSDH-cases. RESULTS: One hundred nineteen full responses were received (8% of neurologists, N = 66 and 35% of neurosurgeons, N = 53). A majority of the respondents had a positive experience with burr-hole craniostomy (93%) and with a conservative policy (56%). Around a third had a positive experience with the use of dexamethasone as primary (30%) and additional (33.6%) treatment. These numbers were also reflected in the treatment preferences in the presented cases. (Peri)operative management corresponded among responding neurosurgeons. Most respondents would be willing to implement dexamethasone (98%) if equally effective as surgery and tranexamic acid (93%) if effective in CSDH-management. CONCLUSION: Variation was found regarding preferential CSDH-treatment. However, this is considered not to be insurmountable when implementing evidence-based treatments. This baseline inventory on current clinical practice and current attitudes toward CSDH-treatment is a stepping-stone in the eventual development and implementation of a national guideline.

Case report: Anterior midline decompression of a cervical epidural abscess: Technical note and case series of seven patients.

Background: A spinal epidural abscess (SEA) of the cervical spine is a relatively rare disease and is generally characterized by progressive neurological deterioration due to compression of the spinal cord. Up to 40% of cervical SEAs are located ventrally of the spinal cord. Urgent surgical intervention is warranted to decompress the spinal cord and collect material for cultures to guide antibiotic treatment. However, the optimal timing of the intervention is unclear, and the associated risk of spinal instability in the presence of an extensive infection is a significant clinical dilemma. Methods: In this paper, we present a novel surgical technique to treat a cervical SEA by anterior decompression through a linear transvertebral midline approach. This technique has the advantage of effectively draining the ventrally located SEA and obtaining material for bacteria culture while maintaining spinal stability without additional instrumentation. Results: This case study presents seven patients with cervical SEAs who were successfully treated with surgical decompression by this transvertebral linear midline technique and antibiotic treatment. Conclusion: Anterior decompression through a linear transvertebral midline approach for a ventrally located cervical SEA is a safe and pragmatic surgical procedure to achieve spinal cord decompression and collect bacteria culture without destabilizing the cervical spine.

[Chronic subdural hematoma: A variable clinical picture that asks for tailored treatment]. / Het chronisch subduraal hematoom.

A chronic subdural hematoma is a common neurological disorder that occurs mainly in the elderly. The inciting event is often a minor head trauma and subsequent inflammation may play a role in the pathogenesis. The clinical spectrum can present heterogeneously, and symptom onset and progression can vary from days to weeks. To date surgical evacuation of the subdural collection remains the main treatment approach for symptomatic patients. Evidence is still scarce for dexamethasone as an effective primary conservative treatment strategy. Future research is necessary to elucidate the effect of various pharmacological therapies compared to primary surgery on functional outcome.

Radiological prognostic factors of chronic subdural hematoma recurrence: a systematic review and meta-analysis.

PURPOSE: Chronic subdural hematoma (CSDH) is associated with high recurrence rates. Radiographic prognostic factors may identify patients who are prone for recurrence and who might benefit further optimization of therapy. In this meta-analysis, we systematically evaluated pre-operative radiological prognostic factors of recurrence after surgery. METHODS: Electronic databases were searched until September 2020 for relevant publications. Studies reporting on CSDH recurrence in symptomatic CSDH patients with only surgical treatment were included. Random or fixed effects meta-analysis was used depending on statistical heterogeneity. RESULTS: Twenty-two studies were identified with a total of 5566 patients (mean age 69 years) with recurrence occurring in 801 patients (14.4%). Hyperdense components (hyperdense homogeneous and mixed density) were the strongest prognostic factor of recurrence (pooled RR 2.83, 95% CI 1.69-4.73). Laminar and separated architecture types also revealed higher recurrence rates (RR 1.37, 95% CI 1.04-1.80 and RR 1.76 95% CI 1.38-2.16, respectively). Hematoma thickness and midline shift above predefined cut-off values (10 mm and 20 mm) were associated with an increased recurrence rate (RR 1.79, 95% CI 1.45-2.21 and RR 1.38, 95% CI 1.11-1.73, respectively). Bilateral CSDH was also associated with an increased recurrence risk (RR 1.34, 95% CI 0.98-1.84). LIMITATIONS: Limitations were no adjustments for confounders and variable data heterogeneity. Clinical factors could also be predictive of recurrence but are beyond the scope of this study. CONCLUSIONS: Hyperdense hematoma components were the strongest prognostic factor of recurrence after surgery. Awareness of these findings allows for individual risk assessment and might prompt clinicians to tailor treatment measures.

Prevalence of Cognitive Complaints and Impairment in Patients with Chronic Subdural Hematoma and Recovery after Treatment: A Systematic Review.

Chronic subdural hematoma (CSDH) is a frequently occurring neurological disease associated with older age and use of anticoagulants. Symptoms vary from headaches to coma, but cognitive deficits can also be present. However, exact prevalence and severity of cognitive deficits in CSDH are still unknown. In this systematic review, we aim to assess cognitive status of patients with CSDH, at presentation and after treatment. PubMed, Embase and PsycInfo were searched for articles concerning cognition in CSDH. We divided cognitive changes into subjective cognitive deficit (cognitive complaints [CC]) and objective cognitive deficit (cognitive impairment [CI]). Two reviewers independently selected studies for inclusion and subsequently extracted data. Quality assessment was done by means of the Newcastle-Ottawa Scale. Reported prevalence of CC and CI was pooled with random effects meta-analysis. Out of 799 identified references, 22 met inclusion criteria. Twenty-one articles reported on prevalence of CC/CI and one study reported solely on CSDH patients with cognitive deficit. Estimated pooled prevalence of both CC and CI in CSDH at presentation was 45% (95% confidence interval [CI]: 36-54%). Four studies concerned a prospective evaluation of the effect of surgical treatment on cognition. These proved to be of fair to good quality after quality assessment. The estimated pre-treatment prevalence of objectified cognitive impairment was 61% (95% CI: 51-70%) decreasing to 18% (95% CI: 8-32%) post-surgery. From this review it can be concluded that CC and CI are very common in CSDH, with a tendency to improve after treatment. Therefore, we underline the importance of increased attention to cognitive status of these patients, with proper testing methods and treatment-testing intervals.

Neurosurgical and Perioperative Management of Chronic Subdural Hematoma.

Objective: Surgery and specifically burr hole craniostomy is the most common first choice treatment of patients with Chronic Subdural Hematoma (CSDH). However, several aspects of neurosurgical and peri-operative management are still a subject of research, such as how to treat bilateral CSDH and the anesthetic approach. We aim to investigate the effect of the surgical approach to bilateral CSDH and the effect of anesthesia modality on outcome of CSDH patients. Methods: We retrospectively included surgically treated CSDH patients between 2005 and 2019 in three hospitals in the Netherlands. The effect of the surgical approach to bilateral CSDH (unilateral vs. bilateral decompression) and anesthesia modality (general vs. local anesthesia) on outcome (complications, recurrence, and length of hospital stay over 4 days) was studied with logistic regression adjusting for potentially confounding radiological and clinical characteristics. Results: Data of 1,029 consecutive patients were analyzed, mean age was 73.5 years (±11) and 75% of patients were male. Bilateral CSDH is independently associated with an increased risk of recurrence within 3 months in logistic regression analysis (aOR 1.7, 95% CI: 1.1-2.5) but recurrence rate did not differ between primary bilateral or unilateral decompression of bilateral CSDH. (15 vs. 17%, p = 0.775). Logistic regression analysis showed that general anesthesia was independently associated with an increased risk of complications (aOR 1.8, 95% CI: 1.0-3.3) and with a length of hospital admission of over 4 days (aOR 8.4, 95% CI: 5.6-12.4). Conclusions: Bilateral CSDH is independently associated with higher recurrence rates. As recurrence rates in bilateral CSDH are similar for different surgical approaches, the optimal choice for primary bilateral decompression of bilateral CSDH could vary per patient. General anesthesia for surgical treatment of CSDH is associated with higher complication rates and longer hospital admission.

Dexamethasone Therapy in Symptomatic Chronic Subdural Hematoma (DECSA-R): A Retrospective Evaluation of Initial Corticosteroid Therapy versus Primary Surgery.

Worldwide, different strategies are being applied for symptomatic chronic subdural hematoma (CSDH). The aim of this study was to evaluate the efficacy of two treatment strategies for symptomatic CSDH: initial dexamethasone (DXM) therapy versus primary surgery by burr hole craniostomy (BHC). We retrospectively collected data for 120 symptomatic CSDH patients in two neurotrauma centers between 2014 and 2016, each with their own treatment protocol. Sixty patients received primary BHC (center A), and another 60 initial DXM therapy (center B). Primary outcome was evaluated by dichotomized modified Rankin Scale (mRS) score (0-3 and 4-6) and Markwalder Grading Scale (MGS) score at 3 months. Secondary outcomes were additional interventions, CSDH recurrence, mortality, complications, and duration of hospital stay. Baseline characteristics were similar in both groups. At 3 months, a favorable mRS score (0-3) was observed in 70% and 76% of patients in cohort A and B, respectively (odds ratio [OR] 0.77, 95% CI 0.30-1.98; p = 0.59). A favorable MGS score (0-1) was observed in 96% of patients in both groups (OR 0.98, 95% CI 0.45-2.15; p = 0.95). CSDH recurrence was 12% in cohort A and 22% in cohort B (p = 0.15). Mortality was 10% in both cohorts. In cohort B, additional surgery was performed in 83% at a median of 6 days, and significantly more patients had complications (55% vs. 35%, p = 0.02), a prolonged hospitalization (10 vs. 5 days; p = 0.02), and one or more follow-up cranial CT's (85% vs. 48%; p < 0.001). To achieve a favorable clinical outcome, initial DXM therapy was associated with a high rate of crossover to surgery, significantly longer overall hospital stay, and more complications compared with primary surgery.

Between-hospital variation in mortality and survival after glioblastoma surgery in the Dutch Quality Registry for Neuro Surgery.

PURPOSE: Standards for surgical decisions are unavailable, hence treatment decisions can be personalized, but also introduce variation in treatment and outcome. National registrations seek to monitor healthcare quality. The goal of the study is to measure between-hospital variation in risk-standardized survival outcome after glioblastoma surgery and to explore the association between survival and hospital characteristics in conjunction with patient-related risk factors. METHODS: Data of 2,409 adults with first-time glioblastoma surgery at 14 hospitals were obtained from a comprehensive, prospective population-based Quality Registry Neuro Surgery in The Netherlands between 2011 and 2014. We compared the observed survival with patient-specific risk-standardized expected early (30-day) mortality and late (2-year) survival, based on age, performance, and treatment year. We analyzed funnel plots, logistic regression and proportional hazards models. RESULTS: Overall 30-day mortality was 5.2% and overall 2-year survival was 13.5%. Median survival varied between 4.8 and 14.9 months among hospitals, and biopsy percentages ranged between 16 and 73%. One hospital had lower than expected early mortality, and four hospitals had lower than expected late survival. Higher case volume was related with lower early mortality (P = 0.031). Patient-related risk factors (lower age; better performance; more recent years of treatment) were significantly associated with longer overall survival. Of the hospital characteristics, longer overall survival was associated with lower biopsy percentage (HR 2.09, 1.34-3.26, P = 0.001), and not with academic setting, nor with case volume. CONCLUSIONS: Hospitals vary more in late survival than early mortality after glioblastoma surgery. Widely varying biopsy percentages indicate treatment variation. Patient-related factors have a stronger association with overall survival than hospital-related factors.

Corticosteroid treatment compared with surgery in chronic subdural hematoma: a systematic review and meta-analysis.

BACKGROUND: There is an ongoing debate on the role of corticosteroids in the treatment of chronic subdural hematoma (CSDH). This study aims to evaluate the effectiveness of corticosteroids for the treatment of CSDH compared to surgery. METHOD: A systematic search was performed in relevant databases up to January 2019 to identify RCTs or observational studies that compared at least two of three treatment modalities: the use of corticosteroids as a monotherapy (C), corticosteroids as an adjunct to surgery (CS), and surgery alone (S). Outcome measures were good neurological outcome, need for reintervention, mortality, and complications. Effect estimates were pooled and presented as relative risk (RR) with 95% confidence interval (95%CI). RESULTS: Of 796 initially identified studies, 7 were included in the meta-analysis. Risk of bias was generally high. There were no differences in good neurological outcome between treatment modalities. The need for reintervention varied between 4 and 58% in C, 4-12% in CS, and 7-26% in S. The need for reintervention was lower in CS compared with C (RR 3.34 [95% CI 1.53-7.29]; p < 0.01) and lower in CS compared with S (RR 0.44 [95% CI 0.27-0.72]; p < 0.01). Mortality varied between 0 and 4% in C, 0-13% in CS, and 0-44% in S. Mortality was lower in CS compared with S (RR 0.39 [95% CI 0.25-0.63]; p < 0.01). There were no differences in complications between treatment modalities. CONCLUSIONS: This meta-analysis suggests that the addition of corticosteroids to surgery might be effective in the treatment of CSDH. However, the results must be interpreted with caution in light of the serious risk of bias of the included studies. This study stresses the need for large randomized trials to investigate the use of corticosteroids in the management of CSDH.

Impact of Early (<24 h) Surgical Decompression on Neurological Recovery in Thoracic Spinal Cord Injury: A Meta-Analysis.

The impact of surgical timing in neurological recovery in thoracic and thoracolumbar traumatic spinal cord injury (tSCI) is still a subject of discussion. While in cervical tSCI one may expect a beneficial effect of early intervention within 24 h, especially in complete cases, this has not yet been demonstrated clearly for thoracic tSCI. This study addresses neurological improvement after early and late surgery for thoracic and thoracolumbar tSCI. A systematic search retrieved 14 publications of observational studies reporting outcome measurements after surgery in 1075 patients with thoracic and thoracolumbar tSCI from PubMed and Embase databases. Surgery was considered early within 24 h and late thereafter. An improvement of at least one and two grades on the American Spinal Injury Association Impairment Scale (ASIA) was evaluated. The Meta-Analyses and Systematic Reviews of Observational Studies guidelines were followed. Improvement rates were summarized using individual patient data in a Bayesian random effects model and compared for those with early and late surgery. In the qualitative analysis, six of seven studies, which investigated the effect of surgical timing, observed a significant effect of early surgery on at least one ASIA grade improvement. Quantitative analysis in 948 patients with thoracic and thoracolumbar tSCI data, however, did not reveal a significant increase in odds of ≥1 ASIA grade recovery in early surgery (66.8% [95% confidence interval (CI): 45.0-87.8%] compared with late surgery (48.9% [95% CI: 25.1-70.7%; odds ratio (OR) 2.2 (95% CI: 0.6-14.0]). This study did not observe a significant beneficial effect of surgical decompression within 24 h in patients with thoracic and thoracolumbar tSCI.

Selective intradural dorsal rhizotomy for persistent radicular leg pain: a contemporary series.

BACKGROUND: Lumbar disc surgery for radicular leg pain is one of the most frequently performed spine procedures. In approximately 20% of patients poor outcome is achieved. The most complex cases have persistent leg pain without residual nerve root compression. Treatment for refractory cases is limited to medical pain management, spinal cord stimulation (SCS), and dorsal root ganglion stimulation. For the latter two, fair to good results are obtained in only 50% of patients and costs and complication rates are high. An alternative surgical procedure is selective intradural dorsal rhizotomy (SIDR). This procedure has been largely abandoned, likely due to poor historic results and readily available modern alternatives. PURPOSE: The goal of this paper is to report our results for SIDR for persistent monoradicular leg pain without residual nerve root compression and to compare the results with those of SCS. STUDY DESIGN: Prospectively followed case series. PATIENT SAMPLE: Consecutive patients with persistent monoradicular leg pain without residual nerve root compression. OUTCOME MEASURES: Visual Analogue Scale (VAS) for leg pain, Roland Disability Questionnaire, and Likert Scale for leg pain were recorded. Complications were documented and patients were asked if, in retrospect, they would undergo the procedure again. METHODS: In Haaglanden Medical Center, SIDR was performed on eight consecutive patients with persistent monoradicular leg pain without residual nerve root compression between December 2013 and September 2017. Patients were followed prospectively and VAS for leg pain, Roland Disability Questionnaire (RDQ), and Likert Scale for leg pain were recorded at intake, 8 weeks and 1 year after surgery and yearly after that. Minimal clinically important differences (MCID) for VAS and RDQ were predefined. Means and ranges were calculated and due to the small sample size further analysis was limited to descriptive analysis. RESULTS: Mean follow-up was 20 months. VAS for leg pain improved from 80 mm at intake to 34 mm at latest follow-up. Five out of eight patients (63%) had good Likert Scale outcome (complete or near complete recovery of leg pain). Patients scored 19, 5 on the RDQ at intake and 12, 7 at the end of follow-up. Four patients (57%) reached a MCID for VAS at 1 year post surgery and one reached borderline MCID. Five patients (71%) reached a MCID for RDQ at 1 year post surgery. Six patients (75%) would undergo the procedure again. CONCLUSIONS: SIDR is a safe and effective procedure in strictly selected patients with persistent monoradicular leg pain without residual nerve root compression. Considering the high costs and complication rates of SCS, the results of this study warrant a randomized controlled trial comparing the cost-effectiveness of SIDR and SCS.

Early Surgical Decompression Improves Neurological Outcome after Complete Traumatic Cervical Spinal Cord Injury: A Meta-Analysis.

In patients with traumatic spinal cord injury (tSCI) a distinction in surgical urgency is made on the basis of the severity of the initial neurological injury. The optimal timing of surgical decompression, as well as its impact on neurological recovery, is as of yet undetermined. This study addresses neurological improvement after early and late surgery for complete and incomplete cervical tSCI. A systematic search retrieved 15 publications of observational studies reporting outcome measurements after surgery in 1126 patients with cervical tSCI from PubMed and Embase databases. Surgery was considered early within 24 h, and late thereafter. An improvement of at least two grades on the American Spinal Injury Association (ASIA) scale was considered clinically meaningful. The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were followed. Improvement rates were summarized using individual patient data in a Bayesian random effects model and compared for those with complete and incomplete tSCI after early and late surgery. In patients with complete cervical tSCI (n = 422), improvement was more frequent after early surgery than after late surgery (respectively, 22.6%, 95% credibility interval [CI]: 16.6-28.7% and 10.4%, 95% CI: 5.6-15.8%; odds ratio [OR] 2.6 [95% CI: 1.4-5.1]). Whereas in patients with incomplete cervical tSCI (n = 636), improvement was similar between early and late surgery (respectively 30.4%, 95% CI: 19.8-41.6% and 32.5%, 95% CI: 21.4-45.8%; OR 0.9 [95% CI: 0.4-1.9]). These data suggest a paradigm shift in the treatment of patients with complete cervical tSCI, as surgical decompression within 24 h is more frequently associated with clinically meaningful improvement. In incomplete cervical tSCI, neurological outcome is similar between early and late surgery.

Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial.

BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurological disease with a rapidly rising incidence due to increasing age and widespread use of anticoagulants. Surgical intervention by burr-hole craniotomy (BHC) is the current standard practice for symptomatic patients, but associated with complications, a recurrence rate of up to 30% and increased mortality. Dexamethasone (DXM) therapy is, therefore, used as a non-surgical alternative but considered to achieve a lower success rate. Furthermore, the benefit of DXM therapy appears much more deliberate than the immediate relief from BHC. Lack of evidence and clinical equipoise among caregivers prompts the need for a head-to-head randomised controlled trial. The objective of this study is to compare the effect of primary DXM therapy versus primary BHC on functional outcome and cost-effectiveness in symptomatic patients with CSDH. METHODS/DESIGN: This study is a prospective, multicentre, randomised controlled trial (RCT). Consecutive patients with a CSDH with a Markwalder Grading Scale (MGS) grade 1 to 3 will be randomised to treatment with DXM or BHC. The DXM treatment scheme will be 16 mg DXM per day (8 mg twice daily, days 1 to 4) which is then halved every 3 days until a dosage of 0.5 mg a day on day 19 and stopped on day 20. If the treatment response is insufficient (i.e. persistent or progressive symptomatology due to insufficient haematoma resolution), additional surgery can be performed. The primary outcomes are the functional outcome by means of the modified Rankin Scale (mRS) score at 3 months and cost-effectiveness at 12 months. Secondary outcomes are quality of life at 3 and 12 months using the Short Form Health Survey (SF-36) and Quality of Life after Brain Injury Overall Scale (QOLIBRI), haematoma thickness after 2 weeks on follow-up computed tomography (CT), haematoma recurrence during the first 12 months, complications and drug-related adverse events, failure of therapy within 12 months after randomisation and requiring intervention, mortality during the first 3 and 12 months, duration of hospital stay and overall healthcare and productivity costs. To test non-inferiority of DXM therapy compared to BHC, 210 patients in each treatment arm are required (assumed adjusted common odds ratio DXM compared to BHC 1.15, limit for inferiority < 0.9). The aim is to include a total of 420 patients in 3 years with an enrolment rate of 60%. DISCUSSION: The present study should demonstrate whether treatment with DXM is as effective as BHC on functional outcome, at lower costs. TRIAL REGISTRATION: EUCTR 2015-001563-39 . Date of registration: 29 March 2015.

Pathophysiology and Nonsurgical Treatment of Chronic Subdural Hematoma: From Past to Present to Future.

BACKGROUND: Chronic subdural hematoma (CSDH) is one of the more frequent pathologic entities in daily neurosurgical practice. Historically, CSDH was considered progressive recurrent bleeding with a traumatic cause. However, recent evidence has suggested a complex intertwined pathway of inflammation, angiogenesis, local coagulopathy, recurrent microbleeds, and exudates. The aim of the present review is to collect existing data on pathophysiology of CSDH to direct further research questions aiming to optimize treatment for the individual patient. METHODS: We performed a thorough literature search in PubMed, Ovid, EMBASE, CINAHL, and Google scholar, focusing on any aspect of the pathophysiology and nonsurgical treatment of CSDH. RESULTS: After a (minor) traumatic event, the dural border cell layer tears, which leads to the extravasation of cerebrospinal fluid and blood in the subdural space. A cascade of inflammation, impaired coagulation, fibrinolysis, and angiogenesis is set in motion. The most commonly used treatment is surgical drainage. However, because of the pathophysiologic mechanisms, the mortality and high morbidity associated with surgical drainage, drug therapy (dexamethasone, atorvastatin, tranexamic acid, or angiotensin-converting enzyme inhibitors) might be a beneficial alternative in many patients with CSDH. CONCLUSIONS: Based on pathophysiologic mechanisms, animal experiments, and small patient studies, medical treatment may play a role in the treatment of CSDH. There is a lack of level I evidence in the nonsurgical treatment of CSDH. Therefore, randomized controlled trials, currently lacking, are needed to assess which treatment is most effective in each individual patient.