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... Show moreBACKGROUND 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]). Non-inferiority 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 burrhole 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.) Show less
Willems, Y.R.; Gaag, N.A. van der; Kho, K.H.; Tveiten, O.V.; Krnger, M.T.; Jakobs, M.; ESSFN Young Functional Neurosurg 2023
Introduction: The success of deep brain stimulation (DBS) treatment depends on several factors, including proper patient selection, accurate electrode placement, and adequate stimulation settings.... Show moreIntroduction: The success of deep brain stimulation (DBS) treatment depends on several factors, including proper patient selection, accurate electrode placement, and adequate stimulation settings. Another factor that may impact long-term satisfaction and therapy outcomes is the type of implantable pulse generator (IPG) used: rechargeable or non-rechargeable. However, there are currently no guidelines on the choice of IPG type. The present study investigates the current practices, opinions, and factors DBS clinicians consider when choosing an IPG for their patients.Methods: Between December 2021 and June 2022, we sent a structured questionnaire with 42 questions to DBS experts of two international, functional neurosurgery societies. The questionnaire included a rating scale where participants could rate the factors influencing their choice of IPG type and their satisfaction with certain IPG aspects. Additionally, we presented four clinical case scenarios to assess preference of choice of IPG-type in each case.Results: Eighty-seven participants from 30 different countries completed the questionnaire. The three most relevant factors for IPG choice were "existing social support," "cognitive status," and "patient age." Most participants believed that patients valued avoiding repetitive replacement surgeries more than the burden of regularly recharging the IPG. Participants reported that they implanted the same amount of rechargeable as non-rechargeable IPGs for primary DBS insertions and 20% converted non-rechargeable to rechargeable IPGs during IPG replacements. Most participants estimated that rechargeable was the more cost-effective option.Conclusion: This present study shows that the decision-making of the choice of IPG is very individualized. We identified the key factors influencing the physician's choice of IPG. Compared to patient-centric studies, clinicians may value different aspects. Therefore, clinicians should rely not only on their opinion but also counsel patients on different types of IPGs and consider the patient's preferences. Uniform global guidelines on IPG choice may not represent regional or national differences in the healthcare systems. Show less
Blaauw, J.; Hertog, H.M.D.; Holl, D.C.; Thuss, N.S.; Gaag, N.A. van der; Jellema, K.; ... ; Naalt, J. van der 2023
ObjectiveChronic subdural hematoma (CSDH) is a common neurological condition, often affecting the elderly. Cognitive impairment is frequently observed at presentation. However, the course and... Show moreObjectiveChronic subdural hematoma (CSDH) is a common neurological condition, often affecting the elderly. Cognitive impairment is frequently observed at presentation. However, the course and longer term aspects of the cognitive status of CSDH patients are unknown. In this study, we aim to explore the cognitive status of CSDH patients after treatment.MethodsAn exploratory study in which CSDH patients were assessed 3 months after treatment and compared to healthy controls. A total of 56 CSDH patients (age 72.1 SD +/- 10.8 years with 43 [77%] males) and 60 healthy controls were included (age 67.5 +/- SD 4.8 with 34 [57%] males). Cognitive testing was performed using the Telephonic Interview of Cognitive Status-modified (TICS-m), a 12-item questionnaire in which a total of 50 points can be obtained on several cognitive domains.ResultsMedian time between treatment and cognitive testing was 93 days (range 76-139). TICS-m scores of CSDH patients were significantly lower than healthy controls, after adjusting for age and sex: mean score 34.6 (95% CI: 33.6-35.9) vs. 39.6 (95% CI: 38.5-40.7), p value < 0.001. More than half (54%) of CSDH patients have cognitive scores at follow-up that correspond with cognitive impairment.ConclusionA large number of CSDH patients show significantly worse cognitive status 3 months after treatment compared to healthy controls. This finding underlines the importance of increased awareness for impaired cognition after CSDH. Further research on this topic is warranted. Show less
Background Glioblastoma (GBM), the most common glial primary brain tumour, is without exception lethal. Every year approximately 600 patients are diagnosed with this heterogeneous disease in The... Show moreBackground Glioblastoma (GBM), the most common glial primary brain tumour, is without exception lethal. Every year approximately 600 patients are diagnosed with this heterogeneous disease in The Netherlands. Despite neurosurgery, chemo -and radiation therapy, these tumours inevitably recur. Currently, there is no gold standard at time of recurrence and treatment options are limited. Unfortunately, the results of dedicated trials with new drugs have been very disappointing. The goal of the project is to obtain the evidence for changing standard of care (SOC) procedures to include whole genome sequencing (WGS) and consequently adapt care guidelines for this specific patient group with very poor prognosis by offering optimal and timely benefit from novel therapies, even in the absence of traditional registration trials for this small volume cancer indication. Methods The GLOW study is a prospective diagnostic cohort study executed through collaboration of the Hartwig Medical Foundation (Hartwig, a non-profit organisation) and twelve Dutch centers that perform neurosurgery and/or treat GBM patients. A total of 200 patients with a first recurrence of a glioblastoma will be included. Dual primary endpoint is the percentage of patients who receive targeted therapy based on the WGS report and overall survival. Secondary endpoints include WGS report success rate and number of targeted treatments available based on WGS reports and number of patients starting a treatment in presence of an actionable variant. At recurrence, study participants will undergo SOC neurosurgical resection. Tumour material will then, together with a blood sample, be sent to Hartwig where it will be analysed by WGS. A diagnostic report with therapy guidance, including potential matching off-label drugs and available clinical trials will then be sent back to the treating physician for discussing of the results in molecular tumour boards and targeted treatment decision making. Discussion The GLOW study aims to provide the scientific evidence for changing the SOC diagnostics for patients with a recurrent glioblastoma by investigating complete genome diagnostics to maximize treatment options for this patient group. Trial registration: ClinicalTrials.gov Identifier: NCT05186064. Show less
Purpose: Chronic subdural hematoma (CSDH) is a common neurological disease often affecting the elderly. Long-term excess mortality for patients after CSDH has been suggested but causes of death are... Show morePurpose: Chronic subdural hematoma (CSDH) is a common neurological disease often affecting the elderly. Long-term excess mortality for patients after CSDH has been suggested but causes of death are unknown. We hypothesize that excess mortality of CSDH patients is related to frailty. In this article, we describe mortality rates and causes of death of CSDH patients compared with the general population and assess the association of frailty with mortality. Methods: A cohort study in which consecutive CSDH patients were compared to the general population regarding mortality rates. Furthermore, the association of six frailty indicators (cognitive problems, frequent falling, unable to live independently, unable to perform daily self-care, use of benzodiazepines or psychotropic drugs, and number of medications) with mortality was assessed. Results: A total of 1307 CSDH patients were included, with a mean age of 73.7 (SD +/- 11.4) years and 958 (73%) were male. Median follow-up was 56 months (range: 0-213). Compared with controls CSDH patients had a hazard ratio for mortality of 1.34 (95% CI: 1.2-1.5). CSDH patients more often died from cardiovascular diseases (37% vs. 30%) and falls (7.2% vs. 3.7%). Among CSDH patients frequent falling (HR 1.3; 95% CI: 1.0-1.7), inability to live independently (HR 1.4, 95% CI: 1.1-1.8), inability to perform daily self-care (HR 1.5; 95% CI: 1.1-1.9), and number of medications used (HR 1.0; 95% CI: 1.0-1.1) were independently associated with mortality. Conclusions: CSDH patients have higher mortality rates than the general population. Frailty in CSDH patients is associated with higher mortality risk. More attention for the frailty of CSDH patients is warranted. Show less
Holl, D.C.; Mikolic, A.; Blaauw, J.; Lodewijkx, R.; Foppen, M.; Jellema, K.; ... ; Klaveren, D. van 2022
Background: Several prognostic models for outcomes after chronic subdural hematoma (CSDH) treatment have been published in recent years. However, these models are not sufficiently validated for use... Show moreBackground: Several prognostic models for outcomes after chronic subdural hematoma (CSDH) treatment have been published in recent years. However, these models are not sufficiently validated for use in daily clinical practice. We aimed to assess the performance of existing prediction models for outcomes in patients diagnosed with CSDH. Methods: We systematically searched relevant literature databases up to February 2021 to identify prognostic models for outcome prediction in patients diagnosed with CSDH. For the external validation of prognostic models, we used a retrospective database, containing data of 2384 patients from three Dutch regions. Prognostic models were included if they predicted either mortality, hematoma recurrence, functional outcome, or quality of life. Models were excluded when predictors were absent in our database or available for < 150 patients in our database. We assessed calibration, and discrimination (quantified by the concordance index C) of the included prognostic models in our retrospective database. Results: We identified 1680 original publications of which 1656 were excluded based on title or abstract, mostly because they did not concern CSDH or did not define a prognostic model. Out of 18 identified models, three could be externally validated in our retrospective database: a model for 30-day mortality in 1656 patients, a model for 2 months, and another for 3-month hematoma recurrence both in 1733 patients. The models overestimated the proportion of patients with these outcomes by 11% (15% predicted vs. 4% observed), 1% (10% vs. 9%), and 2% (11% vs. 9%), respectively. Their discriminative ability was poor to modest (C of 0.70 [0.63-0.77]; 0.46 [0.35-0.56]; 0.59 [0.51-0.66], respectively). Conclusions: None of the examined models showed good predictive performance for outcomes after CSDH treatment in our dataset. This study confirms the difficulty in predicting outcomes after CSDH and emphasizes the heterogeneity of CSDH patients. The importance of developing high-quality models by using unified predictors and relevant outcome measures and appropriate modeling strategies is warranted. Show less
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... Show moreBackground 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. Show less
Rationale Symptoms of chronic subdural hematoma (CSDH) vary widely, including transient neurological deficit(s) (TND). The precise prevalence and the clinical aspects of TND are yet to be... Show moreRationale Symptoms of chronic subdural hematoma (CSDH) vary widely, including transient neurological deficit(s) (TND). The precise prevalence and the clinical aspects of TND are yet to be determined. Most TNDs are regarded and treated as symptomatic seizures, but the rationale for this decision is not always clear. Methods Patients with temporary symptoms were selected from a retrospective cohort of CSDH patients. We analyzed the association of TND characteristics with patients being classified as having a symptomatic seizure and with functional outcome using logistic regression analysis. Results Of the included 1307 CSDH patients, 113 (8.6%) had at least one episode of TND. Most common TNDs were aphasia/dysphasia, impaired awareness or clonic movements. Of these 113 patients, 50 (44%) were diagnosed with symptomatic seizure(s) by their treating physician. Impaired awareness, clonic movements and the presence of 'positive symptoms' showed the strongest association with the diagnosis symptomatic seizure (OR 36, 95% CI 7.8-163; OR 24, 95% CI 6.4-85; and OR 3.1, 95% CI 1.3-7.2). Aphasia/dysphasia lowered the chance of TND being classified as symptomatic seizure together with a longer TND duration (OR 0.2, 95% CI 0.1-0.6; and OR 0.91, 95% CI 0.84-0.99). Treatment with anti-epileptic drugs was related to unfavorable functional outcome (aOR 5.4, 95% CI 1.4-20.7). Conclusion TND was not a rare phenomenon in our cohort of CSDH patients. A TND episode of 5 min, aphasia/dysphasia and/or absence of 'positive' symptoms are suggestive of a different TND pathophysiology than symptomatic seizures. Our results further suggest that treatment of TND in CSDH deserves careful consideration as management choices might influence patient outcome. Show less
Blaauw, J.; Meelis, G.A.; Jacobs, B.; Gaag, N.A. van der; Jellema, K.; Kho, K.H.; ... ; Hertog, H.M. den 2021
Background Patients with chronic subdural hematoma (CSDH) can present with a variety of signs and symptoms. The relationship of these signs and symptoms with functional outcome is unknown.... Show moreBackground Patients with chronic subdural hematoma (CSDH) can present with a variety of signs and symptoms. The relationship of these signs and symptoms with functional outcome is unknown. Knowledge of these associations might aid clinicians in the choice to initiate treatment and may allow them to better inform patients on expected outcomes. Objective To investigate if presenting signs and symptoms influence functional outcome in patients with CSDH. Methods We conducted a retrospective analysis of consecutive CSDH patients in three hospitals. Glasgow Outcome Scale Extended (GOS-E) scores were obtained from the first follow-up visit after treatment. An ordinal multivariable regression analysis was performed, to assess the relationship between the different signs and symptoms on the one hand and functional outcome on the other adjusted for potential confounders. Results We included 1,307 patients, of whom 958 (73%) were male and mean age was 74 (SD +/- 11) years. Cognitive complaints were associated with lower GOS-E scores at follow-up (aOR 0.7, 95% CI: 0.5 - 0.8) Headache and higher Glasgow Coma Scale (GCS) scores were associated with higher GOS-E scores. (aOR 1.9, 95% CI: 1.5-2.3 and aOR 1.3, 95% CI: 1.2-1.4). Conclusion Cognitive complaints are independently associated with worse functional outcome, whereas headache and higher GCS scores are associated with better outcome. The increased probability of unfavorable outcome in patients with CSDH who present with cognitive complaints favors a more prominent place of assessing cognitive status at diagnosis. Show less
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... Show moreObjective: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. Show less
