Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial.

BACKGROUND: It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone. METHODS: In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18-75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5-6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed. FINDINGS: SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51-68), and the median haematoma volume 57 mL (IQR 44-74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5-6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] -13%, 95% CI -26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5-6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD -15%, 95% CI -28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment. INTERPRETATION: SWITCH provides weak evidence that decompressive craniectomy plus best medical treatment might be superior to best medical treatment alone in people with severe deep intracerebral haemorrhage. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups. FUNDING: Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.

Radiotherapy concepts for spinal metastases-results from an online survey among radiation oncologists of the German Society for Radiation Oncology.

PURPOSE: Spinal metastases (SM) are a common radiotherapy (RT) indication. There is limited level I data to drive decision making regarding dose regimen (DR) and target volume definition (TVD). We aim to depict the patterns of care for RT of SM among German Society for Radiation Oncology (DEGRO) members. METHODS: An online survey on conventional RT and Stereotactic Body Radiation Therapy (SBRT) for SM, distributed via e­mail to all DEGRO members, was completed by 80 radiation oncologists between February 24 and April 29, 2022. Participation was voluntary and anonymous. RESULTS: A variety of DR was frequently used for conventional RT (primary: n = 15, adjuvant: n = 14). 30 Gy/10 fractions was reported most frequently. TVD in adjuvant RT was heterogenous, with a trend towards larger volumes. SBRT was offered in 65% (primary) and 21% (adjuvant) of participants' institutions. A variety of DR was reported (primary: n = 40, adjuvant: n = 27), most commonly 27 Gy/3 fractions and 30 Gy/5 fractions. 59% followed International Consensus Guidelines (ICG) for TVD. CONCLUSION: We provide a representative depiction of RT practice for SM among DEGRO members. DR and TVD are heterogeneous. SBRT is not comprehensively practiced, especially in the adjuvant setting. Further research is needed to provide a solid data basis for detailed recommendations.

Use of complementary therapies and supportive measures of patients with intracranial gliomas-a prospective evaluation in an outpatient clinic.

PURPOSE: Patients with intracranial gliomas frequently seek for complementary and alternative medicine (CAM), in addition to guideline-directed therapy. In this study, we therefore assessed patients' information needs regarding treatment and support, and evaluated their attitudes toward experimental trials and alternative therapies. METHODS: A prospective, cross-sectional, descriptive survey was conducted in our center. We developed an interview focusing on how patients obtain further information about therapy and the use of alternative/complementary therapies. RESULTS: A total of 102 patients participated in the survey. 50% (n = 51) of patients reported that they had not attempted any additional therapies. When patients attempted self-therapy, it was most commonly in the areas of nutrition (25%, n = 26) and dietary supplements (17%, n = 17). Alternative or complementary therapies were used by 14% (n = 14) of the patients. Younger age (Odds ratio (OR) 0.96 (95% Confidence interval (CI) 0.92-0.99, p = 0.012) and tumor entity (OR 5.01 (95% CI 1.66-15.11, p = 0.004) for grade 4 vs. 3 tumors and OR 7.22 (95% CI 1.99-26.28) for grade 4 vs. other tumors p = 0.003) were significantly associated with a greater interest in CAM. CONCLUSIONS: Interest in complementary and alternative medicine, as well as nutrition and dietary supplements is high (51%) among glioma patients, and significantly higher among younger patients and those with a worse diagnosis (WHO grade 4). A comprehensive approach to information, including paramedical topics, is needed to provide optimal patient counseling and care for glioma patients.

Treatment outcome of IDH1/2 wildtype CNS WHO grade 4 glioma histologically diagnosed as WHO grade II or III astrocytomas.

BACKGROUND: Isocitrate dehydrogenase (IDH)1/2 wildtype (wt) astrocytomas formerly classified as WHO grade II or III have significantly shorter PFS and OS than IDH mutated WHO grade 2 and 3 gliomas leading to a classification as CNS WHO grade 4. It is the aim of this study to evaluate differences in the treatment-related clinical course of these tumors as they are largely unknown. METHODS: Patients undergoing surgery (between 2016-2019 in six neurosurgical departments) for a histologically diagnosed WHO grade 2-3 IDH1/2-wt astrocytoma were retrospectively reviewed to assess progression free survival (PFS), overall survival (OS), and prognostic factors. RESULTS: This multi-center study included 157 patients (mean age 58 years (20-87 years); with 36.9% females). The predominant histology was anaplastic astrocytoma WHO grade 3 (78.3%), followed by diffuse astrocytoma WHO grade 2 (21.7%). Gross total resection (GTR) was achieved in 37.6%, subtotal resection (STR) in 28.7%, and biopsy was performed in 33.8%. The median PFS (12.5 months) and OS (27.0 months) did not differ between WHO grades. Both, GTR and STR significantly increased PFS (P < 0.01) and OS (P < 0.001) compared to biopsy. Treatment according to Stupp protocol was not associated with longer OS or PFS compared to chemotherapy or radiotherapy alone. EGFR amplification (P = 0.014) and TERT-promotor mutation (P = 0.042) were associated with shortened OS. MGMT-promoter methylation had no influence on treatment response. CONCLUSIONS: WHO grade 2 and 3 IDH1/2 wt astrocytomas, treated according to the same treatment protocols, have a similar OS. Age, extent of resection, and strong EGFR expression were the most important treatment related prognostic factors.

Favorable combinations of antiseizure medication with vagus nerve stimulation to improve health-related quality of life in patients with epilepsy.

BACKGROUND: Vagus nerve stimulation (VNS) is a non-pharmacological treatment of refractory epilepsy, which also has an antidepressive effect. The favorable combinations of VNS with specific mechanisms of action of antiseizure medication (ASM) on mood and health-related quality of life (HrQol) have not yet been studied. The objective was to identify favourable combinations of specific ASMs with VNS for the HrQoL and depression in refractory epilepsy. METHODS: We performed an observational study including patients with refractory epilepsy and an implanted VNS (N = 151). In the first 24 months after VNS implantation, all patients were on stable ASM therapy. We used the standardized questionnaires QOLIE10, EQVAS and EQ5D to evaluate HrQoL as well as the Beck Depression Inventory (BDI). Multiple regression analysis was performed to evaluate the synergistic combinations of ASM with VNS for HrQoL. RESULTS: At the year-two follow-up (N = 151, age 45.2 ± 17.0 years), significant improvement (p < 0.05) in BDI scores was found for combination of VNS with SV2A modulators (58.4 %) or AMPA antagonists (44.4 %). A significant increase of HrQoL by at least 30 % (p < 0.05) was measured for a combination of VNS with SV2A modulators (brivaracetam, levetiracetam) or slow sodium channel inhibitors (eslicarbazepine, lacosamide). CONCLUSION: The results of our study suggests a favorable effect of the combination of SV2A modulators or slow sodium channel inhibitors with VNS on the HrQoL in comparison to other ASMs. Besides the possible synergistic effects on the seizure frequency, the amelioration of behavioral side effects of SV2A modulators by VNS is an important factor of HrQoL-improvement in these combinations.

How do spine surgeons cope with psychological distress: results of a cross-sectional study.

Cross Sectional Study/Online Survey. In this study, we sought to assess stress, psychological distress, resilience, and coping strategies among spine surgeons in German-speaking countries. Recent studies have reported high rates of stress and burnout among surgeons. A survey via Survey Monkey™ was conducted among spine surgeons practicing in German-speaking countries using validated questionnaires for perceived stress, mental burden, resilience, and quality of life. Data on working situation and demographics were also collected. 582 surgeons responded to the survey, representing 15% of those surveyed. 79% of respondents were satisfied with their professional success. Mental burden was higher than in the general population, as was perceived stress. Chairpersons were exposed to the lowest levels of perceived stress and mental burden. Mental distress was high (GHQ ≥ 12) in 59% of residents and 27% chairpersons. Self-reported psychological resilience was higher than levels found in the general population and highest among chairpersons. Quality of life was comparable to levels reported in the general population. There were statistically significant correlations between perceived stress and mental burden scores (r s = 0.65, p < 0.001). Career level (senior physicians vs. residents, OR 0.26; 95% CI 0.10-0.66), perceived stress (OR 1.54; 95% CI 1.33-1.77), self-reported resilience (OR 0.53; 95% CI 0.33-0.84), and mental composite score (SOR 0.86; 95% CI 0.83-0.90) were predictors of high mental burden. There was no interaction between perceived stress and resilience on mental burden (p = 0.835). Spine surgeons are exposed to higher levels of stress than the general population, which are associated with higher mental distress. More professional experience and higher levels of psychological resilience are associated with lower levels of stress.

Surgery as first-line treatment for prolactinoma? Discussion of the literature and results of a consecutive series of surgically treated patients.

Initial treatment for prolactinoma is usually conservative with dopamine agonists. However, the duration of treatment is often lifelong and can be associated with significant side effects. Surgical outcomes are usually favorable and treatment complications low, raising the question whether surgical therapy should be included earlier in the treatment of prolactinoma. The aim of this study was to analyze the outcome of surgical resection of prolactinomas at our institution, to compare it with other published surgical and conservative series and to discuss the role of surgery in modern prolactinoma therapy. The authors reviewed a database of single-center consecutively operated prolactinoma cases and analyzed the extent of resection (EOR), endocrinological and neurological outcomes, and complications. Thirty patients were analyzed. Mean patient age was 37.2 ± 15.5 years (range 16-76) and consisted of 17 (56.7%) females and 13 (43.3%) males. Twenty-one patients (70%) failed medical therapy, the main reasons being intolerable side effects in 11 cases (52.4%) and insufficient response in 10 cases (47.6%). Nine patients (30%) received no medical treatment prior to surgery, of which five (55.6%) were operated because of pituitary apoplexy, two (22.2%) because of acute visual deterioration and two (22.2%) refused medical treatment and opted for surgery as first-line treatment. Of the 30 operated tumors, 56.7% (n = 17) were microadenomas, 30% (n = 9) were macroadenomas (≥ 10 mm), and 13.3% (n = 4) were giant adenomas (≥ 40 mm). GTR was achieved in 75% (n = 21) of cases. The overall remission rate was 63.3%. MRI showed a residual tumor in seven patients (25%), typically with invasive growth. Postoperative CSF leaks did not occur. Mean follow-up was 34.9 ± 60.3 months (range 0-246 months). Endocrine remission was defined as a morning fasting basal PRL level of 22.3 < ng/mL and measured at the last available follow-up. Postoperative Prolactine levels were missing in three patients. Our analysis describes a highly selected sample with a disproportionate number of larger, invasive tumors and emergency cases. Nevertheless, the results are satisfactory and comparable with other published series. The consistently good results of transphenoidal surgery, especially for microprolactinomas, have led to a greater acceptance of surgery in the treatment of prolactinomas in recent years. The timing of surgery in each individual case must be determined by a multidisciplinary team to ensure the best possible outcome.

Characterizing the individual course of health-related quality of life after subarachnoid haemorrhage: Latent growth mixture modelling.

BACKGROUND: Survivors of aneurysmal subarachnoid haemorrhage (SAH) show heterogeneous profiles of health-related quality of life (HrQoL). The aim of this study was to characterize individual differences in the course of HrQoL following SAH using latent growth mixture modelling (LGMM). METHODS: A longitudinal study with 113 incident cases of aneurysmal SAH was performed in order to evaluate clinical outcome (Hunt and Hess scale, Barthel-Index, Beck Depression Inventory) and HrQoL data (EQ-5D) at baseline, 6 and 12 months. The heterogeneity in HrQoL courses after SAH was analysed using LGMM. RESULTS: Four subgroups (classes) of different patterns of HrQoL course after SAH were identified. Two of these classes (1 and 3) comprised patients with considerably reduced initial HrQoL, which was associated with more severe symptoms of SAH. Class 1 showing the worst EQ5D-index values during the entire study period. Class 3 experiencing a considerable improvement in HrQoL values. In comparison to classes 1 and 3, class 2 and 4 were characterized by less severe SAH and better functional outcome. An important difference in the disease course between classes 2 and 4 was a temporary increase in depression scores at the 6-month time point in class 4, which was associated with a considerable reduction in HrQoL.The specific clinical parameters characterizing differences between classes, such as severity of SAH, functional outcome, cognitive impairment and post-stroke depression, were identified and the influence of their potential improvement on HrQoL was estimated. CONCLUSION: By means of LGMM we could classify the course of HrQoL after SAH in four different patterns, which are relevant for the clinical decisions. Clinical parameters, which can be modified in order to improve the course of HrQoL were identified and could help to develop individual therapeutic strategies for the rehabilitation after SAH.

Risk factors for postoperative seizures in patients with chronic subdural haematomas.

Postoperative seizures are a frequently occurring yet not well-understood complication in patients undergoing surgical treatment of chronic subdural haematomas (cSDHs). Therefore, we investigated surgical and non-surgical risk factors that are commonly considered causal in provoking epileptic seizures, paying special attention to the intracranial course of the subdural drain (SDD) and the configuration of the haematoma. Data of patients with a cSDH, that were treated at our neurosurgical department between 2008 and 2014 were analysed. Patients suffering from severe pre-existing conditions and those who have been treated conservatively were excluded. Epidemiologic data as well as relevant clinical data were collected. Pre- and postoperative CT scans were analysed regarding morpho- and volumetric parameters. In order to objectify the influence of the SDD, its intracranial course and localisation (entering angle as well as the angle between drain and brain surface) were measured. For statistical analysis, univariate and multiple logistic regression models as well as Fisher's exact test were used. Two hundred eleven consecutive patients have been included. Mean age was 75.6 years, and 69% were male. Nineteen (9%) patients suffered from postsurgical seizures. Membranes within the haematoma were present in 81.5%. Pre- to postoperative haematoma reduction was significant (mean of difference - 12.76 mm/ - 9.47 mm in coronal/axial CT planes, p = 0.001/ < 0.001). In 77.9%, SDD showed cortical contact with eloquent regions and had an unfavourable course in 30 cases (14.2%). Surgical complications consisted of cortical bleeding in 2.5%, fresh subdural haematoma in 33.5% and wound infections in 1.4% of patients. Neither in univariate nor in multiple regression analyses any of the following independent variates was significantly correlated with postsurgical seizures: pre-existing epilepsy, alcohol abuse, right-sided haematomas, localization and thickness of haematoma, presence of septations, SDD-localization and to-brain angle, subdural air, and electrolyte levels. Instead, in multiple regression analyses, we found the risk of postsurgical seizures to be significantly correlated and increased with left-sided cSDH treated via craniotomy (p = 0.03) and an unfavourable course of the SDD in left-sided cSDH (p = 0.033). Burr hole trepanation should be preferred over craniotomy and care must be taken when placing a SDD to avoid irritating cortical tissue. The configuration of the haematoma does not appear to affect the postoperative seizure rate.

Presurgical selection of the ideal aneurysm clip by the use of a three-dimensional planning system.

Aneurysm occlusion rate after clipping is higher than after endovascular treatment. However, a certain percentage of incompletely clipped aneurysms remains. Presurgical selection of the proper aneurysm clips could potentially reduce the rate of incomplete clippings caused by inadequate clip geometry. The aim of the present study was to assess whether preoperative 3D image-based simulation allows for preoperative selection of a proper aneurysm clip for complete occlusion in individual cases. Patients harboring ruptured or unruptured cerebral aneurysms prior to surgical clipping were analyzed. CT angiography images were transferred to a 3D surgical-planning station (Dextroscope®) with imported models of 58 aneurysm clips. Intracranial vessels and aneurysms were segmented and the virtual aneurysm clips were placed at the aneurysm neck. Operating surgeons had information about the selected aneurysm clip, and patients underwent clipping. Intraoperative clip selection was documented and aneurysm occlusion rate was assessed by postoperative digital subtraction angiography. Nineteen patients were available for final analysis. In all patients, the most proximal clip at the aneurysm neck was the preselected clip. All aneurysms except one were fully occluded, as assessed by catheter angiography. One aneurysm had a small neck remnant that did not require secondary surgery and was occluded 15 months after surgery. 3D image-based preselection of a proper aneurysm clip can be translated to the operating room and avoids intraoperative clip selection. The associated occlusion rate of aneurysms is high.

Analysis of PMMA versus CaP titanium-enhanced implants for cranioplasty after decompressive craniectomy: a retrospective observational cohort study.

Numerous materials of implants used for cranioplasty after decompressive craniectomy (DC) have been investigated to meet certain demanded key features, such as stability, applicability, and biocompatibility. We aimed to evaluate the feasibility and safety of biocompatible calcium-phosphate (CaP) implants for cranioplasty compared to polymethylmethacrylate (PMMA) implants. In this retrospective observational cohort study, the medical records of all patients who underwent cranioplasty between January 1st, 2015, and January 1st, 2022, were reviewed. Demographic, clinical, and diagnostic data were collected. Eighty-two consecutive patients with a mean age of 52 years (range 22-72 years) who received either a PMMA (43/82; 52.4%) or CaP (39/82; 47.6%) cranial implant after DC were included in the study. Indications for DC were equally distributed in both groups. Time from DC to cranioplasty was 143.8 ± 17.5 days (PMMA) versus 98.5 ± 10.4 days (CaP). The mean follow-up period was 34.9 ± 27.1 months. Postoperative complications occurred in 13 patients with PMMA and 6 in those with CaP implants (13/43 [30.2%] vs. 6/39 [15.4%]; p = 0.115). Revision surgery with implant removal was necessary for 9 PMMA patients and in 1 with a CaP implant (9/43 [20.9%] vs. 1/39 [2.6%]; p = 0.0336); 6 PMMA implants were removed due to surgical site infection (SSI) (PMMA 6/43 [14%] vs. CaP 0/39 [0%]; p = 0.012). In this study, a biocompatible CaP implant seems to be superior to a PMMA implant in terms of SSI and postoperative complications. The absence of SSI supports the idea of the biocompatible implant material with its ability for osseointegration.

Endoscopic treatment of sagittal suture synostosis - a critical analysis of current management strategies.

While many centers nowadays offer minimally invasive techniques for the treatment of single suture synostosis, surgical techniques and patient management vary significantly. We provide an overview of how scaphocephaly treated with endoscopic techniques is managed in the reported series and analyze the crucial steps that need to be dealt with during the management process. We performed a review of the published literature including all articles that examined sagittal-suture synostosis treated with endoscopic techniques as part of single- or multicenter studies. Fourteen studies reporting results of 885 patients were included. We identified 5 key steps in the management of patients. A total of 188 patients were female and 537 male (sex was only specified in 10 articles, for 725 included patients, respectively). Median age at surgery was between 2.6 and 3.9 months with a total range from 1.5 to 7.0 months. Preoperative diagnostics included clinical and ophthalmologic examinations as well as neuropsychological and genetic consultations if needed. In 5 publications, a CT scan was routinely performed. Several groups used anthropometric measurements, mostly the cephalic index. All groups analyzed equally recommended to perform endoscopically assisted craniosynostosis surgery with postoperative helmet therapy in children < 3 months of age, at least for non-syndromic cases. There exist significant variations in surgical techniques and patient management for children treated endoscopically for single suture sagittal synostosis. This heterogeneity constitutes a major problem in terms of comparability between different strategies.

What is the current clinical practice in pituitary adenoma surgery in Europe? European Pituitary Adenoma Surgery Survey (EU-PASS) results-technical part.

Pituitary adenoma surgery has evolved rapidly in recent decades, changing clinical practice markedly and raising new challenges. There is no current consensus or guidelines for perioperative care that includes possible complication management. This study aims to determine current practice across European neurosurgical centres. We created a list of eligible departments performing pituitary adenoma surgery based on cooperation with EANS, national neurosurgical societies, and personal communication with local neurosurgeons. We contacted the chairpersons from each department and asked them (or another responsible neurosurgeon) to fill out the survey. The survey consisted of 58 questions. For further analysis, departments were divided into subgroups: "academic"/ "non-academic centre", "high-volume"/"low-volume", "mainly endoscopic"/ "mainly microscopic"/ "mixed practise", and by geographical regions. Data from 254 departments from 34 countries were obtained. The average time to complete the survey was 18 min. Notably, the endoscopic approach is the predominant surgical approach in Europe, used in 56.8% of the centres. In routine cases without intraoperative cerebrospinal fluid leak, high-volume centres are less pedantic with sellar closure when compared with low-volume centres (p < 0.001). On the other hand, when a postoperative cerebrospinal fluid leak occurs, high-volume centres are more active and indicate early reoperation (p = 0.013). Less than 15% of the participating centres perform early postoperative MRI scans. Marked variation was noted among different groups of respondents and some contentious issues are discussed. Such information can encourage useful debate about the reasons for the variations seen and perhaps help develop standardised protocols to improve patient outcomes. A future research focus is to compare European results with other regions.

Impact of Sarcopenia and Bone Mineral Density on Implant Failure after Dorsal Instrumentation in Patients with Osteoporotic Vertebral Fractures.

Background and Objectives: Age-related loss of bone and muscle mass are signs of frailty and are associated with an increased risk of falls and consecutive vertebral fractures. Management often necessitates fusion surgery. We determined the impacts of sarcopenia and bone density on implant failures (IFs) and complications in patients with spondylodesis due to osteoporotic vertebral fractures (OVFs). Materials and Methods: Patients diagnosed with an OVF according to the osteoporotic fracture classification (OF) undergoing spinal instrumentation surgery between 2011 and 2020 were included in our study. The skeletal muscle area (SMA) was measured at the third lumbar vertebra (L3) level using axial CT images. SMA z-scores were calculated for the optimal height and body mass index (BMI) adjustment (zSMAHT). The loss of muscle function was assessed via measurement of myosteatosis (skeletal muscle radiodensity, SMD) using axial CT scans. The bone mineral density (BMD) was determined at L3 in Hounsfield units (HU). Results: A total of 68 patients with OVFs underwent instrumentation in 244 segments (mean age 73.7 ± 7.9 years, 60.3% female). The median time of follow-up was 14.1 ± 15.5 months. Sarcopenia was detected in 28 patients (47.1%), myosteatosis in 45 patients (66.2%), and osteoporosis in 49 patients (72%). The presence of sarcopenia was independent of chronological age (p = 0.77) but correlated with BMI (p = 0.005). The zSMAHT was significantly lower in patients suffering from an IF (p = 0.0092). Sarcopenia (OR 4.511, 95% CI 1.459-13.04, p = 0.0092) and osteoporosis (OR 9.50, 95% CI 1.497 to 104.7, p = 0.014) increased the likelihood of an IF. Using multivariate analysis revealed that the zSMAHT (p = 0.0057) and BMD (p = 0.0041) were significantly related to IF occurrence. Conclusion: Herein, we established sarcopenic obesity as the main determinant for the occurrence of an IF after instrumentation for OVF. To a lesser degree, osteoporosis was associated with impaired implant longevity. Therefore, measuring the SMA and BMD using an axial CT of the lumbar spine might help to prevent an IF in spinal fusion surgery via early detection and treatment of sarcopenia and osteoporosis.

An age-dependent outcome analysis of microvascular decompression and percutaneous thermocoagulation in trigeminal neuralgia.

BACKGROUND: Trigeminal neuralgia (TN) is a severe pain condition and the most common facial neuralgia. While microvascular decompression (MVD) presents an excellent treatment in neurovascular compression cases, percutaneous thermocoagulation (PT) of the ganglion Gasseri is an alternative option. This study aimed to evaluate post-operative complication rate and outcome of both treatment strategies related to the patient's age. METHODS: The medical records of all patients with the diagnosis of trigeminal neuralgia undergoing an MVD or PT of the ganglion Gasseri (between January 2007 and September 2017) were reviewed to determine the efficacy and the complication rate of both methods in regard to the patient's age. RESULTS: Seventy-nine patients underwent MVD surgery and 39 a PT. The mean age of patients in the MVD group was 61 years and 73 years in the PT group. There were 59 (50%) female patients. Nerve-vessel conflict could be identified in 78 (98.7%) MVD and 17 (43.6%) PT patients on preoperative MRI. Charlson comorbidity index was significantly higher in PT group (2.4 (1.8) versus 3.8 (1.8) p < 0.001). The Barrow pain score (BPS) at the last follow-up demonstrated higher scores after PT (p = 0.007). The complication rate was markedly higher in PT group, mostly due to the facial hypesthesia (84.6% versus 27.8%; p < 0.001). Mean symptom-free survival was significantly shorter in the PT group (9 vs. 26 months, p < 0.001). It remained statistically significant when stratified into age groups: (65 years and older: 9 vs. 18 months, p = 0.001). Duration of symptoms (OR 1.005, 95% CI 1.000-1.010), primary procedure (OR 6.198, 95% CI 2.650-14.496), patient age (OR 1.033, 95% CI 1.002-1.066), and postoperative complication rate (OR 2.777, 95% CI 1.309-5.890) were associated with treatment failure. CONCLUSION: In this patient series, the MVD is confirmed to be an excellent treatment option independent of patient's age. However, while PT is an effective procedure, time to pain recurrence is shorter, and the favorable outcome (BPS 1 and 2) rate is lower compared to MVD. Hence MVD should be the preferred treatment and PT should remain an alternative in very selected cases when latter is not possible but not in the elderly patient per se.

Development of screening questions for doctor-patient consultation assessing the quality of life and psychosocial burden of glioma patients: an explorative study.

PURPOSE: Psychosocial screening for glioma patients is challenging because many patients suffer from neurocognitive deficits, which may impair assessment. This study's aim was to exploratively develop three screening questions for unmet needs to prospectively be applicable in patient-doctor consultation. METHODS: Patient interviews, a survey for health-care professionals and a weighted scoring procedure were developed for this study. Six main areas were defined according to main areas of validated questionnaires (psyche, cognition, body, role functioning, social support, unmet needs). Patients and health-care professionals rated the importance of these areas and corresponding items, patients additionally stated whether the issues addressed affected them. RESULTS: A total of 50 patients were included, and 36 health-care professionals participated in the online survey. The three areas (psyche, body and cognition) considered to be most relevant by both, health-care professionals and patients, generated three screening questions. If the patient was affected by the issue addressed with a screening question, a subordinate question from that area that our patient sample considered most important could additionally be asked. The elaborated screening questions are the following: (1) main area psyche: "Has your mood worsened?", (2) main area body: "Do physical changes put a strain on you?", and (3) main area cognition: "Has your memory capacity worsened?" CONCLUSION: These questions represent a basis for further research regarding their application in neuro-oncological clinical routine.

Anxiety is associated with unfulfilled information needs and pain at the informed consent consultation of spine surgery patients: a longitudinal study.

PURPOSE: Meeting the information needs of patients adequately is of high importance in informed consent consultations in surgery. However, information needs often remain unmet in the informed consent consultation. The aim of this study was to assess anxiety and pain in relation to the patients' information needs fulfillment perioperatively. METHODS: We applied a question prompt list (QPL) for patients undergoing spine surgery (SN-QPL) before (t1) and a question answering list (SN-QAL) after (t2) the informed consent consultation. The patients additionally completed the "State-Trait Anxiety Operation Inventory" (STOA, cognitive and affective scale) at t1, as well as a pain numerical rating scale (NRS) at t2 and postoperative (t3). We analyzed (1) the association between anxiety, information needs and pain and (2) anxiety and pain scores regarding information needs fulfillment after the consent consultation. RESULTS: A total of n = 118 patients was included. Affective and cognitive state anxiety was only reduced postoperatively (affective p < .001, cognitive p < .05). The higher trait anxiety was, the more patients longed for information at t1-t3 (t1: r = .58/r = .74, each p < .001), (t2: r = .38/r = .49, each p < .001) and (t3: r = .29, p < .01/r = 34, p < .001). Higher grades of trait anxiety resulted in lower information needs fulfilment. Higher state anxiety levels were associated with higher pain levels. Information needs more often remained unfulfilled in high trait and state anxiety patients. CONCLUSION: Patients' anxiety was associated with (un)fulfilled information needs. Meeting information needs should be optimized in the process of surgeon-patient communication. Adapting the information to the patients' anxiety levels seem to be an effective way to reduce anxiety.

Distress and quality of life do not change over time in patients with operated and conservatively managed intracranial meningioma.

PURPOSE: The patients' burden with asymptomatic meningiomas and patients with good clinical outcome after meningioma resection often remains neglected. In this study, we aimed to investigate the longitudinal changes of psychological distress and quality of life in these patient groups. METHODS: Patients with conservatively managed (CM) or operated (OM) meningiomas and excellent neurological status, who were screened for psychological distress during the follow-up visit (t1), were included. We performed a follow-up mail/telephone-based survey 3-6 months (t2) after t1. Distress was measured using Hospital Anxiety and Depression Scale (HADS), Distress Thermometer (DT), 36-item Short Form (SF-36), and Brief Fatigue Inventory (BFI). RESULTS: Sixty-two patients participated in t1 and 47 in t2. The number of patients reporting increased or borderline values remained high 3 months after initial presentation, with n = 25 (53%) of patients reporting increased anxiety symptom severity and n = 29 (62%) reporting increased depressive symptom severity values. The proportion of distressed patients according to a DT score remained similar after 3 months. Forty-four percent of patients reported significant distress in OM and 33% in CM group. The most common problems among distressed patients were fatigue (t2 75%) and worries (t2 50%), followed by pain, sleep disturbances, sadness, and nervousness. Tumor progress was associated with increased depression scores (OR 6.3 (1.1-36.7)). CONCLUSION: The level of psychological distress in asymptomatic meningiomas and postoperative meningiomas with excellent outcome is high. Further investigations are needed to identify and counsel the patients at risk.

Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Delayed cerebral ischemia (DCI) is the most important cause for a poor clinical outcome after a subarachnoid hemorrhage. The aim of this study was to assess whether goal-directed hemodynamic therapy (GDHT), as compared to standard clinical care, reduces the rate of DCI after subarachnoid hemorrhage. METHODS: We conducted a prospective randomized controlled trial. Patients >18 years of age with an aneurysmal subarachnoid hemorrhage were enrolled and randomly assigned to standard therapy or GDHT. Advanced hemodynamic monitoring and predefined GDHT algorithms were applied in the GDHT group. The primary end point was the occurrence of DCI. Functional outcome was assessed using the Glasgow Outcome Scale (GOS) 3 months after discharge. RESULTS: In total, 108 patients were randomized to the control (n=54) or GDHT group (n=54). The primary outcome (DCI) occurred in 13% of the GDHT group and in 32% of the control group patients (odds ratio, 0.324 [95% CI, 0.11-0.86]; P=0.021). Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P=0.02). The GOS was assessed 3 months after discharge in 107 patients; it showed more patients with a low disability (GOS 5, minor or no deficits) than patients with higher deficits (GOS 1-4) in the GDHT group compared with the control group (GOS 5, 66% versus 44%; GOS 1-4, 34% versus 56%; P=0.025). There was no significant difference in mortality between the groups. CONCLUSIONS: GDHT reduced the rate of DCI after subarachnoid hemorrhage with a better functional outcome (GOS=5) 3 months after discharge. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01832389.

Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial.

BACKGROUND: There is an urgent need for more effective therapies for glioblastoma. Data from a previous unrandomised phase 2 trial suggested that lomustine-temozolomide plus radiotherapy might be superior to temozolomide chemoradiotherapy in newly diagnosed glioblastoma with methylation of the MGMT promoter. In the CeTeG/NOA-09 trial, we aimed to further investigate the effect of lomustine-temozolomide therapy in the setting of a randomised phase 3 trial. METHODS: In this open-label, randomised, phase 3 trial, we enrolled patients from 17 German university hospitals who were aged 18-70 years, with newly diagnosed glioblastoma with methylated MGMT promoter, and a Karnofsky Performance Score of 70% and higher. Patients were randomly assigned (1:1) with a predefined SAS-generated randomisation list to standard temozolomide chemoradiotherapy (75 mg/m2 per day concomitant to radiotherapy [59-60 Gy] followed by six courses of temozolomide 150-200 mg/m2 per day on the first 5 days of the 4-week course) or to up to six courses of lomustine (100 mg/m2 on day 1) plus temozolomide (100-200 mg/m2 per day on days 2-6 of the 6-week course) in addition to radiotherapy (59-60 Gy). Because of the different schedules, patients and physicians were not masked to treatment groups. The primary endpoint was overall survival in the modified intention-to-treat population, comprising all randomly assigned patients who started their allocated chemotherapy. The prespecified test for overall survival differences was a log-rank test stratified for centre and recursive partitioning analysis class. The trial is registered with ClinicalTrials.gov, number NCT01149109. FINDINGS: Between June 17, 2011, and April 8, 2014, 141 patients were randomly assigned to the treatment groups; 129 patients (63 in the temozolomide and 66 in the lomustine-temozolomide group) constituted the modified intention-to-treat population. Median overall survival was improved from 31·4 months (95% CI 27·7-47·1) with temozolomide to 48·1 months (32·6 months-not assessable) with lomustine-temozolomide (hazard ratio [HR] 0·60, 95% CI 0·35-1·03; p=0·0492 for log-rank analysis). A significant overall survival difference between groups was also found in a secondary analysis of the intention-to-treat population (n=141, HR 0·60, 95% CI 0·35-1·03; p=0·0432 for log-rank analysis). Adverse events of grade 3 or higher were observed in 32 (51%) of 63 patients in the temozolomide group and 39 (59%) of 66 patients in the lomustine-temozolomide group. There were no treatment-related deaths. INTERPRETATION: Our results suggest that lomustine-temozolomide chemotherapy might improve survival compared with temozolomide standard therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter. The findings should be interpreted with caution, owing to the small size of the trial. FUNDING: German Federal Ministry of Education and Research.