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Background: We aimed to assess whether the effect of intravenous alteplase treatment (IVT) before endovascular treatment (EVT) on outcome is modified by first-line technique during EVT in IVT eligible patients. Methods: This was a post hoc analysis from MR CLEAN-NO IV (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands - Intravenous Treatment Followed by Intra-Arterial Treatment Versus Direct Intra-Arterial Treatment for Acute Ischemic Stroke Caused by a Proximal Intracranial Occlusion), a randomized trial of IVT followed by EVT versus EVT alone in patients presenting directly to EVT-capable centers. We included data from all patients who underwent EVT with a thrombectomy attempt. We compared patients treated with stent retriever (with or without aspiration) to aspiration alone as first-line EVT technique and assessed the interaction of first-line EVT technique with IVT treatment. Primary outcome was the 90-day modified Rankin Scale score, analyzed with mixed model ordinal regression for a shift towards better outcome. Secondary outcomes included successful reperfusion (extended Thrombolysis in Cerebral Infarction score 2b–3). Results: Of 473 included patients, 102 (21.6%) were treated with aspiration alone as first-line technique. In the full population, functional outcome was similar for patients treated with stent retriever versus aspiration only (adjusted common odds ratio [acOR]‚ 1.07 [95% CI, 0.69–1.66]). We observed a significant interaction between IVT and first-line EVT technique ( P =0.03). In the aspiration-only group, patients treated with EVT alone had worse functional outcome compared to those treated with IVT and EVT (acOR, 0.44 [95% CI, 0.21–0.90]). In the stent retriever group, functional outcome did not differ between patients treated with or without IVT (acOR, 1.08 [95% CI, 0.74–1.57]). There was no statistically significant interaction for successful reperfusion. Conclusions: In MR CLEAN-NO IV, the treatment effect of IVT was modified by first-line EVT technique. Patients treated with aspiration only as first-line technique had worse clinical outcomes if they did not receive IVT. No such difference was observed in patients treated with stent retrievers. Confirmation by pooling with results from other trials is needed to confirm these findings.

Contains fulltext : 251571.pdf (Publisher’s version ) (Open Access) OBJECTIVES: To provide an overview of the existing research concerning the use and effects of AR in patient education. METHODS: Following PRISMA guidelines four electronic databases were systematically searched. INCLUSION CRITERIA: empirical studies using any type of AR intervention in patient education across all medical specialties. Quality assessment of the retrieved literature was carried out. RESULTS: Ten papers, comprising 788 patients, were identified and included (Randomized controlled trial (RCT)(n = 3), non-randomized controlled trial (n = 3), before-and-after study (n = 3), and qualitative survey (n = 1)). Retrieved literature showed itself to be highly heterogeneous. The studied population included patients suffering from a diverse spectrum of chronic diseases (e.g., prostate cancer, diabetes mellitus, multiple sclerosis, epilepsy). Quantitative results indicated that the use of AR had a positive effect on knowledge retention and patient satisfaction. Qualitative findings suggested that patients liked the technology and felt comfortable with its use for educational purposes. The quality of the retrieved results was shown to be moderate to low. CONCLUSION: The limited evidence of this topic suggests the possible potential of AR in patient education. PRACTICE IMPLICATION: More research, using high-quality study designs and more evidence-based interventions, is needed to fully appreciate the value of AR on patient education.

Background: Many randomized controlled trials (RCT) have assessed new treatments in subarachnoid hemorrhage (SAH), yet most show no treatment efficacy. One explanation is the statistical analysis of the primary endpoint was not as efficient as possible. We reanalyzed SAH RCTs with various statistical tests to determine whether the statistical method affects RCT primary outcome.Methods: Individual patient data for the primary outcome (Glasgow outcome scale [GOS]) of two SAH RCTs were analyzed using 15 statistical methods. For tests requiring outcome dichotomization, multiple cut-points in the 5-level GOS were assessed. Next, a synthetic dataset generated using random sampling with replacement from ten SAH RCTs was assessed using the same statistical tests. A Friedman test (two-way non-parametric analysis of variance) determined which tests produced the highest average absolute Z-values. The number of times each test reported significance of pResults: Bootstrapping with replacement produced the best-ranking results, followed by three χ2-tests: one differentiating excellent (GOS=5) from good (GOS=4), poor (GOS=2-3), or dead (GOS=1) outcomes; one differentiating favorable (GOS=4-5) from poor or dead outcomes; and one differentiating favorable (GOS=4-5) from unfavorable outcomes. Each of these reported statistical significance for both RCTs, as did the following ranked tests, respectively: Wilcoxon median test, Student’s t-test, ordinal logistic regression, median test, and a chi-square dichotomizing excellent (GOS≥4) and inferior outcomes. Statistical significance for one or neither RCT was reported by two Cochrane-Armitage tests and two logistic regressions with alternate versions of bucketing, the Kolmogorov-Smirnov test and chi-square test differentiating surviving from dead patients. The synthetic dataset returned similar results, with the same nine most and six least efficient tests.Conclusions: Bootstrapping produced the most efficient results but is time-and resource-intensive. Chi-square tests grouping outcomes into dichotomous or multiple buckets are also efficient, and their ease of use and popularity make them appropriate candidates for statistical analysis in future SAH RCTs.

Background Patients who have been successfully treated for an aneurysmal subarachnoid hemorrhage (aSAH) often retain multiple health complaints, including mood disorders, cognitive complaints, fatigue, and problems with social participation. These problems are not always fully addressed during hospital visits or in current outcome measures, such as the modified Rankin score and the Glasgow Outcome Scale. Here, we present the development of the “Questionnaire for the Screening of Symptoms in aneurysmal Subarachnoid Hemorrhage” (SOS-SAH), which screens for the self-reported symptoms of patients with mild disabilities. Methods During the development of the SOS-SAH we adhered to the PROM-cycle framework for the selection and implementation of patient-reported outcome measures (PROMs). The SOS-SAH was developed in an iterative process informed by a literature study. Patients and healthcare professionals were involved in the development process through participating in a working group, interviews, and a cognitive validation study. Results and conclusions Relevant patient-reported outcomes (PROs) were identified for patients with aSAH. The SOS-SAH was developed primarily using domains and items from existing PROMs and, if necessary, by developing new items. The SOS-SAH consists of 40 items and covers 14 domains: cognitive abilities, hypersensitivity to stimuli, anxiety, depression, fatigue, social roles, personality change, language, vision, taste, smell, hearing, headache, and sexual function. It also includes a proxy measurement for use by family members to assess cognitive functioning and personality change.

Background In patients with spontaneous cerebellar intracerebral hemorrhage (ICH) guidelines advocate evacuation when the hematoma diameter is > 3 cm. We studied outcome in patients with cerebellar ICH > 3 cm who did not undergo immediate hematoma evacuation. Methods We included consecutive patients with cerebellar ICH > 3 cm at two academic hospitals between 2008 and 2017. Patients who died Results Of 130 patients with cerebellar ICH, 98 (77%) had a hematoma > 3 cm of whom 22 (23%) died 24 h, of whom 1 (14%) had received an EVD Conclusions While cerebellar ICH > 3 cm is often considered an indication for immediate hematoma evacuation, there may be a subgroup of patients in whom surgery can be safely deferred. Further data are needed to assess the optimal timing and indications of surgical treatment in these patients.

Introduction The role of surgery in spontaneous intracerebral haemorrhage (sICH) remains controversial. This leads to variation in the percentage of patients who are treated with surgery between countries. Patients and methods We sent an online survey to all neurosurgeons (n = 140) and to a sample of neurologists (n = 378) in Dutch hospitals, with questions on management in supratentorial sICH in general, and on treatment in six patients, to explore current variation in medical and neurosurgical management. We assessed patient and haemorrhage characteristics influencing treatment decisions. Results Twenty-nine (21%) neurosurgeons and 92 (24%) neurologists responded. Prior to surgery, neurosurgeons would more frequently administer platelet-transfusion in patients on clopidogrel (64% versus 13%; p = 0.000) or acetylsalicylic acid (61% versus 11%; p = 0.000) than neurologists. In the cases, neurosurgeons and neurologists were similar in their choice for surgery as initial treatment (24% and 31%; p = 0.12), however variation existed amongst physicians in specific cases. Neurosurgeons preferred craniotomy with haematoma evacuation (74%) above minimally-invasive techniques (5%). Age, Glasgow Coma Scale score and ICH location were important factors influencing decisions on treatment for neurosurgeons and neurologists. 69% of neurosurgeons and 80% of neurologists would randomise patients in a trial evaluating the effect of minimally-invasive surgery on functional outcome. Discussion Our results reflect the lack of evidence about the right treatment strategy in patients with sICH. Conclusion New high quality evidence is needed to guide treatment decisions for patients with ICH. The willingness to randomise patients into a clinical trial on minimally-invasive surgery, contributes to the feasibility of such studies in the future.

ObjectivePatient-reported outcomes (PROs) are aspects of a patient's health status and are considered important for stimulating patient-centered care. Current outcome measures in clinical care for patients with aneurysmal subarachnoid hemorrhage (aSAH) are insufficient to capture PROs. In this systematic review, we aimed to summarize the evidence regarding the quality of patient-reported outcome measures (PROMs) in aSAH patients.MethodsWe performed a systematic review of the literature published from inception until October 29, 2018, in PubMed, the Cochrane Central Register of Controlled Trials, and EMBASE. Eligible studies had to evaluate measurement properties and capture PROs in aSAH patients. The quality of the studies and measurement properties were assessed using the consensus-based standards for the selection of health status measurement instruments (COSMIN) checklist. The review protocol was registered with PROSPERO (CRD42018058566).ResultsWe identified 9 articles that reported the assessment of 7 different disease-specific and generic PROMs used for aSAH patients, including 5 that focused on the Stroke-Specific Quality of Life Scale (SS-QoL). The methodologic quality of the validation processes used was generally doubtful. None of the PROMs complied with current standards for content validity.ConclusionsDue to the low quality of evidence for the measurement properties, the evidence base for selecting a suitable PROM for use with aSAH patients is insufficient. Given the specific long-term consequences of aSAH, we consider a disease-specific PROM the most appropriate, with SS-QoL the most suitable PROM currently available.

OBJECTIVE: To study the rate of superficial temporal artery (STA) preservation and the effectiveness of STA reconstruction in patients undergoing a pterional craniotomy. METHODS: Included patients (n = 136) underwent either an emergency or an elective pterional craniotomy. In case of deliberate transection or accidental damage of the STA, it was repaired microsurgically at the end of the procedure. Postoperatively, the patency of the STA was assessed on CT angiography, MR angiography, or conventional angiography and complications related to wound healing were recorded. RESULTS: Of the 136 operated patients, the STA could be identified in 120 cases (88%). Of these 120 cases, the STA could be dissected and left undamaged in 60 patients (44%). In 52 patients (38%), 1 of the 2 branches of the STA had to be transsected to elevate the muscle-skin flap. Forty-six of the transected arteries could be anastomosed at the end of the procedure. All of these arteries were patent directly after repair. In the remaining 16 patients (12%), the STA was not identified during approach. All anastomosed arteries (n = 46) were patent. Two patients developed a postoperative infection. CONCLUSIONS: Preserving or reconstructing of the STA during pterional craniotomy is feasible in the majority of the patients with very high rate of anastomosis patency. STA hinders elevation of the skin/muscle flap in approximately 38% of the pterional approaches and without reconstruction afterwards, the STA would been occluded.

The previous chapters of this book have shown that becoming an evidence-based neurosurgeon is not a simple task. Both the editors and the authors have tried to take the next step in the synthesis of higher-level evidence for practicing neurosurgeons. The chapters are organized around common clinical scenarios taken from real-life experience. The results show that some scenarios are more common and subsequently comprise more high quality evidence, whereas others are extremely rare resulting on only a few retrospective case series. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used in this book for grading the quality of evidence [1]. GRADE provides a comprehensive framework for evaluation of the quality of evidence in systematic reviews and clinical guidelines, succeeding the hierarchical levels of evidence classification system which has been widely used for the past decades [2].

Contains fulltext : 170347.pdf (Publisher’s version ) (Open Access) BACKGROUND AND PURPOSE: Flow diverters for the treatment of posterior circulation aneurysms remain controversial. We aimed to identify factors contributing to outcome measures in patients treated with the Surpass flow diverter for aneurysms in this location. MATERIALS AND METHODS: We conducted an observational study of 53 patients who underwent flow-diverter treatment for posterior circulation aneurysms at 15 centers. Key outcome measures were mortality, complete aneurysm occlusion, and modified Rankin Scale score at follow-up. RESULTS: At follow-up (median, 11.3 months; interquartile range, 5.9-12.7 months), 9 patients had died, resulting in an all-cause mortality rate of 17.3% (95% CI, 7%-27.6%); 7 deaths (14%) were directly related to the procedure and none occurred in patients with a baseline mRS score of zero. After adjusting for covariates, a baseline mRS of 3-5 was more significantly (P = .003) associated with a higher hazard ratio for death than a baseline mRS of 0-2 (hazard ratio, 17.11; 95% CI, 2.69-109.02). After adjusting for follow-up duration, a 1-point increase in the baseline mRS was significantly (P < .001) associated with higher values of mRS at follow-up (odds ratio, 2.93; 95% CI, 1.79-4.79). Follow-up angiography in 44 patients (median, 11.3 months; interquartile range, 5.9-12.7 months) showed complete aneurysm occlusion in 29 (66%; 95% CI, 50.1%-79.5%). CONCLUSIONS: Clinical results of flow-diverter treatment of posterior circulation aneurysms depend very much on patient selection. In this study, poorer outcomes were related to the treatment of aneurysms in patients with higher baseline mRS scores. Angiographic results showed a high occlusion rate for this subset of complex aneurysms.

Background and Purpose— In patients harboring intracranial aneurysms, the major goal in treatment is to prevent bleeding. A new generation of an endoluminal device (Surpass Flow Diverter [Surpass]) was developed to reconstruct parent artery and occlude the aneurysm. We present our clinical and angiographic single-center experience. Methods— Patients with a wide range of complex unruptured aneurysms were treated with the Surpass placed in the parent artery and bridging the aneurysm. Clinical and angiographic follow-up were performed at 6 months. Data were prospectively collected. Results— Thirty seven patients (mean age, 56 years; range, 32–79), harboring 49 unruptured aneurysms were treated at our center. All except 1 patient were treated with a single device. Successful delivery of the device was achieved in all patients. All 35 nonbifurcation aneurysm necks were covered completely, whereas 14 bifurcation aneurysms were only partially covered. There was no major periprocedural morbidity or mortality. During follow-up, 4 patients (10.4%) experienced transient neurological deficit. One patient (3%) developed a minor stroke at 4-month follow-up with persistent neurological deficit. Twelve patients had neurological symptoms related to their aneurysm and 7 showed improvement of these symptoms during follow-up. At 6-month follow-up, 29 of 31 aneurysms studied that had complete neck coverage showed a complete occlusion (94%) including 1 case with a 95% to 100% occlusion, whereas 5 of the 10 bifurcation aneurysms were occluded. Conclusions— Our study shows high safety and efficacy profile of a new generation endoluminal device in treatment of complex intracranial aneurysms. Long-term studies of treated bifurcation aneurysms are needed.

OBJECTIVE: To evaluate the safety and performance of a synthetic dural sealant as an adjunct to standard surgical dural repair techniques to prevent cerebrospinal fluid (CSF) leakage. METHODS: This study was designed as a prospective, nonrandomized, single-center clinical trial. The dural sealant is a synthetic absorbable hydrogel. Consecutive series of patients scheduled for elective cranial and intradural spinal surgery were included until a total of 50 applications were achieved. It was used primarily as an adjunct to ensure watertight dural closure. The end point was defined as no leak with the Valsalva maneuver after dural sealant application. The patients were followed up for 3 months after surgery to check for CSF leakage, standard laboratory and neurological examinations, and possible adverse advents. RESULTS: Of the 49 patients, 46 were included and treated with the dural sealant because of spontaneous leak (n = 34; 69%) or leak after the Valsalva maneuver (n = 12; 25%). There was no leak in the other patients (n = 3; 6%). After application of the dural sealant, there was no leak in all 46 patients (100%). Of the 46 patients included, there was one case of overt CSF leak. One patient had a pseudomeningocele. There were no adverse events other than those related to the disease or to the surgical procedure itself. CONCLUSION: The dural sealant, a synthetic absorbable hydrogel, is a useful adjunct to achieve watertight dural closure. Application resulted in 100% closure of intraoperative CSF leaks. There are no evident adverse effects.

Purpose: The Surpass NeuroEndograft (Surpass FD, Tel Aviv, Israel), a low porosity, high pore density flow diverting (FD) device, was evaluated for the treatment of intracranial aneurysms in a single center. Materials and Methods: A total of 45 aneurysms in 35 patients were treated. To achieve the calculated flow disruption between the parent artery and aneurysm and required for an occlusion, single devices, tailored to local boundary conditions, were placed endovascularly in parent arteries and covering the aneurysm. Implanted devices measured 2.9-5.3mm in diameter with a length of 10-50mm. Thirty-five aneurysms had complete neck coverage after implantation and ten bifurcation aneurysms had a planned incomplete neck coverage. Results: Six-month follow-up angiography available for 28 aneurysms with complete neck coverage, showed a complete occlusion in 27 aneurysms and a less than 50% occlusion in one, resulting in a 96% occlusion rate. Five aneurysms with incomplete neck coverage had complete occlusion at six months follow-up, and four had less than 50% occlusion. There were two parent artery occlusions, leading to a permanent stroke in one patient. There were no other permanent neurological morbidities and there was no mortalitiy., thus permanent morbidity in these series was 2,9%. Infarctions caused by occlusion of perforating arteries covered by the implant during the follow-up period were not seen. Conclusion: Preliminary data demonstrate in treatment of complex aneurysms the efficacy of a new generation of FD device.

Background Reporting financial disclosures has become standard practice in both journal publications and during oral forum at scientific meetings. Despite this, the effect of reporting a financial disclosure of any member of an authorgroup, on the tone of the conclusion of an article has gained little attention. This study was performed to determine what effect reporting a financial disclosure has on the conclusion of an article. Methods A literature search for all articles on interspinous devices and cervical disc prostheses, published from January 1st, 2008 until December 1st, 2010 was performed. Financial disclosures were reported, as were funding by commercially active parties. The tone of the conclusions was graded as positive, neutral or negative. Results The odds ratio (OR) for a positive conclusion in cases where a financial disclosure was reported was 16.5 (95% CI: 4.7–58.1). Effect modification occurs with the presence of funding by a commercially active party. In cases where a financial disclosure was reported and funding was available for the study, the OR was 1.0 (95% CI: 0.08–12.6), whilst the OR was 33.3 (95%CI: 4.2–262.3) if funding was not provided. This discrepancy is mainly due to the large number of articles with a neutral/negative conclusion if the authors failed to report any financial disclosure and were not funded by a commercially active party. Conclusions Reporting a financial disclosure is a potential source of bias. Authors with disclosed financial relationships less often publish articles with a neutral/negative conclusion. This source of bias should certainly be taken into account during the critical appraisal of articles, particularly when the quality of the literature is being assessed. Electronic supplementary material The online version of this article (doi:10.1007/s00586-011-2086-x) contains supplementary material, which is available to authorized users.