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In patients with idiopathic normal-pressure hydrocephalus responsive to CSF drainage, shunting improved gait and balance at 3 months, but not cognition or incontinence, and was associated with some procedure-related risks.

Lumboperitoneal shunt surgery has the potential to alleviate symptoms of normal pressure hydrocephalus but the benefits of such surgery have not been tested in a randomised trial. The aim of this trial was to determine the safety and efficacy of the lumboperitoneal shunt surgery for this disorder. For the open-label randomised SINPHONI-2 trial, eligible participants (60–85 years of age) with idiopathic normal pressure hydrocephalus, with ventriculomegaly, and tightness of the high-convexity and medial subarachnoid spaces on MRI, were recruited from 20 neurological and neurosurgical centres in Japan. Enrolled participants were randomly assigned in a 1:1 ratio according to a random code generated by the trial statistician, with a permuted block design (using a block size of 4 or 6) within each centre, to receive lumboperitoneal shunt surgery within 1 month after randomisation, or to surgery postponed for 3 months. Patients and assessors were not masked to treatment assignment. The primary endpoint was favourable outcome, defined as an improvement of one point or more on the modified Rankin scale (mRS) at 3 months after randomisation, analysed by intention to treat, and the main secondary endpoint was the same outcome 12 months after surgery, analysed per protocol. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), number UMIN000002730. Between March 1, 2010, and Oct 19, 2011, 93 patients with idiopathic normal pressure hydrocephalus were enrolled and randomly assigned to the immediate treatment group (n=49) or the postponed treatment group (n=44). More patients in the immediate treatment group than in the postponed treatment group had an improvement of one point or more on the mRS at 3 months: 32 (65%) of 49 in the immediate group vs 2 (5%) of 44 in the postponed group (difference 61% [95% CI 42–68]; p<0·0001). The number of patients who had an improvement of one point or more on the mRS at 12 months after surgery was similar between the two groups: 30 (67%) of 45 patients in the immediate group vs 22 (58%) of 38 in the postponed group (difference 9% [95% CI −14 to 31]; p=0·496). The proportions of patients with serious adverse events did not differ significantly between the groups during the 3 months post-randomisation (7 [15%] of 46 in the immediate group vs 1 [2%] of 42 in the postponed group; p=0·060). During the 12 months after surgery, 19 (22%) of 87 patients had serious adverse events, the most common of which was cerebral infarction (six patients [7%]). Our results suggest that lumboperitoneal shunt surgery might be beneficial for patients with idiopathic normal pressure hydrocephalus and, if these findings are confirmed in larger studies, could be a first-line treatment option for this disease. Johnson & Johnson and Nihon Medi-Physics.

Purpose Post infective hydrocephalus (PIH) is a type of hydrocephalus which occurs after an infection of the brain or cerebrospinal fluid (CSF). Treatment of PIH requires temporary measures such as external ventricular drain (EVD) and ventriculosubgaleal shunt (VSGS) until CSF becomes clear and ready to implement VP shunt. Limited research has been done to explore the tradeoff between these approaches particularly in pediatric PIH patients. Our study compares the complications, mortality rates, and the cost of used resources of both procedures. Methods A prospective study was conducted for 18 months in which we compared between VSGS and EVD for management of PIH involving 42 randomized cases with 21 patients in group A operated by VSGS and 21 patients in group B operated by EVD. Results Our results show a statistically significant difference between both groups in the duration of implementation of VSGS/EVD until resolution of infection occurs. Additionally, a higher rate of pediatric intensive care unit (PICU) admission and a longer length of hospital stay (LOS) were recorded among the EVD group. No statistically significant difference between the number of complications that happened in both despite variations in their forms. Moreover, both groups showed nearly similar mortality rates. Conclusion There is no significant difference in the rate of complications between VSGS and EVD for PIH. Based on that, VSGS emerges as a favorable and cost-effective option for the management of PIH which leads to less economic burden on patients and the country’s health resources, especially in developing countries.

Introduction One of the most important unanswered questions in pediatric hydrocephalus is determining whether treatment with endoscopic third ventriculostomy (ETV) versus shunt results in improved health status and quality of life (QOL). To answer this, the International Infant Hydrocephalus Study (IIHS) was started in 2005 as a prospective, multicenter study to compare ETV and shunt in infants (< 24 months old) with symptomatic triventricular hydrocephalus from aqueductal stenosis. Herein, we present the 5-year primary outcome results. Methods IIHS utilized a prospective comprehensive cohort design, in which patients received ETV or shunt, based on either randomization or parental preference. For this analysis, we pooled the randomized arm and the parental preference arm, analyzing them together. At 5 years of age, children were assessed with the Health Utilities Index Mark 2 (HUI-2) (primary outcome) and the Hydrocephalus Outcome Questionnaire (HOQ), a measure of QOL. Results were compared in an analysis of covariance, adjusting for baseline variables including age at surgery and baseline development status. Results From a total of 158 patients who met eligibility criteria, complete 5-year outcomes were available on 78 (19 treated initially with shunt, 61 treated initially with ETV), assessed at a mean age of 62.1 months (SD 6.3). The mean 5-year HUI-2 utility score was 0.90 (SD 0.19) for ETV and 0.94 (SD 0.10) for shunt ( p  = 0.21). The mean 5-year HOQ overall score was 0.81 (SD 0.15) for ETV and 0.85 (SD 0.12) for shunt ( p  = 0.42). Similarly, there were no significant differences noted between 5-year HOQ subscores (cognitive, social-emotional, physical) or developmental measures at 1, 2, and 3 years. Conclusions This is the first prospective direct comparison of long-term outcomes of ETV and shunt for infant hydrocephalus. These results suggest that overall health status and quality of life in this cohort of infants treated for aqueductal stenosis are high, with no significant difference between those treated initially with ETV or shunt. Trial registration NCT00652470

Introduction The IIHS is an international, prospective, multicenter study to compare endoscopic third ventriculostomy (ETV) and shunt in infants (<24 months old) with symptomatic triventricular hydrocephalus from aqueductal stensosis. Recruitment started in 2004, and here, we present the first results of IIHS. Methods IIHS utilized a prospective comprehensive cohort design, which contained both a randomized and a non-randomized arm. Patients received either an ETV or shunt, based on randomization or parental preference. Patients were followed prospectively for time to treatment failure, defined as the need for repeat CSF diversion procedure (shunt or ETV) or death due to hydrocephalus. Survival analysis was used to compare time to failure for ETV versus shunt. The trial was registered at clinicaltrials.gov (NCT00652470). Results A total of 158 patients met eligibility criteria (median age at surgery 3.6 months, IQR 1.6–6.6 months) across 27 centers in 4 continents. Since only 52 patients (32.9 %) were randomized, all 158 patients were analyzed together (115 ETV, 43 shunt). Actuarial success rates for ETV vs shunt at 3, 6, and 12 months were as follows: 68 vs 95 %, 66 vs 88 %, and 66 vs 83 %. The 6-month ETV success rate of 66 % was slightly higher than would have been predicted by the ETV Success Score (57 %).The hazard ratio for time to treatment failure favored shunt over ETV (3.17, 95 % CI 1.45–6.96, p  = 0.004), after adjusting for age at surgery, history of previous hemorrhage or infection, continent, and randomization status. Patients younger than 6 months of age appeared to do relatively worse with ETV than older patients. Conclusions The IIHS has provided the first prospective direct comparison of ETV and shunt for infant hydrocephalus. These initial results suggest that shunting has a superior success rate compared to ETV, although the success rate for both was relatively high. This patient cohort continues to be followed, and we will await the results of the important primary outcome of health status at 5 years of age.

Abstract BACKGROUND In patients with aneurysmal subarachnoid hemorrhage (SAH), preliminary results indicate that the amplitude of the single intracranial pressure (ICP) wave is a better predictor of the early clinical state and 6-month outcome than the mean ICP. OBJECTIVE To perform a randomized and blinded single-center trial comparing the effect of mean ICP vs mean ICP wave amplitude (MWA)-guided intensive care management on early clinical state and outcome in patients with aneurysmal SAH. METHODS Patients were randomized to 2 different types of ICP management: maintenance of mean ICP less than 20 mm Hg and MWA less than 5 mm Hg. Early clinical state was assessed daily using the Glasgow Coma Scale. The primary efficacy variable was 12-month outcome in terms of the Rankin Stroke Score. RESULTS Ninety-seven patients were included in the study. There were no significant differences in treatment between the 2 groups apart from a larger volume of cerebrospinal fluid drained during week 1 in the MWA group. There was a tendency toward higher Glasgow Coma Scale scores in the MWA group during weeks 1 (P = .08) and 2 (P = .07). Outcome in terms of Rankin Stroke Score at 12 months was significantly better in the MWA group (P < .05). CONCLUSION This randomized and blinded trial disclosed a significant better primary efficacy variable (Rankin Stroke Score after 12 months) in the MWA patient group. We suggest that proactive intensive care management with MWA-tailored cerebrospinal fluid drainage during the first week improves aneurysmal SAH outcome.

IntroductionIn Neuro Intensive Care Units (NICU) and neurosurgical units, patients with an external ventricular drain (EVD) due to hydrocephalus following aneurysmal subarachnoid haemorrhage (SAH) are commonly seen. Cessation of the EVD involves the dilemma of either closing the EVD directly, or gradually weaning it before removal. Development of increased intracranial pressure (ICP) and acute hydrocephalus with subsequent need of a permanent shunt has been associated with prompt closure of theEVD, whereas increased risk of infection with possible spreading to the brain and subsequent patient fatality is suspected in connection to a longer treatment as seen in gradual weaning. Sparse data exist on the recommendation of cessation strategy and patients are currently being treated on the basis of personal experience and expert opinion. The objective of this systematic review is to assess the available evidence from clinical trials on the effects of prompt closure versus gradual weaning of EVD treatment for hydrocephalus in adult patients with SAH.Methods and analysisWe will search for randomised clinical trials in major international databases. Two authors will independently screen and select references for inclusion, extract data and assess the methodological quality of the included randomised clinical trials using the Cochrane risk of bias tool. Any disagreement will be resolved by consensus. We will analyse the extracted data using Review Manager and trial sequential analysis. To assess the quality of the evidence, we will create a ‘Summary of Findings’ table containing our primary and secondary outcomes using the GRADE assessment.Ethics and disseminationResults will be published widely according to the interest of the society. No possible impact, harm or ethical concerns are expected doing this protocol.Trial registration numberPROSPERO CRD42018108801

External ventricular drains (EVDs) are valuable adjuncts in the management of neurosurgical patients but are associated with a significant risk of cerebrospinal fluid (CSF) infection (range, 0% to 27%); a review of 23 studies reported a mean of 8.8%. To compare the efficacy of 2 different antibiotic-impregnated EVD catheters in preventing CSF infections. Patients were prospectively enrolled in an Institutional Review Board-approved study. During alternating 3-month periods, all patients received either a minocycline/rifampin-impregnated (M/R) ventricular catheter or a clindamycin/rifampin-impregnated (C/R) EVD catheter. CSF cultures were collected at the time of insertion and twice weekly. Positive cultures were defined a priori as growth of the same bacteria on 2 media (eg, blood agar and broth) or 2 cultures of the same bacteria on 1 medium (eg, broth). Altogether, 129 patients (mean age, 58.4 years; 55 male) received 65 C/R catheters and 64 M/R catheters. The most common indications for EVD placement were aneurysmal subarachnoid hemorrhage (48.1%), spontaneous intraparenchymal hemorrhage (13.2%), and tumor (11.6%). The mean duration of ventriculostomy drainage was 11.8 and 12.7 days in the C/R and M/R groups, respectively. No positive CSF cultures were identified in either cohort. The use of antibiotic-impregnated catheters was associated with an extremely low risk of CSF infection compared with the reported mean of nearly 9% for standard EVD catheters. Infection rates for both C/R and M/R EVD catheters were zero. These results support the use of antibiotic-impregnated EVD catheters in routine clinical practice.

Background The standard technique for the placement of ventricular catheters (VC) comprises a high proportion of malpositioning of the catheter (12.5 to 40%). Technical advances such as neuronavigation or ultrasound have been shown to increase the accuracy of the procedure. Since these means result in significant technical and time consuming efforts, they are used for selected cases only. In order to simplify the controlled placement of ventricular catheters a newly developed smartphone assisted guiding tool has been introduced. In this study the efficacy and safety of this guiding tool is determined. Methods/design This study is a multicentre, randomised, controlled trial. A total of 144 patients planned for an elective shunting procedure will be enrolled throughout 10 study centres within two years. The primary objective of the trial is to show the superiority of the guided placement in comparison to the standard freehand technique of ventricular catheter application. Patients will be followed up for 30 days after the operation in regard to image-based evaluation of the catheter position as well as possible shunt dysfunction and complications. Discussion The Guided Application of Ventricular Catheters (GAVCA) trial compares the guided catheter positioning with the standard freehand technique of catheter placement in hydrocephalic patients. If superiority is shown, the standard technique may be changed with the advantage of a more reliable and safer positioning of the ventricular catheter with just a slight effort in time and pre-operative planning. Trial registration The GAVCA trial is registered at ClinicalTrials.gov under the number NCT01811589 .

Background We examine two accepted methods of managing cerebrospinal fluid (CSF) drainage in patients following subarachnoid hemorrhage (SAH). The first is intermittent CSF drainage when intracranial pressure (ICP) reaches a pre-defined threshold (monitor-first) and the second is continuous CSF drainage (drain-first) at set pressure thresholds. This pilot study is designed to determine if there is a cause for a randomized study of comparing the two methods. Methods This prospective observational pilot study enrolled 37 patients with SAH and external ventricular drainage between October 2008 and August 2009. Patients were treated with one of two methods of ICP management (drain-first vs. monitor-first) according to the discretion of the admitting physician. Results There were no significant differences in baseline characteristics including age, gender, severity of neurological dysfunction, and radiographic findings between the two groups. The incidence of vasospasm was not different between the drain-first group (66.7%; 16 of 24 patients) and the monitor-first group (53.9%; 7 of 13 patients). Conclusion This pilot study was neither powered, nor expected to detect a difference between groups. The results of this study provide support for the design and conduct of a randomized study to assess the impact of two methods of CSF diversion for patients with SAH.