BackgroundThe primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device.MethodsThe CLARYS ...study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year.ResultsSixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%.ConclusionsThe interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.
A unique extraction procedure leading to the separation of 2 different pharmaceutical classes molecules has been developed and optimised by chemometric tools. From only one sampling, this analytical ...method allows the determination of 21 pharmaceuticals from corticosteroids and β-blockers classes. Performing the SPE on Oasis MCX (mixed-mode cation exchange), the sequential elution of each pharmaceutical class is achievable, allowing a high purity level of extracts as well as high recovery rates. Performing a unique sample preparation results in an important save of time. The extracts were then analysed by LC/MS/MS, using a Hibar Purospher Star column for β-blockers and an X-Bridge column for corticosteroids with formate buffer (pH 3.8)/AcN and water/AcN mobile phases, respectively. This work also includes a study of the chromatographic and mass spectrometric parameters in order to increase the analyte signal. The optimised SPE-LC/MS/MS method was then applied to environmental samples from sewage treatment plant (STP). β-Blockers and corticosteroids were detected, respectively, in concentrations up to 318
ng
L
−1 (sotalol) and 174
ng
L
−1 (cortisone), in STP influents. Moreover, both pharmaceutical classes have also been detected in STP effluents. As far as we know, this is the first paper reporting the detection of corticosteroids in environmental waters. The developed analytical method can be used in further studies to investigate the environmental contamination by these drugs.
To evaluate outcomes of thrombectomy in patients with a basilar artery occlusion (BAO) and mild symptoms, defined by an initial National Institutes of Health Stroke Scale (NIHSS) score ≤6.
We ...performed a retrospective analysis of a multicenter prospective cohort of consecutive patients with acute ischemic stroke with BAO who underwent thrombectomy. We compared baseline and procedural characteristics, as well as outcomes between patients with BAO with an NIHSS score ≤6 and >6. Multivariate analyses were performed to determine baseline and procedural predictors of good outcome (modified Rankin Scale score 0–2) among patients with an NIHSS score ≤6.
A total of 269 patients were included: 50 (19%) had an initial NIHSS score ≤6 and 219 (81%) had an NIHSS score >6. Patients with mild strokes (NIHSS score ≤6) had better outcomes (68% of modified Rankin Scale score 0–2 vs. 27% for NIHSS score >6; P < 0.0001), lower mortality (14% vs. 48; P < 0.0001) and fewer parenchymal hematomas at day 1 (0% vs. 10%; P = 0.016). A multivariate analysis identified the following predictors for good outcome among patients with BAO with an NIHSS score ≤6: younger age, fewer passes, a cardioembolic cause, and the absence of need for angioplasty/stenting.
Thrombectomy seems to be safer and more effective for mild BAO strokes with NIHSS score ≤6 than for more severe patients. Even although thrombectomy showed high rates of recanalization, a substantial proportion (32%) nevertheless had a poor long-term clinical outcome. The number of passes, patient's age, and stroke cause seem to be predictors of clinical outcome.
To develop a multidisciplinary French reference that addresses initial pre- and in-hospital management of a mild traumatic brain injury patient.
A panel of 22 experts was formed on request from the ...French Society of Emergency Medicine (SFMU) and the French Society of Anaesthesiology and Critical Care Medicine (SFAR). A policy of declaration and monitoring of links of interest was applied and respected throughout the process of producing the guidelines. Similarly, no funding was received from any company marketing a health product (drug or medical device). The expert panel had to respect and follow the Grade® (Grading of Recommendations Assessment, Development and Evaluation) methodology to evaluate the quality of the evidence on which the recommendations were based. Given the impossibility of obtaining a high level of evidence for most of the recommendations, it was decided to adopt a “Recommendations for Professional Practice” (RPP) format, rather than a Formalized Expert Recommendation (FER) format, and to formulate the recommendations using the terminology of the SFMU and SFAR Guidelines.
Three fields were defined: 1) pre-hospital assessment, 2) emergency room management, and 3) emergency room discharge modalities. The group assessed 11 questions related to mild traumatic brain injury. Each question was formulated using a PICO (Patients Intervention Comparison Outcome) format.
The experts’ synthesis work and the application of the GRADE® method resulted in the formulation of 14 recommendations. After two rounds of rating, strong agreement was obtained for all recommendations. For one question, no recommendation could be made.
There was strong agreement among the experts on important, transdisciplinary recommendations, the purpose of which is to improve management practices for patients with mild head injury.
Background and purposeFlow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this ...treatment although safety results were worse compared with coiling or balloon-assisted coiling. The Safety and Efficacy Analysis of FRED Embolic Device in Aneurysm Treatment (SAFE) trial is a single-arm, multicenter, prospective study conducted to precisely analyze the safety and efficacy of the FRED and FRED Jr devices.MethodsUnruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. Adverse events were independently evaluated by a Clinical Event Committee with a vascular neurosurgeon and an interventional neuroradiologist. Primary safety outcome measures were morbidity and mortality rates at 6 months after treatment.ResultsA total of 103 patients/aneurysms were included in 13 interventional neuroradiology (INR) centers. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral artery or anterior communicating artery in nine (8.7%), and middle cerebral artery in eight (7.8%). Aneurysms were small (<10 mm) in 71 patients (68.9%). Treatment was successfully performed in 98/103 patients (95.1%). Thromboembolic (TE) complications occurred in 5/103 patients (4.9%), intraoperative rupture in 2/103 patients (1.9%), delayed aneurysm rupture in 1/103 patient (1.0%), and delayed hematoma occurred in 1/103 patient (1.0%). Six-months' mortality and morbidity rates were 1/102 (1.0%) and 2/102 (2.0%), respectively.ConclusionsAneurysm treatment with the FRED device is safe with low mortality (1.0%) and morbidity (2.0%).Clinical trial registrationNCT02921698.
BackgroundThe CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is ...safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study.MethodsThe CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging.ResultsSixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond–Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment.ConclusionsThe CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.
BackgroundCoiling, including balloon-assisted coiling (BAC), is the first-line therapy for ruptured and unruptured aneurysms. Its efficacy can be clinically evaluated by bleeding/rebleeding rate ...after coiling, and anatomically evaluated by aneurysm occlusion post-procedure and during follow-up. We aimed to analyze immediate post-coiling aneurysm occlusion and associated factors within the Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) population.MethodsBetween December 2013 and May 2015, 16 neurointerventional departments prospectively enrolled participants treated for ruptured and unruptured aneurysms (ClinicalTrials.gov: NCT01942512). Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. In patients with aneurysms treated by coiling or BAC, immediate post-operative aneurysm occlusion was independently evaluated by a core lab using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.ResultsOf 1135 participants (age 53.8±12.8 years, 754 women (66.4%)), 1189 aneurysms were analyzed. Treatment modality was standard coiling in 645/1189 aneurysms (54.2%) and BAC in 544/1189 (45.8%). Immediate post-operative aneurysm occlusion was complete occlusion in 57.8%, neck remnant in 34.4%, and aneurysm remnant in 7.8%. Adequate occlusion (complete occlusion or neck remnant) was significantly more frequent in aneurysms with size <10 mm (93.1% vs 86.3%; OR 1.8, 95% CI 1.1 to 3.2; p=0.02) and in aneurysms with a narrow neck (95.8% vs 89.6%; OR 2.5, 95% CI 1.5 to 4.1; p=0.0004). Patients aged <70 years had significantly more adequate occlusion (92.7% vs 87.2%; OR 1.9, 95% CI 1.1 to 3.4; p=0.04).ConclusionsImmediately after aneurysm coiling, including BAC, adequate aneurysm occlusion was obtained in 92.2%. Age <70 years, aneurysm size <10 mm, and narrow neck were factors associated with adequate occlusion.Trial registration number NCT01942512, http://www.clinicaltrials.gov.
Functional arterial spin labeling (fASL) is an innovative biomarker of neuronal activation that allows direct and absolute quantification of activation-related CBF and is less sensitive to venous ...contamination than BOLD fMRI. This study evaluated fASL for motor activation mapping in comparison with BOLD fMRI in terms of involved anatomical area localization, intra-individual reproducibility of location, quantification of neuronal activation, and spatial accuracy. Imaging was performed at 3T with a 32-channel coil and dedicated post-processing tools were used. Twelve healthy right-handed subjects underwent fASL and BOLD fMRI while performing a right hand motor activation task. Three sessions were performed 7
days apart in similar physiological conditions. Our results showed an activation in the left primary hand motor area for all 36 sessions in both fASL and BOLD fMRI. The individual functional maps for fASL demonstrated activation in ipsilateral secondary motor areas more often than the BOLD fMRI maps. This finding was corroborated by the group maps. In terms of activation location, fASL reproducibility was comparable to BOLD fMRI, with a distance between activated volumes of 2.1
mm and an overlap ratio for activated volumes of 0.76, over the 3 sessions. In terms of activation quantification, fASL reproducibility was higher, although not significantly, with a CVintra of 11.6% and an ICC value of 0.75. Functional ASL detected smaller activation volumes than BOLD fMRI but the areas had a high degree of co-localization. In terms of spatial accuracy in detecting activation in the hand motor area, fASL had a higher specificity (43.5%) and a higher positive predictive value (69.8%) than BOLD fMRI while maintaining high sensitivity (90.7%). The high intra-individual reproducibility and spatial accuracy of fASL revealed in the present study will subsequently be applied to pathological subjects.
► We evaluated functional ASL for motor activation mapping compared to BOLD fMRI. ► fASL revealed activation in ipsilateral secondary motor areas. ► In terms of activation location, fASL reproducibility was comparable to BOLD. ► In terms of activation quantification, fASL reproducibility was higher than BOLD. ► In terms of spatial accuracy, fASL had higher specificity than BOLD.
Background and purpose
Better characterization of the thrombus could be useful to determine acute ischaemic stroke (AIS) aetiology and predict response to thrombolysis and endovascular therapy (EVT). ...To test the hypothesis that susceptibility vessel sign (SVS) on baseline magnetic resonance imaging (MRI) is related to red blood cell (RBC) content of AIS thrombi, the total haemoglobin contents (HbCs) of AIS thrombi retrieved by EVT from patients with or without SVS or two‐layered SVS (TLSVS) were compared.
Methods
Baseline MRI of 84 anterior AIS patients was reviewed by neuro‐radiologists blinded to clinical and biochemical data. Thrombi from these patients were retrieved by EVT and analysed for HbC by quantitative enzyme‐linked immunosorbent assay and measurement of haem concentration.
Results
Susceptibility vessel sign and TLSVS were respectively observed in 85.7% and 50.0% of cases. The median HbC content was 253 µg/mg thrombus (interquartile range 177–333) and the median haem content was 219 µg/mg thrombus (131–264). Thrombus HbC and haem content were highly correlated with thrombus RBC content determined by flow cytometry (r = 0.94). Thrombi from patients with TLSVS weighed more 31.1 (16.5–68.3) mg vs. 17.7 (11.7–33.3) mg; P = 0.005 and had a higher HbC content 278 (221–331) µg/mg vs. 196 (139–301) µg/mg; P = 0.010 compared to thrombi from patients without TLSVS. There was no difference in thrombus weight or HbC content according to SVS status.
Conclusions
Our study shows that TLSVS is significantly associated with a higher thrombus weight and RBC content, as determined by quantitative assays.
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