Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial.

BACKGROUND: Mechanical thrombectomy (MT) has become a standard treatment for acute ischemic strokes (AIS). However, MT failure occurs in approximately 10-30% of cases, leading to severe repercussions (with mortality rates up to 40% according to observational data). Among the available rescue techniques, rescue intracranial stenting (RIS) appears as a promising option. OBJECTIVE: This trial is poised to demonstrate the superiority of RIS in addition to the best medical treatment (BMT) in comparison with BMT alone, in improving the functional outcomes at 3 months for patients experiencing an AIS due to a large vessel occlusion refractory to MT (rLVO). METHODS: Permanent Intracranial STenting for Acute Refractory large vessel occlusions (PISTAR) is a multicenter prospective randomized open, blinded endpoint trial conducted across 11 French University hospitals. Adult patients (≥18 years) with an acute intracranial occlusion refractory to standard MT techniques will be randomized 1:1 during the procedure to receive either RIS+BMT (intervention arm) or BMT alone (control arm). RESULTS: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin Scale score ≤2 and evaluated by an independent assessor blinded to the randomization arm. Secondary outcomes include hemorrhagic complications, all adverse events, and death. The number of patients to be included is 346. Two interim analyses are planned with predefined stopping rules. CONCLUSION: The PISTAR trial is the first randomized controlled trial focusing on the benefit of RIS in rLVOs. If positive, this study will open new insights into the management of AIS. TRIAL REGISTRATION NUMBER: NCT06071091.

Embolization of the middle meningeal artery for the prevention of chronic subdural hematoma recurrence in high-risk patients: a randomized controlled trial-the EMPROTECT study protocol.

BACKGROUND: Middle meningeal artery (MMA) embolization has been proposed as a treatment of chronic subdural hematoma (CSDH). The benefit of the procedure has yet to be demonstrated in a randomized controlled trial. We aim to assess the efficacy of MMA embolization in reducing the risk of CSDH recurrence 6 months after burr-hole surgery compared with standard medical treatment in patients at high risk of postoperative recurrence. METHODS: The EMPROTECT trial is a multicenter open label randomized controlled trial (RCT) involving 12 French centers. Adult patients (≥18 years) operated for CSDH recurrence or for a first episode with a predefined recurrence risk factor are randomized 1:1 to receive either MMA embolization within 7 days of the burr-hole surgery (experimental group) or standard medical care (control group). The number of patients to be included is 342. RESULTS: The primary outcome is the rate of CSDH recurrence at 6 months. Secondary outcomes include the rate of repeated surgery for a homolateral CSDH recurrence during the 6-month follow-up period, the rate of disability and dependency at 1 and 6 months, defined by a modified Rankin Scale (mRS) score ≥4, mortality at 1 and 6 months, total cumulative duration of hospital stay during the 6-month follow-up period, directly or indirectly related to the CSDH and embolization procedure-related complication rates. CONCLUSIONS: The EMPROTECT trial is the first RCT evaluating the benefit of MMA embolization as a surgical adjunct for the prevention of CSDH recurrence. If positive, this trial will have a significant impact on patient care. TRIAL REGISTRATION NUMBER: NCT04372147.

Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial.

RATIONALE: Mechanical thrombectomy (MT) associated with the best medical treatment (BMT) has recently shown efficacy for the management of acute ischemic stroke (AIS) secondary to a large vessel occlusion. However, evidence is lacking regarding the benefit of MT for more distal occlusions. AIM: To evaluate the efficacy in terms of good clinical outcome at 3 months of MT associated with the BMT over the BMT alone in AIS related to a distal occlusion. METHODS: The DISCOUNT trial is a multicenter open-label randomized controlled trial involving French University hospitals. Adult patients (⩾18 years) with an AIS involving the anterior or posterior circulation secondary to a distal vessel occlusion within 6 h of symptom onset or within 24 h if no hyperintense signal on fluid attenuation inversion recovery acquisition will be randomized 1:1 to receive either MT associated with the BMT (experimental group) or BMT alone (control group). The number of patients to be included is 488. STUDY OUTCOMES: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin scale (mRS) ⩽2 and evaluated by an independent assessor blinded to the intervention arm. Secondary outcomes include recanalization of the occluded vessel within 48 h, angiographic reperfusion in the experimental group, 3-month excellent clinical outcome (mRS ⩽ 1), all adverse events, and death. A cost utility analysis will estimate the incremental cost per quality-adjusted life year (QALY) gained. DISCUSSION: If positive, this study will open new insights in the management of AISs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05030142 registered on 1 September 2021.

Antithrombotic therapies for neurointerventional surgery: a 2021 French comprehensive national survey.

BACKGROUND: Neurointerventionists lack guidelines for the use of antithrombotic therapies in their clinical practice; consequently, there is likely to be significant heterogeneity in antithrombotic use between centers. Through a nationwide survey, we aimed to obtain an exhaustive cross-sectional overview of antithrombotic use in neurointerventional procedures in France. METHODS: In April 2021, French neurointerventional surgery centers were invited to participate in a nationwide 51-question survey disseminated through an active trainee-led research collaborative network (the JENI-RC). RESULTS: All 40 centers answered the survey. Fifty-one percent of centers reported using ticagrelor and 43% used clopidogrel as premedication before intracranial stenting. For flow diversion treatment, dual antiplatelet therapy was maintained for 3 or 6 months in 39% and 53% of centers, respectively, and aspirin was prescribed for 12 months or more than 12 months in 63% and 26% of centers, respectively. For unruptured aneurysms, the most common heparin bolus dose was 50 IU/kg (59%), and only 35% of centers monitored heparin activity for dose adjustment. Tirofiban was used in 64% of centers to treat thromboembolic complications. Fifteen percent of these comprehensive stroke centers reported using tenecteplase to treat acute ischemic strokes. Cangrelor appeared as an emergent drug in specific indications. CONCLUSION: This nationwide survey highlights the important heterogeneity in clinical practices across centers. There is a pressing need for trials and guidelines to further evaluate and harmonize antithrombotic regimens in the neurointerventional field.

Post-contrast 3D T1-weighted TSE MR sequences (SPACE, CUBE, VISTA/BRAINVIEW, isoFSE, 3D MVOX): Technical aspects and clinical applications.

Post-contrast three-dimensional T1-weighted imaging of the brain is widely used for a broad range of vascular, inflammatory or tumoral diseases. The variable flip angle 3D TSE sequence is now available from several manufacturers (CUBE, General Electric; SPACE, Siemens; VISTA/BRAINVIEW, Philips; isoFSE, Itachi; 3D MVOX, Canon). Compared to gradient-echo (GRE) techniques, 3D TSE offers the advantages of useful image contrasts and reduction of artifacts from static field inhomogeneity. However, the respective role of 3D TSE and GRE MR sequences remains to be elucidated, particularly in the setting of post-contrast imaging. The purpose of this review was (1) to describe the technical aspects of 3D TSE sequences, (2) to illustrate the main clinical applications of the post-contrast 3D T1-w TSE sequence through clinical cases, (3) to discuss the respective role of post-contrast 3D TSE and GRE imaging in the field of neuroimaging.

Intracranial aneurysms in sickle cell disease: Aneurysms characteristics and modalities of endovascular approach to treat these patients.

INTRODUCTION: The neurological complications of Sickle Cell Disease (SCD) include cerebral infarction and haemorrhage with rarely subarachnoid haemorrhage due to cerebral aneurysms. MATERIALS AND METHODS: In our interventional department, working with SCD referral department, we reported our experience concerning management of adult's patients with cerebral aneurysms. We identified 26 adults with 48 intracranial aneurysms documented by imaging. RESULTS: 18 patients, with 26 cerebral aneurysms were treated by endovascular approach for their aneurysms. No patient was treated by surgical way in our institution. 50% of patients had multiple aneurysms. Locations of aneurysms treated were typical with 70% of cerebral anterior artery and 30% of posterior artery. Three patients suffered from subarachnoid haemorrhage. Two procedure-related complications occurred during the treatment: one thrombo-embolic event with good recovery after medical treatment and one aneurismal perforation leading to the death of patient. Hypercoagulability is a major specific risk in SCD and use of permanent device as stent of flow diverter should be discussed to prevent complications. CONCLUSION: Endovascular management of these aneurysms seems to be a good alternative to treat these patients, with stability of occlusion at follow-up.

Characteristics of Moyamoya Syndrome in Sickle-Cell Disease by Magnetic Resonance Angiography: An Adult-Cohort Study.

Background: Sickle cell disease (SCD) can be complicated by moyamoya syndrome. Brain magnetic resonance angiography (MRA) is a non-invasive method to diagnose this syndrome and, steno-occlusion and moyamoya vessels (MMV) scores have been proposed to evaluate its severity. Previous studies of SCD moyamoya syndrome did not evaluate the severity according to MRA scores. The objective was to assess the characteristics of moyamoya syndrome in an adult cohort of SCD using these MRA scores. Methods: Twenty-five SCD patients with moyamoya syndrome were included using MRA with 3D time of flight technique. We evaluate steno-occlusion score for each hemisphere (range 0-10) from: steno-occlusion severity of internal carotid (ICA) (0-3), anterior cerebral (ACA) (0-3), middle cerebral (MCA) (0-2), and posterior cerebral (PCA) (0-2) arteries. MMV score for each hemisphere (range 0-5) depended from 5 MMV areas: (1) anterior communicating artery (2) basal ganglia (3) ICA/MCA (4) posterior communicating artery/PCA (5) basilar artery. Results: Eight patients (32%) showed unilateral moyamoya syndrome. ICA steno-occlusion was involved in 22 patients (88%), MCA in 23 patients (92%), ACA in 9 patients (36%), and PCA in 3 patients (12%). MMV involved ACoA area in 10 patients (40%), basal ganglia in 13 patients (52%), PCoA/PCA in 10 patients (40%), MCA/ICA in 7 patients (28%), and BA in 1 patient (4%). Steno-occlusion and MMV mean hemisphere scores were 3.4/10 (± 1.42) and 1.6/5 (± 0.71), respectively. Conclusion: Frequent unilateral moyamoya syndrome, uncommon PCA involvement and, moderate steno-occlusion and MMV scores seem to be features of SCD moyamoya syndrome. In future studies, MRA scores could be collected to assess the follow-up in these patients.

Low fetal hemoglobin percentage is associated with silent brain lesions in adults with homozygous sickle cell disease.

Silent white matter changes (WMCs) on brain imaging are common in individuals with sickle cell disease (SCD) and are associated with cognitive deficits in children. We investigated the factors predictive of WMCs in adults with homozygous SCD and no history of neurological conditions. Patients were recruited from a cohort of adults with homozygous SCD followed up at an adult sickle cell referral center for which steady-state measurements of biological parameters and magnetic resonance imaging scans of the brain were available. WMCs were rated by consensus, on a validated age-related WMC scale. The prevalence of WMCs was 49% (95% confidence interval [CI], 39%-60%) in the 83 patients without vasculopathy included. In univariable analysis, the patients who had WMCs were more likely to be older (P = .003) and to have hypertension (P = .02), a lower mean corpuscular volume (P = .005), a lower corpuscular hemoglobin concentration (P = .008), and a lower fetal hemoglobin percentage (%HbF) (P = .003). In multivariable analysis, only a lower %HbF remained associated with the presence of WMCs (odds ratio [OR] per 1% increase in %HbF, 0.84; 95% CI, 0.72-0.97; P = .021). %HbF was also associated with WMC burden (P for trend = .007). Multivariable ordinal logistic regression showed an inverse relationship between WMC burden (age-related WMC score divided into 4 strata) and HbF level (OR for 1% increase in %HbF, 0.89; 95% CI, 0.79-0.99; P = .039). Our study suggests that HbF may protect against silent WMCs, decreasing the likelihood of WMCs being present and their severity. It may therefore be beneficial to increase HbF levels in patients with WMCs.

Occlusion assessment of intracranial aneurysms treated with the WEB device.

INTRODUCTION: The Woven EndoBridge (WEB) system is an innovative device under evaluation for its capacity to treat wide-neck bifurcation intracranial aneurysms. The purpose of this study is to evaluate the use of the different occlusion scales available in clinical practice. METHODS: Seven WEB-experienced neurointerventionalists were provided with 30 angiographic follow-up data sets and asked to grade each evaluation point according to the Bicêtre Occlusion Scale Score (BOSS), firstly based on DSA images only then using additional C-Arm VasoCT analysis. This BOSS evaluation was then converted into the WEB Occlusion Scale (WOS) and into a dichotomized scale (complete occlusion or not). To estimate the inter-rater agreement among the seven raters, an overall kappa coefficient [1] and its standard error (SE) were computed. RESULTS: Using the five-grade BOSS, raters showed "moderate" agreement (kappa = 0.56). Using the three-grade WOS, agreement appeared slightly better (kappa = 0.59). Strongest inter-rater agreement was observed with a dichotomized version of the scale (complete occlusion or not), which enabled an "almost perfect" agreement (kappa = 0.88). VasoCT consistently enhanced the agreement particularly with regards depicting intra-WEB residual filling. CONCLUSION: The WOS is a consistent means to angiographically evaluate the WEB device efficiency. But the five-grade BOSS scale allows to identify aneurysm subgroups with differing risks of recurrence and/or rehemorrhage, which needs to be separated especially at the initial phase of evaluation of this innovative device. The additional use of VasoCT allows better inter-rater agreement in evaluating occlusion and specially in depicting intra-WEB persistent filling.

Efficacity and feasibility of vertebroplasty for severe vertebral fracture: a retrospective study of 12 vertebroplasties.

Vertebroplasty is commonly contraindicated for severe vertebral fractures, or vertebra plana. However, we decided after multidisciplinary staff decision to perform vertebroplasty for few severe vertebral fractures which were still painful after optimal medical treatment. We retrospectively studied the charts of patients who benefited from vertebroplasty for severe vertebral body compression fracture between May 2006 and January 2012 in a rheumatology department. Clinical and biological data were collected and patients were consulted to assess effectiveness of that technique. We performed vertebroplasty of 12 severe vertebral fractures in 10 patients (nine women and one man). Mean age was 74.9±10.7 years. Mean VAS score was 9/10±1.15 before vertebroplasty and 2.4±2 after. Global improvement was 80% and patient satisfaction was 7/10. After vertebroplasty, use of drugs was significantly reduced or even stopped. The complications observed were: three infraclinical cement leakages, one haematoma at the site of the puncture, one atrial fibrillation and one classic pulmonary embolism. Mean follow-up was 28.6±22.3 months. Vertebroplasty is indeed a delicate procedure for severe vertebral fracture but quickly and sustainably effective.

Functional MRI comparison of passive and active movement: possible inhibitory role of supplementary motor area.

Recent studies have hypothesized that the supplementary motor area plays a role in motor inhibition. To study this possible role, we used functional MRI study to compare conditions, which require various level of inhibition of motor patterns. Seventeen healthy participants were scanned while executing - actively or passively - rhythmic opening/closing movements of their right hand, with and without congruent visual information. The contrast passive>active movement in the visual guidance condition which requires inhibition in order 'not' to perform the movement, yields to significant activation of areas commonly involved in the inhibitory brain circuitry among which, notably, controlateral supplementary motor area.