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High systolic blood pressure after successful endovascular therapy for acute ischaemic stroke is associated with increased risk of intraparenchymal haemorrhage. However, no randomised controlled trials are available to guide optimal management. We therefore aimed to assess whether an intensive systolic blood pressure target resulted in reduced rates of intraparenchymal haemorrhage compared with a standard systolic blood pressure target. We did a multicentre, open-label, randomised controlled trial at four academic hospital centres in France. Eligible individuals were adults (aged ≥18 years) with an acute ischaemic stroke due to a large-vessel occlusion that was successfully treated with endovascular therapy. Patients were randomly assigned (1:1) to either an intensive systolic blood pressure target group (100–129 mm Hg) or a standard care systolic blood pressure target group (130–185 mm Hg), by means of a central web-based procedure, stratified by centre and intravenous thrombolysis use before endovascular therapy. In both groups, the target systolic blood pressure had to be achieved within 1 h after randomisation and maintained for 24 h with intravenous blood pressure lowering treatments. The primary outcome was the rate of radiographic intraparenchymal haemorrhage at 24–36 h and the primary safety outcome was the occurrence of hypotension. Analyses were done on an intention-to-treat basis. BP-TARGET is registered with ClinicalTrials.gov, number NCT03160677, and the trial is closed at all participating sites. Between June 21, 2017, and Sept 27, 2019, 324 patients were enrolled in the four participating stroke centres: 162 patients were randomly assigned to the intensive target group and 162 to the standard target group. Four (2%) of 162 patients were excluded from the intensive target group and two (1%) of 162 from the standard target group for withdrawal of consent or legal reasons. The mean systolic blood pressure during the first 24 h after reperfusion was 128 mm Hg (SD 11) in the intensive target group and 138 mm Hg (17) in the standard target group. The primary outcome was observed in 65 (42%) of 154 patients in the intensive target group and 68 (43%) of 157 in the standard target group on brain CT within 24–36 h after reperfusion] (adjusted odds ratio 0·96, 95% CI 0·60–1·51; p=0·84). Hypotensive events were not significantly different between both groups and occurred in 12 (8%) of 158 patients in the intensive target and five (3%) of 160 in the standard target group. Mortality within the first week after randomisation occurred in 11 (7%) of 158 patients in the intensive target group and in seven (4%) of 160 in the standard target group. An intensive systolic blood pressure target of 100–129 mm Hg after successful endovascular therapy did not reduce radiographic intraparenchymal haemorrhage rates at 24–36 h as compared with a standard care systolic blood pressure target of 130–185 mm Hg. Notably, these results are applicable to patients with successful reperfusion and systolic blood pressures of more than 130 mm Hg at the end of procedure. Further studies are needed to understand the association between blood pressure and outcomes after reperfusion. French Health Ministry.

Background and purposeFlow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year.MethodsPatients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results.ResultsThirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%).ConclusionsSAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)).Clinical trial registrationUnique identifier: NCT02921698; Results.

To report the occurrence of non-ischemic cerebral enhancing (NICE) lesions following mechanical thrombectomy (MT) through the retrospective French nationwide registry of NICE lesions. All thrombectomy capable stroke centers (TSC) in France were invited to fill out a questionnaire disseminated through a trainee-led research network (JENI-RC: Jeunes en Neuroradiologie Interventionnelle-Research Collaborative ). NICE lesions were defined according to previous literature as delayed onset punctate, nodular, or annular foci enhancements with peri-lesion edema and vascular distribution in the territory of the MT with no other confounding disease. All 43 TSC French centers responded. Three patients were reported by 3 different centers over a total of 34,824 MT (2015–2020). Patient no. 1 developed symptomatic NICE lesions 8 weeks after MT with combination of aspiration and stentriever for a right middle cerebral artery occlusion. Patient no. 2 developed asymptomatic NICE lesions 5 weeks after MT with direct thromboaspiration for a right middle cerebral artery occlusion. Patient no. 3 developed symptomatic NICE lesions 6 weeks after MT with direct thromboaspiration, and combination of aspiration and stentriever for a basilar artery occlusion. This study provides evidence that NICE lesions following MT are a possible rare complication with a similar presentation as previously described following endovascular aneurysm treatment. Both radiologists and neurologists should be aware of this adverse event and make use of MRI contrast agents in case of unexplained symptoms/images during follow-up after MT.

Background Aneurysms at the posterior face of the internal carotid artery can lead to oculomotor nerve palsy (ONP) with an uncertain prognosis of recovery post-treatment. The aim of this study was to define the prognostic factors for ONP recovery, with particular interest in treatment modality (surgery or endovascular techniques). Method A literature review was performed to select the most pertinent prognostic factors. A retrospective study was then performed to determine whether these factors had significantly modified the prognosis of ONP recovery in our series of patients. Results In the literature, factors linked to poorer outcome were age, vascular risk factors, initial ONP severity and delay before treatment; better recovery was associated with surgical treatment. Between 2000 and 2013, 23 consecutive patients were treated in our department for ONP-inducing aneurysms: 14 by endovascular embolization and 9 by surgical clipping and aneurysm puncture. Mean follow-up was 48.8 months. After treatment, overall recovery occurred in 87 % of cases, always within 6 months. Apart from treatment modality, no selected prognostic factor significantly modified the quality or timing of ONP recovery. In the endovascular group, four patients recovered completely, seven partially and three did not recover. In the surgical group, seven patients recovered completely and two partially. Surgery was significantly associated with a more complete and earlier ONP recovery ( p  < 0.05). Conclusions Surgery was associated with a more complete and earlier ONP recovery as compared to endovascular treatment, confirming the results of previous studies. However, conclusions must be confirmed by a prospective randomized study.

Background and purposeThe Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up.Materials and methodsThe Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond–Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months.ResultsTwenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19).ConclusionsThis prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms.Registered clinical trial NCT02125097;Results.

Introduction Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial. Methods Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up. Results Five hundred thirteen patients were randomized (hydrogel n  = 256, bare platinum n  = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n  = 243, bare platinum n  = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n  = 28, bare platinum n  = 30, p  = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively ( p  < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate ( p  = 0.8). Conclusion Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils. Trial registration http://www.germanctr.de , DRKS00003132

Abstract BACKGROUND An increased incidence of various neoplasms has been described in patients with acromegaly, and there is evidence to suggest that growth factors are risk factors for the development of meningiomas. OBJECTIVE To study if patients with acromegaly are more at risk for developing intracranial meningiomas. METHODS We conducted an observational study on 221 consecutive acromegalic patients recruited between January 1, 2000 and December 31, 2015, and 357 consecutive patients with a nonsomatotropic pituitary adenoma recruited between March 1, 2015 and December 31, 2016, in our institution. Patients underwent a gadolinium-enhanced 3D T1 brain magnetic resonance imaging to look for meningiomas. The proportion of meningiomas was compared between the 2 groups, and the standardized incidence ratio (SIR) was computed from the incidence rates of meningiomas observed in the population of acromegalic patients and compared to that of the general population given by the local registry of central nervous system tumors. RESULTS Patients with acromegaly had a significant risk for developing intracranial meningiomas as compared to patients without acromegaly (7.7% vs 2.2%, P = .005, OR = 3.45 [1.46; 8.15]). There was a significant increased incidence of intracranial meningiomas in patients with acromegaly (SIR = 126 [25; 367]) as compared to the general population. CONCLUSION Our study suggests strongly that patients with acromegaly are more at risk for developing intracranial meningiomas.

BackgroundSelection of the appropriate device size mandatory during aneurysm treatment with a Woven EndoBridge (WEB). We aimed to investigate if virtual simulation with Sim&Size software may have an impact on technical, angiographic, and clinical outcomes after WEB treatment.MethodsData from two large-volume centers were collected and compared (January 2017–January 2020). Virtual simulation was systematically adopted in one center, while conventional sizing was used in the other one. Outcomes were the duration of intervention, the radiation dose (in milligrays, the number of corrective interventions for inappropriate WEB size, the number of WEBs not deployed, angiographic occlusion, and complications. Univariate and multivariate linear models were adopted.ResultsA total of 186 aneurysms were treated with WEB (109 with and 77 without virtual simulation). Patient characteristics and aneurysm features were comparable among virtual and conventional sizing, except for mean age (62.2±11.8 years and 56.2±10.1 years, P=0.0004) and median aspect ratio (1.6, IQR=1.2–2 and 1.2, IQR=1–1.6, P=0.0001). Years of operator experience were comparable. Virtual simulation was independently associated with shorter intervention time (45 min, IQR=33–63.5 min vs 63.5 min, IQR=41–84.7 min, P=0.0001), lower radiation dose (1051 mGy, IQR=815–1399 mGy vs 1207 mGy, IQR=898–2084 mGy, P=0.0001), and lower number of WEBs not deployed (26/77=33.7% vs 8/109=7.3%, P=0.0001). The need for additional maneuvers was significantly lower in the virtual simulation group (5/109=4.6% vs 12/77=15.6%, P=0.021). Angiographic outcomes and complications were comparable.ConclusionsIn this multicenter experience, virtual simulation with Sim&Size software seems to facilitate the selection of the appropriate WEB device for aneurysm treatment, reducing the time of intervention, the radiation dose, the number of devices not deployed, and the need for corrective interventions.Trial registration numberclinicaltrials.gov Identifier: NCT04621552.

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.

Purpose To evaluate the feasibility, safety and efficacy of endovascular treatment with flow diverters in patients with recanalized and multitreated aneurysms in a retrospective, multicenter, single-arm study. Methods The study included 29 patients with 29 recanalized aneurysms who were treated by flow diverters (Silk or Pipeline devices). Pre- and post-procedural complications and morbidity and mortality rates were evaluated and functional outcomes (modified Rankin Score (mRS)) at 1 month (short-term) and 3–4 months (mid-term) were compared with preoperative mRS (before the procedure). Mid-term angiographic follow-up was performed assessing aneurysmal occlusion by the Montreal scale (complete occlusion, neck remnant, aneurysm remnant). Results Placement of the flow diverters was achieved in all patients. Two misdeployments of the flow diverters necessitated balloon dilation in two patients, which was associated with stent delivery in one patient. Permanent morbidity related to treatment was 6.9% (2/29), transient morbidity was 10.3% (3/29) and there were no deaths resulting from the treatment. One patient died from a myocardial infarct 4 weeks after the procedure. 25/29 patients (86.2%) had a good final functional outcome, 26/29 (89.7%) had an unchanged functional outcome and 2/29 patients (6.9%) had clinical worsening. Angiographic follow-up showed complete occlusion in 17/28 patients (60.7%), neck remnants in 6/28 patients (21.4%) and residual aneurysms in 5/28 (17.9%). Conclusions Flow diverter placement is feasible and safe in patients with recanalized and multitreated aneurysms. The procedure is associated with a high percentage of good functional outcomes as well as good mid-term anatomical results (82.1%).