In-vitro testing of stent retrievers for cerebral thrombi removal

International audienceRecent articles appeared in literature demonstrated that early mechanical thrombectomy offered to patients presenting with acute ischemic stroke is related to improved functional outcome. Stent retrievers (STR) are recognized as the most effective devices for intracranial thrombectomy. In the present study we experimentally analyzed devices mechanical properties, behavior during retrieval and their interaction with clots of different features. The aim of this study was to identify any device feature that was functional to the thrombus removal

Intracranial aneurismal pulsatility as a new individual criterion for rupture risk evaluation: Biomechanical and numerical approach (IRRAs project).

International audienceThis study was designed to highlight by means of numerical simulations, the correlation between aneurism sac pulsatility and the risk of rupture through the mechanical properties of the wall. In accordance to previous work suggesting a correlation between the risk of rupture and the material properties of cerebral aneurysms, twelve fluid-structure interaction (FSI) computations were performed on 12 "patient-specific" cases, corresponding to typical shapes and locations of cerebral aneurysms. The variations of the aneurismal volume during the cardiac cycle (3V) are compared using wall material characteristics of either degraded and non-degraded tissues. Aneurysms were located on 7 different arteries: Middle Cerebral Artery (4), Anterior Cerebral Artery (3), Internal Carotid Artery (1), Vertebral Artery (1), Ophthalmic Artery (1) and Basilar Artery (1). Aneurysms presented different shapes (uniform or multi-lobulated) and diastolic volumes (from 18 to 392 mm3). The pulsatility (3V/V) was significantly larger for a soft aneurismal material (average of 26 %) than for a stiff material (average of 4 %). The difference between 3V, for each condition, was statistically significant: p = 0.005. The difference in aneurismal pulsatility as highlighted in this work might be a relevant patientspecific predictor of aneurysm risk of rupture

Bridging intravenous thrombolysis in patients with atrial fibrillation.

Background and purpose 40% of acute ischemic stroke patients treated by mechanical thrombectomy (MT) have a clinical history of atrial fibrillation (AF). The safety of bridging intravenous thrombolysis (IVT) (MT + IVT) is currently being discussed. We aimed to analyze the interaction between oral anticoagulation (OAC) status or AF with bridging IVT, regarding the occurrence of symptomatic intracranial hemorrhage (sICH) and functional outcome. Materials and Methods Multicentric observational cohort study (BEYOND-SWIFT registry) of consecutive patients undergoing MT between 2010 and 2018 (n = 2,941). Multinomial regression models were adjusted for prespecified baseline and plausible pathophysiological covariates identified on a univariate analysis to assess the association of AF and OAC status with sICH and good outcomes (90-day modified Rankin Scale score 0-2). Results In the total cohort (median age 74, 50.6% women), 1,347 (45.8%) patients had AF. Higher admission National Institutes of Health Stroke Scale (NIHSS) score (aOR 1.04 [95% 1.02-1.06], per point of increase) and prior medication with Vitamin K antagonists (VKA) (aOR 2.19 [95% 1.27-3.66]) were associated with sICH. Neither AF itself (aOR 0.71 [95% 0.41-1.24]) nor bridging IVT (aOR 1.08 [0.67-1.75]) were significantly associated with increased sICH. Receiving bridging IVT (aOR 1.61 [95% 1.24-2.11]) was associated with good 90-day outcome, with no interaction between AF and IVT (p = 0.92). Conclusion Bridging IVT appears to be a reasonable clinical option in selected patients with AF. Given the increased sICH risk in patients with VKA, subgroup analysis of the randomized controlled trials should analyze whether patients with VKA might benefit from withholding bridging IVT. Registration clinicaltrials.gov; Unique identifier: NCT03496064

GREAT — a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment

International audienceThe effectiveness of a hybrid hydrogel platinum detachable coil (HydroCoil; MicroVention Inc., Tustin, CA) for endovascular aneurysm treatment has been proven in a recently published RCT. Due to technical restrictions (coil stiffness, time restriction for placement), the HydroSoft coil as well as a corresponding 3D framing coil, the HydroFrame coil (MicroVention Inc., Tustin, CA), a class of new softer coils containing less hydrogel and swelling more slowly than the HydroCoil, have been developed and brought to clinical practice. The present study aims to compare the effectiveness of endovascular aneurysm treatment with coil embolization between patients allocated HydroSoft/HydroFrame versus bare platinum coiling. GREAT is a randomized, controlled, multicentre trial in patients bearing cerebral aneurysms to be treated by coil embolization. Eligible patients were randomized to either coil embolization with HydroSoft/HydroFrame coils (>50 % of administered coil length), or bare platinum coils. Inclusion criteria were as follows: age 18-75, ruptured aneurysm (WFNS 1-3) and unruptured aneurysm with a diameter between 4 and 12 mm. Anatomy such that endovascular coil occlusion deemed possible and willingness of the neurointerventionalist to use either HydroSoft/HydroFrame or bare platinum coils. Exclusion criteria were as follows: aneurysms previously treated by coiling or clipping. Primary endpoint is a composite of major aneurysm recurrence on follow-up angiography and poor clinical outcome (modified Rankin scale 3 or higher), both assessed at 18 months post treatment. Risk differences for poor outcomes will be estimated in a modified intention-to-treat analysis stratified by rupture status (DRKS-ID: DRKS00003132)

Endovascular Stroke Treatment and Risk of Intracranial Hemorrhage in Anticoagulated Patients.

Background and Purpose- We aimed to determine the safety and mortality after mechanical thrombectomy in patients taking vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs). Methods- In a multicenter observational cohort study, we used multiple logistic regression analysis to evaluate associations of symptomatic intracranial hemorrhage (sICH) with VKA or DOAC prescription before thrombectomy as compared with no anticoagulation. The primary outcomes were the rate of sICH and all-cause mortality at 90 days, incorporating sensitivity analysis regarding confirmed therapeutic anticoagulation. Additionally, we performed a systematic review and meta-analysis of literature on this topic. Results- Altogether, 1932 patients were included (VKA, n=222; DOAC, n=98; no anticoagulation, n=1612); median age, 74 years (interquartile range, 62-82); 49.6% women. VKA prescription was associated with increased odds for sICH and mortality (adjusted odds ratio [aOR], 2.55 [95% CI, 1.35-4.84] and 1.64 [95% CI, 1.09-2.47]) as compared with the control group, whereas no association with DOAC intake was observed (aOR, 0.98 [95% CI, 0.29-3.35] and 1.35 [95% CI, 0.72-2.53]). Sensitivity analyses considering only patients within the confirmed therapeutic anticoagulation range did not alter the findings. A study-level meta-analysis incorporating data from 7462 patients (855 VKAs, 318 DOACs, and 6289 controls) from 15 observational cohorts corroborated these observations, yielding an increased rate of sICH in VKA patients (aOR, 1.62 [95% CI, 1.22-2.17]) but not in DOAC patients (aOR, 1.03 [95% CI, 0.60-1.80]). Conclusions- Patients taking VKA have an increased risk of sICH and mortality after mechanical thrombectomy. The lower risk of sICH associated with DOAC may also be noticeable in the acute setting. Improved selection might be advisable in VKA-treated patients. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT03496064. Systematic Review and Meta-Analysis: CRD42019127464

Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms.

BACKGROUND Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases. OBJECTIVE To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms. METHODS This prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events. RESULTS The study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2. CONCLUSIONS This first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures. TRIAL REGISTRATION NUMBER NCT04236856

Endovascular Treatment of Atherosclerotic Tandem Occlusions in Anterior Circulation Stroke: Technical Aspects and Complications Compared to Isolated Intracranial Occlusions

Background and Purpose: Endovascular treatment of tandem occlusions is an emerging option. We describe our multicenter experience with endovascular management of atherosclerotic tandem occlusions in the anterior circulation, particularly the technical aspects and complications in comparison to isolated intracranial occlusions.Materials and Methods: Consecutive patients with tandem occlusions due to atherosclerotic causes who underwent mechanical thrombectomy at two major stroke centers between January 2010 and September 2015 were reviewed. Clinical data, procedural aspects, recanalization rates, complication rates, and clinical outcome were analyzed and compared to findings in patients with isolated intracranial occlusions.Results: One hundred and twenty-one patients with tandem occlusions and 456 patients with isolated intracranial occlusions (carotid-T/M1) were included. Mean intervention time was faster (33 min vs. 57 min, p < 0.001) and recanalization success was higher (TICI 2b/3 83.6 vs. 70.2%, p = 0.002) in patients with isolated occlusions. No difference was seen in clinical outcome and complications, except for a higher rate of asymptomatic hemorrhage in the tandem group (29.8 vs. 17.1%, p = 0.003). Choice of recanalization approach (antegrade vs. retrograde) in the tandem group made no difference, except for a trend toward less distal emboli using the retrograde approach (4.0 vs. 13.0%, p = 0.082). Stenting of the extracranial internal carotid artery (ICA) was performed in 81%, PTA alone in 7.4%, and deferred stenting in 11.6%. Rate of stent/ICA occlusion within 7 days was 10.3% after stenting and 33.3% after PTA (p = 0.127). In the tandem group, age (p = 0.034), National Institutes of Health Stroke Scale score (NIHSS) at admission (p = 0.002), recanalization rate (p < 0.001), complications (p = 0.016), and symptomatic intracranial hemorrhage (sICH) (p = 0.001) were associated with poor outcome, whereas extracranial treatment modality and stent/ICA occlusion within 7 days did not affect outcome.Conclusion: Endovascular treatment of tandem occlusions is technically feasible, achieves recanalization rates and rates of good clinical outcome comparable to those in patients with isolated intracranial occlusions. Following acute ICA stenting, the risk of stent occlusion and sICH appeared to be low, but was associated with an increased rate of asymptomatic ICH

A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke

The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations. METHODS We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points. RESULTS The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P=0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81). CONCLUSIONS In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups

Reconstruction neurovasculaire par le dispositif d'embolisation Pipeline TM (Série bicentrique portant sur 66 anévrysmes intracrâniens)

Introduction :Le Dispositif d'Embolisation Pipeline (PED), est un outil thérapeutique prometteur pour les anévrysmes intracrâniens complexes et à collet large, Nous présentons les résultats à court et moyen terme de l'utilisation du PED sur une série consécutive de 66 anévrysmes intracrâniens. Matériels et méthodes Un total de 66 anévrysmes intracrâniens chez 59 patients ne pouvant être traités par les thérapies conventionnelles (coils avec ou sans remodeling) ont été traités avec le PED au sein de 2 centres neuroradiologiques français. Les résultats cliniques et radiologiques de la période post-opératoire, à 6 et 12 mois ont été revus de mananière rétrospective.Résultats : Quatre-vingt-douze PED (95,8%) ont été déployés avec succès. Cinq patients ont été traités en phase aiguë d'HSA. A 6 mois, les taux de morbidité et de mortalité étaient de 6,8% chacun. Un cas d infarctus territorial a ete Observe en cas de couverture de l ACM. Deux cas de thrombose Intrastent conduisant à un déficit permanent ou au décès ont été rapportés en cas d'arrêt prématuré du traitement antiplaquettaire. Une rupture retardée d'anévrysme était le mécanisme présumé de deux morts subites et inattendues. Aucune complication n'a été rapportée lors des traitements en phase aiguë d'HSA. Le taux d'occlusion complète était 72.7% à 12 mois. Conclusion Le traitement des anévrysmes intracrâniens complexes et à collet large par le dispositif PED est faisable et efficace. Toutefois,les taux élevés de morbi-mortalité ainsi que la survenue de complications dont l'origine exacte reste incomprise oblige à réserver ce traitement aux anévrysmes pour lesquels les techniques conventionnelles sont inaccessibles.Introduction The Pipeline Embolization Device is a promising therapy for vvide-necked and challenging intracraniaL We present our bicentric experience and mid-term follow-up results with the PED for al series of 66 :intracranial aneurysms. Materials and methods A total of 66 intracranial aneurysms ln 59 patients not suitable for conventional therapies were treated with the PED at 2 centers in France. we retrospectfully reviewed imaging and clinical results during the post-operative period, at 6 months and at 12 months. Results 1 Ninety two PED (95.8%) were successfullly deployed in 55. Five patients were treated in the acute 1 phase of SAH. Mean aneurysm size was 10.7 Inm (range 1.3-37 mm). At 6 months follow-up, permanent morbidity and mortality rates were 6.8% each. One territorial infarction was observed in cases Of MCA coverage by the PED. Two cases of in-stent thrombosis leading to permanent deficit or death were reported in cases of premature discontinuation of antiplate1et therapy. Delayed large aneurysm rupture was the suspected mechanism oftwo unexpected sudden death. No complication 1 "\-vas reported in cases treated during the acute phase of S~A.......t-I. Complete aneurysm occlusion occurred vvithin 6 months in 65.9<}û ofaneurysms and in 72.70/0 within 12 months. Conclusion The PED is a feasible and effective device for wide-necked and challenging intracranial aneurysmS. However, the high rate of morbi-mortality related ta unpredictable and Inisunderstood complications indicated the need for further research. For now, and until further clarifications, PED should be utilized mainly when conventional therapies are not feasible.MONTPELLIER-BU Médecine UPM (341722108) / SudocMONTPELLIER-BU Médecine (341722104) / SudocSudocFranceF