Endovascular therapy has revolutionized the treatment of acute ischemic stroke with large vessel occlusion, becoming the standard of care across anterior and posterior circulation. With expanding indications, including large infarct cores, extended time windows, and older patients, the number and complexity of procedures are steadily increasing worldwide. Although overall rates of successful reperfusion approach 90%, the remaining 10% of failed endovascular therapy highlight the technical challenges still confronting interventionalists. Procedural failure may occur at multiple stages, from arterial puncture to supra-aortic catheterization, intracranial navigation, or closure, each requiring tailored strategies. This review gathers advanced tips and tricks to manage demanding situations, reflecting both published evidence and the long-standing oral transmission that often occurs during fellowships. Practical solutions are described for frequent challenges, including complex femoral access and closure, tortuous supra-aortic vessels, difficult carotid siphons, and hostile intracranial anatomy. Techniques such as buddy-wire, balloon anchoring, stent-anchoring, balloon tracking, direct carotid puncture, and the flossing technique are detailed, alongside structured escalation strategies. Beyond technical skills, this review emphasizes the importance of comprehensive training. Mastery of complex diagnostic cerebral angiographies, supported by simulation-based learning, is considered more relevant than procedural counts to determine readiness for on-call independence. Ultimately, competence is defined not by the number of endovascular therapies performed, but by the ability to anticipate and safely manage complications in unpredictable anatomic settings. Future training should integrate procedural volume, case complexity, and simulation to prepare the next generation of interventionalists to perform endovascular therapy and navigate the unexpected with safety and confidence.
BACKGROUND:Direct transfer to angiography suite (DTAS) for patients with suspected stroke primarily admitted to an endovascular-capable centre could accelerate in-hospital workflow and improve outcome. We aimed to assess the safety and efficacy of DTAS for patients with acute severe neurological deficit highly suggestive of ischaemic stroke due to a large vessel occlusion (ASND-LVO). METHODS:We did an open-label, multicentre, randomised controlled trial in ten comprehensive stroke centres in France. We enrolled adult patients (age ≤85 years) with ASND-LVO (unilateral motor deficit with a score ≥5 plus a cortical symptom with a score ≥1 based on the National Institues of Health Stroke Scale) admitted within 5 h of symptom onset. Patients were randomly assigned (1:1) with a web-based system to DTAS or conventional pathway (ie, imaging followed by transfer to the angiography suite for endovascular treatment if eligible). The primary outcome was functional independence defined as a modified Rankin Scale score 0 to 2 at 90 days in the intention-to-treat population-ie, all randomly assigned patients in their originally assigned treatment groups, irrespective of diagnosis, imaging findings, or treatments received. Symptomatic intracranial haemorrhage and all-cause mortality at 90 days were the main safety outcomes. This study was registered on ClinicalTrials.gov (NCT03969511). FINDINGS:Between July 9, 2020, and April 18, 2023, 115 patients were randomly assigned to the DTAS group (n=57) or the conventional group (n=58). An interim analysis was done on Sept 27, 2023. The trial steering committee permanently stopped the trial on Dec 1, 2023, for safety reasons after unmasking and analysis of the data. In the intention-to-treat analysis, the risk of symptomatic intracranial haemorrhage was increased in the DTAS group compared with the conventional group (five [15%] of 34 vs zero [0%] of 42; adjusted odds ratio [OR] 11·0 [95% CI 1·28-1406]). All-cause mortality did not differ significantly between groups (ten [18%] of 56 vs six [11%] of 53; adjusted OR 1·65 [95% CI 0·52-5·55]). Functional independence was reached in 20 [36%] of 56 participants in the DTAS group vs 22 [42%] of 53 in the conventional group (adjusted OR 0·73 [95% CI 0·32-1·69]). INTERPRETATION:DTAS for patients with ASND-LVO was associated with an increased risk of symptomatic intracranial haemorrhage without evidence of a beneficial effect on functional outcome at 90 days. However, because the trial was stopped early for safety reasons, the small sample size limits the precision of the effect estimates on the primary outcome and all secondary and safety outcomes. Therefore, further clinical trials are required to firmly conclude on the safety and efficacy of DTAS for patients with suspected acute ischaemic stroke due to a large vessel occlusion. FUNDING:French Ministry of Health and Medtronic.
Although we are making progress in overcoming infectious diseases and cancer, one of the major medical challenges of the mid-21st century will be the increasing prevalence of stroke. Occlusions in large vessels are especially debilitating, yet effective treatment-needed within hours to achieve best outcomes-remains limited because of geographic accessibility. One solution for improving timely access to mechanical thrombectomy in geographically diverse populations is the widespread deployment of robotic surgical systems. Artificial intelligence assistance may enable the safe and effective upskilling of operators in this emerging therapeutic delivery approach. Our aim was to establish consensus frameworks for developing and validating artificial intelligence-assisted robots for thrombectomy. Objectives included standardizing effectiveness metrics and defining reference testbeds across in silico, in vitro, ex vivo, and in vivo environments. To achieve this, we convened experts in neurointervention, robotics, data science, health economics, policy, statistics, and patient advocacy. Consensus was built through an incubator day, a Delphi process, and a final position statement. We identified that the 4 essential testbed environments each had distinct validation roles. Realism requirements vary: simpler testbeds should include realistic vessel anatomy compatible with guidewire and catheter use, whereas standard testbeds should incorporate deformable vessels. More advanced testbeds should include blood flow, pulsatility, and disease features, such as atheromatous plaques. There are 2 macroclasses of effectiveness metrics: one for in silico, in vitro, and ex vivo stages focusing on technical navigation (eg, path-following error), and another for in vivo stages, focused on clinical outcomes (eg, modified treatment in cerebral infarction scores). Patient safety is central, and not a barrier, to this technology's development. One requisite patient safety task needed now is to correlate in vitro measurements to in vivo complications.
BACKGROUND:Glenzocimab is a humanized fragment of a monoclonal antibody directed against the human platelet glycoprotein VI, which has shown promising features, including thrombus growth inhibition and minimal bleeding risk. The first inpatient study suggested the benefit of glenzocimab with alteplase in subgroups of patients with acute ischemic stroke (AIS) receiving endovascular treatment (EVT), with increased reperfusion rates and decreased risk of symptomatic hemorrhagic transformation. The objective of the GREEN (Glenzocimab for REperfusion in the setting of Endovascular therapy for brain infarctioN) study is to evaluate the efficacy of glenzocimab with EVT compared with EVT plus placebo, with or without intravenous thrombolysis (IVT), on functional outcome. METHODS:GREEN is a multicenter, randomized, double blind, placebo controlled study. Participants presenting with AIS and a large vessel occlusion of the anterior circulation (intracranial internal carotid artery or middle cerebral artery, or both), with symptoms onset within 24 hours, will be randomized to one of two groups: intravenous glenzocimab 1000 mg with standard of care (SoC-EVT±IVT) or SoC (EVT±IVT) plus placebo. The main primary efficacy endpoint is functional outcome (assessed by the modified Rankin Scale score) at 90 days. CONCLUSION:This is the first randomized trial evaluating the efficacy of glenzocimab with EVT. This prospective trial aims to determine whether glenzocimab with EVT improves functional outcome. TRIAL REGISTRATION:ClinicalTrials.gov NCT05559398.
BACKGROUND:The endovascular clip system (eCLIPs), a unique extra-saccular device for treatment of wide necked bifurcation aneurysms (WNBAs), was evaluated in the French eCLIPs efficacy and safety study (EESIS-FR). This paper summarizes the patient demographics, procedural characteristics, and 30 day adverse event (AE) data. METHODS:The EESIS-FR trial was a prospective study from 18 centers, enrolling 123 adults with WNBAs at the carotid (CT) and basilar (BT) termini. The study protocol was approved by a central ethics committee, had independent adjudication of AEs by a Clinical Events Committee, and had independent core laboratory adjudication of effectiveness outcomes. RESULTS:Mean age was 55.0±1.2 years (19-78 years); 73% were women. 43% and 57% of the aneurysms were located at BT and CT, respectively. Mean neck length was 4.8 mm, neck depth 4.2 mm, dome height 5.4 mm, and dome width 6.3 mm. Successful implantation was achieved in 115 cases (93%). Implant time averaged 36 min. Three primary safety events (2.4%) occurred within the first 30 days, all at the index procedure: subarachnoid hemorrhage (SAH) due to a distal guidewire perforation, death from SAH due to rupture of the aneurysm, and spinal cord infarction caused by an occlusive access catheter. Five minor strokes (4.1%) and three transient ischemic attacks (2.4%) occurred, all of which were procedurals. None of these patients had a modified Rankin Scale score of >2 at 30 days. No patient had further ischemic or hemorrhagic events beyond the periprocedural period to 30 days. CONCLUSION:eCLIPs treated WNBAs at BT and CT, with procedural safety and technical success similar to those with intrasaccular devices.
Abstract Background and aims We aimed to assess the effect of DTAS for patients with acute severe neurological deficit highly suggestive of ischemic stroke due to a large vessel occlusion (ASND-LVO). Methods We did an open-label, multicentre, randomised controlled trial performed in 10 comprehensive stroke centres in France. We enrolled adult patients (85 years) with ASND-LVO (unilateral motor deficit with a score 5 plus a cortical symptom with a score 1 based on the NIHSS) admitted within 5 hours of symptom onset. Patients were randomised in (1:1) ratio to DTAS or conventional pathway. The primary outcome was functional independence defined as modified Rankin Scale score 0 to 2 at 90 days in the intention-to-treat population. Results 115 patients (57 in the DTAS and 58 in the conventional group) were randomised. The steering committee permanently stopped the trial for safety reasons. In the ITT analysis, the risk of symptomatic intracranial hemorrhage was increased in the DTAS group compared to the conventional group (5 15% of 34 vs 0 0% of 42; adjusted odds ratio OR 10·2; 95% confidence interval [CI] 1·18-1296). DTAS led to a non-significant lower rate of functional independence (20 36% of 56 vs 22 42% of 53; adjusted OR 0·73; 95% CI 0·32-1·69). Analysis in the modified intention-to-treat (patients with LVO) population yielded similar findings. Conclusions DTAS pathway are associated with an increased risk of symptomatic intracranial hemorrhage without evidence for a beneficial effect on functional outcome. Conflict of interest
BACKGROUND AND PURPOSE:Cryptogenic strokes, accounting for 25%-40% of ischemic strokes, represent a major challenge in secondary prevention due to their uncertain etiology and high recurrence risk. Identifying biomarkers to reliably distinguish cardioembolic (CE) strokes among embolic strokes of undetermined source (ESUS) could help guide therapeutic decisions. Previous studies have indicated thrombus DNA content as a potential biomarker of CE stroke etiology, but direct quantification of fibrin, another key component, has not been adequately explored. METHODS:We analyzed thrombi collected from 186 ischemic stroke patients undergoing endovascular treatment between 2019 and 2023. Thrombi were processed using a quantitative method based on ex vivo tPA-mediated fibrinolysis followed by mechanical homogenization. Stroke etiology was classified according to TOAST criteria: 40% cardioembolic, 24% non-cardioembolic (large artery atherosclerosis or dissection), and 36% ESUS. Biomarker content was correlated with stroke etiology, and the diagnostic performance of DNA and fibrin (D-dimer) content was evaluated. RESULTS:Cardioembolic thrombi contained significantly higher levels of DNA (median [IQR]: 325.3 [177-484] ng/mg) and D-dimer (17.5 [9.1-23.8] μg/mg) compared to non-cardioembolic thrombi (DNA: 128 [76.4-263] ng/mg; D-dimer: 11.4 [6.8-13.2] μg/mg), with no significant differences observed in heme or GPVI content. The combined use of thrombus DNA and fibrin (D-dimer) content provided good discrimination between CE and non-CE thrombi, with an area under the ROC curve of 0.79 (95% CI, 0.70-0.87). CONCLUSION:DNA and fibrin content in thrombi are promising biomarkers for identifying cardioembolic stroke etiology. Prospective studies should evaluate their use in selecting ESUS patients who may benefit from anticoagulant therapy.
BACKGROUND AND OBJECTIVES:Current recommended blood pressure (BP) targets during mechanical thrombectomy (MT) rely on a one-size-fits-all approach aiming at preventing hypertension. The efficacy and safety of an individualized BP control during thrombectomy for ischemic stroke has not been well studied. We aimed to evaluate whether an individualized BP control during MT could improve functional outcome at 90 days. METHODS:We conducted a multicenter, open-label, blinded-endpoint, randomized clinical trial at 8 academic comprehensive stroke centers in France. Adult patients with an acute ischemic stroke due to an anterior large vessel occlusion and an indication for MT were eligible. Recruitment was performed between March 10, 2021, and September 18, 2023. Patients were randomly assigned (1:1) to an individualized BP group during MT (where the mean arterial pressure [MAP] was maintained within 10% of the first MAP measured before MT) or a control BP group (systolic BP maintained within 140 and 180 mm Hg). The primary outcome was favorable functional outcome, defined as a modified Rankin Scale score between 0 and 2 at 90 days. Safety outcomes included symptomatic intracranial hemorrhages at 24 hours and mortality at 90 days. RESULTS:Overall, 433 patients (median age, 69.3 years, 228 females [52.8%]) were assigned to an individualized BP group (n = 215) or the control BP group (n = 218); one was excluded because of consent withdrawal. No significant differences in mean BP levels or BP variability were observed between groups during the procedure. Favorable functional outcome at 90 days was observed in 94 patients (44.2%) in the individualized BP group and 106 patients (48.8%) in the control group (adjusted odds ratio, 0.82; 95% CI 0.54-1.24; p = 0.34). Mortality from any cause at 90 days was not significantly different between groups (18.8% in the individualized BP group vs 16.4% in the control BP group: adjusted odds ratio, 1.19; 95% CI 0.70-2.03). Rates of symptomatic intracranial hemorrhages were not different between the 2 groups. DISCUSSION:In patients with acute ischemic stroke due to an anterior large vessel occlusion, an individualized BP management during MT did not increase rates of favorable functional outcome at 90 days compared with a standard BP management. TRIAL REGISTRATION INFORMATION:ClinicalTrials.gov, DETERMINE, number NCT04352296. CLASSIFICATION OF EVIDENCE:This study provides Class II evidence that in patients undergoing mechanical thrombectomy for stroke due to anterior large vessel occlusion, functional outcomes at 90 days were similar with individualized BP management and standard BP management.
INTRODUCTION:The best first-line mechanical thrombectomy treatment for acute ischemic stroke (AIS) caused by anterior large vessel occlusion (LVO) remains unclear despite four randomised controlled trials (RCTs). We compared the effectiveness and safety of the first-line combined stent retriever (SR) + contact aspiration (CA) approach with SR or CA alone for the treatment of AIS due to LVO. PATIENTS AND METHODS:This retrospective analysis combines individual patient data from 3 large multicenter, RCTs: ASTER, ASTER2, and VECTOR. The primary outcome was the proportion of patients who achieved favourable recanalisation (defined as a modified Thrombolysis in Cerebral Infarction score of 2b, 2c or 3) after the first-line treatment, without a second-line rescue technique. Secondary outcomes included the first pass effect, disability assessed by the 90-day modified Rankin Scale (mRS) score, 24-hour change in National Institutes of Health Stroke Scale (NIHSS), 90-day all-cause mortality, and serious procedure-related adverse events. RESULTS:Among 1,185 included patients, 434 received the combined approach, 414 received CA alone, and 337 received SR alone. Baseline characteristics were similar among groups. After adjusting for factors using propensity score weighting, the primary outcome was achieved more often in the combined group compared to CA alone (risk ratio = 1.95; 95% CI, 1.42 to 2.68; P < 0.001) or SR alone (Odds ratio = 1.70; 95% CI, 1.21 to 2.38; P = .002). There were no significant differences in 24-hour change in NIHSS, 90-day mRS, or adverse events among the groups. CONCLUSIONS:In this pooled analysis of 3 RCTs, the combined approach as the first-line treatment for anterior circulation LVO increased the probability of achieving favourable recanalisation without the need for a second-line approach, compared to CA or SR alone but no impact on clinical outcomes was detected.
Importance Evidence regarding efficacy and safety of thrombectomy in acute ischemic stroke (AIS) due to medium or distal vessel occlusions (MDVOs) is lacking. Objective To evaluate the benefit of thrombectomy, in addition to medical treatment over medical treatment alone, in patients with an AIS related to a primary and isolated MDVO. Design, Setting, and Participants Randomized clinical trial conducted at 22 stroke centers in France from November 2021 to April 2025, with planned enrollment of 488 patients. The trial has been stopped after the planned interim analysis on the recommendation of the data and safety monitoring board for futility and increased rate of symptomatic intracranial hemorrhage with thrombectomy. Eligible adult patients had an AIS due to a primary MDVO within 8 hours of symptom onset or within 24 hours of last seen well if no hyperintense signal was present on fluid-attenuated inversion recovery imaging. Intervention Thrombectomy in addition to medical treatment (n = 123) or medical treatment alone (n = 121). Main Outcomes and Measures The primary end point was a good clinical outcome at 3 months, defined as a modified Rankin Scale score of 0 to 2, assessed by an independent, blinded assessor. Secondary end points included mortality rate at 3 months and adverse and serious adverse events. Results Of the 244 patients randomized (median age, 75 years [IQR, 67-81]; 56% male; median National Institutes of Health Stroke Scale score, 8 [IQR, 6-12]), 100 of the 123 patients in the thrombectomy group (81%) received thrombectomy and none of the 121 patients in the control group received thrombectomy; 217 (89%) completed follow-up. At 3 months, 72 of 116 patients (62%) in the thrombectomy group had a good clinical outcome vs 81 of 119 patients (68%) in the control group (odds ratio, 0.73 [95% CI, 0.40-1.31]; P = .29; adjusted absolute difference, −6.8% [95% CI, −19.4% to 5.7%]). The incidence of symptomatic intracranial hemorrhages was higher among the 100 patients who actually received thrombectomy than in those who did not (11% vs 3%, P = .008), as was incidence of subarachnoid hemorrhages (13% vs 2%, P < .001) and embolus migration (5% vs 1%, P = .04). Mortality rate did not significantly differ between the 2 groups (6% vs 8%; P = .49). Conclusions and Relevance Thrombectomy did not lead to a higher rate of good clinical outcome at 3 months compared with medical treatment alone in patients with acute ischemic stroke related to an MDVO. Hemorrhagic complications were more frequent after thrombectomy. Trial Registration ClinicalTrials.gov Identifier: NCT05030142
Middle meningeal artery (MMA) embolization has been proposed as a potential treatment for chronic subdural hematoma (CSDH). To assess the efficacy of MMA embolization in reducing the risk of CSDH recurrence at 6 months compared with standard care in patients who underwent an operation and were at high risk of CSDH recurrence. Multicenter, open-label, randomized clinical trial with blinded end point assessment. Patients who underwent an operation for CSDH recurrence or a first CSDH episode at high risk of recurrence were recruited from July 2020 to March 2023 in 12 French neurosurgical or comprehensive neurosurgical and interventional neuroradiology centers. Last follow-up took place on November 2, 2023. Participants were randomized 1:1 to undergo MMA embolization with microparticles within 7 days of surgery (171 patients, intervention group) or standard medical care alone (171 patients, control group). The primary end point was the rate of CSDH recurrence at 6 months assessed by an independent, blinded adjudication committee. There were 5 secondary end points, including rates of repeat surgery for homolateral CSDH recurrence during the 6-month follow-up period and embolization procedure–related complications. Among 342 randomized patients (median [IQR] age, 77 [68-83] years; 274 [80.1%] male), 308 (90.1%) completed the trial. The primary end point was observed in 24 of 162 (14.8%) and 33 of 157 (21.0%) patients in the intervention and control groups, respectively (after imputation: odds ratio, 0.64 [95% CI, 0.36-1.14]; adjusted absolute difference, −6% [95% CI, −14% to 2%]; P = .13). The groups did not significantly differ in any of the secondary end points. Repeat surgery was performed in 7 of 162 (4.3%) and 13 of 157 (8.3%) patients in the intervention and control groups (P = .14), respectively. Minor and major embolization procedure–related complications occurred in 3 of 171 (1.8%) and 1 of 171 (0.6%) patients, respectively. In this randomized clinical trial, among patients who underwent an operation for CSDH recurrence or a first CSDH episode at high risk of recurrence, MMA embolization did not lead to a significantly lower rate of recurrence at 6 months compared with standard medical care alone. However, the magnitude of the effect estimate is consistent with other recent trials, including some that demonstrated the benefit of MMA embolization with nonadhesive liquid embolic agents, and these findings considered together may inform future studies and potential use of this therapeutic approach for CSDH management. ClinicalTrials.gov Identifier: NCT04372147
INTRODUCTION:Idiopathic intracranial hypertension (IIH) is severe condition affecting patients' vision and quality of life. When medical treatment is insufficient, an invasive approach may be proposed, consisting of either performing a ventricular shunt or stenting a stenosed venous sinus. The aim of this study is to compare these two techniques. METHODS:All patients who received one of these treatments for IIH associated with papilledema over a 5-year period were analysed. The primary outcome was the resolution of papilledema at 3 months coupled with the absence of complications. RESULTS:Over a 5-year period, 101 patients were analysed, of whom 61 underwent endovascular treatment and 40 underwent surgical treatment. Resolution of papilledema at three months without complications was achieved in 72% of cases in the surgical group and in 89% of cases in the endovascular group (p = 0.04). There was a higher proportion of IIH in the surgical group (60% vs 1.6%, p < 0.001) associated with higher intracranial pressure (38.8 vs 33.1 cmH2O) and more severe visual impairment (55% vs 15%). Resolution of papilledema at three months, headache, tinnitus, and visual improvement did not differ significantly between the groups. The average time to improvement was significantly (p < 0.0001) shorter in the surgery-treated group (3.62 vs 8.74 weeks). CONCLUSION:Endovascular treatment appears to have a better benefit-risk balance compared to surgery, with the caveat that the surgery group had a more severe presentation in this study. This encourages the conduction of a randomized study to have two homogeneous groups.
Objective: Active catheters are intended to support endovascular navigation in complex anatomies. Nevertheless, their configuration and utilization are challenging. Finite element (FE) modeling representing the navigation of active guidewires alongside catheters can be considered at an early stage to identify the best parameters and support physicians in their planning and procedure. However, FE simulations require significant computation time. We introduce the concept of case-based simulation (CBS) to quickly find adequate configuration parameters for complex catheterization scenarios. Method: Combining case-based reasoning and FE simulation, CBS approach is considered to reuse design and navigation parameters from previous simulations. A case base is made of successful catheterization simulations performed on reference aorta geometries. For a new patient, a distance metric based on a statistical shape model is used to determine appropriate catheterization parameters from previously simulated cases. The proof-of-concept of this method is performed in the case of the navigation from the aortic arch to the left carotid artery. Among 11 patient-specific aortic arches, three were selected for the reference FE simulations of the left carotid artery hooking to constitute the case base and three others were selected for evaluation.
BACKGROUND AND OBJECTIVES:Intracranial wide neck bifurcation aneurysms treated with intrasaccular devices can have recurrences, with adverse morphologies, that are challenging to manage. We report our initial experience of the latest generation endovascular clip system (eCLIPs) (eVasc, Vancouver, British Columbia, Canada) device in treating these complex lesions. METHODS:A prospectively maintained registry was reviewed for patients that were initially treated with a Woven EndoBridge (WEB) (Microvention, Aliso Viejo, California, USA), Contour (Cerus Endovascular, Fremont, California, USA), or Artisse (Medtronic, Irvine, California, USA) intrasaccular device, and subsequently underwent retreatment with an eCLIPs implant. The following data were analyzed: aneurysm location, recurrence dimensions, dome-to-neck and aspect ratios, rupture status, procedural time metrics, complications, anti-platelet medication, baseline and 6 month modified Rankin Scores (mRS), angiographic outcome and follow-up using modified Raymond-Roy Occlusion Classification (mRROC). RESULTS:Twenty-one aneurysm recurrences across 21 patients were treated between October 2022 and December 2024. eCLIPs was successfully deployed in all cases intended for retreatment with the device. Primary treatment was performed using a WEB (n=14), Contour (n=5) or Artisse device (n=2). The median aneurysm recurrence size was 7.0 mm (range: 2.1 mm-10.3 mm). The median aspect ratio was 0.87 (range: 0.50-2.24) and the median dome-to-neck ratio 1.16 (range: 0.53-1.69). Of the 13 patients with available follow-up (median duration=11 months), all had adequate occlusion (10 were mRROC=1, and three were mRROC=2). There were no device related safety events. CONCLUSION:The new generation eCLIPs can be used safely and with a high rate of technical success for a range of bifurcation aneurysm recurrences initially treated with an intrasaccular device. While treatment durability appears promising, further long-term prospective studies are needed to confirm these findings.
This Polish multicenter study aims to evaluate the effectiveness and safety of the Flow Direction Endoluminal Device (FRED) in treating selected unruptured intracranial aneurysms. The FRED Poland Study was an observational, multicenter, prospective study conducted in 8 Polish investigational sites. Imaging results were independently assessed by a Corelab and adverse events were adjudicated by a Clinical Events Committee (CEC). Clinical results up to 24 months and anatomical results at 6-, 12- and 24-months post-treatment were reported. A total of 86 patients with 89 target aneurysms were enrolled between January 2016 and September 2017. Most aneurysms were located on the anterior circulation (93.2%, 83/89 aneurysms) with the majority (64.0%, 57/89) being small (< 10 mm) in size. Treatment was successfully performed in 86 out of 89 cases (96.6%). The permanent neurological morbidity rate was 3.6%, and the neurological mortality rate was 2.4%. Imaging follow-up at 6 months showed complete occlusion of the aneurysm in 64.9% of cases, increasing to 79.5% at 12 months and 85.5% at 24 months. This study offers a comprehensive overview of the flow diversion treatment approach, demonstrating that the FRED device is effective and safe for use in intracranial aneurysm treatment. These results align with existing literature, reaffirming the device reliability and suitability for clinical use.
Endovascular therapies enable minimally invasive treatment of vascular pathologies by guiding long tools towards the target area. However, certain pathways, such as the Supra-Aortic Trunks (SATs), present complex trajectories that make navigation challenging. To improve catheterization access to these challenging targets, an active guidewire composed of Shape Memory Alloy has been developed. Our study focuses on navigating this device and associated catheters to reach neurovascular targets via the left carotid artery. In previous work, a finite element model was used to simulate the navigation of the active guidewire and catheters from the aortic arch to the branching of the left carotid artery in patient-specific aortas. However, these numerical simulations are computationally intensive, limiting their feasibility for real-time navigation assistance. To address this, we present the development of numerical charts that enable real-time computation based on high-fidelity FE simulations. These charts predict: (1) the behavior of the active guidewire, and (2) the navigation of the guidewire and catheters within specific anatomical configurations, based on guidewire and navigation parameters. Using the High Order Proper Generalized Decomposition (HOPGD) method, these charts achieve accurate real-time predictions with errors below 5 % and a response time of 10-3 seconds, based on a limited number of preliminary high-fidelity computations. These findings could significantly contribute to the development of clinically applicable methods to enhance endovascular procedures and the advance the broader field of neurovascular interventions.
BACKGROUND AND AIMS:Achieving a first pass recanalization (FPR) improves clinical outcomes in patients with basilar artery strokes, but its association with initial infarct burden is unknown. We aimed to study the benefits of FPR for basilar artery strokes by initial infarct burden using the Posterior Circulation Alberta Stroke Program Early CT score (pc-ASPECTS). METHODS:We retrospectively analyzed the prospective multicentric Endovascular Treatment of Ischemic Stroke registry and included 194 patients diagnosed with an acute basilar artery occlusion who were treated with thrombectomy. Our primary outcome was a modified Rankin Scale (mRS) of 0-3 at 90 days, and our secondary outcomes were an mRS of 4-6 and mortality. We compared the 90-day clinical outcomes of achieving an FPR versus multiple thrombectomy passes based on patients' initial infarct size on pretreatment MRI: small (pc-ASPECTS = 9-10), medium (pc-ASPECTS = 6-8) and large (pc-ASPECTS <6). RESULTS:Patients with a medium or large infarct size had significantly better outcomes (mRS 0-3 at 3 months) if FPR was achieved than if multiple passes were required (RR = 1.61, 95% CI: 1.16, 2.24; p-value = 0.005; and RR = 3.41, 95% CI: 1.54-7.57; p-value = 0.003, respectively). No similar difference was seen among patients with small infarcts. Achieving an FPR was also associated with a significantly lower mortality risk among patients with a moderate infarct size (RR = 0.36, 95% CI: 0.17-0.79; p-value = 0.010) but not with those with small or large infarcts. CONCLUSIONS:Achieving an FPR significantly improves clinical outcomes in acute stroke patients with basilar artery occlusions undergoing thrombectomy when their infarcts are medium or large. Ongoing research to develop surgical techniques to achieve FPR is crucial to improving patients' prognoses.
BACKGROUND AND OBJECTIVES:The endovascular clip systems (eCLIPs) implant bridges the neck of wide neck bifurcation aneurysms. This study presents safety and efficacy of eCLIPs cases of the first generation, eCLIPs bifurcation remodeling system (eBRS), and the current generation, eCLIPs electrolytic bifurcation system (eB). METHODS:A prospective registry collected: patient age, sex, aneurysm details, safety end points, and occlusion scores. All patients were reported for safety events. A subset of 74% with eBRS implants and 99% with eB implants formed a group for efficacy. RESULTS:The mean age was 57 years, and 70% were female. The Registry describes 280 patients: 101 in eBRS group and 179 in eB, with aneurysms at bifurcation locations. Implantation success was 81% and 92% for eBRS and eB, respectively ( P = .007). The follow-up period averaged 38 months for eBRS and 12 months for eB cases. The all-cause death rate was 3.2% (7% for eBRS and 1.1% for eB, P = .007), and neurological death rate was 2.3% (5% for eBRS and 0.5% for eB, P = .014). The rate of stroke was 1.8%, 2.0% for eBRS and 1.7% for eB ( P = NS). Rate of repeat procedure was 4.6% (8.9% for eBRS and 2.2% for eB, P = .01). For 57 eBRS patients at average 38 months postprocedure, 77% had modified Raymond-Roy Occlusion Classification (mRROC) scores of 1, 19% had mRROC 2, and satisfactory result (1 + 2) of 96%. For 144 eB patients at average 12 months postprocedure, 81% had mRROC 1, 15% mRROC 2, and satisfactory result (1 + 2) of 96%. CONCLUSION:The eCLIPs implant provides durable aneurysm occlusion with a favorable safety profile. The current eB delivery system resulted in improved procedural and safety results over the archived eBRS. The eCLIPs platform offers an alternative treatment strategy for wide neck bifurcation aneurysms.