Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.

BACKGROUND: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. METHODS: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. RESULTS: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. CONCLUSION: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER: NCT03844334.

Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study.

BACKGROUND: The Low profile visualized intraluminal support (LVIS)/LVIS Jr is a self-expanding braiding stent for the treatment of intracranial aneurysm. This study is to determine the safety and effectiveness of the LVIS/LVIS Jr for the treatment of intracranial aneurysms in a real-world setting. METHODS: This prospective, observational, multicenter study enrolled patients with unruptured, ruptured and recanalized intracranial aneurysms treated with the LVIS stents, between February 2018 to December 2019. Primary endpoint was the cumulative morbidity and mortality rate (CMMR) assessed at 12 months follow-up (FU). RESULTS: A total of 130 patients were included (62.3 % women, mean age 55.9 ± 11.4) on an intention-to-treat basis. Four patients (3.1 %) had 2 target aneurysms; 134 total aneurysms were treated. The aneurysms were mainly located on the middle cerebral artery (41/134; 30.6 %) and the anterior communicating artery (31/134; 23.1 %). The CMMR at 1 year linked to the procedure and/or device was 4.6 % (6/130). The overall mortality was 1.5 % (2/130), none of these deaths adjudged as being linked to the procedure and/or device. All aneurysms (134/134, 100 %) were successfully treated with LVIS stent and/or other devices. At a mean FU of 16.8 months post-procedure, complete/nearly complete occlusion was achieved in 112 aneurysms (92.6 %), and only 3 patients (2.5 %) required aneurysm retreatment. CONCLUSION: This study provides evidence that the LVIS/LVIS Jr devices are safe and effective in the treatment of complex intracranial aneurysms, with very high rates of adequate occlusion at FU. These angiographic results are stable over time with an acceptable complication rate. TRIAL REGISTRATION: ClinicalTrial.gov under NCT03553771.

Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.

BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715. FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. FUNDING: EU Horizon 2020.

Longitudinal radiological follow-up of individual level non-ischemic cerebral enhancing lesions following endovascular aneurysm treatment.

BACKGROUND: Non-ischemic cerebral enhancing (NICE) lesions following aneurysm endovascular therapy are exceptionally rare, with unknown longitudinal evolution. OBJECTIVE: To evaluate the radiological behavior of individual NICE lesions over time. METHODS: Patients included in a retrospective national multicentric inception cohort were analyzed. NICE lesions were defined, using MRI, as delayed onset punctate, nodular, or annular foci enhancements with peri-lesion edema, distributed in the vascular territory of the aneurysm treatment, with no other confounding disease. Lesion burden and the longitudinal behavior of individual lesions were assessed. RESULTS: Twenty-two patients were included, with a median initial lesion burden of 36 (IQR 17-54) on the first MRI scan. Of the 22 patients with at least one follow-up MRI scan, 16 (73%) had new lesions occurring mainly within the first 200 weeks after the date of the procedure. The median number of new lesions per MRI was 6 (IQR 2-16). Among the same 22 patients, 7 (32%) had recurrent lesions. The median persistent enhancement of a NICE lesion was 13 weeks (IQR 6-30). No factor was predictive of early regression of enhancement activity with lesion regression kinetics mainly being patient-dependent. CONCLUSIONS: The behavior of individual NICE lesions was found to be highly variable with an overall patient-dependent regression velocity.

Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up.

BACKGROUND: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. RESULTS: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). CONCLUSIONS: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%). CLINICAL TRIAL REGISTRATION: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design.

BACKGROUND: Due to its high efficacy, flow diversion is increasingly used in the management of unruptured and recanalized aneurysms. Because of the need for perioperative dual antiplatelet treatment (DAPT), flow diversion is not indicated for the treatment of ruptured aneurysms. To overcome this major limitation, surface modification-'coating'-of flow diverters has been developed to reduce platelet aggregation on the implanted device, reduce thromboembolic complications, and facilitate the use of coated flow diverter treatment in patients with single antiplatelet treatment (SAPT). COATING (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) is a prospective, randomized, multicenter trial that aims to determine whether the use of the coated flow diverter p64 MW HPC under SAPT is non-inferior (or even superior) to the use of the bare flow diverter p64 MW under DAPT in relation to thromboembolic and hemorrhagic complications. METHODS: Patients with unruptured or recanalized aneurysms for which endovascular treatment with a flow diverter is indicated will be enrolled and randomly assigned on a 1:1 ratio to one of two treatment groups: p64 MW HPC with SAPT or p64 MW with DAPT. RESULTS: The primary endpoint is the number of diffusion-weighted imaging lesions visualized via MRI assessed within 48 hours (±24 hours) of the index procedure. Secondary primary endpoints are comparing safety and efficacy in both arms. CONCLUSIONS: This randomized controlled trial is the first to directly compare safety and efficacy of coated flow diverters under SAPT with bare flow diverters under DAPT. TRIAL REGISTRATION NUMBER: http://clinicaltrials.gov/ - NCT04870047.

A Systematic Literature Review and Meta-Analysis of the Treatment of Ruptured Intracranial Aneurysms with Hydrophilic Polymer and Phosphorylcholine-Coated Flow Diverters Under Single Antiplatelet Therapy.

OBJECTIVE: Flow diverters coated with antithrombogenic substances were recently introduced and have shown encouraging results in the preclinical setting. Our aim was to analyze their clinical application in patients with ruptured intracranial aneurysms using single antiplatelet therapy (SAPT). METHODS: We performed a PRISMA-compliant systematic review and meta-analysis covering 3 major data bases until March 2022.Two reviewers independently reviewed clinical studies for eligibility.Random-effects analysis of proportions was used to pool safety outcomes (hemorrhagic, thrombembolic, and overall complications). Studies were tested for publication bias and heterogeneity. RESULTS: Five studies reporting 43 patients with 46 aneurysms were identified. More than 1 stent was implanted in 16%, and additional coil embolization was performed in 53.8% of patients. SAPT with one of various acetylsalicylic acid regimens was used in 86%, altogether antiplatelet protocols were variable. The pooled risks of thromboembolic (23.9%; 95% confidence interval [CI], 9.6-47.9), hemorrhagic (9.4%; 95% CI, 3.6-22.6), and overall complications (28.3%; 95% CI, 12.4-52.5) were calculated in the absence of publication bias with low to moderate study heterogeneity measures. All complications occurred in patients under acetylsalicylic acid SAPT. Adequate aneurysm occlusion was described in 65.5% of patients.few retrospective observational studies with moderate heterogeneity, encompassing a limited number of patients treated with variable SAPT regimens. CONCLUSIONS: Flow diversion for ruptured aneurysms under SAPT with coated stents is feasible. Although the risk of hemorrhagic complications was low, thromboembolic complications occurred in a significant number of patients, all under ASA SAPT.

Management of aneurysmal recurrence after Woven EndoBridge (WEB) treatment.

BACKGROUND: Around 10% of Woven EndoBridge device (WEB)-treated intracranial aneurysms will need retreatment, and it is generally believed to be more challenging than retreatment after an initial coiling. We aim to report retreatment strategies and outcomes after initial WEB embolizations. METHODS: Databases from four treatment centers, containing consecutive aneurysms treated with a WEB between 2013 and 2022, were reviewed. Demographics, aneurysm characteristics, retreatment strategies and outcomes were collected and analyzed. RESULTS: From a 756 WEB database, 57 aneurysms were included. The global retreatment rate was 7.5% (95% CI 5.6% to 9.4%). The retreatment rate was significantly higher in the ruptured compared with the unruptured population (13% vs 3.9%, respectively, P<0.0001). Aneurysms were retreated on average 21.2 months after the initial WEB treatment (range 4.8-70 months). Surgery was performed in 11% and endovascular treatment in 89% of cases, consisting of flow diversion (48%), stent-assisted coiling (30%), coiling (12%), and second WEB placement (10%). Imaging follow-up was available in 88% of all WEB retreatments (50/57) (average 17 months, 49% digital subtraction angiography), demonstrating complete occlusion in 56% and 'adequate' occlusion in 88%. Morbidity was 5.3% (95% CI 0% to 12.0%) and mortality 0%. No patient experienced rebleeding during the follow-up period. CONCLUSION: The retreatment rate after an initial WEB treatment seems to compare favorably with that of coiling. Endovascular treatment of recurrence following WEB implantation is feasible in most situations; it generally requires the use of a stent and leads to a high rate of satisfactory occlusion.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.

BACKGROUND: The 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. METHODS: The 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. RESULTS: Sixty 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. CONCLUSIONS: The 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.

Bilateral carotid-cavernous fistula after trauma presenting as hemorrhagic shock: Case report.

Bilateral carotid-cavernous fistula (CCF) is a rare complication associated with severe head injury and skull base fractures. Initial presentation with hemodynamically relevant epistaxis is unusual. We report a case of a 27-year-old male presenting with severe craniocerebral injury associated with massive epistaxis. To stabilize the patient hemodynamically, the bleeding was stopped by embolization of left internal carotid artery with coils, after checking that the Willis circle is well compensated. The left CCF was embolized later with flow diverter stent when it was safe to use platelet aggregation inhibitors. Reporting this case enlighten the management of bilateral CCF with hemorrhagic shock.

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.

ADC measurement relevance to predict hemorrhage transformation after mechanical thrombectomy.

BACKGROUND: ADC (apparent coefficient diffusion) value has been known to predict hemorrhage transformation (HT) after thrombolysis and recently, after mechanical thrombectomy (MT). We aimed to evaluate that utility separately in basal ganglia and superficial territory. We used HT occurrence with or without NIHSS change as primary outcome measures. METHODS: This single-center retrospective study included consecutive stroke patients receiving MT for internal carotid artery (ICA) or middle cerebral artery (M1 or M2) occlusion. In patient with or without HT, using the Heidelberg Bleeding Classification, on follow-up CT scan at 24-48 h, we assessed the ADC value separately in basal ganglia and superficial territory on MRI before MT to search for the correlation. Multivariable analysis was performed using variables with significant differences between the HT group and non-HT group. RESULTS: One hundred seventeen patients were included in the final analysis. HT distribution was as follows: 9 patients (7.69%) HI1 or 2; 14 patients (11.97%) PH1; 21 patients (17.95%) PH2; 29 patients (24.79%) subarachnoid hemorrhage; and 21 patients (17.95%) symptomatic intracranial hemorrhage (sICH). Mean ADC minimal value in basal ganglia in the HT group was significantly lower than in the non-HT group (377.6 × 10-6 mm2/s [± 52.4] vs 413.3 × 10-6 mm2/s [± 72.5]; p = 0.0229) with an area under the curve (AUC) of 0.6622 (95% CI: 0.5-0.8; p = 0.014). MRI-MT time was significantly longer in the HT group (p = 0.0002), but there was no association between ADC value and onset-MRI or MRI-MT times (Spearman's coefficients <0.7, p > 0.05). Glycemia at admission (>1.5 g/L) (OR = 4.2; 95% CI [1.611; 10.961]) and carotid occlusion (OR = 2.835; 95% CI [1.134; 7.091]) were independently associated with HT. CONCLUSIONS: ADC value in basal ganglia, unlike brain superficial territory, are correlated to HT risk after MT.

Predictive Factors for Clinical Outcome After Direct Mechanical Thrombectomy for Anterior Circulation Large Vessel Occlusion Within 4.5 h.

Background: Recent trials including DIRECT-MT, DEVT, and SKIP have found that direct mechanical thrombectomy (MT) is equally effective as the combination of MT and intravenous thrombolysis. However, the results of the other trials, namely MR-CLEAN NO-IV and the SWIFT-DIRECT trial have failed to confirm the non-inferiority of direct MT vs. the combination therapy. Aim: We aimed to identify prognostic factors of direct MT for anterior circulation large vessel occlusion within 4.5 h. Materials and Methods: Data from January 2018 to January 2022 were retrospectively collected and analyzed. Adult patients with confirmed anterior circulation large vessel occlusion within 4.5 h of onset with baseline NIHSS of ≥6 and baseline ASPECTS of ≥6 treated using direct MT within 6 h were recruited. Results: A total of 140 patients were enrolled in the study with a median age of 65.5 years [interquartile range (IQR), 59-76.5], median baseline NIHSS of 13.5 (IQR, 11-16), and median baseline ASPECTS of 8 (IQR, 7-8). Direct MT was feasible in all patients (100%). Successful reperfusion (mTICI 2b-3) was achieved in 124/140 patients (88.6%) with a low rate of complications (8/140, 5.7%). Any type of intracranial hemorrhage (ICH) and symptomatic ICH occurred in 44/140 (31.4%) and 5/140 (3.6%), respectively. Overall, a good outcome (mRS 0-2) was achieved in 93/140 (66.4%), and the mortality rate was 9.3% (13/140 patients). Using multivariate analysis, lower age [odds ratio (OR), 0.96; 95% CI, 0.92-1.00; P = 0.05], low baseline NIHSS (OR, 0.82; 95% CI, 0.74-0.92; P = 0.00), and absence of ICH (OR, 0.29; 95% CI, 0.10-0.81; P = 0.02) were independently associated with favorable outcome. Independent predictors of mortality were baseline NIHSS (OR, 1.21; 95% CI, 1.01-1.46; P = 0.04), successful reperfusion (OR, 0.02; 95% CI, 0.00-0.58; P = 0.02), and ICH (OR, 0.12; 95% CI, 0.02-0.75; P = 0.02). Further analysis showed that the median mRS at 90 days was significantly better in the MCA occlusion group compared to the ICA plus M1 occlusion group [1 (IQR 0-3) vs. 2 (IQR 1-4); P = 0.05]. Conclusions: Our findings suggest that direct thrombectomy may be an adequate clinical option for younger patients (≤70) experiencing proximal middle artery occlusion within 4.5 h and who have low baseline NIHSS (≤14).

Deployment of low-profile flow-diverter through a double lumen balloon catheter (remo-diversion technique) to treat recurrent middle cerebral artery bifurcation aneurysm: A technical note.

Wide neck intracranial aneurysms are often difficult to treat with coiling alone, and sophisticated techniques such as balloon-assisted coiling, stent-assisted coiling, flow-diversion, or intrasaccular flow-disruption are sometimes required.This technical note reports the endovascular treatment of a recurrent middle cerebral bifurcation aneurysm by remodeling technique followed by flow-diverter (Silk Vista Baby) deployment through a remodeling balloon (double lumen balloon Eclipse 2L).

Intracranial aneurysm treatment with WEB and adjunctive stent: preliminary evaluation in a single-center series.

BACKGROUND: Intrasaccular flow disruption with WEB is a safe and efficacious technique that has significantly changed endovascular management of wide-neck bifurcation aneurysms (WNBAs). Use of stent in combination with WEB is occasionally required. We analyzed the frequency of use, indications, safety, and efficacy of the WEB-stent combination. METHODS: All aneurysms treated with WEB and stent were extracted from a prospectively maintained database. Patient and aneurysm characteristics, complications, and anatomical results were independently analyzed by a physician independent of the procedures. RESULTS: From June 2011 to January 2020, 152 patients with 157 aneurysms were treated with WEB. Of these, 17/152 patients (11.2%) with 19/157 aneurysms (12.1%) were treated with WEB device and stent. Indications were very wide neck with a branch emerging from the neck in 1/19 (5.2%) aneurysms and WEB protrusion in 18/19 (94.7%). At 1 month, no morbimortality was reported. At 6 months, anatomical results were complete aneurysm occlusion in 15/17 aneurysms (88.2%), neck remnant in 1/17 (5.9%), and aneurysm remnant in 1/17 (5.9%). At 12 months, there was complete aneurysm occlusion in 13/14 aneurysms (92.9%) and neck remnant in 1/14 (7.1%). CONCLUSIONS: Combining WEB and stent is a therapeutic strategy to manage WNBA. In our series, this combination was used in 11.2% of patients treated with WEB, resulting in no morbidity or mortality with a high efficacy at 6 and 12 months (complete aneurysm occlusion in 88.2% and 92.9%, respectively).

Intracranial aneurysm treatment with intrasaccular flow disruption: comparison of WEB-21 and WEB-17 systems.

BACKGROUND: New generations of Woven EndoBridge (WEB) devices (WEB-21 and WEB-17) are available to treat aneurysms with a width <6.5 mm. Limited comparisons between both systems exist in the literature, but mid-term efficacy has not been compared. Our study aimed to compare the indications, feasibility, and safety of both systems and to evaluate their efficacy at mid-term follow-up (12 months). METHODS: Aneurysms treated with WEB-21 and WEB-17 were extracted from a prospective database. Patient and aneurysm characteristics, complications, and anatomical results were analyzed by an interventional neuroradiologist, independent of the procedures. RESULTS: From June 2015 to November 2019, 87 patients with 92 aneurysms were treated with WEB-21 (38/92, 41.3%) and WEB-17 (54/92, 58.7%). WEB-21 and WEB-17 had high treatment feasibility (97.4% and 94.4%, respectively). A higher percentage of ruptured aneurysms were treated with WEB-17 (9.3%) than with WEB-21 (2.6%; p=0.03). Morbidity and mortality at 1 month were similar in both groups (no morbidity in either group, and mortality 2.7% in the WEB-21 group and 2.0% in the WEB-17 group). The rate of complete and adequate aneurysm occlusion was not significantly higher with the WEB-17 system (59.2% and 95.9%, respectively) compared with the WEB-21 (52.9% and 85.3%, respectively). CONCLUSIONS: This study showed the high feasibility of aneurysm treatment with both the WEB-21 and WEB-17 systems. Indications were relatively similar with both devices except for ruptured aneurysms, which were more frequently treated with the WEB-17 device. Efficacy at 12 months (complete and adequate occlusions) was slightly, but not significantly, better with the WEB-17 device.

Non-ischemic cerebral enhancing lesions after intracranial aneurysm endovascular repair: a retrospective French national registry.

BACKGROUND: Non-ischemic cerebral enhancing (NICE) lesions are exceptionally rare following aneurysm endovascular therapy (EVT). OBJECTIVE: To investigate the presenting features and longitudinal follow-up of patients with NICE lesions following aneurysm EVT. METHODS: Patients included in a retrospective national multicentre inception cohort were analysed. NICE lesions were defined, using MRI, as delayed onset punctate, nodular or annular foci enhancements with peri-lesion edema, distributed in the vascular territory of the aneurysm EVT, with no other confounding disease. RESULTS: From a pool of 58 815 aneurysm endovascular treatment procedures during the study sampling period (2006-2019), 21/37 centres identified 31 patients with 32 aneurysms of the anterior circulation who developed NICE lesions (mean age 45±10 years). Mean delay to diagnosis was 5±9 months, with onset occurring a month or less after the index EVT procedure in 10 out of 31 patients (32%). NICE lesions were symptomatic at time of onset in 23 of 31 patients (74%). After a mean follow-up of 25±26 months, 25 patients (81%) were asymptomatic or minimally symptomatic without disability (modified Rankin Scale (mRS) score 0-1) at last follow-up while 4 (13%) presented with mild disability (mRS score 2). Clinical follow-up data were unavailable for two patients. Follow-up MRI (available in 27 patients; mean time interval after onset of 22±22 months) demonstrated persistent enhancement in 71% of cases. CONCLUSIONS: The clinical spectrum of NICE lesions following aneurysm EVT therapy spans a wide range of neurological symptoms. Clinical course is most commonly benign, although persistent long-term enhancement is frequent.