Safety and efficacy of Surpass Evolve Flow diverter for intracranial aneurysms: A study of 116 patients.

BACKGROUND AND PURPOSE: Flow diverter embolization is a recognized method for treating intracranial aneurysms. This study evaluates the safety and efficacy of the Surpass Evolve flow diverter in treating intracranial aneurysm. MATERIAL AND METHODS: From May 2019 to June 2022, our center prospectively enrolled patients presenting with both ruptured and unruptured intracranial aneurysms. We assessed aneurysm occlusion, along with the occurrence of ischemic and hemorrhagic complications, and mortality at 6-months. The 3-month occlusion rate was determined using MR angiography, while the 6-month occlusion rate employed the O'Kelly-Marotta (OKM) grading scale on DSA. RESULTS: A total of 116 patients with 120 aneurysms received treatment with the Surpass Evolve device. The average aneurysm size was 6.6 mm (range: 2-30 mm). All patients were administered two loading doses of ticagrelor (180 mg) one day before the procedure and 2 h pre-embolization. A procedural complication occurred in one case, involving wire-related perforation of an M3 branch distant from the giant aneurysm; however, this evolved favorably. There were no reported deaths linked to the treatment. Permanent neurological deficits were observed in 3 (2.5%) patients, primarily due to early in-stent thrombosis. MR angiography results at 3 months indicated complete occlusion for 87 out of 115 (75.6%) monitored aneurysms. The 6-month DSA showed neck remnant or complete occlusion (OKM grade C or D) in 86 out of the 107 (80.4%) patients who underwent follow-up. CONCLUSION: The Surpass Evolve stands out as a reliable and effective flow diverter for the management of intracranial aneurysms.

Persistent flow inside the Woven EndoBridge at angiographic follow-up: A multicenter study.

BACKGROUND: The occurrence of persistent intra-device filling (BOSS 1, using the Bicêtre Occlusion Scale Score (BOSS)) in aneurysms treated with a Woven Endobridge (WEB) device is infrequent based on angiographic follow-up. To date, three monocentric case series were published studying BOSS 1 cases. Through a multicenter retrospective study, we aimed to report the incidence, and risk factors of intra-WEB persistent filling. METHODS: We reached out to European academic centers that treat patients using WEB devices and requested de-identified data of patients treated with a WEB device and underwent angiographic follow-up, at least 3 months after embolization, to assess the BOSS 1 occlusion score. We compared baseline characteristics, treatment modalities, and aneurysm data of the included BOSS 1 patients with those of a control group consisting of non-BOSS 1 patients (n = 116) who had an available angiographic follow-up. Univariable and multivariable models were employed for analysis. RESULTS: Among the pooled sample of 591 aneurysms treated with WEB, the rate of persistent flow (BOSS 1) at angiographic follow-up was 5.2% (n = 31 out of 591), performed after an average of 8.7 ± 6.3 months. In the multivariable-adjusted analysis, dual antiplatelet therapy in the postoperative period (adjusted odds ratio [aOR] 4.3 [95% CI 1.3-14.2]), and WEB undersizing (aOR 10.8 [95% CI 2.9-40]) were independently associated with a BOSS 1 persistent flow result. CONCLUSION: Persistent blood flow within the WEB device during angiographic follow-up (BOSS 1) is an uncommon occurrence. Our findings indicate that post-procedural dual antiplatelet therapy and undersizing of the WEB device are independently associated with the presence of BOSS 1 at follow-up.

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.

Acute hydrocephalus and delayed cerebral infarction after aneurysmal subarachnoid hemorrhage.

BACKGROUND: Delayed cerebral infarction (DCIn) following aneurysmal subarachnoid hemorrhage (aSAH) is a major cause of morbi-mortality; yet, the causes for DCIn remain incompletely understood. OBJECTIVE: We tested the hypothesis that acute hydrocephalus could be related to the occurrence of DCIn, independently of the occurrence and severity of vasospasm. METHODS: Radiological and clinical data of patients treated at a single large volume academic center for aSAH between 2017 and 2019 were retrospectively analyzed. DCIn was defined as imaging stigma of cerebral infarction visible on 6-week imaging follow-up after aSAH. Hydrocephalus was defined on baseline imaging as a relative bicaudate index above 1. Cerebral vasospasm was defined by reduction of artery diameter in comparison with initial diameter. We used uni- and multivariable models to test the associations between these variables, hydrocephalus and DCIn. RESULTS: Of 164 included patients, vasospasm occurred in 58 patients (35.4%), and DCIn in 47 (28.7%). Acute hydrocephalus was present in 85 patients (51.8%) on baseline CT. No relation was found between acute hydrocephalus and delayed cerebral infarction in our multivariate analysis (adjusted OR: 1.20 95% CI [0.43-3.37]; p = 0.732). Only vasospasm occurrence was independently associated with DCIn (adjusted OR: 10.97 95% CI [4.60-26.01]). CONCLUSION: Our study did not show an association between acute hydrocephalus and DCIn after aSAH, after adjustment for the presence and severity of cerebral vasospasm.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study.

BACKGROUND: The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. METHODS: The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. CONCLUSIONS: The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.

Quantitative analysis of thrombus migration before mechanical thrombectomy: Determinants and relationship with procedural and clinical outcomes.

BACKGROUND AND PURPOSE: In patients with acute ischemic stroke (AIS) and a large vessel occlusion (LVO), thrombus migration (T-Mig) is a common phenomenon before mechanical thrombectomy (MT), revealed by pre-treatment imaging. Previous works have used qualitative scales to define T-Mig. The aim of this study was to evaluate the determinants and impact of quantitatively assessed T-Mig on procedural characteristics and clinical outcome. METHODS: Consecutive patients with AIS due to LVO treated by MT at a reference academic hospital were analysed. Distance between vessel origin and beginning of the thrombus on MRI (3D-time-of-flight and/or contrast-enhanced magnetic-resonance-angiography) and digital-substracted-angiography (DSA) were measured in millimeters using a curve tool. Thrombus migration was defined quantitatively as ∆TD calculated as the difference between pre-MT-DSA and MRI thrombus location. ∆TD was rated as significant if above 5mm. RESULTS: A total of 267 patients were included (mean age 70±12 years; 46% females) were analyzed. Amongst them, 65 (24.3%) experienced any degree of T-Mig. T-Mig was found to be associated with iv-tPA administration prior to thrombectomy (ß-estimate 2.52; 95% CI [1.25-3.79]; p<0.001), fewer device passes during thrombectomy (1.22±1.31 vs 1.66±0.99; p<0.05), and shorter pre-treatment thrombi (ß-estimate -0.1millimeter; 95% CI [-0.27-0.07]; p<0.05). There was no association between T-Mig and a favourable outcome (defined by a 0-to-2 modified-Rankin-Scale at 3months, adjusted OR: 2.16 [0.93 - 5.02]; p=0.06) CONCLUSION: Thrombus migration happens in almost a fourth of our study sample, and its quantitative extent was associated with iv-tPA administration prior to MT, but not with clinical outcome.

Ovarian arteries embolization in women with persistent symptoms following uterine arteries embolization for uterus fibroids.

PURPOSE: In patients with persisting symptoms after uterine arteries embolization (UAE), ovarian arteries embolization (OAE) may play a role to improve symptoms and decrease subsequent surgery rates. In a retrospective cohort, we aimed to investigate the efficacy and safety of OAE in females with recurrent or persistent symptoms following UAE. METHODS: We performed a retrospective analysis of prospectively collected cases at a single reference academic hospital; we identified patients who benefited from OAE for persisting symptoms following UAE from 2008 to 2021. Outcome variables included the rates of subsequent surgery, a quality-of-life questionnaire with the UFS-QOL tool, the MRI reduction in uterine and fibroids volumes and the fibroid devascularization rate. RESULTS: Among 1300 women treated with UAE during the study period, 18 eventually received OAE and were included (mean age 44 ± 4.3 SD). There was no OAE procedural complication. There was a decrease in uterine volume and a complete devascularization of the dominant fibroid in 10/11 (90.9%) patients who underwent 12 months MRI. Three women underwent subsequent hysterectomy. Among 10/18 patients who answered the quality-of-life questionnaire after a mean follow-up of 70 months, eight reported an improvement or stability of symptoms. CONCLUSION: OAE for persisting symptoms after UAE was associated with improvement or stability of quality-of-life in most study subjects and less than a fifth of the cohort underwent hysterectomy after OAE. This study highlights the role of OAE as an adjunct to UAE.

EASY score (Eloquent, Age and baseline SYmptoms score) for outcome prediction in patients with acute ischemic stroke.

OBJECTIVE: A pragmatic tool for the early and reliable prediction of recovery in patients with acute ischemic stroke is needed. We aimed to test the addition of brain eloquent areas involvement in variables predicting poor outcome, using a simple scoring system. METHODS: Retrospective study of patients with anterior circulation acute ischemic stroke treated with best medical treatment and/or endovascular reperfusion. Primary outcome measure was 3-months poor outcome (mRs 3-6). We developed a prognostic model based on clinical data and a quantitative scoring system of the main eloquent brain areas involved on early follow-up CT, and analyzed its accuracy to predict poor outcome comparatively to three other prognostic models. The final model was used to develop a score for outcome prediction based on the multivariable analysis. RESULTS: A total of 197 patients were included (poor outcome = 62; mean age 67 ± 15.1 years; 44% females). Independent predictors of poor outcome were increasing age (p < 0.001), baseline NIHSS (p = 0.03), and the involvement of two brain areas: posterior limb of internal capsule (p < 0.001) and postero-superior corona radiata (p < 0.001). This model showed to be the most accurate to predict poor outcome (Balance Accuracy = 77.74%; C-Statistic = 0.891). The derived risk score attributing points for each of these variables (EASY score) showed similar performances (Balance Accuracy = 82.11%; C-Statistic = 0.90). CONCLUSION: The EASY score is an easy-to-apply and accurate tool to predict the 3-months functional outcome after ischemic stroke, relying on simple clinical features and the assessment of two key eloquent brain areas on early follow-up CT.

Quantitative evaluation of WEB shape modification: A five-year follow-up study.

BACKGROUND AND PURPOSE: Web shape modification (WSM) has previously been associated with aneurysm recurrence. We report here our five-year experience of WEB device use with a quantitative approach of the WSM phenomenon. METHODS: From July 2012 to July 2017, 50 patients with 51 unruptured aneurysms treated with the WEB device have been prospectively enrolled in our data base and retrospectively analyzed. An independent "core lab" evaluated anatomical results and potential WSM in DSA follow-up. We defined the WSM ratio (WSMr) as a relative index between the height and the width of the device in working projections which gave an evaluation of the device deformation over the time. RESULTS: During the total follow-up period, WSM was observed in 35/48 aneurysms (72.9%). Adequate occlusion rates were 87.0% and 92.6% with and without WSM respectively (P = 0.65). 30 out the 35 (85.7%) shape modifications were already noticed at short-term follow-up (6-month DSA). 33 patients had 2 DSA controls and WSMr measurements were available in 24 patients: 18 (75%) with WSM and 6 (25%) without WSM. In the group with WSM, WSMr values were 0.80 in post-embolization, 0.52 at the first DSA angiogram and 0.42 at the second DSA angiogram. CONCLUSION: WEB shape modification was observed in more than half of cases but with no influence regarding adequate occlusion rate. This quantitative approach of WSM highlights that this phenomenon appears to be early and progressive over time. This supports the hypothesis that WSM could be more probably related to aneurysm healing rather than external compression.

[Stroke prevention]. / Prévention de l'AVC ischémique.

Prevention is essential to stroke management because of the high risk of recurrence. Stroke incidence is increased by known risk factors, which can be prevented. Cardiovascular prevention after stroke or TIA also includes aetiology-specific treatment, when it is known. Endovascular treatment is not indicated as a first-line treatment for atheromatous cervical or intracranial stenosis. Endovascular or surgical treatment is not indicated as first-line treatment for cervical arterial dissection because of its minor risk of stroke recurrence.

Dual Antiplatelet Therapy Combining Aspirin and Ticagrelor for Intracranial Stenting Procedures: A Retrospective Single Center Study of 154 Consecutive Patients With Unruptured Aneurysms.

BACKGROUND: Dual antiplatelet therapy (DAPT) associating aspirin + clopidogrel is commonly utilized in neurovascular interventions despite unpredictable clopidogrel efficacy with 4% to 50% of patients considered nonresponders. Ticagrelor is an antiplatelet agent with low resistance rates but unknown efficacy and safety in neurovascular patients. OBJECTIVE: To evaluate frequency of ischemic and hemorrhagic events in patients treated with aspirin and ticagrelor when associated with perioperative heparin bolus for unruptured aneurysms treated with intracranial stents. METHODS: One hundred fifty-four consecutive patients with unruptured intracranial aneurysms treated by stent procedures (113 = flow diverter stent [FDS], 41 = stent-assisted coiling) were retrospectively analyzed. All patients received aspirin and ticagrelor without platelet function testing. Patients were separated in 2 groups following perioperative heparin dose: group I = 70 U/kg; group II = 50 U/kg. FDS versus stent-assisted coiling procedures were also separately analyzed. RESULTS: Nine patients (5.8%) presented symptomatic neurological complications poststenting (3 ischemic, 6 hemorrhagic): 8 patients received 70 U/kg of heparin (11.1%) and 1 patient received 50 U/kg (1.2%; P < .009). Four patients died (2.6%) during the 3-mo follow-up period-all deaths were correlated to intracranial hemorrhage: 3 at group I and 1 at group II (P < .251). No difference in complications or death was observed considering separately FDS and stent-assisted coiling procedures. CONCLUSION: This study did not find more neurological complications than in previous neurointerventional reports using DAPT with aspirin + ticagrelor or aspirin + clopidogrel. Overall number of neurological complications was lower when a lower dose of heparin was administered. Neurovascular studies comparing clopidogrel to ticagrelor and different doses of heparin are necessary to demonstrate which association is more efficient with lower complication rates.

Reversible Brain Edema Associated with Flow Diverter Stent Procedures: A Retrospective Single- Center Study to Evaluate Frequency, Clinical Evolution, and Possible Mechanism.

BACKGROUND: Hemorrhage and ischemia after flow diverter stent (FDS) procedures for intracranial aneurysms are the most common complications and have been extensively described. Temporary brain edema (TBE) is an unknown complication that could be associated with particular FDS procedures. OBJECTIVE: To estimate the frequency, clinical presentation, imaging findings, and possible mechanisms associating TBE with FDS. METHODS: Unruptured aneurysms treated with FDS implantation performed in our service from June 2015 to March 2018 were reviewed. Medical antecedents, endovascular procedure, clinical assessments before and after treatment, aneurysm characteristics, and image records were collected. Artery diameters of patients in whom TEB developed were also calculated to investigate any correlation between TBE and anatomic descriptors. RESULTS: A total of 179 FDS procedures in 176 patients were reviewed. Six patients (3.4%) presented with symptomatic TBE, and all TBE patients had undergone FDS implantation from the middle cerebral artery (MCA) to the internal carotid artery (ICA). A Pearson product-moment correlation coefficient (PPCC) found smaller MCA diameters and MCA/ICA ratios in these 6 patients (respectively PPCC = -0.619, P < 0.04; PPCC = -0.647, P < 0.03). Hemorrhagic and ischemic complications were less frequent than TBE (2.3% and 1.1% vs. 3.4%). CONCLUSIONS: TBE was more frequent than ischemic or hemorrhagic complications after FDS in this study. TBE seemed to be associated with a particular FDS positioning in small arteries, inducing flow changes and disruption of the blood-brain barrier.