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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. [ABSTRACT FROM AUTHOR]

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 followup 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Intracranial aneurysms (IAs) are usually asymptomatic with a low risk of rupture, but consequences of aneurysmal subarachnoid hemorrhage (aSAH) are severe. Identifying IAs at risk of rupture has important clinical and socio-economic consequences. The goal of this study was to assess the effect of patient and IA characteristics on the likelihood of IA being diagnosed incidentally versus ruptured. Patients were recruited at 21 international centers. Seven phenotypic patient characteristics and three IA characteristics were recorded. The analyzed cohort included 7992 patients. Multivariate analysis demonstrated that: (1) IA location is the strongest factor associated with IA rupture status at diagnosis; (2) Risk factor awareness (hypertension, smoking) increases the likelihood of being diagnosed with unruptured IA; (3) Patients with ruptured IAs in high-risk locations tend to be older, and their IAs are smaller; (4) Smokers with ruptured IAs tend to be younger, and their IAs are larger; (5) Female patients with ruptured IAs tend to be older, and their IAs are smaller; (6) IA size and age at rupture correlate. The assessment of associations regarding patient and IA characteristics with IA rupture allows us to refine IA disease models and provide data to develop risk instruments for clinicians to support personalized decision-making. [ABSTRACT FROM AUTHOR]

Purpose: Pediatric intracranial aneurysms (PIA) are rarer and more complex when compared to adult aneurysms. In general, the clinical presentation of PIA is due to a mass effect, but the presenting symptoms can be also related to ischemia, subarachnoid hemorrhage (SAH), or in a combination of different symptoms. This paper aimed to report a single-center experience with clinical and angiographic aspects of brain aneurysm in children. Methods: We retrospectively reviewed our prospectively maintained database for patients with intracranial aneurysms in our institution from July 2015 to February 2021. Among these, all patients under 18 years of age submitted to a diagnostic or therapeutic procedure for an intracranial aneurysm were included. Results: Twelve patients were submitted to diagnostic or therapeutic procedures in our department. Three of them had multiple aneurysms, and in total, 17 intracranial aneurysms were assessed in this study. The most frequent location was in the middle cerebral artery (7 cases/41%). Five out of twelve children (42%) presented SAH due to ruptured aneurysm. Three patients (25%) had symptoms due to the mass effect from large aneurysms, with compression of cranial nerves or brainstem. Aneurysms diameters ranged from 1.5 mm to 34 mm (mean 14.2 mm), with six aneurysms being giant and eight being nonsaccular/fusiform. Twelve aneurysms were submitted to endovascular treatment, with one treatment-related clinical complication and later death. Conclusion: PIAs are rare diseases that can arise from a variety of different underlying pathological mechanisms. The management of these conditions requires a detailed understanding of the pathology and a multidisciplinary approach. Despite the availability of new technologies, parent vessel occlusion remains a valid option for aneurysms in the pediatric population. [ABSTRACT FROM AUTHOR]

Background The Woven EndoBridge (WEB) shape modification (WShM) during follow-up may be a potential cause of poor angiographic outcomes. WShM predisposing factors have not yet been determined. Our systematic use of rotational cone beam computed tomography (VasoCT) imaging during follow-up allowed us to perform the first quantitative analysis of the shape of WEBs over time. Our goal was to identify possible strategies to reduce the occurrence of this phenomenon. Methods All patients treated in our hospital with a WEB device between October 2015 and January 2019 were included. Using VasoCT acquisitions, systematically performed after implantation and during follow-up, we analyzed WEB morphology. WShM was defined as the percentage reduction in the distance between the two WEB markers. Results Sixty-three aneurysms treated with a WEB device were finally included in this analysis. At the last follow-up (mean 15.5 months), mean WShM was 48%±24. The mean WShM was significantly higher in the aneurysm recurrence group than in the adequate occlusion group (51±6.5% vs 36±3.4%, difference 15% points (95% CI 0.7 to 30); p<0.05). Conversely, the extent of WShM did not directly correlate with occlusion rates. Indeed, 32% of completely occluded aneurysms presented severe WShM (≥50%). Importantly, the absence of WShM guaranteed complete occlusion in our study (n=12). We demonstrated that oversizing the width of the WEB significantly correlated with WShM reduction during follow-up (r=-0.38, p=0.002). Conclusion WShM can be partly overcome by use of an appropriate width oversizing strategy that could lead to improved angiographic results. [ABSTRACT FROM AUTHOR]

Background High frequency optical coherence tomography (HF-OCT) is a novel intravascular imaging technology developed for use in the cerebral vasculature. We hypothesize that HF-OCT characterization of intrasaccular device neck coverage can prognosticate exclusion of the aneurysm from the circulation. Methods Bifurcation and sidewall aneurysms were made in six dogs. Seven aneurysms were treated with next generation intrasaccular devices (NGID) and four with traditional platinum coils. HF-OCT was performed to interrogate gaps in the neck coverage, coil herniation, or acute thrombus formation. Animals were re-imaged at 7, 30, 90, and 180 days following aneurysm embolization. An automated image processing method segmented the devices at the neck of the aneurysm and quantified neck coverage. The largest coverage gap was used to predict aneurysm occlusion at 180 days. Results No difference was found in occlusion rates between the coil and NGID groups (P=0.45). Successful segmentation of the NGID construct was achieved in all cases. A coverage gap >1mm2 was found to predict failed aneurysm occlusion (P=0.047). This threshold was able to predict all cases of failed occlusion. The average number of devices needed to treat the aneurysm was lower in the NGID group (1.9 vs 6.75, P=0.009). HF-OCT showed strong agreement with scanning electron microscopy (bias 0.0024mm2 (95% CI -0.0279, 0.0327)). Conclusions HF-OCT enables precise and accurate measurement of coverage gaps at the neck of aneurysms treated with intrasaccular devices in vivo. We provide in vivo evidence that uniform aneurysm neck coverage by intrasaccular devices is critical for aneurysm occlusion. [ABSTRACT FROM AUTHOR]

Background Aneurysms of the anterior communicating artery (ACoA) are difficult to treat with coiling or clipping because of the anatomical variation in this region. Flow diversion represents a feasible treatment, but no consensus exists as to which stent deployment technique is more suitable. Methods All patients with AC oA aneurysms treated with flow diverters between April 2014 and November 2018 were retrospectively analyzed. Aneurysm characteristics, follow-up results, and clinical outcome data were recorded, and a new classification comparing the diameters of both A1 segments is proposed: H1=same diameters; H2=<50% difference in diameters; H3= ≥50% difference; and Y=no A1 segment. Results We analyzed 30 procedures in 30 patients with AC oA aneurysms, including 16 ruptured aneurysms treated with coiling embolization and 4 previously unruptured aneurysms (two Medina and two Woven EndoBridge devices). Adequate aneurysm occlusion occurred in 86.9%; one patient (3.3%) experienced symptomatic ischemic stroke. The global thromboembolic complications for each group were 17.6% (H1), 25% (H2), and 60% (H3). Conclusion Flow diversion treatment in this region is safe, feasible, and effective. The most suitable anatomical configuration for flow diverter treatment seems to be the H1 configuration where the 'I technique' is suitable (from an A1 segment to the ipsilateral A2). There is a tendency that the H3 configuration is not a good indication for flow diverter treatment. However, further studies are needed to evaluate the feasibility of this anatomical classification and the reproducibility of our findings. [ABSTRACT FROM AUTHOR]

Backround The treatment of wide neck bifurcation aneurysms remains challenging despite the introduction of new techniques (Y stenting, waffle cone technique, or flow diverter stents). The Woven endoBridge (WEB) device is an innovative solution for this type of cerebral aneurysm. A new WEB 17 is now available and has been designed to offer smaller sized devices to optimize navigability and delivery. Methods Between February 2017 and April 2018 all patients treated with the WEB 17 device in our center were retrospectively reviewed. 25 patients with 28 nonruptured aneurysms were identified and analyzed. Three patients with two aneurysms both treated with the WeB device were identified. Results The device was successfully deployed in all cases. Procedure related morbidity was 4% and mortality was 0%. In one case, a delayed postprocedural thromboembolic event occurred owing to device protrusion. Technical success, complications, angiographic outcomes, procedural data, and follow-ups are reported. The modified rankin scale score at discharge was 0 for 24 patients (96%). At the 3, 6, or 9 month follow-up, angiograms were taken of 21 of the 25 patients (84%) (24 of 28 aneurysms had been controlled); 3 patients (3 aneurysms) did not receive angiographic follow-up at the time of submission of this work. Complete occlusion was achieved in 22 of 24 aneurysms (91.66%), and 2 of 24 aneurysm (8.33%) showed a neck remnant. Conclusions The WEB 17 is safe and technically feasible, according to this retrospective single center analysis. For very small bifurcation aneurysms, the WeB 17 seems to have lower complication rates than stent assisted techniques. However, further studies are needed to evaluate the complication rate and long term efficiency. [ABSTRACT FROM AUTHOR]

Background Optical coherence tomography (OCT) is a high resolution intravascular imaging method that allows visualization of flow diverter struts and the vessel wall. In this study, malapposition of the flow diverter that continues into the neck of the aneurysm, named communicating malapposition (CM), was investigated as a potential factor for delayed aneurysm healing. Methods 40 New Zealand White rabbits underwent elastase induced aneurysm creation, and were subsequently assigned to one of four treatment groups based on flow diverter type and administration of antiplatelet therapy. All animals underwent post device deployment balloon angioplasty and subsequent OCT to assess device/vessel apposition. The incidence of CM seen on OCT was assessed with a binary scoring system: 0-CM present; 1-CM absent. At 30 days, DSA was acquired to assess aneurysm healing. Aneurysm healing on terminal DSA was measured using a previously developed 5 point scale, with a score of 3 or 4 considered a positive outcome. Results All animals were grouped into a single cohort for analysis as no difference in the rate of CM or healing was seen in the four treatment groups. Significant interaction between the absence of CM and a positive outcome was confirmed by Fisher exact test (P=0.0034). Angioplasty was shown to treat 33% of the cases of CM seen at implant, and these treated cases overwhelmingly had a positive outcome (P<0.001). Conclusion The use of OCT to assess CM of flow diverters has been shown to be predictive of the 30 day healing rate of an animal model of aneurysms. [ABSTRACT FROM AUTHOR]

Introduction: Endovascular treatment of ruptured wide-neck bifurcation aneurysms presents a challenge. While still under evaluation, the Woven Endobridge (WEB) aneurysm embolization system has so far shown promising results in the treatment of complex bifurcation aneurysms. We aimed to evaluate the feasibility and short-term follow-up of endovascular treatment of ruptured wide-neck aneurysm with the WEB device. Methods: Six patients referred to our institution for acute symptomatic subarachnoid hemorrhage (SAH) and treated with the WEB device were enrolled in this study. Clinical presentations, technical details, intraoperative and postoperative complications, and outcomes were recorded. Immediate and 3-month angiographic results were also evaluated. Results: Three middle cerebral artery (MCA) and three anterior communicating artery aneurysms were treated between 1 and 14 days after rupturing. Average dome width was 5.8 mm (range 5-7), average neck size was 4.5 mm (range 4-5), and average dome-to-neck ratio was 1.3 (range 1-1.7). The WEB system was the exclusive treatment and was successfully deployed in all cases. Per procedural thromboembolic events occurred in two cases and were treated with intra-arterial administration of antiplatelet agents without any clinical consequences. The modified Rankin Scale (mRS) score at discharge was 0 for all patients. The 3-month angiographic follow-up showed adequate occlusion in four of our six patients (67 %). Conclusion: From this preliminary study, the high feasibility rate and lack of need for systematic antiplatelet agents favor the WEB device providing a solution for endovascular treatment of ruptured wide-neck bifurcation aneurysms during the acute phase. However, further studies are needed to evaluate the complication rate and long-term efficiency. [ABSTRACT FROM AUTHOR]