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Abstract BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed. CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

Herein, we describe the use of a novel multiplug flow control technique for the curative transarterial embolisation of cerebrovascular malformations using liquid embolic agents (LEAs). The idea behind the use of this technique is to substantially control or arrest flow during LEA injection, with multiple plugs simultaneously formed from microcatheters that are placed within all or multiple feeders, so that the penetration of LEAs is facilitated, with flow control decreasing the washout of a malformation. This technique enables the complete occlusion of a vascular malformation in a shorter injection time than that in other methods because penetration is achieved faster. Details of this technique have been described in the treatment of two cases: one case of unruptured temporal arteriovenous malformation and in the other with a falcotentorial dural arteriovenous fistula, in which the vascular malformations were successfully occluded with transarterial embolisation.

IntroductionThe US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients.Methods150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator.Results83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade.ConclusionsFive year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time.

BackgroundFlow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD.MethodsPatients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed.Results60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure.ConclusionsThe new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.

After a brief summary of the published embolization results, we describe and discuss the latest curative advanced embolization techniques in the endovascular management of bAVMs from the perspective of the authors who have a long-standing, significant experience in the curative treatment of brain AVMs.5 This review does not intend to discuss the merits or pitfalls of treating unruptured versus ruptured AVMs; or to provide a comparison between different treatment techniques such as endovascular versus microsurgery, radiosurgery or a combined approach. bAVMs constitute a heterogeneous group of pathologies, being sporadic and considered to be acquired in the majority; however, they can also be congenital and associated with some syndromes in a very small group of patients which are not within the scope of this review. Presenting symptoms are variable, including intracranial bleeding, being the most fearful, but also seizures, headache or migraine, symptoms due to ischemia resulting from steal phenomenon or mass effect, bruit, vision abnormalities, congestive heart failure, etc., related to the extent of the shunt, location of the lesion, size, patient’s age, and many other factors. [...]with the introduction of Onyx and the refinement of its use with ‘prolonged repetitive reflux and push technique’ that is, forming a plug with repetitive reflux followed by intranidal penetration which was, then, varified as the so-called ‘Pressure-Cooker technique’ to simulate the same effect, offered cure with only embolization in an increased percentage of overall patients (15–51%).5 11–13 Given the relative rarity and heterogeneity of the disease, the existing literature, including case series, original research, systematic reviews, and meta-analyses, could not put forward a standardized treatment algorithm. The results were echoed at the final follow-up with a mean duration of 50 months to further support the initial conclusion.15 Following ARUBA, the Treatment of Brain Arteriovenous Malformations Study (TOBAS) was designed as a pragmatic randomized trial and registry to investigate the benefits of preventive interventions compared with conservative management; that is, no intervention of any kind, whether they can offer the primary outcome of death or disabling stroke (modified Rankin Scale (mRS) score >2) at 10 years was reduced by 10% or more.16 When patients are not eligible for randomization, they are included in the registries to collect data on the particular management strategy, as indicated by the local clinical team.

Herein, we describe the use of a novel multiplug flow control technique for the curative transarterial embolisation of cerebrovascular malformations using liquid embolic agents (LEAs). The idea behind the use of this technique is to substantially control or arrest flow during LEA injection, with multiple plugs simultaneously formed from microcatheters that are placed within all or multiple feeders, so that the penetration of LEAs is facilitated, with flow control decreasing the washout of a malformation. This technique enables the complete occlusion of a vascular malformation in a shorter injection time than that in other methods because penetration is achieved faster. Details of this technique have been described in the treatment of two cases: one case of unruptured temporal arteriovenous malformation and in the other with a falcotentorial dural arteriovenous fistula, in which the vascular malformations were successfully occluded with transarterial embolisation.

Purpose Our aim was to determine the long-term safety and efficacy of the Flow Re-Direction Endoluminal Device (FRED) in this multicenter study with prospective design. Materials-method This study included 136 consecutive patients with 155 aneurysms treated between March 2013 and June 2016 in 10 centers. Twenty-two (16.2%) patients presented with rupture of the index aneurysm. Large/giant aneurysms comprised 1/3 of the cohort. Adjuvant coil use during the treatment was 15.5%. The effectiveness measure in the study was the percentage of aneurysms with stable occlusion at follow-up. Results Vascular imaging follow-up was performed at least once in 131/136 (96.3%) patients with 148/155 (95.5%) aneurysms up to 75 months (mean: 37.3 months; median: 36 months according to latest follow-up), and 102/155(65.8%) aneurysms in 90/136 (66.2%) patients had ≥ 24-month control. According to the latest controls, the overall stable occlusion rate was 91.9% (95% CI, 87.5 to 96.3%). Three out of 148 aneurysms with follow-up were retreated (2%, 95% CI 0.0 to 4.3%). Adverse events were noted in 19/136 (14%, 95% CI, 9 to 21%) patients with a morbidity of 1.5% (95% CI, 0.0 to 3.5%). Mortality was 1/136 (0.7%, 95% CI, 0.02 to 2.2%) and was unrelated to aneurysm treatment. In-stent stenosis (ISS) was detected in 10/131 of the patients with follow-up (7.6%, 95% CI; 3.1 to 12.2%), only one being symptomatic. No adverse events have occurred in any of the patients with follow-up after 24 months, except the one resulting from ISS. Conclusion In the treatment of cerebral aneurysms which were candidates for flow diversion technique, this study showed long-term efficacy of FRED with good safety and occlusion rates.

BackgroundMultiple studies and meta-analyses have described the technical and clinical outcomes in large cohorts of aneurysm patients treated with flow diverters (FDs). Variations in evaluation methodology complicate making comparisons among studies, hinder understanding of the device behavior, and pose an obstacle in the assessment of further advances in FD therapy.MethodsA multidisciplinary panel of neurointerventionalists, imaging experts, and neuroradiologists convened with the goal of establishing consensus recommendations for the standardization of image analyses in FD studies.ResultsA standardized methodology is proposed for evaluating and reporting radiological outcomes of FD treatment of intracranial aneurysms. The recommendations include general imaging considerations for clinical studies and evaluations of longitudinal changes, such as neointimal lining and stenosis. They cover standards for classification of aneurysm location, morphology, measurements, as well as the assessment of aneurysm occlusion, wall apposition, and neck coverage. These reporting standards further define four specific braid deformation patterns: foreshortening, fish-mouthing, braid bump deformation, and braid collapse, collectively termed ‘F2B2’.ConclusionsWhen widely applied, standardization of methods of measuring and reporting outcomes will help to harmonize the assessment of treatment outcomes in clinical studies, help facilitate communication of results among specialists, and help enable research and development to focus on specific aspects of FD techniques and technology.

BackgroundThe aim of this study was to evaluate the overall rates of braid changes associated with flow diverter (FD) treatment for intracranial aneurysms (IAs). Additionally, we sought to provide an overview of the currently reported definitions related to these complications.MethodsA systematic search was conducted from the inception of relevant literature up to April 2023, encompassing six databases. The included studies focused on patients with IAs treated with FDs. We considered four main outcome measures as FD braid changes: (1) fish-mouthing, (2) device braid narrowing, (3) device braid collapsing, and (4) device braid deformation. The data from these studies were pooled using a random-effects model.ResultsA total of 48 studies involving 3572 patients were included in the analysis. Among them, 14 studies (39%) provided definitions for fish-mouthing. However, none of the included studies offered specific definitions for device braid narrowing, collapsing, or deformation, despite reporting rates for these complications in six, five, and three studies, respectively. The pooled rates for braid changes were as follows: 3% (95% CI 2% to 4%, I2=27%) for fish-mouthing, 7% (95% CI 2% to 20%, I2=85%) for narrowing, 1% (95% CI 0% to 3%, I2=0%) for collapsing, and 1% (95% CI 1% to 4%, I2=0%) for deformation.ConclusionThe findings of this study suggest that FD treatment for IAs generally exhibits low rates of fish-mouthing, device braid narrowing, collapsing, and deformation. However, the lack of standardized definitions hinders the ability to compare device outcomes objectively, emphasizing the need for uniform definitions for FD braid changes in future prospective studies on FD.