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PURPOSE: Intracranial arteriovenous-malformation (AVM) is a relatively rare condition in pediatrics, yet is a major cause of spontaneous intracranial hemorrhage with a risk of fatal hemorrhage reported to be between 4 and 29%. Little is known about vessel morphology and optimum treatment modalities including multimodality combination therapy and prognosis in children. METHODS: A retrospective review of all children presenting to our institution from 2006 to 2020 that had an AVM was undertaken. RESULTS: A total of 50 children were identified with median age of 11 (range 1-16) years. The mean follow-up was 7.6 years. Forty-one children presented as an emergency and of those, 40 had hemorrhage identified on initial brain imaging. The average nidus size was 25 mm, drainage was superficial in 51% of cases, and located in eloquent cortex in 56%. The supplemental Spetzler-Martin grading indicated 78% (39/50) were grade 4 and above (moderate to high risk). Primary treatment modalities included embolization in 50% (25) or SRS in 30% (15) and surgery in 20% (10).The AVM was obliterated on follow-up DSA in 66% children. Three children had post-treatment hemorrhage, two related to embolization and one the day following SRS, giving a re-bleed rate of 6%. The GOSE was available for 32 children at long term follow and 94% had a good outcome (GOSE 5-8). Two children died due to acute hemorrhage (4%). CONCLUSION: The majority of children with AVM present with hemorrhage. The rebleed rate during definitive treatment is low at 6% over the study period. The selective use of the 3 modalities of treatment has significantly reduced mortality and severe disability.
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Malformações Arteriovenosas Intracranianas , Radiocirurgia , Humanos , Criança , Lactente , Pré-Escolar , Adolescente , Resultado do Tratamento , Radiocirurgia/métodos , Malformações Arteriovenosas Intracranianas/complicações , Malformações Arteriovenosas Intracranianas/diagnóstico por imagem , Malformações Arteriovenosas Intracranianas/terapia , Prognóstico , Estudos Retrospectivos , Hemorragias Intracranianas/cirurgia , SeguimentosRESUMO
BACKGROUND: The impact on clinical outcomes of patient selection using perfusion imaging for endovascular thrombectomy (EVT) in patients with acute ischemic stroke presenting beyond 6 hours from onset remains undetermined in routine clinical practice. METHODS: Patients from a national stroke registry that underwent EVT selected with or without perfusion imaging (noncontrast computed tomography/computed tomography angiography) in the early (<6 hours) and late (6-24 hours) time windows, between October 2015 and March 2020, were compared. The primary outcome was the ordinal shift in the modified Rankin Scale score at hospital discharge. Other outcomes included functional independence (modified Rankin Scale score ≤2) and in-hospital mortality, symptomatic intracerebral hemorrhage, successful reperfusion (Thrombolysis in Cerebral Infarction score 2b-3), early neurological deterioration, futile recanalization (modified Rankin Scale score 4-6 despite successful reperfusion) and procedural time metrics. Multivariable analyses were performed, adjusted for age, sex, baseline stroke severity, prestroke disability, intravenous thrombolysis, mode of anesthesia (Model 1) and including EVT technique, balloon guide catheter, and center (Model 2). RESULTS: We included 4249 patients, 3203 in the early window (593 with perfusion versus 2610 without perfusion) and 1046 in the late window (378 with perfusion versus 668 without perfusion). Within the late window, patients with perfusion imaging had a shift towards better functional outcome at discharge compared with those without perfusion imaging (adjusted common odds ratio [OR], 1.45 [95% CI, 1.16-1.83]; P=0.001). There was no significant difference in functional independence (29.3% with perfusion versus 24.8% without; P=0.210) or in the safety outcome measures of symptomatic intracerebral hemorrhage (P=0.53) and in-hospital mortality (10.6% with perfusion versus 14.3% without; P=0.053). In the early time window, patients with perfusion imaging had significantly improved odds of functional outcome (adjusted common OR, 1.51 [95% CI, 1.28-1.78]; P=0.0001) and functional independence (41.6% versus 33.6%, adjusted OR, 1.31 [95% CI, 1.08-1.59]; P=0.006). Perfusion imaging was associated with lower odds of futile recanalization in both time windows (late: adjusted OR, 0.70 [95% CI, 0.50-0.97]; P=0.034; early: adjusted OR, 0.80 [95% CI, 0.65-0.99]; P=0.047). CONCLUSIONS: In this real-world study, acquisition of perfusion imaging for EVT was associated with improvement in functional disability in the early and late time windows compared with nonperfusion neuroimaging. These indirect comparisons should be interpreted with caution while awaiting confirmatory data from prospective randomized trials.
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Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/cirurgia , Hemorragia Cerebral , Procedimentos Endovasculares/métodos , Humanos , Imagem de Perfusão , Estudos Prospectivos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Resultado do TratamentoRESUMO
INTRODUCTION: Paediatric intracranial aneurysms are rare, with a differing natural history and thought to account for only up to 7% of all intracranial aneurysms. There is much uncertainty that surrounds the prevalence of unruptured intracranial aneurysms and it is estimated to be anywhere between 2 and 90 per 1000. This is the largest British single-centre analysis of paediatric intracranial aneurysms. We present the patient course from their initial presentations to the outcome of treatment and evaluate a serial assessment of adequacy of aneurysmal obliteration radiologically. RESULTS: Twenty-two paediatric cases were identified that required treatment. The median age of presentation was 11.3 years (mean 9.9, range 0 to 15.9), 68% (15/22) were male and 77% (17/22) were ruptured on presentation. The majority of aneurysms were located at the anterior circulation (77% (17/22)). The overall median aneurysm size (n = 21) was 7.4 mm (mean 5 mm, range 2.5-19 mm). Twenty patients survived the acute phase and 80% (16/20) underwent coil embolisation and the other patients' surgical clipping. The overall outcomes were available for the 20 patients; on discharge, 90% (18/20) had a favourable clinical outcome (GOS score of 3-5). Treatment-specific clinical favourable outcomes were 88% (14/16) for coil embolisation against 100% (4/4) after surgical clipping. Of the two patients that died in the acute phase, one had sickle cell anaemia. Aneurysm aetiology was unknown in all other cases. None of the patients had a family history of aneurysms. CONCLUSION: Paediatric intracranial aneurysms while rare should be considered a differential diagnosis of children presenting with unexplained loss of consciousness with or without focal neurological deficit and/or headache. There is a two to one preponderance for males with a larger proportion of aneurysms within the posterior circulation (25%). Coil embolisation is the preferred method of securing a paediatric intracranial aneurysm.
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Aneurisma Roto/diagnóstico , Aneurisma Roto/cirurgia , Embolização Terapêutica/métodos , Aneurisma Intracraniano/diagnóstico , Aneurisma Intracraniano/cirurgia , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Procedimentos Neurocirúrgicos/métodos , Estudos Retrospectivos , Instrumentos Cirúrgicos , Resultado do TratamentoRESUMO
BACKGROUND: The Woven EndoBridge (WEB) device (MicroVention, Tustin, CA, USA) has an excellent safety profile. While major complications such as device malposition and migration are rare, they can have serious consequences if not addressed promptly. Our case series describes the safety and efficacy of Amplatz goose neck microsnare device (Medtronic in Irvine, CA, USA) in endovascular retrieval of a detached WEB device. METHODS: We retrospectively reviewed six consecutive patients who underwent endovascular WEB retrieval using Amplatz microsnare device between March 2012 and December 2022. RESULTS: All six WEB devices were successfully retrieved either directly from the aneurysm sac due to device malpositioning or from a distal branch following device migration. None of the patients experienced intra-operative aneurysm perforation, arterial dissection, or vasospasm attributable to the process of WEB extraction. Five out of six patients (83.3%) had a good functional outcome (mRS 0-1) upon discharge from the hospital and at 24 months. CONCLUSION: Our experience suggests that detached WEB devices can be safely retrieved using an Amplatz microsnare. Apart from addressing device migration, direct removal of an undersized or malpositioned WEB from the aneurysm sac appears to be a safe option that can be considered when all other rescue techniques have been exhausted.
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BACKGROUND AND PURPOSE: The Woven EndoBridge (WEB) system has established itself as a safe and effective option for managing wide-neck bifurcation aneurysms. Addressing aneurysms with a greater height than width using conventional WEB-sizing methods has proved ineffective due to the inherent configuration of the devices. To overcome this limitation, we propose an intuitive approach that involves swapping the width and height dimensions of the aneurysm to determine the appropriate WEB size. MATERIALS AND METHODS: A retrospective analysis was conducted on patients undergoing WEB embolization at a single neuroscience center from March 2013 to February 2023. RESULTS: Twenty-five eligible aneurysms were identified, with the height dimension exceeding the width by an average of 2.33 mm (ranging from 1.4 to 4.5 mm). Of these, 20 cases adhered to the recommended sizing technique, resulting in a 100% success rate of adequate occlusion (14/20 complete occlusion, 6/20 proximal recess filling). In contrast, the outcomes for the remaining 5 cases that did not follow the proposed sizing method were less favorable (P < .05). Among these, 4 cases treated with undersized WEBs showed neck remnants during follow-up, and 1 patient who received an oversized WEB required device replacement during the same procedure. CONCLUSIONS: The simple sizing method we proposed for treating taller-than-wide aneurysms has demonstrated promising results, allowing the WEB system to address twice the original size range of treatable aneurysms. Further research with a larger sample size is recommended.
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Embolização Terapêutica , Aneurisma Intracraniano , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Embolização Terapêutica/instrumentação , Embolização Terapêutica/métodos , Adulto , Resultado do Tratamento , Angiografia CerebralRESUMO
BACKGROUND: Intrasaccular devices have become increasingly popular in the treatment of cerebral aneurysms, particularly at the bifurcation. Here we evaluate the Contour Neurovascular System, an intrasaccular device for the endovascular treatment of cerebral aneurysms, in a multicenter cohort study, the largest to the best of our knowledge. METHODS: Consecutive patients with intracranial aneurysms treated with the Contour Neurovascular System between February 2017 and October 2022 at 10 European neurovascular centers were prospectively collected and retrospectively reviewed. Patient and aneurysm characteristics, procedural details, and angiographic and clinical outcomes were evaluated. RESULTS: During the study period, 279 aneurysms (median age of patients 60 years, IQR 52-68) were treated with Contour. In 83.2% of patients the device was placed electively, whereas the remaining patients were treated in the setting of acute subarachnoid hemorrhage. The most common locations were the middle cerebral artery (26.5%) followed by the anterior communicating region (26.2%). Median aneurysm dome and neck size were 5.2 mm (IQR 4.2-7) and 3.9 mm (IQR 3-5). Contour size 7 (39%) and 9 (25%) were most used. Thromboembolic and hemorrhagic complications occurred in 6.8% and 0.4% of aneurysms, respectively. Raymond-Roy 1 and 2 occlusions at last follow-up were achieved in 63.2% and 28.3%, respectively, resulting in adequate occlusion of 91.5% of aneurysms. CONCLUSION: This is the largest multicenter study reporting the outcome on the Contour Neurovascular System. At 1 year, the self-evaluated data on safety and efficacy are comparable to data of existing intrasaccular devices. Contour is a promising technology in the treatment of cerebral aneurysms.
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BACKGROUND: Multiple 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. METHODS: A 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. RESULTS: A 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'. CONCLUSIONS: When 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.
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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.
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Procedimentos Endovasculares , Aneurisma Intracraniano , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Resultado do Tratamento , Estudos Retrospectivos , Stents , Procedimentos Endovasculares/métodosRESUMO
BACKGROUND: The 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. METHODS: A 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. RESULTS: A 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. CONCLUSION: The 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.
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We report the case of a 58-year old man who presented with a 4 cm right acoustic neuroma. He underwent a translabyrinthine resection. Two years later he presented with multiple strokes and progressive generalised deterioration. A cerebral angiogram demonstrated an extensive right side cerebellar dural arteriovenous fistula with retrograde flow causing corticovenous reflux. The fistula was treated successfully endovascularly. There is only one published report of a dural arteriovenous fistula occurring following acoustic neuromas surgery. The pathogenesis and management of this unusual complication is discussed.
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Fístula Arteriovenosa/etiologia , Dura-Máter/irrigação sanguínea , Neuroma Acústico/cirurgia , Complicações Pós-Operatórias , Fístula Arteriovenosa/cirurgia , Angiografia Cerebral , Humanos , Masculino , Pessoa de Meia-Idade , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: The first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs. METHODS: The SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death. RESULTS: Of 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death. CONCLUSIONS: The findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02719522.
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Embolização Terapêutica/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Assistência Perioperatória/métodos , Vigilância de Produtos Comercializados/métodos , Adulto , Idoso , Prótese Vascular/tendências , Embolização Terapêutica/tendências , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória/tendências , Vigilância de Produtos Comercializados/tendências , Estudos Prospectivos , Retratamento/tendências , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/terapia , Fatores de Tempo , Resultado do TratamentoRESUMO
Wide-necked bifurcation aneurysms (WNBAs) make up 26-36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment.
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Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Stents Metálicos Autoexpansíveis , Embolização Terapêutica/instrumentação , Embolização Terapêutica/métodos , Feminino , Humanos , Masculino , Resultado do TratamentoRESUMO
Diabetes is one of the main health problems among Saharawi refugees living in Algerian camps, especially for women. As is known, diet plays an important role in the management of diabetes. However, the dietary habits of Saharawi diabetic women are unknown. Therefore, we investigated the dietary habits and established their relationship with the nutritional status and glycemic profile of such women. We recruited 65 Saharawi type II diabetic women taking orally glucose-lowering drugs only. Dietary habits were investigated using qualitative 24 h recall carried out over three non-consecutive days. Anthropometric measurements were taken and blood parameters were measured. About 80% of the women were overweight and about three out of four women had uncompensated diabetes and were insulin resistant. The Saharawi diet was found to mainly include cereals, oils, sugars, vegetables (especially onions, tomatoes, and carrots), tea, and meat. Principal component analysis identified two major dietary patterns, the first one "healthy" and the second one "unhealthy". Women in the higher tertile of adherence to the unhealthy dietary pattern had a higher homeostatic model assessment for insulin resistance (HOMA) index (b = 2.49; 95% CI: 0.41-4.57; p = 0.02) and circulating insulin (b = 4.52; 95% CI: 0.44-8.60; p = 0.03) than the women in the lowest tertile. Food policies should be oriented to improve the quality of diet of Saharawi diabetic women.
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Glicemia/análise , Diabetes Mellitus Tipo 2/diagnóstico , Comportamento Alimentar/etnologia , Resistência à Insulina/fisiologia , Refugiados/estatística & dados numéricos , Argélia , Estudos Transversais , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/etnologia , Diabetes Mellitus Tipo 2/prevenção & controle , Comportamento Alimentar/fisiologia , Feminino , Humanos , Itália , Pessoa de Meia-Idade , Política Nutricional , Estado Nutricional/etnologia , Estado Nutricional/fisiologia , Campos de Refugiados/normas , Campos de Refugiados/estatística & dados numéricosRESUMO
PURPOSE: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. RESULTS: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. CONCLUSIONS: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.
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Angiografia Cerebral/tendências , Embolização Terapêutica/instrumentação , Embolização Terapêutica/tendências , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Adulto , Idoso , Prótese Vascular/efeitos adversos , Prótese Vascular/tendências , Angiografia Cerebral/efeitos adversos , Embolização Terapêutica/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Retratamento/tendências , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND AND IMPORTANCE: Microguidewire entrapment and failure related to endovascular therapy is a rare complication with limited case reports available, most of which are from cardiac endovascular intervention. Migration of the microguidewire has been reported in coronary intervention with some resulting in severe complications, but there are no reported cases of spontaneous extrusion of wire fragment following a neurointerventional procedure. We report the first case of a microguidewire entrapment with subsequent fracture, followed by spontaneous extrusion of the wire fragment. CLINICAL PRESENTATION: A 40-yr-old woman was admitted for an elective flow-diversion stent treatment of an unruptured paraophthalamic aneurysm. Microguidewire entrapment occurred during an attempted balloon-aided dilatation of the partially opened stent. Careful attempts failed to retrieve the wire; hence, the decision was made to leave it behind. She presented to her family doctor 6 mo later with spontaneous extrusion of a 60-cm fragment of the retained wire, from her heel ipsilateral to the femoral puncture site. This had not resulted in any further vascular or non-vascular complications. CONCLUSION: Fracture with extrusion is a potential consequence of a retained microguidewires. While this is an extremely rare complication, it is important to alert clinicians and patient about the possibility of wire migration and extrusion. Early follow-up with clinical assessment, and targeted imaging should lead to identification of this occurrence.
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Embolização Terapêutica/efeitos adversos , Pé , Corpos Estranhos , Aneurisma Intracraniano/terapia , Stents , Adulto , Embolização Terapêutica/instrumentação , Feminino , HumanosRESUMO
OBJECTIVE The Woven Endobridge (WEB) device has been in clinical use for the treatment of brain aneurysms for the past 4 years. Observational studies to assess clinical outcome and related complications have been published. Clear evidence is required to better understand the safety profile of the WEB device. The authors here present a multicenter series that provides a detailed safety analysis focused on patient selection, procedural events, and technical issues of treated patients throughout the United Kingdom (UK). METHODS A nationwide password-protected database was set up to collect anonymous information across the UK (14 centers). Complications and clinical outcome were analyzed for the initial 109 patients (112 procedures). An independent root cause analysis classified the complications into groups (procedural, disease, device, ancillary device, and other). The modified Rankin Scale (mRS) was used as a marker of clinical outcome. RESULTS Each of the 109 patients had 1 aneurysm suitable for WEB treatment (109 aneurysms). Three patients had 2 procedures, making a total of 112 procedures performed. Eight procedures were abandoned because of access issues; 2 patients went on to have a successful procedure. All 109 patients had a preprocedure and discharge mRS scores recorded. One hundred patients had a recorded mRS score from a > 3-month follow-up. Deployment of the WEB device was successful in 103 (94.5%) of 109 patients and 104 (92.9%) of 112 procedures. One patient had 2 successful WEB procedures on separate occasions. Patients without a successfully implanted WEB device were included in the analysis. Selection analysis showed that the average patient age was 56.5 years among 34 men and 75 women. The percentage of incidental aneurysms was 58.7%, acute 16.5%, symptomatic 18.3%, and recurrent 6.4%. Further results analysis showed that 40 (36.7%) of 109 patients had recorded adverse events, including those unrelated to the WEB device. Events that could be related to the WEB device numbered 17 (15.6%) among the 109 patients. Two patients with device-related complications were symptomatic. Overall, 11 patients (10.1%) had persistent clinical sequelae. Thromboembolism was the most prevalent event, affecting 15.6% of the patients (17 of 109), and 6.4% of the patients (7 of 109) with a thromboembolism were symptomatic. Overall mortality before discharge was 0% and at the > 3-month follow-up was 5% (5 of 100 patients). Morbidity was defined as an mRS score increase to > 2. Overall morbidity at discharge was 1.8% (2 of 109) and at the > 3-month follow-up was 6% (6 of 100). No device-related morbidity or mortality was associated with this group. CONCLUSIONS The UK data show that the WEB device is safe for clinical use. Thromboembolic complication adds a risk that should be minimized with appropriate anticoagulation and correct sizing of the device. There is scope for further evaluation and standardization of an anticoagulation regimen for the WEB device.
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Aneurisma Intracraniano/cirurgia , Próteses e Implantes , Feminino , Seguimentos , Humanos , Aneurisma Intracraniano/mortalidade , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Complicações Pós-Operatórias/mortalidade , Dados Preliminares , Reino UnidoRESUMO
BACKGROUND AND PURPOSE: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1â year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes. RESULTS: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15â mm. Thirty-eight aneurysms (76%) were small (<10â mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period. CONCLUSIONS: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. CLINICAL TRIAL REGISTRATION: NCT02390037.
Assuntos
Embolização Terapêutica/métodos , Aneurisma Intracraniano/diagnóstico , Aneurisma Intracraniano/terapia , Assistência Perioperatória/métodos , Stents , Adulto , Idoso , Embolização Terapêutica/tendências , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória/tendências , Estudos Prospectivos , Resultado do TratamentoRESUMO
The WEB is an endovascular flow-disrupting device used in treating wide-necked intracranial aneurysms. Although the device is available in varying sizes, large aneurysms pose a challenge with the need for custom-made devices. We describe the use of coils as an adjunct to the WEB device in successfully treating large aneurysms in two patients, one with an acutely ruptured aneurysm. This novel technique of jailing a microcatheter, deploying the WEB and then coiling the aneurysm saves the need for intracranial stenting, thereby avoiding the need for antiplatelet therapy, which is of benefit in the setting of acute aneurysm rupture.
Assuntos
Cateterismo Periférico/métodos , Embolização Terapêutica/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Stents , Angiografia Digital , Feminino , Artéria Femoral/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Liquid embolic agents are the preferred embolic material in endovascular treatment of pial and brain arteriovenous malformations and dural arteriovenous fistulas (DAVFs). There is little choice available in interventional neuroradiology practice other than two of the most commonly used liquid embolic agents-n-butyl cyanoacrylate and the Onyx liquid embolic system (ev3 Neurovascular, Irvine, California, USA). PHIL (Precipitating Hydrophobic Injectable Liquid) (Microvention, Inc California, USA) is a new liquid embolic agent, CE marked and available for clinical use in Europe. OBJECTIVE: To present our preliminary experience using PHIL in treating cranial and spinal DAVFs. METHODS: Between September 2014 and January 2015, eight patients, with five cranial DAVFs and three spinal DAVFs were treated with PHIL as the sole embolic agent used with intent to cure. Clinical presentation, location of DAVF, Borden type, fluoroscopic time, radiation dose, procedural time, injecting microcatheter used, volume of PHIL injected, complications, immediate angiographic data, premorbid and discharge modified Rankin Scale score, and any neurologic deficits were included in the analysis. RESULTS: Seven patients were successfully treated with complete angiographic exclusion of the fistula in a single sitting. Treatment failed in one patient where only suboptimal microcatheter positioning could be achieved and PHIL failed to penetrate the fistula's nidus. Venous penetration was achieved in all other patients except one with a small fistula, but with adequate fistula penetration by the embolic material. No other technical complication or neurologic deterioration occurred in any of the patients. CONCLUSIONS: PHIL liquid embolic agent appears to be an excellent alternative embolic material with certain advantages compared with other available liquid embolic agents. Further studies are required to fully evaluate its safety and efficacy.