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BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.
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Embolização Terapêutica , Aneurisma Intracraniano , Idoso , Angiografia Cerebral , Feminino , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Stents , Resultado do TratamentoRESUMO
BACKGROUND: Prior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate. OBJECTIVE: This WOVEN study assesses the 1-year follow-up from this cohort. METHODS: Twelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis. RESULTS: In the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up. CONCLUSIONS: The WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.
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Arteriosclerose Intracraniana/terapia , Doenças do Sistema Nervoso/etiologia , Stents/tendências , Acidente Vascular Cerebral/terapia , Idoso , Estudos de Coortes , Constrição Patológica/diagnóstico por imagem , Constrição Patológica/etiologia , Constrição Patológica/mortalidade , Feminino , Seguimentos , Humanos , Arteriosclerose Intracraniana/diagnóstico por imagem , Arteriosclerose Intracraniana/mortalidade , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Doenças do Sistema Nervoso/diagnóstico por imagem , Doenças do Sistema Nervoso/mortalidade , Stents/efeitos adversos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/mortalidade , Resultado do TratamentoRESUMO
UNLABELLED: OBJECT.: Endovascular coiling and surgical clipping are viable treatment options of cerebral aneurysms. Outcome data of these treatments in children are limited. The objective of this study was to determine hospital mortality and complication rates associated with surgical clipping and coil embolization of cerebral aneurysms in children, and to evaluate the trend of hospitals' use of these treatments. METHODS: The authors identified a cohort of children admitted with the diagnoses of cerebral aneurysms and aneurysmal subarachnoid hemorrhage from the Kids' Inpatient Database for the years 1998 through 2009. Hospital-associated complications and in-hospital mortality were compared between the treatment groups and stratified by aneurysmal rupture status. A multivariate regression analysis was used to identify independent variables associated with in-hospital mortality. The Cochrane-Armitage test was used to assess the trend of hospital use of these operations. RESULTS: A total of 1120 children were included in this analysis; 200 (18%) underwent aneurysmal clipping and 920 (82%) underwent endovascular coiling. Overall in-hospital mortality was higher in the surgical clipping group compared with the coil embolization group (6.09% vs 1.65%, respectively; adjusted odds ratio [OR] 2.52, 95% CI 0.97-6.53, p = 0.05). The risk of postoperative stroke or hemorrhage was similar between the two treatment groups (p = 0.86). Pulmonary complications and systemic infection were higher in the surgical clipping population (p < 0.05). The rate of US hospitals' use of endovascular coiling has significantly increased over the years included in this study (p < 0.0001). Teaching hospitals were associated with a lower risk of death (OR 0.13, 95% CI 0.03-0.46; p = 0.001). CONCLUSIONS: Although both treatments are valid, endovascular coiling was associated with fewer deaths and shorter hospital stays than clip placement. The trend of hospitals' use of coiling operations has increased in recent years.
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Embolização Terapêutica , Mortalidade Hospitalar , Aneurisma Intracraniano/mortalidade , Aneurisma Intracraniano/terapia , Procedimentos Neurocirúrgicos , Hemorragia Subaracnóidea/mortalidade , Hemorragia Subaracnóidea/terapia , Procedimentos Cirúrgicos Vasculares , Adolescente , Criança , Estudos de Coortes , Bases de Dados Factuais , Embolização Terapêutica/instrumentação , Embolização Terapêutica/mortalidade , Feminino , Humanos , Pacientes Internados , Aneurisma Intracraniano/cirurgia , Tempo de Internação , Modelos Logísticos , Masculino , Análise Multivariada , Procedimentos Neurocirúrgicos/instrumentação , Procedimentos Neurocirúrgicos/mortalidade , Razão de Chances , Hemorragia Subaracnóidea/cirurgia , Resultado do Tratamento , Estados Unidos/epidemiologia , Procedimentos Cirúrgicos Vasculares/instrumentação , Procedimentos Cirúrgicos Vasculares/mortalidadeRESUMO
Traumatic injuries of the carotid artery may result in severe morbidity and mortality. The most common location of carotid artery injury is the cavernous segment, which may result in fistulous connection to the cavernous sinus and ophthalmic veins, which in turn lead to pressure symptoms in the ipsilateral orbit. Unlike the commonly reported direct traumatic carotid-cavernous fistula, we describe an unusual case of a 38-year-old man presented with a traumatic brain injury led to a fistula connection between the cavernous carotid artery and the ipsilateral basal vein of Rosenthal, with eventual drainage to the straight and transverse sinuses. The basal vein of Rosenthal is usually formed from confluence of anterior and middle cerebral veins deep in the Sylvian fissure and drain the insular cortex and the cerebral peduncles to the vein of Galen. Immediate endovascular deployment of a covered stent in the cavernous carotid artery allowed sealing the laceration site. Three months follow up showed a non-focal neurological examination and healed carotid laceration over the covered stent.
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BACKGROUND: Glycoprotein IIB/IIIA inhibitors are occasionally utilized during carotid artery stenting (CAS) in the presence or absence of a visualized intra-operative thrombus. OBJECTIVE: We assess the hemorrhagic and clinical outcomes associated with the use of eptifibatide during CAS. METHODS: A retrospective analysis of prospectively collected data on patients with the diagnosis of carotid artery stenosis underwent CAS in a single center. We identified those who received intravenous eptifibatide intra-operatively and compared to the rest of the cohort. Hemorrhagic outcomes included intracerebral hemorrhage (ICH) or groin hematoma that occurred during the hospital stay. RESULTS: In this analysis, 81 patients had CAS during a 3-year span; 16 of those had received 15 mg of intravenous eptifibatide intra-operatively. The mean age of the treated and untreated patients was similar (65.6 ± 13.4 versus 65.4 ± 10.2; P = 0.13). One patient (1.2%) in this series had ICH in the perioperative period that occurred in the non-eptifibatide group. Five patients (6.2%) in this series had groin hematoma; only one in the non-eptifibatide group required surgical repair. No mortality was reported and clinical outcomes including discharge modified Rankin scale, NIH stroke scale, as well as discharge destination were similar in both groups. A stratified analysis among those who underwent an urgent CAS showed no significant differences in the risks of hemorrhages or any clinical outcome (P > 0.05). CONCLUSION: The use of eptifibatide during CAS is safe. The risk of any hemorrhagic complication is rare in this series; however, a prospective study to validate this observation will be helpful.
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BACKGROUND AND PURPOSE: The purpose of this study was to evaluate the mortality rates associated with cerebral venous-sinus thrombosis in a large national sample. METHODS: A cohort of patients with cerebral venous-sinus thrombosis was identified from the National Inpatient Sample database for the years 2000 to 2007. According to the International Classification of Diseases, 9th Revision, Clinical Modification codes, cerebral venous-sinus thrombosis is categorized into pyogenic and nonpyogenic groups. Multivariate logistic regression analysis was used to assess covariates associated with hospital mortality. RESULTS: Among 3488 patients, the overall mortality rate was 4.39%, which was nonsignificantly higher among the pyogenic group (4.55% versus 3.52%; OR, 0.76; 95% CI, 0.47-1.23). In the pyogenic cerebral venous-sinus thrombosis group, hematologic disorders were the most frequent predisposing condition (16.2%); whereas systemic malignancy followed by hematologic disorders were most common in the nonpyogenic group (14.08% and 10.04%, respectively). Predictors of mortality included age, intracerebral hemorrhage as well as the predisposing conditions of hematologic disorders, systemic malignancy, and central nervous system infection. CONCLUSIONS: Compared with arterial stroke, CVST harbors a relatively low mortality rate. Death is determined by age, the presence of intracerebral hemorrhage, and certain predisposing conditions.
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Trombose dos Seios Intracranianos/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida , Estados Unidos/epidemiologiaRESUMO
BACKGROUND AND PURPOSE: Methods to increase recruitment into acute stroke trials are needed. The purposes of this study were to evaluate the safety and acceptability of initiating acute stroke trials during early helicopter evacuation and to test an intervention to facilitate informed consent. METHODS: A randomized, controlled trial was done with patients with acute stroke who were transferred by helicopter to the University of Iowa Hospitals and Clinics from February 2007 to January 2008. The intervention to be evaluated was the use of fax and a telephone call to the patient/surrogate ahead of helicopter arrival at the outside emergency department. The aim was to improve the rate of subsequent consent (primary outcome) for a pilot trial of a potentially beneficial, low-risk medical intervention (ranitidine) to prevent aspiration pneumonitis. Consenting eligible patients received the infusion during the flight to University of Iowa Hospitals and Clinics. RESULTS: One hundred patients were enrolled. Consent rate was 54% in the intervention group and 50% in the control group (P=0.69). However, the consent rate was higher (69%) when prearrival communications between the coinvestigator and potential subjects were successful (P=0.04). This approach resulted in an average gain of 59 minutes as compared with initiating recruitment on arrival to University of Iowa Hospitals and Clinics. CONCLUSIONS: Enrollment into stroke intervention trials is feasible during helicopter transportation from a community hospital emergency department to a tertiary stroke center. This underused resource may improve trial efficiency by enabling and expediting participation of remote populations currently excluded from research. Consent rates might be further improved by communication strategies that are more successful in reaching patients at outside emergency departments.
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Resgate Aéreo , Acidente Vascular Cerebral/terapia , Doença Aguda , Antiácidos/uso terapêutico , Comunicação , Serviços Médicos de Emergência , Antagonistas dos Receptores H2 da Histamina/efeitos adversos , Antagonistas dos Receptores H2 da Histamina/uso terapêutico , Humanos , Consentimento Livre e Esclarecido , Iowa , Projetos Piloto , Pneumonia Aspirativa/prevenção & controle , Ranitidina/efeitos adversos , Ranitidina/uso terapêutico , Projetos de Pesquisa , Resultado do TratamentoRESUMO
Overall management to lower risk for ischemic stroke is multifaceted. Management includes measures to treat risk factors for accelerated atherosclerosis and stroke, antithrombotic therapies to lower the risk for thromboembolism, and surgery to treat a defined arterial or cardiac lesion. Treatment decisions are made on a case-by-case basis, with most patients receiving some combination of medication and recommendations for lifestyle modification. Some patients will also undergo surgical or endovascular interventions. This article discusses antithrombotic treatment for ischemic stroke prevention, placing major emphasis on the indications for and administration of antiplatelet therapy.
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Isquemia Encefálica/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Isquemia Encefálica/complicações , Humanos , Acidente Vascular Cerebral/etiologiaRESUMO
The 25% of Americans living in rural areas receive suboptimal stroke care. To eliminate the current disparity in rural acute stroke care, we need a comprehensive plan of education and increased resources targeting all levels of the paradigm. This plan includes improving recognition of stroke in rural areas, rural prehospital emergency services, emergency room care in small hospitals, remote support from tertiary stroke centers, and expeditious interhospital transfer with adequate communication and transfer of data between all the stakeholders. Because stroke trials are generally conducted by expert vascular neurologists working in large urban academic centers, physicians in small rural hospitals cannot be expected to immediately embrace future stroke therapies that were not tested in their system of care. The methodology of stroke trials needs to be adapted to allow the inclusion of a proportional number of patients treated in small, rural hospitals in order to improve fairness and adequately generalize future stroke therapies to large, underserved areas.