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BACKGROUND: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy. METHODS: Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTM system compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI ≥ 2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24â h post-procedure. RESULTS: Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5%) were male. Median NIHSS score was 16 (IQR: 13-22). Median ASPECTS score was 9 (IQR: 8-10). The rate of mTICI ≥ 2c after first pass was 53.9% in ITT population (60.0% in per-protocol population) versus 38.5% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1% (22/36) in the RapidPulseTM arm and 52.8% (19/36) in the control arm. In the RapidPulseTM arm, no sICH within 24â h and no device-related morbidity or mortality occurred. CONCLUSION: Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.
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ABSTRACT Introduction: Although the 2019 severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV-2, COVID-19) pandemic poses new challenges to the healthcare system to provide support for thousands of patients, there is special concern about common medical emergencies, such as stroke, that will continue to occur and will require adequate treatment. The allocation of both material and human resources to fight the pandemic cannot overshadow the care for acute stroke, a time-sensitive emergency that with an inefficient treatment will further increase mortality and long-term disability. Objective: This paper summarizes the recommendations from the Scientific Department on Cerebrovascular Diseases of the Brazilian Academy of Neurology, the Brazilian Society of Cerebrovascular Diseases and the Brazilian Society of Neuroradiology for management of acute stroke and urgent neuro-interventional procedures during the COVID-19 pandemic, including proper use of screening tools, personal protective equipment (for patients and health professionals), and patient allocation.
RESUMO Introdução: A pandemia causada pelo novo coronavírus da síndrome respiratória aguda grave 2 (SARS-CoV-2, COVID-19) apresenta novos e importantes desafios à gestão de saúde no Brasil. Além da difícil missão de prestar atendimento aos milhares de pacientes infectados pelo COVID-19, os sistemas de saúde têm que manter a assistência às emergências médicas comuns em períodos sem pandemia, tais como o acidente vascular cerebral (AVC), que continuam ocorrendo e requerem tratamento com presteza e eficiência. A alocação de recursos materiais e humanos para o enfrentamento à pandemia não pode comprometer o atendimento ao AVC agudo, uma emergência cujo tratamento é tempo-dependente e se não realizado implica em importante impacto na mortalidade e incapacitação a longo prazo. Objetivo: Este trabalho resume as recomendações do Departamento Científico de Doenças Cerebrovasculares da Academia Brasileira de Neurologia, da Sociedade Brasileira de Doenças Cerebrovasculares e da Sociedade Brasileira de Neurorradiologia para o tratamento do AVC agudo e para a realização de procedimentos de neurointervenção urgentes durante a pandemia de COVID-19, incluindo o uso adequado de ferramentas de triagem e equipamentos de proteção pessoal (para pacientes e profissionais de saúde), além da alocação apropriada de pacientes.
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Humanos , Transmisión de Enfermedad Infecciosa de Profesional a Paciente/prevención & control , Infecciones por Coronavirus/prevención & control , Coronavirus , Manejo de la Enfermedad , Neurología/normas , Neumonía Viral/complicaciones , Neumonía Viral/prevención & control , Neumonía Viral/epidemiología , Sociedades Médicas , Brasil , Infecciones por Coronavirus , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/epidemiología , Accidente Cerebrovascular/terapia , Pandemias/prevención & control , BetacoronavirusRESUMEN
ABSTRACT Background: Malignant infarction of the middle cerebral artery (MCA) occurs in a subgroup of patients with ischemic stroke and early decompressive craniectomy (DC) is one of its treatments. Objective: To investigate the functional outcome of patients with malignant ischemic stroke treated with decompressive craniectomy at a neurological emergency center in Northeastern Brazil. Methods: Prospective cohort study, in which 25 patients were divided into two groups: those undergoing surgical treatment with DC and those who continued to receive standard conservative treatment (CT). Functionality was assessed using the modified Rankin Scale (mRS), at follow-up after six months. Results: A favorable outcome (mRS≤3) was observed in 37.5% of the DC patients and 29.4% of CT patients (p=0.42). Fewer patients who underwent surgical treatment died (25%), compared to those treated conservatively (52.8%); however, with no statistical significance. Nonetheless, the proportion of patients with moderate to severe disability (mRS 4‒5) was higher in the surgical group (37.5%) than in the non-surgical group (17.7%). Conclusion: In absolute values, superiority in the effectiveness of DC over CT was perceived, showing that the reduction in mortality was at the expense of increased disability.
RESUMO Introdução: O infarto maligno da artéria cerebral média (ACM) ocorre em um subgrupo de pacientes com acidente vascular cerebral (AVC) isquêmico e a craniectomia descompressiva (CD) precoce é um de seus tratamentos. Objetivo: Investigar o desfecho funcional de pacientes com acidente vascular cerebral isquêmico maligno submetidos à craniectomia descompressiva em um centro de emergência neurológica do nordeste do Brasil. Métodos: Nesta coorte prospectiva, os pacientes foram divididos em dois grupos: aqueles submetidos a tratamento cirúrgico com craniectomia descompressiva (CD) e aqueles que mantiveram tratamento conservador (TC) padrão. A funcionalidade foi avaliada por meio da Escala de Rankin modificada (ERm) ao final de seis meses de seguimento. Resultados: Evidenciou-se desfecho favorável (ERm≤3) em 37,5% dos pacientes craniectomizados e em 29,4% dos pacientes não craniectomizados (p=0,42). A mortalidade foi menor no grupo de pacientes que se submeteram a tratamento cirúrgico (25%) do que entre aqueles tratados conservadoramente (52,8%), porém sem significância estatística. Por outro lado, a proporção de pacientes com incapacidade moderada a grave (ERm 4‒5) foi maior no grupo cirúrgico (37,5%) do que no grupo não cirúrgico (17,7%). Conclusão: Em valores absolutos, percebeu-se superioridade na eficácia do tratamento cirúrgico sobre o conservador, mostrando que a redução de mortalidade se dá à custa de aumento da incapacidade funcional.
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Humanos , Accidente Cerebrovascular/cirugía , Craniectomía Descompresiva , Brasil , Estudios Prospectivos , Resultado del Tratamiento , Infarto de la Arteria Cerebral Media/cirugía , Infarto de la Arteria Cerebral Media/diagnóstico por imagenRESUMEN
These guidelines are the result of a joint effort from writing groups of the Brazilian Stroke Society, the Scientific Department of Cerebrovascular Diseases of the Brazilian Academy of Neurology, the Brazilian Stroke Network and the Brazilian Society of Diagnostic and Therapeutic Neuroradiology. Members from these groups participated in web-based discussion forums with predefined themes, followed by videoconference meetings in which controversies and position statements were discussed, leading to a consensus. This guidelines focuses on the implications of the recent clinical trials on endovascular therapy for acute ischemic stroke due to proximal arterial occlusions, and the final text aims to guide health care providers, health care managers and public health authorities in managing patients with this condition in Brazil.
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Isquemia Encefálica/terapia , Procedimientos Endovasculares/normas , Fibrinolíticos/administración & dosificación , Accidente Cerebrovascular/terapia , Brasil , HumanosRESUMEN
ABSTRACT These guidelines are the result of a joint effort from writing groups of the Brazilian Stroke Society, the Scientific Department of Cerebrovascular Diseases of the Brazilian Academy of Neurology, the Brazilian Stroke Network and the Brazilian Society of Diagnostic and Therapeutic Neuroradiology. Members from these groups participated in web-based discussion forums with predefined themes, followed by videoconference meetings in which controversies and position statements were discussed, leading to a consensus. This guidelines focuses on the implications of the recent clinical trials on endovascular therapy for acute ischemic stroke due to proximal arterial occlusions, and the final text aims to guide health care providers, health care managers and public health authorities in managing patients with this condition in Brazil.
RESUMO Estas diretrizes são o resultado de um esforço conjunto de membros da Sociedade Brasileira de Doenças Cerebrovasculares (SBDCV), Departamento científico de Doenças Cerebrovasculares da Academia Brasileira de Neurologia (ABN), Rede Brasil AVC (RBAVC) e da Sociedade Brasileira de Neurorradiologia Diagnóstica e Terapêutica (SBNR). Membros destas 4 entidades participaram de fórum de discussões por internet de temas pré-definidos, seguidos de encontros de videoconferência para discussão de pontos controversos e das recomendações, em busca de um consenso final. Estas diretrizes tem seu foco sobre as implicações dos recentes ensaios clínicos de tratamento endovascular do acidente vascular cerebral (AVC) isquêmico agudo relacionado a oclusão de artérias proximais. O texto final foi elaborado para servir de orientação no manejo destes pacientes AVC isquêmico pelos diferentes profissionais de saúde, gestores de saúde pública e de saúde complementar no Brasil.