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Catheter Cardiovasc Interv ; 97(6): 1270-1278, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33347739

RESUMO

OBJECTIVES: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. BACKGROUND: The MANTA is a novel plug-based device for large bore arteriotomy closure. METHODS: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. RESULTS: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. CONCLUSION: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.


Assuntos
Aneurisma da Aorta Abdominal , Estenose da Valva Aórtica , Implante de Prótese Vascular , Cateterismo Periférico , Procedimentos Endovasculares , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Cateterismo Periférico/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Hemorragia/etiologia , Técnicas Hemostáticas/efeitos adversos , Humanos , Sistema de Registros , Resultado do Tratamento
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