A Stopped Pilot Study of the ProGlide Closure Device After Transbrachial Endovascular Interventions.
J Endovasc Ther
; 26(5): 727-731, 2019 10.
Article
em En
| MEDLINE
| ID: mdl-31288644
ABSTRACT
Purpose:
To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials andMethods:
From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications.Results:
Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions:
surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped.Conclusion:
Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Artéria Braquial
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Cateterismo Periférico
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Técnicas Hemostáticas
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Procedimentos Endovasculares
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Dispositivos de Oclusão Vascular
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Hemorragia
Tipo de estudo:
Etiology_studies
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Observational_studies
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Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
J Endovasc Ther
Assunto da revista:
ANGIOLOGIA
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Holanda