Size matters: first-in-human study of a novel 4 French REBOA device

Background Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the f...

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Autores principales:	Neil Parry, Laura Moore, Adam Power, Asha Parekh, Oonagh Scallan, Shane Smith, Teresa Novick
Formato:	article
Lenguaje:	EN
Publicado:	BMJ Publishing Group 2021
Materias:	Surgery RD1-811 Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
Acceso en línea:	https://doaj.org/article/a248bd54eca0494c88583132a993310a
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spelling	oai:doaj.org-article:a248bd54eca0494c88583132a993310a2021-11-11T10:00:08ZSize matters: first-in-human study of a novel 4 French REBOA device10.1136/tsaco-2020-0006172397-5776https://doaj.org/article/a248bd54eca0494c88583132a993310a2021-11-01T00:00:00Zhttps://tsaco.bmj.com/content/6/1/e000617.fullhttps://doaj.org/toc/2397-5776Background Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the feasibility of a novel 4 French REBOA device called the COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System).Methods This study is the first-in-human feasibility trial of the COBRA-OS. Due to the difficulty of trialing the device in the trauma setting, we performed a feasibility study using organ donors (due to the potential usefulness of the COBRA-OS for normothermic regional perfusion) after neurological determination of death (NDD) prior to organ retrieval. Bilateral 4 French introducer sheaths were placed in both femoral arteries and the COBRA-OS was advanced up the right side and deployed in the thoracic aorta (Zone 1). Once aortic occlusion was confirmed via the left-sided arterial line, the device was deflated, moved to the infrarenal aorta (Zone 3), and redeployed.Results A total of 7 NDD organ donors were entered into the study, 71% men, with a mean age 46.6 years (range 26 to 64). The COBRA-OS was able to occlude the aorta in Zones 1 and 3 in all patients. The mean time of placing a 4 French sheath was 47.7 seconds (n=13, range 28 to 66 seconds). The mean time from skin to Zone 1 aortic occlusion was 70.1 seconds (range 58 to 105 seconds); mean balloon volumes were 15 mL for Zone 1 (range 13 to 20 mL) and 9 mL for Zone 3 (range 6 to 15 mL); there were no complications and visual inspection of the aorta in all patients revealed no injury.Discussion The COBRA-OS is a novel 4 French REBOA device that has demonstrated fast and safe aortic occlusion in this first-in-human feasibility study.Level of evidence Level V, therapeutic.Neil ParryLaura MooreAdam PowerAsha ParekhOonagh ScallanShane SmithTeresa NovickBMJ Publishing GrouparticleSurgeryRD1-811Medical emergencies. Critical care. Intensive care. First aidRC86-88.9ENTrauma Surgery & Acute Care Open, Vol 6, Iss 1 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Surgery RD1-811 Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
spellingShingle	Surgery RD1-811 Medical emergencies. Critical care. Intensive care. First aid RC86-88.9 Neil Parry Laura Moore Adam Power Asha Parekh Oonagh Scallan Shane Smith Teresa Novick Size matters: first-in-human study of a novel 4 French REBOA device
description	Background Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the feasibility of a novel 4 French REBOA device called the COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System).Methods This study is the first-in-human feasibility trial of the COBRA-OS. Due to the difficulty of trialing the device in the trauma setting, we performed a feasibility study using organ donors (due to the potential usefulness of the COBRA-OS for normothermic regional perfusion) after neurological determination of death (NDD) prior to organ retrieval. Bilateral 4 French introducer sheaths were placed in both femoral arteries and the COBRA-OS was advanced up the right side and deployed in the thoracic aorta (Zone 1). Once aortic occlusion was confirmed via the left-sided arterial line, the device was deflated, moved to the infrarenal aorta (Zone 3), and redeployed.Results A total of 7 NDD organ donors were entered into the study, 71% men, with a mean age 46.6 years (range 26 to 64). The COBRA-OS was able to occlude the aorta in Zones 1 and 3 in all patients. The mean time of placing a 4 French sheath was 47.7 seconds (n=13, range 28 to 66 seconds). The mean time from skin to Zone 1 aortic occlusion was 70.1 seconds (range 58 to 105 seconds); mean balloon volumes were 15 mL for Zone 1 (range 13 to 20 mL) and 9 mL for Zone 3 (range 6 to 15 mL); there were no complications and visual inspection of the aorta in all patients revealed no injury.Discussion The COBRA-OS is a novel 4 French REBOA device that has demonstrated fast and safe aortic occlusion in this first-in-human feasibility study.Level of evidence Level V, therapeutic.
format	article
author	Neil Parry Laura Moore Adam Power Asha Parekh Oonagh Scallan Shane Smith Teresa Novick
author_facet	Neil Parry Laura Moore Adam Power Asha Parekh Oonagh Scallan Shane Smith Teresa Novick
author_sort	Neil Parry
title	Size matters: first-in-human study of a novel 4 French REBOA device
title_short	Size matters: first-in-human study of a novel 4 French REBOA device
title_full	Size matters: first-in-human study of a novel 4 French REBOA device
title_fullStr	Size matters: first-in-human study of a novel 4 French REBOA device
title_full_unstemmed	Size matters: first-in-human study of a novel 4 French REBOA device
title_sort	size matters: first-in-human study of a novel 4 french reboa device
publisher	BMJ Publishing Group
publishDate	2021
url	https://doaj.org/article/a248bd54eca0494c88583132a993310a
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Size matters: first-in-human study of a novel 4 French REBOA device

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