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

• Published in: Trauma surgery & acute care open Vol. 6; no. 1; p. e000617
• Main Authors: Power, Adam, Parekh, Asha, Scallan, Oonagh, Smith, Shane, Novick, Teresa, Parry, Neil, Moore, Laura
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd 01-01-2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Arterial lines; Blood & organ donations; COBRA-OS; Consent; Coronary vessels; Feasibility studies; Hemorrhage; organ donor; Original Research; Ostomy; Patients; REBOA; Trauma; Veins & arteries; Ontario Canada; Canada; COBRA-OS; trauma; organ donor; REBOA
• ISSN: 2397-5776; 2397-5776
• DOI: 10.1136/tsaco-2020-000617

BackgroundResuscitative 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).MethodsThis 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.ResultsA 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.DiscussionThe 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 evidenceLevel V, therapeutic.