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

Abstract

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.

Life over limb: Arterial access-related limb ischemic complications in 48-hour REBOA survivors

“…French have been approved and are coming to market in the United States, which may serve to limit the incidence of ARLIC moving forward. 14 Unstable pelvic injuries can be associated with life threatening arterial hemorrhage and exsanguination without urgent intervention. These injuries are frequently stabilized with pelvic binders followed by external fixation during the initial phases of resuscitation and support has been growing for the use of zone III REBOA in the setting of these injuries.…”

Balloons for kids: Anatomic candidacy and optimal catheter size for pediatric resuscitative endovascular balloon occlusion of the aorta

“…A 4-Fr REBOA device was recently FDA approved for use in adults and has demonstrated safe and rapid placement in the first in-human study of this device 11,22 . Although the 7-Fr and novel 4-Fr REBOA catheters are not yet FDA approved for use in children, these devices may serve as useful interventions in pediatric trauma patients with life-threatening noncompressible hemorrhage that is below the level of the diaphragm and amenable to aortic inflow occlusion.…”

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Non-Traumatic Cardiac Arrest: A Narrative Review of Known and Potential Physiological Effects

“…These risks are mitigated by the use of smaller catheters and consequently smaller sheaths [37,38], guidewire-free catheters, and atraumatic tips.…”