Efficacy of a novel fluoroscopy-free endovascular balloon device with pressure release capabilities in the setting of uncontrolled junctional hemorrhage.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as an alternative to gauze packing (GP) in the setting of non-compressible torso hemorrhage (NCTH). Our objective was to describe placement and physiologic impact of a novel REBOA device during uncontrolled junctional hemorrhage. We hypothesized that REBOA could be deployed without fluoroscopic guidance or intraaortic barotrauma, and increase survival in the setting of profound shock physiology. METHODS: Fourteen adult swine (35-50kg) underwent a hemorrhage and ischemia/reperfusion injury protocol to produce shock physiology and dilutional coagulopathy and randomized to REBOA (N=8) vs standard gauze packing (GP) (N=6) groups. A complex contralateral groin soft tissue and vascular injury was then created, followed by 30 sec of free bleeding and gauze packing for 5 min. REBOA group had the aortic balloon inflated in aortic zone III until the pressure release valve opened followed by 45 minutes post-packing survival, after which native and balloon-exposed aortae were harvested for histologic analysis. RESULTS: Control and REBOA groups had similar baseline hemodynamics (MAP 32 vs 43 mmHg, p=0.228) levels of coagulopathy (INR 1.3 vs 1.2, p=0.476; fibrinogen 108 vs 135 mg/dl, p=0.747) and hemorrhage/ischemia/reperfusion insult (lactate 7 vs 7, p=0.950 ; BD 9 vs 5, p=0.491). No histologic barotrauma was identified and 88% of REBOA devices were successfully deployed into zone III of the aorta. REBOA group had significantly decreased hemorrhage volumes (0.5 vs 0.2 L, p=0.014) and increased survival times (45 vs 8 min, p

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