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

• Published in: The journal of trauma and acute care surgery Vol. 80; no. 6; pp. 907 - 914
• Main Authors: Sokol, Kyle K, Black, George E, Shawhan, Robert, Marko, Shannon T, Eckert, Matthew J, Tran, Nam T, Starnes, Benjamin W, Martin, Matthew J
• Format: Journal Article
• Language: English
• Published: United States 01-06-2016
• Subjects: Animals; Aorta - injuries; Balloon Occlusion - instrumentation; Disease Models, Animal; Hemodynamics; Hemorrhage - therapy; Pressure; Random Allocation; Resuscitation - methods; Survival Rate; Swine
• ISSN: 2163-0755; 2163-0763
• DOI: 10.1097/TA.0000000000001051

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as an alternative to gauze packing (GP) in the setting of noncompressible torso hemorrhage. 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 intra-aortic barotrauma and could increase survival in the setting of profound shock physiology.
Fourteen adult swine (35-50 kg) underwent a hemorrhage and ischemia/reperfusion injury protocol to produce shock physiology and dilutional coagulopathy and randomized to REBOA (n = 8) or standard GP (n = 6) groups. A complex contralateral groin soft tissue and vascular injury was then created, followed by 30 seconds of free bleeding and GP for 5 minutes. The REBOA group had the aortic balloon inflated in aortic Zone III until the pressure release valve opened, followed by 45-minute postpacking survival, after which native and balloon-exposed aortae were harvested for histologic analysis.
Control and REBOA groups had similar baseline hemodynamics (mean arterial pressure, 32 mm Hg vs. 43 mm Hg; p = 0.228), levels of coagulopathy (international normalized ratio, 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; base deficit, 9 vs. 5, p = 0.491). No histologic barotrauma was identified, and 88% of the REBOA devices were successfully deployed into the Zone III of the aorta. The REBOA group had significantly decreased hemorrhage volumes (0.5 L vs. 0.2 L, p = 0.014) and increased survival times (45 minutes vs. 8 minutes, p < 0.001).
This study reinforces results found in previous studies that REBOA is an effective method to increase survival in the setting of noncompressible torso hemorrhage and is the first to show that this specific REBOA device can be blindly guided into the appropriate zone of the aorta without generating aortic wall injury during unmeasured balloon inflation.