A novel REBOA system: prototype and proof of concept

Background: Lower torso hemorrhage is a significant cause of death from injuries in combat. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has been used to rescue patients successfully in the hospital setting, but its prehospital use is controversial. We designed a device that would be easy to use, safer in injured vessels, migration-resistant and amenable to a prehospital environment.
Methods: We designed a novel, balloon-led device using common commercial materials. Thin latex rubber was reassembled in cylindrical conformation aligned to the shape of the aorta and invaginated into vinyl tubing. The catheter is placed into the femoral vessel, followed by expression of the balloon with CO2 inflation in a proximal direction to navigate and treat damaged pelvic vasculature, occluding the distal aorta. The system was tested on model aortas (both intact and injured cadaveric porcine aorta) with inline fluid flow and pressure monitoring to determine the maximum pressure the balloons could occlude. The device was also tested on a perfused human cadaveric model.
Results: Flow was occluded with the balloon up to an average of 561.1 ± 124.3 mm Hg. It always ruptured before causing damage to the porcine aorta and was able to occlude injured iliac vessels and proceed to occlude the distal aorta. The device was effective in occluding the distal aorta of a perfused human cadaver.
Conclusion: This novel, high-volume, low-pressure device can occlude the distal aorta in a simulated human aorta model, cadaveric porcine model and perfused human cadaver. It can occlude fluid flow to supraphysiologic pressures. It is easy to use, migration-resistant, able to navigate and treat injured pelvic vessels, and amenable to prehospital care.