Safe balloon inflation parameters for resuscitative endovascular balloon occlusion of the aorta

BACKGROUND Noncompressible hemorrhage is a leading cause of preventable death in civilian and military trauma populations. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising method for controlling noncompressible hemorrhage, but safe balloon inflation parameters are not well defined. Our goal was to determine the balloon inflation parameters associated with benchtop flow occlusion and aortic/balloon rupture in ex vivo human aortas and test the hypothesis that optimal balloon inflation characteristics depend on systolic pressure and subject demographics. METHODS Aortic occlusion parameters in human thoracic aortas (TAs) and abdominal aortas (AAs) from 79 tissue donors (median +/- SD age, 52 +/- 18 years [range, 13-75 years]; male, 52; female, 27) were recorded under 100/40, 150/40, and 200/40 mm Hg flow pressures for ER-REBOA and Coda balloons. Rupture tests were done with Coda balloons only without flow. RESULTS In the TA, the average balloon inflation volumes and pressures resulting in 100/40 mm Hg flow occlusion were 11.7 +/- 3.8 mL and 174 +/- 65 mm Hg for the ER-REBOA, and 10.6 +/- 4.3 mL and 94 +/- 57 mm Hg for the Coda balloons. In the AA, these values were 6.2 +/- 2.6 mL and 110 +/- 47 mm Hg for the ER-REBOA, and 5.9 +/- 2.2 mL and 71 +/- 30 mm Hg for the Coda. The average balloon inflation parameters associated with aortic/Coda balloon rupture were 39.1 +/- 6.5 mL and 1,284 +/- 385 mm Hg in the TA, and 27.7 +/- 7.7 mL and 1,410 +/- 483 mm Hg in the AA. Age, sex, and systolic pressure all had significant effects on balloon occlusion and rupture parameters. CONCLUSION Optimal balloon inflation parameters depend on anatomical, physiological, and demographic characteristics. Pressure-guided rather than volume-guided balloon inflation may reduce the risk of aortic rupture. These results can be used to help improve the safety of REBOA procedures and devices.