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. 2020 Sep;89(3):464-473.
doi: 10.1097/TA.0000000000002797.

Use of bilobed partial resuscitative endovascular balloon occlusion of the aorta is logistically superior in prolonged management of a highly lethal aortic injury

Jevgenia Zilberman-Rudenko  1 , Brandon Behrens, Belinda McCully, Elizabeth N Dewey, Sawyer G Smith, James M Murphy, Andrew Goodman, Samantha J Underwood, Elizabeth A Rick, Brianne M Madtson, Michelle E Thompson, Jacob J Glaser, John B Holcomb, Martin A Schreiber
Affiliations

Use of bilobed partial resuscitative endovascular balloon occlusion of the aorta is logistically superior in prolonged management of a highly lethal aortic injury

Jevgenia Zilberman-Rudenko et al. J Trauma Acute Care Surg. 2020 Sep.

Abstract

Background: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a viable technique for management of noncompressible torso hemorrhage. The major limitation of the current unilobed fully occlusive REBOA catheters is below-the-balloon ischemia-reperfusion complications. We hypothesized that partial aortic occlusion with a novel bilobed partial (p)REBOA-PRO would result in the need for less intraaortic balloon adjustments to maintain a distal goal perfusion pressure as compared with currently available unilobed ER-REBOA.

Methods: Anesthetized (40-50 kg) swine randomized to control (no intervention), ER-REBOA, or pREBOA-PRO underwent supraceliac aortic injury. The REBOA groups underwent catheter placement into zone 1 with initial balloon inflation to full occlusion for 10 minutes followed by gradual deflation to achieve and subsequently maintain half of the baseline below-the-balloon mean arterial pressure (MAP). Physiologic data and blood samples were collected at baseline and then hourly. At 4 hours, the animals were euthanized, total blood loss and urine output were recorded, and tissue samples were collected.

Results: Baseline physiologic data and basic laboratories were similar between groups. Compared with control, interventions similarly prolonged survival from a median of 18 minutes to over 240 minutes with comparable mortality trends. Blood loss was similar between partial ER-REBOA (41%) and pREBOA-PRO (51%). Partial pREBOA-PRO required a significantly lower number of intraaortic balloon adjustments (10 ER-REBOA vs. 3 pREBOA-PRO, p < 0.05) to maintain the target below-the-balloon MAP. The partial ER-REBOA group developed significantly increased hypercapnia, fibrin clot formation on TEG, liver inflammation, and IL-10 expression compared with pREBOA-PRO.

Conclusion: In this highly lethal aortic injury model, use of bilobed pREBOA-PRO for a 4-hour partial aortic occlusion was logistically superior to unilobed ER-REBOA. It required less intraaortic balloon adjustments to maintain target MAP and resulted in less inflammation.

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Conflict of interest statement

Conflict of interest: Dr. Behrens received consultancy stipend from Grifols. Dr. Holcomb is a co-founder and on the Board of Directors of Decisio Health, on the Board of Directors of QinFlow and Zibrio, a Co-inventor of the Junctional Emergency Tourniquet Tool, an adviser to Arsenal Medical, Cellphire, Spectrum, and PotentiaMetrics. Dr. Schreiber received consultancy payments from Haemonetics, Arsenal Medical and Velico Medical to Oregon Health & Science University. Oregon Health & Science University received an unrestricted grant from Prytime Medical, the manufacturer of the ER-REBOA and pREBOA-PRO, for this research. Potential conflicts of interest have been reviewed and managed by the Oregon Health and Science University Conflict of Interest in Research Committee.

Figures

Figure 1:
Figure 1:. Experimental set up.
(A) Graphic representation of the experimental protocol, where 1-denotes catheter inserted through the right femoral introducer and advanced under direct palpation until the balloon was confirmed above the level of the diaphragm in Zone 1. All study groups received 1000 mL of Lactated Ringer’s during the intervention and a 5 mL/kg/hr rate of maintenance fluids during MAP maintenance stage. (B) Graphical depiction of vascular lines, injury site and the REBOA balloon placement.
Figure 2:
Figure 2:. Schematic representation REBOA catheters used in this study.
Left, currently on the market unilobed ER-REBOA. Right, a novel bilobed pREBOA-PRO with controlled below-the-balloon flow channels.
See this image and copyright information in PMC

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