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November 15, 2023

Written by Michael Stocker

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In the first ever randomized clinical trial (RCT) of resuscitative endovascular balloon occlusion of the aorta (REBOA), exsanguinating patients receiving REBOA and standard care suffered greater mortality than those receiving standard care alone. But don’t throw those balloons away just yet, this study had significant limitations.

REBOA is dead. Long live REBOA!
This multicenter RCT included 90 patients ages 16 years and older presenting to major trauma centers with traumatic hemorrhage. Patients were randomized to either REBOA with standard care or standard care alone. All-cause mortality at 90 days was the primary outcome, with several secondary outcomes to include mortality at multiple time points from 3 hours to 6 months, time to definitive hemorrhage control, and length of stay. The REBOA group experienced 54% all-cause mortality at 90 days while standard care alone experienced 42%, OR 1.58 (95%CI 0.72-3.52) with posterior probability of 86.9% that the REBOA group would experience an increased odds of mortality. Secondary outcomes analysis indicated the REBOA group experienced greater mortality earlier (3 to 24 hour) and had longer time to definitive hemorrhage control.

At first glance, these results paint a grim future for REBOA; however, the limitations of this study hinder its impact significantly. Only 3% of patients presented with penetrating injuries, restricting the generalizability. The fairly small enrollment goal of 120 patients was limited to 90 patients by early termination, and there is plenty of discussion to be had about the decision to terminate. Furthermore, only 19 patients (41%) randomized to REBOA had successful device deployment.

How will this change my practice?
REBOA has a lot to prove, but considering the limitations here, there just isn’t enough to convince me it’s dead. That said, key issues with REBOA are apparent. The low number of successful device deployments and increased time to definitive hemorrhage control highlight the immense technical difficulty of the procedure. Widespread mastery of time-critical femoral artery access will be necessary to give REBOA a fighting chance.

Editor’s note: This is disappointing, but I wonder if this will be like the early endovascular trials for stroke. As skill and technology improve, this may improve. More studies are ongoing, including one at my hospital. ~Clay Smith

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial. JAMA. 2023 Oct 12:e2320850. doi: 10.1001/jama.2023.20850. Online ahead of print.

What are your thoughts?