Resuscitative Endovascular Balloon Occlusion of the Aorta has had lots of exciting coverage over the past few years. But despite the hype, we don’t really know if it helps or harms patients.
don’t we know if it works?
data has exclusively been observational. Researchers have passively sat back
and looked to see if there are outcome differences between those who got REBOA
and those who didn’t. The problem is these are two VERY different groups. Despite
all the fancy statistical analysis, it is impossible to properly adjust
for all the between group confounding.
What is the
best way to get rid of confounding?
of randomization ensures that there are equal amounts of known and unknown
confounders in each group. Problems solved… theoretically.
So here is
the first randomized clinical trial of REBOA in trauma!
UK-REBOA RCT was conducted in 16 major trauma centers in the UK. Patients with
exsanguinating hemorrhage were enrolled over 4+ years.
outcome was all-cause mortality at 90 days. There were lots of secondary
were enrolled almost all (97%) with blunt trauma. As expected, they were super
sick with a median injury severity score (ISS) of 41.
In the end,
the trial was stopped for harm. Mortality was 54% with REBOA vs. 42% in the standard
care arm. Number needed to kill (NNK) is 8. In addition, all the secondary outcomes and bleeding seemed to be worse with REBOA.
Does this signal
the death of REBOA?
this paper has lots of limitations. The biggest of which is only 19
out of 46 patients randomized to REBOA got the device inserted and balloon
inflated. It is hard to demonstrate a treatment effect when most patients don’t
get the treatment. But perhaps this shows the real-world difficulties of
this paper will highlight many other issues: training of providers, time
delays, specific device used, small numbers, stopped early, baseline
differences favored the control arm, no penetrating trauma, etc.
the issues, I think there is a big take home point.
REBOA is very
hard to study.
went to great efforts. They included 16 centers over 4+ years and still they
had major issues. In the end, I doubt we will see much better evidence anytime soon. Nevertheless, I think we will see a shift away from REBOA... don't believe the hype.
Hudson J, Cochran C, et al. Emergency Department Resuscitative Endovascular
Balloon Occlusion of the Aorta in Trauma Patients with Exsanguinating
Hemorrhage: The UK-REBOA Randomized Clinical Trail. JAMA. 2023;330(19):1862-1871.