Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) may increase complications and mortality in severely injured trauma patients, researchers say.

“REBOA has emerged as a potential tool to control hemorrhage in trauma patients and there is an effort to transition from military use to civilian use,” Dr. Bellal Joseph of the University of Arizona in Tucson said in an email to Reuters Health. “However, there is still a lack of clinical data that adequately addresses the appropriate use of REBOA and which patient, if any, would benefit. The technology has spread faster than the evidence to support it.”

“In this analysis from the national American College of Surgeons Trauma Quality Improvement Program database, REBOA placement in severely injured trauma patients was associated with a higher mortality rate compared to a similar cohort of patients with no placement of REBOA,” he noted. “Similar patients who received REBOA had higher complication rates with higher rates of acute kidney injury and lower-leg amputations.”

“Our data in the United States is similar to data in other regions of the world,” he said, “all of which show no advantage to REBOA in its current practice.”

Dr. Joseph and colleagues analyzed data on close to 600,000 adult trauma patients and matched 420 for the case-control study.

As reported online March 20 in JAMA Surgery, the REBOA group consisted of 140 patients and the no-REBOA group, 280. The mean age overall was about 44, and about 74 percent of both groups were men.

Most patients (92 percent) in both groups had blunt trauma, and the median injury severity score was 29. There was no significant difference between groups in median four-hour receipt of blood products: REBOA patients received six units packed red blood cells and no-REBOA patients received seven units; both groups each received four units platelets and three units plasma.

Similarly, no significant differences were seen in 24-hour blood transfusion, median hospital stay (REBOA, eight days; no-REBOA, 10 days), or median intensive care unit stay (REBOA, five days; no-REBOA, six days).

By contrast, the mortality rate was higher in the REBOA group: 35.7 versus 18.9 percent. As Dr. Joseph noted, REBOA patients were also more likely to develop acute kidney injury (10.7 versus 3.2 percent) and to undergo lower extremity amputation (3.6 versus 0.7 percent).

“The focus forward needs to be a concerted effort to clearly define when and in which patient population REBOA should be used,” Dr. Joseph said. “Although the theory makes sense in an austere environment when no other option is suitable, we must read this data and [be cautious with] REBOA’s implementation.”

“Further randomized clinical trials are required…in accordance with specific well-defined protocols,” he concluded. “Currently, a randomized clinical trial is going on in the U.K. that might identify the specific subset of trauma patients who might benefit from REBOA placement and help us create specific protocols for placement of REBOA in these patients.”

Dr. Gilbert Upchurch Jr. of the University of Florida in Gainesville, coauthor of a related editorial, reviewed the study findings in an email to Reuters Health, noting that “the authors conclude by stating there is a significant need for a concerted effort to clearly define when and in which patient population REBOA has a benefit.”

That message was echoed in his editorial, which concluded, “it is imperative for us to better define who should undergo REBOA, who should perform it, and where it should be performed to maximize the survival benefit from this technique for our badly injured trauma patients.”