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Three Part Question

In [adults with major trauma (ISS>15) and significant uncontrolled bleeding distal to the arch of the aorta] is [Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) better than standard management] for [the odds of surviving to discharge].

Clinical Scenario

A 40 year old pedestrian is stuck by a car travelling at 40mph. On primary survey she is shocked and hypotensive with signs of significant pelvic and intra-abdominal injury. FAST shows large volumes of peritoneal fluid and pelvic radiograph shows marked disruption of the pelvic ring. Despite four units of pRBCs and FFP you are unable to obtain a radial pulse. You wonder whether Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) might be helpful.

Search Strategy

Ovid interface
1] Ovid MEDLINE(R) 1946 to 2015 October 30
2] Embase 1974 to 2015 October 30
["balloon occlusion".mp. or exp Balloon Occlusion/] AND [aort*.mp or exp Aorta/] AND [trauma*.mp. or exp "Wounds and Injuries"/] OR [reboa.mp]

Search Outcome

Of the 330 papers identified only two made any attempt to compare a REBOA treated group to a control in humans. Of these, one fell into the category of providing evidence at level III or better. There were a number of papers describing case series.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Norii T et. al. April 2015 USA/Japan	1807 Adults with blunt trauma on Japan Trauma Data Bank (2004-2011) of whom 351 received REBOA.	Case-control study, level IIIb	Odds ratio of survival	0.3 (95% confidence interval, 0.23-0.40)	Observational study. Controls identified using propensity matching which potentially obscures significant clinical differences between patients who were treated with REBOA and those who weren't.
Moore L et. al. October 2015 USA	Adults identified from trauma registries at two US level 1 trauma centres with refractory haemorrhagic shock caused by non-compressible torso injury and treated with either resuscitative thoracotomy (n=72) or REBOA (n=24)	Cohort study, poor quality, level IV	Survival	37.5% (REBOA) vs. 9.%(Resuscitative thoracotomy) p = 0.003	Observational study. No attempt to control for significant differences between groups - 71% of patients undergoing REBOA had vital signs present compared to only 38% undergoing resuscitative thoracotomy.
Saito N. et. al May 2015 Japan	24 Patients 18 years or older who underwent REBOA identified from single hospital trauma registry over seven years.	Case series, level IV	N/A		The study demonstrated the clinical application of REBOA but has no comparison to untreated patients.

Comment(s)

There are no prospective controlled trials evaluating REBOA. Two retrospective observational studies compared patients to a control group but of these only one (Norii et. al.) was rigorous enough to meet the standards of level III evidence. The paper suggests that REBOA is associated with an increased risk of mortality but the methodology employed to match REBOA treated patients with controls may have obfuscated significant differences between the groups. Other studies provide level IV evidence suggesting that REBOA may be feasible (Saito et. al.) and efficacious (Moore et. al.). More research is needed before reaching any conclusions. In particular, REBOA must be compared to modern trauma practices such as haemostatic resuscitation.

Clinical Bottom Line

There is an lack of evidence for the use of REBOA in this patient group. One observational study which is methodologically limited suggests there may be some harm. Further research is needed.

Level of Evidence

Level 3 - Small numbers of small studies or great heterogeneity or very different population.

References

1. Norii T, Crandall C, Terasaka Y Survival of severe blunt trauma patients treated with resuscitative endovascular balloon occlusion of the aorta compared with propensity score/adjusted untreated patients The Journal of Trauma and Acute Care Surgery 2015 Apr;78(4):721-8
2. Moore L, Brenner M, Kozar R, Pasley J, Wade C, Baraniuk M, Scalea T, Holcomb J Implementation of resuscitative endovascular balloon occlusion of the aorta as an alternative to resuscitative thoracotomy for noncompressible truncal hemorrhage The Journal of Trauma and Acute Care Surgery 2015 Oct;79(4):523-32
3. Saito N, Matsumoto H, Yagi T, Hara Y, Hayashida K, Motomura T, Mashiko K, Iida H, Yokota H, Wagatsuma Y. Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta The Journal of Trauma and Acute Care Surgery 2015 May;78(5):897-903