Robbie A. Lendrum

Background: The most common cause of preventable death after injury is haemorrhage. Resuscitative endovascular balloon occlusion of the aorta is intended to provide earlier, temporary haemorrhage control, to facilitate transfer to an operating theatre or interventional radiology suite for definitive haemostasis. Objective: To compare standard care plus resuscitative endovascular balloon occlusion of the aorta versus standard care in patients with exsanguinating haemorrhage in the emergency department. Design: Pragmatic, multicentre, Bayesian, group-sequential, registry-enabled, open-label, parallel-group randomised controlled trial to determine the clinical and cost-effectiveness of standard care plus resuscitative endovascular balloon occlusion of the aorta, compared to standard care alone. Setting: United Kingdom Major Trauma Centres. Participants: Trauma patients aged 16 years or older with confirmed or suspected life-threatening torso haemorrhage deemed amenable to adjunctive treatment with resuscitative endovascular balloon occlusion of the aorta. Interventions: Participants were randomly assigned 1 : 1 to: standard care, as expected in a major trauma centre standard care plus resuscitative endovascular balloon occlusion of the aorta. Main outcome measures: Primary: Mortality at 90 days. Secondary: Mortality at 6 months, while in hospital, and within 24, 6 and 3 hours; need for haemorrhage control procedures, time to commencement of haemorrhage procedure, complications, length of stay (hospital and intensive care unit-free days), blood product use. Health economic: Expected United Kingdom National Health Service perspective costs, life-years and quality-adjusted life-years, modelled over a lifetime horizon. Data sources: Case report forms, Trauma Audit and Research Network registry, NHS Digital (Hospital Episode Statistics and Office of National Statistics data). Results: Ninety patients were enrolled: 46 were randomised to standard care plus resuscitative endovascular balloon occlusion of the aorta and 44 to standard care. Mortality at 90 days was higher in the standard care plus resuscitative endovascular balloon occlusion of the aorta group (54%) compared to the standard care group (42%). The odds ratio was 1.58 (95% credible interval 0.72 to 3.52). The posterior probability of an odds ratio > 1 (indicating increased odds of death with resuscitative endovascular balloon occlusion of the aorta) was 86.9%. The overall effect did not change when an enthusiastic prior was used or when the estimate was adjusted for baseline characteristics. For the secondary outcomes (3, 6 and 24 hours mortality), the posterior probability that standard care plus resuscitative endovascular balloon occlusion of the aorta was harmful was higher than for the primary outcome. Additional analyses to account for intercurrent events did not change the direction of the estimate for mortality at any time point. Death due to haemorrhage was more common in the standard care plus resuscitative endovascular balloon occlusion of the aorta group than in the standard care group. There were no serious adverse device effects. Resuscitative endovascular balloon occlusion of the aorta is less costly (probability 99%), due to the competing mortality risk but also substantially less effective in terms of lifetime quality-adjusted life-years (probability 91%). Limitations: The size of the study reflects the relative infrequency of exsanguinating traumatic haemorrhage in the United Kingdom. There were some baseline imbalances between groups, but adjusted analyses had little effect on the estimates. Conclusions: This is the first randomised trial of the addition of resuscitative endovascular balloon occlusion of the aorta to standard care in the management of exsanguinating haemorrhage. All the analyses suggest that a strategy of standard care plus resuscitative endovascular balloon occlusion of the aorta is potentially harmful. Future work: The role (if any) of resuscitative endovascular balloon occlusion of the aorta in the pre-hospital setting remains unclear. Further research to clarify its potential (or not) may be required. Trial registration: This trial is registered as ISRCTN16184981. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/199/09) and is published in full in Health Technology Assessment; Vol. 28, No. 54. See the NIHR Funding and Awards website for further award information.

Purpose of review: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a minimally invasive damage control procedure for life-threatening abdominal or pelvic haemorrhage. The purpose of this review is to summarize the current understanding and experience with REBOA, outline potential future applications of this technology, and highlight priority areas for further research. Recent findings: REBOA is a feasible method of achieving temporary aortic occlusion and can be performed rapidly, with a high degree of success, in the emergency setting (including at the scene of injury) by appropriately trained clinicians. The procedure supports central perfusion, controls noncompressible haemorrhage, and may improve survival in certain profoundly shocked patient groups; but is also associated with significant risks, including ischaemic tissue damage and procedural complications. Evolutions of this strategy are being explored, with promising proof-of-concept studies in the fields of partial aortic occlusion and the combination of REBOA with extracorporeal support. Summary: Noncompressible torso haemorrhage is the leading cause of preventable trauma deaths. The majority of these deaths occur soon after injury, often before any opportunity for definitive haemorrhage control. For a meaningful reduction in trauma mortality, novel methods of rapid haemorrhage control are required.

Summary: The word ‘trauma’ describes the disease entity resulting from physical injury. Trauma is one of the leading causes of death worldwide and deaths due to injury look set to increase. As early as the 1970s, it became evident that centralisation of resources and expertise could reduce the mortality rate from serious injury and that organisation of trauma care delivery into formal systems could improve outcome further. Internationally, trauma systems have evolved in various forms, with widespread reports of mortality and functional outcome benefits when major trauma management is delivered in this way. The management of major trauma in England is currently undergoing significant change. The London Trauma System began operating in April 2010 and others throughout England became operational this year. Similar systems exist internationally and continue to be developed. Anaesthetists have been and continue to be involved with all levels of trauma care delivery, from the provision of pre‐hospital trauma and retrieval teams, through to chronic pain management and rehabilitation of patients back into society. This review examines the international development of major trauma care delivery and the components of a modern trauma system.