Resuscitative endovascular balloon occlusion of the aorta (REBOA): a population based gap analysis of trauma patients in England and Wales

INTRODUCTION: Non-compressible torso haemorrhage (NCTH) carries a high mortality in trauma as many patients exsanguinate prior to definitive haemorrhage control. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an adjunct that has the potential to bridge patients to definitive haemostasis. However, the proportion of trauma patients in whom REBOA may be utilised is unknown. METHODS: We conducted a population based analysis of 2012-2013 Trauma Audit and Research Network (TARN) data. We identified the number of patients in whom REBOA may have been utilised, defined by an Abbreviated Injury Scale score ≥3 to abdominal solid organs, abdominal or pelvic vasculature, pelvic fracture with ring disruption or proximal traumatic lower limb amputation, together with a systolic blood pressure <90 mm Hg. Patients with non-compressible haemorrhage in the mediastinum, axilla, face or neck were excluded. RESULTS: During 2012-2013, 72 677 adult trauma patients admitted to hospitals in England and Wales were identified. 397 patients had an indication(s) and no contraindications for REBOA with evidence of haemorrhagic shock: 69% men, median age 43 years and median Injury Severity Score 32. Overall mortality was 32%. Major trauma centres (MTCs) received the highest concentration of potential REBOA patients, and would be anticipated to receive a patient in whom REBOA may be utilised every 95 days, increasing to every 46 days in the 10 MTCs with the highest attendance of this injury type. CONCLUSIONS: This TARN database analysis has identified a small group of severely injured, resource intensive patients with a highly lethal injury that is theoretically amenable to REBOA. The highest density of these patients is seen at MTCs, and as such a planned evaluation of REBOA should be further considered in these hospitals

Randomised controlled trials in pre-hospital trauma : a systematic mapping review

Acknowledgements The authors thank Paul Manson (HSRU Information Scientist) for help with the database searches, Professor Graeme MacLennan for advice on categorising adaptive design trials, and Professor Marion Campbell for commenting on a draft version of the manuscript. Funding statement RL held an NHS Research Scotland Fellowship during the delivery of this project. The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.Peer reviewedPublisher PD

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage : study protocol for a randomised clinical trial (the UK-REBOA trial)

Acknowledgements The UK-REBOA trial grantholders include Jan O. Jansen, University of Aberdeen, UK, and University of Alabama at Birmingham, USA; Marion K. Campbell, University of Aberdeen, UK; Chris Moran, Nottingham University Hospital Trust, UK; Karim Brohi, Queen Mary University of London, UK; Fiona Lecky, University of Sheffield, UK; Robbie Lendrum, Bart’s Health NHS Trust, UK; Graeme MacLennan, University of Aberdeen, UK; Jonathan J. Morrison, University of Maryland, USA; Nigel Tai, Academic Department of Military Surgery and Trauma, Royal Centre for Defence Medicine, UK; Tim Harris, Bart’s Health NHS Trust, UK; John Norrie, University of Edinburgh, UK; Dwayne Boyers, University of Aberdeen, UK; Alan Paterson, University of Strathclyde, UK; and Nick Welch. Funding {4} This study/project is funded by the National Institute for Health Research (NIHR) HTA Programme (reference 14/199/09). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funder has/had no role in the design of the study; the collection, analysis, and interpretation of data; or writing the manuscript. The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.Peer reviewedPublisher PD

The UK resuscitative endovascular balloon occlusion of the aorta in trauma patients with life-threatening torso haemorrhage : The (UK-REBOA) multicentre RCT

Peer reviewe

The UK resuscitative endovascular balloon occlusion of the aorta in trauma patients with life-threatening torso haemorrhage: the (UK-REBOA) multicentre RCT

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

A Practical Approach to Introducing Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), the Problems Encountered and Lessons Learned

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is an endovascular procedure which utilises a catheter based balloon device to achieve aortic occlusion. The aim of this resuscitative measure is to improve blood pressure proximal to the occlusion site and therefore preserve cardiac and cerebral perfusion in order to prevent cardiac arrest; additionally there is a relative reduction in arterial inflow to the site of injury. Endovascular techniques are gaining acceptance for the in-hospital management of haemorrhage, however their use in pre-hospital care is still limited. This is due to a number of factors including the technical challenges, training and skill sets of pre-hospital care teams and the potential for harm of REBOA, particularly with extended balloon occlusion times. However, non compressible torso haemorrhage is associated with a mortality of approximately 50% and a significant proportion of these deaths  occur in the pre-hospital phase of care. In the exsanguinating patient, resuscitative thoracotomy (RT) with direct aortic compression is often the only means to control haemorrhage. This resuscitative measure is now an established pre-hospital intervention which has significantly improved outcomes in the context of penetrating trauma, particularly thoracic injury. In the context of blunt injury and subdiaphragmatic haemorrhage, however, the outcomes from pre-hospital resuscitative thoracotomy remain poor. We present our initial technique for successfully introducing REBOA for the pre-hospital management of exsanguinating pelvic or groin heamorrhage following trauma, our indications for REBOA and comment on the problems and limitations encountered as well the lessons learned. </jats:p