Prehospital Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Exsanguinating Subdiaphragmatic Hemorrhage.

Importance: Hemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care. Objective: To establish whether prehospital zone 1 (supraceliac) partial resuscitative endovascular balloon occlusion of the aorta (Z1 P-REBOA) can be achieved in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination. Design, Setting, and Participants: This was a prospective observational cohort study (Idea, Development, Exploration, Assessment and Long-term follow-up [IDEAL] 2A design) with recruitment from June 2020 to March 2022 and follow-up until discharge from hospital, death, or 90 days evaluating a physician-led and physician-delivered, urban prehospital trauma service in the Greater London area. Trauma patients aged 16 years and older with suspected exsanguinating subdiaphragmatic hemorrhage, recent or imminent hypovolemic traumatic cardiac arrest (TCA) were included. Those with unsurvivable injuries or who were pregnant were excluded. Of 2960 individuals attended by the service during the study period, 16 were included in the study. Exposures: ZI REBOA or P-REBOA. Main Outcomes and Measures: The main outcome was the proportion of patients in whom Z1 REBOA and Z1 P-REBOA were achieved. Clinical end points included systolic blood pressure (SBP) response to Z1 REBOA, mortality rate (1 hour, 3 hours, 24 hours, or 30 days postinjury), and survival to hospital discharge. Results: Femoral arterial access for Z1 REBOA was attempted in 16 patients (median [range] age, 30 [17-76] years; 14 [81%] male; median [IQR] Injury Severity Score, 50 [39-57]). In 2 patients with successful arterial access, REBOA was not attempted due to improvement in clinical condition. In the other 14 patients (8 [57%] of whom were in traumatic cardiac arrest [TCA]), 11 successfully underwent cannulation and had aortic balloons inflated in Z1. The 3 individuals in whom cannulation was unsuccessful were in TCA (failure rate = 3/14 [21%]). Median (IQR) pre-REBOA SBP in the 11 individuals for whom cannulation was successful (5 [46%] in TCA) was 47 (33-52) mm Hg. Z1 REBOA plus P-REBOA was associated with a significant improvement in BP (median [IQR] SBP at emergency department arrival, 101 [77-107] mm Hg; 0 of 10 patients were in TCA at arrival). The median group-level improvement in SBP from the pre-REBOA value was 52 (95% CI, 42-77) mm Hg (P < .004). P-REBOA was feasible in 8 individuals (8/11 [73%]) and occurred spontaneously in 4 of these. The 1- and 3-hour postinjury mortality rate was 9% (1/11), 24-hour mortality was 27% (3/11), and 30-day mortality was 82% (9/11). Survival to hospital discharge was 18% (2/11). Both survivors underwent early Z1 P-REBOA. Conclusions and Relevance: In this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death. Trial Registration: ClinicalTrials.gov Identifier: NCT04145271.

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Importance: Bleeding is the most common cause of preventable death after trauma. Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. Design, Setting, and Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days. Intervention: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44). Main Outcomes and Measures: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death. Results: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours. Conclusions and Relevance: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone. Trial Registration: isrctn.org Identifier: ISRCTN16184981.

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).

BACKGROUND: Haemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted balloon is deployed in the aorta, providing a relatively quick means of temporarily controlling haemorrhage and augmenting cerebral and coronary perfusion, until definitive control of haemorrhage can be attained. The aim of the UK-REBOA trial is to establish the clinical and cost-effectiveness of a policy of standard major trauma centre treatment plus REBOA, as compared with standard major trauma centre treatment alone, for the management of uncontrolled torso haemorrhage caused by injury. METHODS: Pragmatic, Bayesian, group-sequential, randomised controlled trial, performed in 16 major trauma centres in England. We aim to randomise 120 injured patients with suspected exsanguinating haemorrhage to either standard major trauma centre care plus REBOA or standard major trauma centre care alone. The primary clinical outcome is 90-day mortality. Secondary clinical outcomes include 3-h, 6-h, and 24-h mortality; in-hospital mortality; 6-month mortality; length of stay (in hospital and intensive care unit); 24-h blood product use; need for haemorrhage control procedure (operation or angioembolisation); and time to commencement of haemorrhage control procedure (REBOA, operation, or angioembolisation). The primary economic outcome is lifetime incremental cost per QALY gained, from a health and personal social services perspective. DISCUSSION: This study, which is the first to randomly allocate patients to treatment with REBOA or standard care, will contribute high-level evidence on the clinical and cost-effectiveness of REBOA in the management of trauma patients with exsanguinating haemorrhage and will provide important data on the feasibility of implementation of REBOA into mainstream clinical practice. TRIAL REGISTRATION: ISRCTN16184981.

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

BACKGROUND: Trauma is a leading cause of morbidity and mortality worldwide with about 5.8 million deaths globally and the leading cause of death in those aged 45 and younger. The pre-hospital phase of traumatic injury is particularly important as care received during this phase has effects on survival. The need for high quality clinical trials in this area has been recognised for several years as a key priority to improve the evidence base and, ultimately, clinical care in prehospital trauma. We aimed to systematically map the existing evidence base for pre-hospital trauma trials, to identify knowledge gaps and inform decisions about the future research agenda. METHODS: A systematic mapping review was conducted first employing a search of key databases (MEDLINE, CINAHL, EMBASE, and Cochrane Library from inception to March 23rd 2020) to identify randomised controlled trials within the pre-hospital trauma and injury setting. The evidence 'map' identified and described the characteristics of included studies and compared these studies against existing priorities for research. Narrative description of studies informed by analysis of relevant data using descriptive statistics was completed. RESULTS: Twenty-three eligible studies, including 10,405 participants across 14 countries, were identified and included in the systematic map. No clear temporal or geographical trends in publications were identified. Studies were categorised into six broad categories based on intervention type with evaluations of fluid therapy and analgesia making up 60% of the included trials. Overall, studies were heterogenous with regard to individual interventions within categories and outcomes reported. There was poor reporting across several studies. No studies reported patient involvement in the design or conduct of the trials. CONCLUSION: This mapping review has highlighted that evidence from trials in prehospital trauma is sparse and where trials have been completed, the reporting is generally poor and study designs sub-optimal. There is a continued need, and significant scope, for improvement in a setting where high quality evidence has great potential to make a demonstrable impact on care and outcomes.

Reperfusion repercussions: A review of the metabolic derangements following resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Current resuscitative endovascular balloon occlusion of the aorta (REBOA) literature focuses on improving outcomes through careful patient selection, diligent catheter placement, and expeditious definitive hemorrhage control. However, the detection and treatment of post-REBOA ischemia-reperfusion injury (IRI) remains an area for potential improvement. Herein, we provide a review of the metabolic derangements that we have encountered while managing post-REBOA IRI in past swine experiments. We also provide data-driven clinical recommendations to facilitate resuscitation post-REBOA deflation that may be translatable to humans. METHODS: We retrospectively reviewed the laboratory data from 25 swine across three varying hemorrhagic shock models that were subjected to complete REBOA of either 45 minutes, 60 minutes, or 90 minutes. In each model the balloon was deflated gradually following definitive hemorrhage control. Animals were then subjected to whole blood transfusion and critical care with frequent electrolyte monitoring and treatment of derangements as necessary. RESULTS: Plasma lactate peaked and pH nadired long after balloon deflation in all swine in the 45-minute, 60-minute, and 90-minute occlusion models (onset of peak lactate, 32.9 ± 6.35 minutes, 38.8 ± 10.55 minutes, and 49.5 ± 6.5 minutes; pH nadir, 4.3 ± 0.72 minutes, 26.9 ± 12.32 minutes, and 42 ± 7.45 minutes after balloon deflation in the 45-, 60-, and 90-minute occlusion models, respectively). All models displayed persistent hypoglycemia for more than an hour following reperfusion (92.1 ± 105.5 minutes, 125 ± 114.9 minutes, and 96 ± 97.8 minutes after balloon deflation in the 45-, 60-, and 90-minute occlusion groups, respectively). Hypocalcemia and hyperkalemia occurred in all three groups, with some animals requiring treatment more than an hour after reperfusion. CONCLUSION: Metabolic derangements resulting from REBOA use are common and may worsen long after reperfusion despite resuscitation. Vigilance is required to detect and proactively manage REBOA-associated IRI. Maintaining a readily available "deflation kit" of pharmacological agents needed to treat common post-REBOA electrolyte abnormalities may facilitate management. LEVEL OF EVIDENCE: Level V.

Feasibility study for implementation of resuscitative balloon occlusion of the aorta in peri-arrest, exsanguinating trauma at an adult level 1 Australian trauma centre.

OBJECTIVE: This prospective, observational, interventional study sought to determine if the introduction of resuscitative balloon occlusion of the aorta (REBOA) at an Australian adult major trauma centre would improve survival for major trauma patients. METHODS: Patients aged 18-60 years, transported directly from scene with exsanguinating, sub-diaphragmatic haemorrhage and hypovolaemic shock (systolic BP <70 mmHg or hypovolaemic cardiac arrest) were eligible for recruitment and followed up until hospital discharge (ACTRN12618000550202). RESULTS: During the 14-month study period (17 January 2015 to 12 March 2016) 3032 patients were admitted direct from scene with an overall mortality of 97 (3.71%). Of these patients 3019 had trauma centre vital signs recorded in the data set (99.57%) and 1523 were between the ages of 18-60, including 143 patients with a shock index of >1.0 (4.74%). There were 13 (0.43%) patients with a systolic BP <70 mmHg and/or cardiorespiratory arrest on arrival. The mortality in this group was six out of 13 (46.15%). Of these 13 patients, there were two (0.07% of the total cohort) where REBOA was attempted. There were no eligible patients for whom REBOA was achieved. None of the six patients who died would have benefited from REBOA deployment. CONCLUSIONS: Despite considerable training and resource allocation to ensure 24-h availability, the introduction of REBOA failed to effectively demonstrate any impact on patient outcome. Despite retrospective literature supporting the introduction of REBOA, in this 14-month prospective study there was no evidence of benefit. Further studies may define indications and subgroups of patients who may benefit.

Pre-hospital Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for exsanguinating pelvic haemorrhage.

AIM: To report the initial experience and outcomes of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an adjunct to pre-hospital resuscitation of patients with exsanguinating pelvic haemorrhage. METHODS: Descriptive case series of consecutive adult patients, treated with pre-hospital Zone III REBOA by a physician-led pre-hospital trauma service, between January 2014 and July 2018. RESULTS: REBOA was attempted in 19 trauma patients (13 successful, six failed attempts) and two non-trauma patients (both successful) with exsanguinating pelvic haemorrhage. Trauma patients were severely injured (median ISS 34, IQR: 27-43) and profoundly hypotensive (median systolic blood pressure [SBP] 57, IQR: 40-68 mmHg). REBOA significantly improved blood pressure (Pre-REBOA median SBP 57, IQR: 35-67 mmHg versus Post- REBOA SBP 114, IQR: 86-132 mmHg; Median of differences 66, 95% CI: 25-74 mmHg; P < 0.001). REBOA was associated with significantly lower risk of pre-hospital cardiac arrest (REBOA 0/13 [0%] versus no REBOA 3/6 [50%], P = 0.021) and death from exsanguination (REBOA 0/13 [0%] versus no REBOA 4/6 [67%], P = 0.004), when compared to patients with a failed attempt. Successful REBOA was associated with improved survival (REBOA 8/13 [62%] versus no REBOA 2/6 [33%]; P = 0.350). Distal arterial thrombus requiring thrombectomy was common in the REBOA group (10/13, 77%). CONCLUSION: REBOA is a feasible pre-hospital resuscitation strategy for patients with exsanguinating pelvic haemorrhage. REBOA significantly improves blood pressure and may reduce the risk of pre-hospital hypovolaemic cardiac arrest and early death due to exsanguination. Distal arterial thrombus formation is common, and should be actively managed.

Resuscitative endovascular balloon occlusion of the aorta: promise, practice, and progress?

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.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) in the pre-hospital setting: An additional resuscitation option for uncontrolled catastrophic haemorrhage.

This report describes the first use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in the pre-hospital setting to control catastrophic haemorrhage. The patient, who had fallen 15 meters, suffered catastrophic internal haemorrhage associated with a pelvic fracture. He was treated by London's Air Ambulance's Physician-Paramedic team. This included insertion of a REBOA balloon catheter at the scene to control likely fatal exsanguination. The patient survived transfer to hospital, emergency angio-embolization and subsequent surgery. He was discharged neurologically normal after 52 days and went on to make a full recovery. The poor prognosis in catastrophic torso haemorrhage and novel endovascular methods of haemorrhage control are discussed. Also the challenges of Pre-Hospital REBOA are discussed together with the training and governance required for a safe system.

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.

Case studies in prehospital care from London HEMS: pre-hospital administration of prothrombin complex concentrate to the head-injured patient.

A case of pre-hospital administration of prothrombin complex concentrate to a patient anticoagulated with warfarin and with suspected intracranial haemorrhage is described. Effective, early reversal of anticoagulation by the time of arrival at hospital was achieved.