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A gap analysis of the potential use of resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma at two major Canadian trauma centers

Abstract

Objective

Uncontrolled hemorrhage poses significant morbidity and mortality among injured patients. Resuscitative endovascular balloon occlusion of the aorta (REBOA) utilizes a rapidly-administered minimally invasive transfemoral balloon catheter that is inflated for aortic occlusion, allowing for time to arrange definitive surgical or angiographic intervention. As indications for its use continue to evolve, this study sought to evaluate whether there is a potential need for REBOA implementation in two high-volume trauma centers in Edmonton.

Methods

Patient data within our provincial trauma registry was reviewed between 2015 and 2017 to identify major trauma patients (Injury Severity Score ≥ 12). Patients eligible for REBOA included patients with blunt or penetrating trauma to the torso or pelvis, AND death prior to discharge; and patients taken to the operating room or interventional radiology suite within 4 h of arrival. Charts were reviewed to determine if patients met current conventional criteria for REBOA.

Results

Out of 3415 trauma patients during our study period, 237 patients met the registry screen as potentially eligible for REBOA. After primary researcher review, 67 patients underwent full chart review and then 2 trauma surgeons determined that 38 (1.1% of the study population) met criteria for deploying REBOA.

Conclusion

A small but significant number of trauma patients at the two trauma centers were identified as potential candidates for REBOA use. Implementation of a REBOA program should be done in alignment with existing clinical practice guidelines and professional society recommendations.

Résumé

Objectif

L’hémorragie incontrôlée entraîne une morbidité et une mortalité importantes chez les patients blessés. Le clampage aortique par sonde d’occlusion aortique endovasculaire (resuscitative endovascular balloon occlusion of the aorta [REBOA]) utilise un cathéter à ballonnet transfémoral mini-invasif à administration rapide qui est gonflé pour l'occlusion aortique, ce qui laisse le temps d'organiser une intervention chirurgicale ou angiographique définitive. Alors que les indications de son utilisation continuent d'évoluer, cette étude a cherché à évaluer s'il y avait un besoin potentiel de mise en œuvre de REBOA dans deux centres de traumatologie à haut volume à Edmonton.

Méthodes

Les données sur les patients dans notre registre provincial des traumatismes ont été examinées entre 2015 et 2017 afin d’identifier les patients traumatisés majeurs (Score de gravité des blessures ≥ 12). Les patients éligibles au REBOA comprenaient des patients présentant un traumatisme contondant ou pénétrant au torse ou au bassin, ET le décès avant la sortie; et les patients conduits à la salle d'opération ou à la salle de radiologie interventionnelle dans les 4 heures suivant leur arrivée. Les graphiques ont été examinés pour déterminer si les patients répondaient aux critères conventionnels actuels de REBOA.

Résultats

Sur les 3 415 patients traumatisés pendant notre période d'étude, 237 patients ont répondu à l'examen du registre comme étant potentiellement éligibles pour le REBOA. Après examen par le chercheur principal, soixante-sept patients ont été soumis à un examen complet de leur dossier, puis deux chirurgiens traumatologues ont déterminé que 38 (1,1 % de la population étudiée) répondaient aux critères de déploiement de la REBOA.

Conclusion

Un nombre restreint mais significatif de patients traumatisés dans les deux centres de traumatologie a été identifié comme des candidats potentiels à l'utilisation de REBOA. La mise en œuvre d'un programme REBOA doit se faire en conformité avec les directives de pratique clinique existantes et les recommandations de la société professionnelle.

FormalPara Clinician’s capsule
What is known about this topic?
REBOA can temporize torso hemorrhage with increased adoption in American trauma centers and in a handful of Canadian trauma centres.
What did this study ask?
Are there significant numbers of trauma patients at two Canadian tertiary trauma centers that meet indication for REBOA.
What did this study find?
This gap analysis identified a small but significant number of patients as potential REBOA candidates, supporting consideration for REBOA implementation.
Why does this study matter to clinicians?
A similar number of eligible patients might exist in other Canadian trauma centers supporting wider application of this procedure.

Introduction

Proximal aortic occlusion is a management strategy for life-threatening torso hemorrhage [1]. Traditionally, open thoracotomy has been the method of aortic occlusion [2]. Endovascular balloon occlusion of the aorta is a less invasive technique first described during the Korean War [3]. Resuscitative endovascular balloon occlusion of the aorta (REBOA), has improved temporization of non-compressible torso hemorrhage [46]. Initial studies comparing REBOA to thoracotomy with aortic cross-clamping showed equivalent morbidity, thus supporting REBOA as an adjunct to trauma care [7]. A recent review found that REBOA improved mortality and patient physiologic parameters [8]. Subsequently, a retrospective study suggested higher mortality with REBOA, contributing to ongoing equipoise regarding this technology [9]. REBOA has been adopted widely in American and Japanese trauma centers and in a handful of Canadian trauma centres [7, 10]. Low volumes of penetrating trauma and long distance patient transfers due to challenging geography raise the question of clinical benefit in Canada. The cost of the technology, education, and implementing REBOA within the emergency department (ED) is significant. Evidence from North America, and the UK suggest approximately 0.5% of major trauma patients are REBOA candidates [10, 11]. Edmonton has 2 major trauma centres, seeing 1180 adult major trauma patients (combined) in 2017: 90% of these cases sustained blunt trauma. To determine if REBOA could benefit our patients, we designed a gap analysis using the Alberta Trauma Registry. The primary objective was to identify the total number of patients who were potentially eligible for REBOA in Edmonton. Additionally, a secondary objective of this study was to describe the current management of trauma patients deemed eligible for REBOA to assess for quality improvement gaps.

Methods

The Alberta Trauma Registry is a prospectively maintained database that collects information on all trauma patients with an Injury Severity Score ≥ 12. After obtaining ethics approval from the University of Alberta Board of Ethics (Protocol Number Pro00079221), the registry was queried to identify patients presenting at the two trauma centres in Edmonton from January 2015 to December 2017. Site A is a Level 1 trauma centre with 700–800 trauma admissions each year; Site B is a Level 2 trauma centre that has 400–500 trauma admissions annually. [12] Both sites use Advanced Trauma Life Support® as a standardized approach to trauma care. We established a priori screening criteria to determine eligibility for REBOA deployment, based on anatomic and physiologic criteria. Inclusion criteria were patients presenting with blunt or penetrating trauma to the torso or pelvis AND death prior to discharge OR taken to the operating room or interventional radiology within 4 h of arrival. Exclusion criteria included age < 18 years, isolated head injury, isolated trauma to the upper chest, upper extremities, or neck, or suspected proximal aortic injury. Four-hour inclusion time was chosen to err on over-inclusion of candidates from the Registry on initial screening.

Cases identified through the registry were then abstracted with demographic data, injury data, and initial vital signs to screen for full chart review. Two trauma surgeons independently assessed REBOA eligibility based on published indications: mechanism of injury (blunt or penetrating abdominal trauma), suspected anatomical injury pattern (abdominal or pelvic hemorrhage), and physiological response to initial resuscitation (non-responder or transient responder) [13, 14]. Consistent with published contraindications, patients with pericardial tamponade or major thoracic hemorrhage were excluded [13]. Patients were excluded if the surgeons deemed resuscitation efforts should be ceased owing to clinical futility, such as patients outside the accepted window for ED thoracotomy, as per recent guidelines [14]. Decisions to include or exclude patients were based on information available in the resuscitation room, including bedside ultrasound and X-ray results. If consensus was not achieved, a third trauma surgeon was consulted. Data abstraction from physical charts was performed by trained abstractors utilizing a standardized form. Following calibration exercises, 10% of charts were double abstracted in a blinded fashion to assess abstraction reliability; inter-observer reliability was 100%. A detailed independent patient screen occurred after full data abstraction to generate a final list of potential REBOA candidates. Patients included in the final analysis had a suspected injury amenable to REBOA based on published indications, no contraindications, and persistent hypotension (defined as a systolic blood pressure < 90 mmHg) in the emergency department despite administration of blood products [14].

Results

From January 2015 to December 2017, 3415 patients were enrolled in the Alberta Trauma Registry from Edmonton’s two trauma centres. There were 237 patients who met inclusion criteria for our study based on screening the registry: of these, 170 were excluded due to injuries that were not amenable to REBOA. Ultimately, 67 patient records underwent full surgeon chart review, resulting in 38 patients (1.1%) included in the cohort of eligible REBOA candidates (Fig. 1). Twenty-nine patients were excluded for: large hemothoraces with significant chest injury (12, 43%), patients responsive to blood products (4, 14%), major intracranial bleeding (5, 17%), proximal neck vessel injuries (2, 7%), patient taken to the operating room in < 30 min (2, 7%), pericardial rupture (2, 7%), and proximal aortic injury (1, 4%), and one patient (1, 4%) in cardiac arrest > 20 min secondary to pelvic hemorrhage but was a confirmed Jehovah’s witness who declined blood products.

Fig. 1
figure1

Flowchart demonstrating file screening and review process

Characteristics of the 38 included patients are provided in Table 1. Nine (24%) were transported via rotor-wing with the remainder via ground emergency medical services. The majority of patients sustained blunt trauma (26, 68%). Based on yearly quartiles, 15 patients presented in the months of July to September (39%), 10 patients (26%) from January to March, nine patients (24%) from April to June and four patients (11%) from October to December. Approximately, one-third of cases presented overnight (2000-0700).

Table 1 Characteristics of included patients

Blood product transfusion in the ED was measured for all patients. The mean number of packed red blood cell units, fresh frozen plasma units, and pooled platelets was five, one, and zero respectively (Fig. 2). Excluding patients that had not maintained code red criteria (i.e. partial responders to packed red blood cells with first ED systolic blood pressure above 90), for sites A and B, it took an average of 22.3 and 19.9 min from patient arrival in the ED to transfuse the first unit of packed red blood cells, respectively.

Fig. 2
figure2

Average ED blood product administration per patient

In most patients, hemorrhage was due to abdominal injuries (61%). Of the remaining patients, eight (21%) had unstable pelvic fractures and seven (18%) had a combination of visceral and orthopedic (including pelvis or femur) injuries. Twelve patients (32%) (5 penetrating and 7 blunt trauma) lost vital signs in the ten minutes prior to hospital arrival. Twenty-nine (76%) patients underwent laparotomy for hemorrhage control. One patient underwent primary angioembolization, with a second patient receiving angioembolization post laparotomy. The practice pattern in Edmonton trauma centres is to prioritize laparotomy and pelvic packing, resulting in only two patients receiving angioembolization. Median time to the operating room was 64 min, with 18 (47%) patients being transferred in under 1 h. Eight patients (21%) died in the ED, although only two of these patients were part of the cohort that received resuscitative thoracotomy. Of the four patients who underwent resuscitative thoracotomy, three died and one survived to hospital discharge (Table 2). Based on reported injuries, cause of death varied by hospital area. In the ED and Operating Room, hemorrhage was most common (ED: 7/8 patients died from hemorrhage; Operating Room 4/4 patients died from hemorrhage). In the intensive care unit, multi-organ failure was most common (multi-organ failure 9/11). Of the 15 surviving patients, all were discharged home, suggesting a reasonable neurologic recovery. However, details about neurologic status were not reported in the charts reviewed.

Table 2 Individual REBOA candidate case analysis

Discussion

Interpretation

This gap analysis at two major Canadian trauma centers identified a small but clinically significant number of trauma patients as potential candidates for REBOA. Given the number of patients identified, our two trauma centers could utilize the technology on a monthly basis. Based on local injury patterns, most patients would require Zone 1 REBOA (79%). The relatively low number of patients presenting with penetrating trauma parallels other Canadian trauma centers [15]. Overall, potential REBOA candidates had significant injuries with an average injury severity score of 33 and presenting systolic blood pressure of 79 mmHg, with a mortality rate of 61%; moreover, laboratory results revealed that most of the patients were coagulopathic on arrival to the emergency department. For resuscitation non-responders, REBOA could potentially assist in gaining hemorrhage control in the ED, while facilitating rapid transport to the operating room.

Previous studies

Our study findings were similar to the 2015 gap analysis of trauma patients in Wales and England where 397 of 72,677 patients (0.5%) were potential candidates for REBOA [11]. Current literature shows that REBOA improves blood pressure proximal to the catheter, thereby increasing cerebral and coronary perfusion pressures [4]. REBOA has also been shown to reduce blood product usage once the catheter has been deployed, both in the emergency room and operating room [16]. However, the degree of beneficial effect on mortality and neurological outcomes remains to be seen, with one study suggesting an increase in mortality [9]. In contrast, a recent review suggested improved mortality, further highlighting the need for careful patient selection and ongoing study of REBOA use in a number of different areas [8].

Strengths and limitations

Though deliberate effort was taken to mitigate the potential for bias, standard limitations of chart reviews apply. Our methods included an a priori data collection form, trained data abstractors, and assessment of abstraction quality with dual abstraction on some charts. However, coding and clerical error may have contributed to charts being missed by the trauma registry. Cause of death estimation could have missed unrecognized cases due to lack of post-mortem record assessment. The decision to deploy REBOA is made clinically in the resuscitation room with often limited information, and we erred on the side of excluding patients with significant trauma proximal to the diaphragm that would have been apparent on exam or by non-invasive imaging modalities. Significant provider and system factors have already been rectified at our trauma centres which would be considered prerequisites prior to implementing REBOA. We believe this requirement for critical system reflection and improvement prior to REBOA implementation will have a larger positive effect on a greater number of patients than REBOA itself. Thus, our focus was to quantify potential candidates based on injury pattern and physiology, rather than potentially modifiable barriers.

Clinical implications

The number of patients identified in this study and the high mortality rate supports the implementation of REBOA at our Trauma Centres as an adjunct to hemorrhage control protocols. However, identification of bleeding sources, basic hemorrhage management, expedited balanced transfusion, and streamlined operative and interventional access remain a priority [13, 14]. Collaboration with all associated services, including emergency, surgery, anesthesia, radiology, and allied health is required. Significant staff training and maintenance, including simulation training, is necessary to optimize performance and patient safety. REBOA does not replace resuscitative thoracotomy or immediate transfer to the operating room. The time for REBOA deployment must be balanced against traditional aortic cross-clamping or operative hemorrhage control. Ultrasound-guided central vascular access increases rates of successful placement, and must be immediately available [17]. The decision to deploy REBOA should be made by the trauma team with surgeon(s) present, to manage vascular access and complications, definitive trauma care, and operative treatment [13, 14].

Based on the secondary objectives of our study, three main quality gaps were identified: underutilization of resuscitative thoracotomy; timing and provision of blood products in the ED; and timing of patient transfer to the operating room. Twelve patients presented to the ED within 10 min of cardiac arrest, with 7 patients losing pulses after arrival in the ED. Eight patients achieved return of circulation with fluid or blood product administration and only four resuscitative thoracotomies were performed. Although our local criteria for thoracotomy are consistent with published guidelines [18], there may have been exclusions to thoracotomy in patients sustaining a blunt mechanism, or reluctance to perform a thoracotomy on patients who lost pulses prior to ED arrival. Recruitment of trauma surgeons to both sites has impacted trauma resuscitative care from 2018 onwards. Despite evidence that balanced transfusions result in improved patient outcomes [19], the average ratio of administered blood products in our sites was six units of packed red blood cells for every one unit of fresh frozen plasma, and no platelets. While one possible explanation is survivorship bias, this deviation from the recommended ratios suggests a significant opportunity for improvement. In addition, delayed time to first blood product transfusion in the ED may have resulted in higher volumes of crystalloid utilization. Local quality improvement initiatives have resulted in significant changes to the preparation and timely release of blood products, with ongoing review for optimization. Finally, patient transfer to the operating room was more than 1 h for over 50% of cases. This could be due to patient, provider, and system factors. Some patients may have been transient responders to initial resuscitation, delaying the decision to operate. Provider factors could include lack of recognition of operative injury, and lack of onsite trauma surgeon availability at the time of the study. Ongoing provider training and increased trauma surgeon manpower has helped mitigate provider-related issues in Edmonton Zone. System factors include lack of an available “trauma ready” operating room at both sites. Time to the operating room brings up an important consideration for REBOA placement. Many published studies report REBOA occlusion time of 20 min and that occlusive time should not exceed 60 min to minimize complications. [8] Operating room availability must be able to accommodate this target timeline for site deployment.

Research implications

Prior to adding REBOA to hemorrhage control protocols, trauma centres should perform a needs assessment, identify stakeholders, ensure adequate expertise and surgical supports are in place, and plan for quality improvement metrics related to REBOA [13, 14]. Centres should also ensure optimization of existing quality processes such as timeliness of resuscitation, delivery of blood, and emergent operating room and interventional radiology availability. For Canadian centers implementing REBOA, prospective data collection is important to assess outcomes and complications. Collaboration with other Canadian centers is critical for knowledge-sharing to develop rigorous protocols and minimize complications.

Conclusion

Overall, 1.1% of critically injured patients at two Canadian trauma centres were identified as potential candidates for REBOA from 2015 to 2017, using conservative a priori criteria. Implementation of a REBOA program should be done in alignment with existing clinical practice guidelines and professional society recommendations.

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The authors AE, JO, DOD, KON, RA, AG, SW, NB, and MJD equally contributed to the drafting and editing of this review. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Alistair Eksteen.

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We the authors have no conflicts of interest to disclose, material or otherwise. The views expressed do not necessarily represent those of our respective employers.

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Our work is unfunded and we have no relationships with industry, medication or device manufacturers. The views expressed do not necessarily represent those of our respective employers.

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Eksteen, A., O’Dochartaigh, D., Odenbach, J. et al. A gap analysis of the potential use of resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma at two major Canadian trauma centers. Can J Emerg Med 23, 36–44 (2021). https://doi.org/10.1007/s43678-020-00007-5

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Keywords

  • REBOA
  • Resuscitative endovascular balloon occlusion
  • Gap analysis