Med Lasers 2023; 12(4): 220-227  https://doi.org/10.25289/ML.23.040
Advances in resuscitative endovascular balloon occlusion of the aorta (REBOA): a comprehensive review of the evolution, patient criteria, and technological innovations in trauma management
Kyoung Min Ryu
Department of Thoracic and Cardivascular Surgery, Dankook University Hospital, Cheonan, Republic of Korea
Correspondence to: Kyoung Min Ryu
E-mail: cskmin@naver.com
ORCID: https://orcid.org/0000-0001-8461-6010
Received: November 16, 2023; Accepted: November 21, 2023; Published online: December 4, 2023.
© Korean Society for Laser Medicine and Surgery. All rights reserved.

This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Hemorrhagic shock, a leading cause of mortality in military and civilian trauma, necessitates innovative strategies for effective management. This review explores the evolution of resuscitative endovascular balloon occlusion of the aorta (REBOA) from its inception in the 1950s to contemporary applications. The patient selection criteria, emphasizing hypotension, demonstrated consensus among algorithms. Technological advances, such as wire-free catheters and anti-thrombogenic coatings, enhanced the device performance. Precision in device placement, guided by portable digital X-ray imaging, and the time limitations of post-aortic occlusion underscored the critical considerations. Despite its widespread utilization, the adoption of REBOA varies, reflecting diverse practices and barriers, from the lack of protocols to the reluctance to embrace novel procedures. This comprehensive overview highlights the dynamic landscape of trauma management, shaping the future of REBOA in specific patient populations. Ongoing research is crucial for optimizing its potential and addressing implementation challenges.
Keywords: Shock, hemorrhagic; Resuscitation; Balloon occlusion; Vascular access device; Trauma center
INTRODUCTION

Hemorrhagic shock stands as the predominant cause of mortality on the battlefield and ranks as the second most frequent cause of death among civilian trauma patients [1]. The intricate management of hemorrhagic bleeding, particularly in cases of noncompressible torso hemorrhage below the diaphragm resulting from truncal injury, presents a formidable challenge where traditional manual pressure application is ineffective. Historically, the recourse for addressing such scenarios involved the performance of a resuscitative thoracotomy with aortic cross-clamping—a procedure associated with substantial morbidity and undertaken to preserve perfusion to critical coronary and cerebral vessels [2].

However, the landscape of managing noncompressible torso hemorrhage has evolved with the emergence of resuscitative endovascular balloon occlusion of the aorta (REBOA) as a viable alternative for temporizing hemorrhage in these challenging cases [3]. The REBOA procedure entails the strategic placement of an endovascular balloon catheter into the aorta through a sheath in the common femoral artery, subsequently inflating the balloon to achieve aortic occlusion [4]. The historical roots of endoluminal aortic occlusion trace back to 1954 when Hughes et al. first applied the technique to soldiers in the Korean War [5]. Although the initial attempts did not yield survival, this pivotal case report paved the way for the utilization of intravascular balloon occlusion, primarily within the domain of treating ruptured abdominal aortic aneurysms.

Instances of employing this technique for trauma patients were sporadically documented in select centers as early as the 1980s by interventionalists, often hindered by limited availability and the use of larger-profile devices [6,7]. Due to these constraints and associated complications, the application of this technique remained infrequent. However, with the advancement and evolution of endovascular technology, interest in utilizing balloon occlusion for treating hemorrhage below the diaphragm experienced a resurgence. Standardized training platforms for trauma surgeons and technological advancements facilitated the incorporation of REBOA into the armamentarium of trauma care, with trauma surgeons performing the procedure for over a decade [8].

Surprisingly, contemporary use of REBOA has not been universally embraced by trauma surgeons responding to bleeding scenarios during pelvic surgery [9], hepatobiliary surgery [10], postpartum hemorrhage [11,12], and gastrointestinal bleeding [13-15]. A 2019 survey of 158 trauma medical directors in the United States revealed that nearly half of the respondents reported their institutions employing REBOA for managing pelvic fractures [16]. Presently, both American College of Surgeons (ACS) Level I and Level II trauma hospitals in the United States have adopted the 7Fr catheter. The AORTA (Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery) registry, encompassing patients from 58 hospitals, 90% of which are ACS Level I trauma centers, reflects the widespread utilization of REBOA. However, the practice varies even within institutions, with certain faculty members incorporating REBOA into their practice while others abstain. As with any novel procedure or technology, barriers to implementation range from a lack of level 1 evidence to a reluctance to acquire proficiency in a new procedural technique [17].

The aim of this review is to provide guidance on the clear rationale for the application of REBOA by presenting patient selection criteria based on the studies to date and to summarize the evolution of REBOA devices and technology to suggest future directions for research and development of REBOA.

MAIN TEXT

Harmonizing patient selection criteria for REBOA in trauma management

An analysis of 10 recent studies of REBOA in trauma patients describing patient selection criteria found that most described similar criteria (Table 1) [3,18-26]. A pivotal criterion uniformly identified across these articles is the manifestation of hypotension, characterized by a transient or insufficient response to resuscitative interventions. While variations exist in the specified blood pressure thresholds, 40% of the studies advocate for a systolic blood pressure (SBP) below 90 mmHg, while one stipulates a threshold of SBP below 80 mmHg. Remarkably, the consensus on endorsing an SBP of less than 80 to 90 mmHg as a guiding parameter in trauma patients has endured since 2015, predating the evolution of trauma-specific REBOA devices and the widespread integration of REBOA into clinical practice [27]. This persistence in threshold application is noteworthy, especially considering advancements in device technology and the escalating utilization of REBOA.

Table 1 . Recent studies about selection criteria of REBOA in trauma patient

YearReferencePatient selection criteria of REBOAContraindication
2018Brenner et al. [18]Traumatic life-threatening hemorrhage below the diaphragm in patients in hemorrhagic shock who are unresponsive or transiently responsive to resuscitation
Patients arriving in arrest from injury
Not specified
2019Borger van der Burg et al. [19]Traumatic abdominopelvic hemorrhage
Trauma patients with initial SBP<90 who do not respond to resuscitation
Any trauma victim with ATLS class IV hypovolemic shock
Major bleeding in the neck or proximal to the left subclavian artery
2020Glaser et al. [20]SBP<90 and transient or no response to initial resuscitation in blunt trauma or penetrating abdominal/pelvic/junctional injury
Traumatic arrest (blunt or penetrating) based on injury location and CPR time
Severe blunt chest injury
Profound shock or traumatic arrest due to penetrating neck, chest, or extremity injury
2020Brenner et al. [21]Blunt or nonthoracic penetrating injury
Hemorrhage location unknown or below the diaphragm
Consider with hemorrhage location in the thorax in combination with resuscitative thoracotomy
Not specified
2020Ordoñez et al. [22]Noncompressible torso hemorrhage
Blunt or penetrating mechanism
SBP<90 and transient responder to resuscitation
Not specified
2021Johnson et al. [23]SBP<90 and partial or nonresponderThoracic hemorrhage
2021Castellini et al. [3]Hypotensive trauma patients with suspected torso hemorrhage
Nonresponders to resuscitation
Positive FAST or positive pelvic X-ray
Suspicion of thoracic aorta injury
2021Hadley et al. [24]SBP<80 and hemorrhage location
Traumatic arrest with pelvic or extremity hemorrhage
Thoracic hemorrhage
2022Inaba et al. [25]Sustained hypotension refractory to resuscitationMajor thoracic vascular injury
2022Nagashima et al. [26]Hypotensive partial or nonresponderNear/recent cardiac arrest
Possible aortic injury

REBOA, resuscitative endovascular balloon occlusion of the aorta; SBP, systolic blood pressure; ATLS, advanced trauma life support; CPR, cardiopulmonary resuscitation; FAST, focused assessment with sonography in trauma.



The clinical significance of maintaining an SBP below 90 mmHg is underscored by its correlation with a nearly 50% mortality rate in trauma patients subjected to laparotomy and a 32% mortality rate in patients with pelvic fractures [28,29].

While trauma centers uniformly agree on considering REBOA for patients exhibiting an inadequate hemodynamic response to initial resuscitation, the specific trigger for deploying REBOA lacks explicit definition. Several articles advocate for the recognition of persistent or recurrent hypotension after the administration of 1 to 2 units of blood products as a pragmatic metric across diverse clinical settings [30].

Divergence among the studies emerges concerning chest trauma as a contraindication to REBOA, with 63% asserting major chest trauma as a contraindication and 13% positing it as a criterion for REBOA patient selection [30]. Notably, many articles lack precision in delineating major chest trauma, thoracic vascular trauma, or significant bleeding proximal to the left subclavian artery. The diagnostic approach likely involves a composite evaluation, incorporating physical examination, extended Focused Assessment with Sonography for Trauma (eFAST), and portable chest radiography [22,30]. However, the quantification of the risk associated with REBOA deployment in the context of major chest trauma remains challenging due to a scarcity of high-quality data, reflecting a recurring impediment in establishing precise criteria for REBOA patient selection.

Technological advancements in cannulation techniques for REBOA

In recent years, notable advancements in materials and coatings employed in REBOA catheters have significantly enhanced performance and safety. Traditional catheters encountered challenges such as kinking, deformation, and thrombus formation, prompting the exploration of innovative solutions [31-34].

Progress in catheter materials includes the adoption of robust and flexible polymers, such as polyurethane blends and high-strength plastics. These materials enhance durability, minimizing the risk of catheter deformation during deployment and ensuring optimal functionality throughout the procedure. Teeter et al. [31] exemplify the advantages of smaller introducer sheaths, demonstrating reduced complications and enhanced ease of use during REBOA procedures.

Anti-thrombogenic coatings have become integral to modern catheter design, reducing thrombogenicity for smoother catheter insertion and mitigating thrombus formation along the catheter surface. Russo et al. [32] emphasize factors influencing the success and safety of REBOA procedures, including the importance of ABO-identical blood use in combat trauma.

The conventional application of aortic balloon occlusion, as performed by vascular surgeons for intraabdominal hemorrhage management, involves needle cannulation of the common femoral artery, insertion of a steerable wire under fluoroscopic guidance, and subsequent placement of a compliant balloon after upsizing. The Coda balloon (Cook Medical) initially used in trauma patients, required fluoroscopy for optimal deployment. Technological advancements led to wire-free balloon catheters, eliminating the need for fluoroscopy. Concerns regarding wire and device placement were addressed through portable digital X-rays, readily available in trauma bays [33].

Recent strides in catheter technology include the development of smaller diameter catheters, promising to revolutionize the REBOA landscape. Traditional catheters face limitations in smaller vascular anatomies, making smaller, more flexible catheters crucial for improved versatility and patient safety [34-37].

Smaller diameter catheters, designed for 7Fr or 4Fr sheaths, incorporate wire-free technology and feature a compliant balloon beneath curved tips with proximal and distal radiopaque markers for visualization on X-ray (Fig. 1). These compact devices are particularly suitable for emergent aortic balloon occlusion in cases of hemodynamic collapse [37].

Figure 1. COBRA-OS (Control System for Bleeding, Resuscitation, Arterial Occlusion) device: the first 4-french REBOA device developed and commercialized by Frontline Medical Technologies. (A) Schematic diagram of COBRA-OS. (B) 4-French sheath insertion kit holster. (C) COBRA-OS with syringe attached. RO, radiopaque.

Upon completing the primary survey, including chest or pelvis X-ray imaging and focused abdominal sonography for trauma, consideration for balloon occlusion arises when life-threatening hemorrhage below the diaphragm is identified. Rapid percutaneous cannulation, facilitated by small-bore common femoral arterial lines, proves faster than emergency department thoracotomy [35]. Some trauma centers adopt the practice of placing small-bore common femoral arterial lines in all hypotensive patients arriving at the trauma center, aligning with the clinical guideline established for REBOA use in 2013 [38].

Precision in optimal placement: navigating REBOA for bleeding focus

The consideration of REBOA becomes imperative in cases of abdominal or pelvic bleeding where the patient exhibits a transient or nonresponder status to conventional resuscitation methods. This intervention emerges as a compelling alternative to emergency department thoracotomy, especially when deployed in hypotensive patients before the onset of cardiac arrest. Balloon occlusion is strategically performed in either Zone 1 or Zone 3, aiming to stabilize the patient for definitive therapy [4].

Zone 1, spanning from the left subclavian artery’s origin to the diaphragm in the distal thoracic aorta, serves as the focal point for occlusion, facilitating inflow control for hemorrhage below the diaphragm. However, the temporal window for occlusion in Zone 1 is constrained by compromised blood flow to visceral organs and lower extremities. Zone 3, extending from the renal arteries to the aortic bifurcation, is identified for inflow occlusion in scenarios involving pelvic or groin junctional bleeding. Device placement is optimally executed in the resuscitation area, guided by portable digital X-ray imaging. External anatomical landmarks serve as proxies for measurements, determining the p-tip of the device to the sheath. In Zone 1 occlusion, the p-tip aligns with the sternal notch, and the catheter’s terminus extends to the length of the femoral access sheath, ensuring precise positioning of the balloon in Zone 1, above the diaphragm. Conversely, in Zone 3, the p-tip is situated at the xiphoid process, and the catheter is gauged to the femoral access sheath, culminating in the accurate deployment of the balloon in the distal aorta above the bifurcation. Rigorous confirmation of appropriate device placement is achieved through meticulous X-ray imaging before balloon inflation [39].

Catheter stability is a critical aspect of successful REBOA deployment, and recent advancements in catheter design aim to address this challenge comprehensively. The integration of stability features represents a pivotal step forward in minimizing the risks associated with catheter dislodgement, a concern with potentially severe consequences in trauma.

In current practice, stabilization during REBOA is often achieved through careful manual manipulation and anatomical considerations. However, the demand for more reliable stabilization has led to innovative solutions. External stabilizers provide additional support by securing the catheter externally, reducing the likelihood of unintended migration [31]. These stabilizers, often composed of radiolucent materials, contribute to procedural safety without compromising imaging quality.

Furthermore, intra-aortic hooks have emerged as an internal anchoring mechanism to enhance catheter stability. Saito et al. [33] have investigated the efficacy of these hooks in preventing migration during simulated REBOA procedures, showcasing promising results in terms of improved stability and reduced displacement risks. These developments underscore the commitment to refining catheter design for heightened procedural safety.

Full aortic occlusion is verified by improvements in SBP upon inflation, measured using upper extremity cuff or radial arterial line, or by noting the disappearance of the contralateral femoral pulse. Visualization of the balloon opposing the aortic wall is feasible in settings equipped with portable X-ray or fluoroscopy. Considering variations in occlusion volumes among patients, thoughtful inflation is essential, accounting for factors such as patient age, likely aortic diameter at the desired occlusion level, volume status, and vessel compliance [40].

To enhance visualization under radiographic imaging, the balloon is inflated with a contrast and saline mixture at a ratio of 1:4. Tactile feedback for inflation is cautioned against, given the exceptional compliance of the smaller devices’ balloons. While this compliance enhances safety, reliance on tactile feedback may lead to overinflation, posing risks of subsequent balloon or vessel rupture. Careful consideration of these procedural nuances is paramount to ensuring the efficacy and safety of REBOA deployment in the management of life-threatening hemorrhage.

Balancing balloon time and intervention: guidelines and innovations in the management of ischemia during REBOA

Upon achieving aortic occlusion, the expeditious attainment of definitive hemorrhage control assumes paramount significance due to the life-threatening consequences of ischemia below the occlusion level [41].

REBOA involves placing a balloon catheter in the femoral artery to control blood hemorrhage, typically performed in three zones (Zone 1, 2, 3). Zone 1 extends from the left subclavian artery to below the chest, used for controlling abdominal and pelvic bleeding. Zone 2, extending from below the chest to the level of the renal arteries, is less commonly used due to potential complications. Zone 3 spans from the renal arteries to near the aortic bifurcation, utilized for controlling pelvic and lower extremity bleeding. The selection of these zones depends on the location of hemorrhage, and their precise placement is guided by portable imaging. Trauma surgeons carefully consider anatomical and physiological factors to effectively manage life-threatening bleeding.

Recent expert consensus guidelines advocate limiting full aortic occlusion to less than 30 minutes at Zone 1 and less than 60 minutes at Zone 3. Consequently, full aortic occlusion is recommended only in proximity to a location where definitive hemostasis can be promptly administered.

Partial REBOA (p-REBOA) is a method of occluding only a certain volume of the aorta, and intermittent REBOA (i-REBOA) is a method of releasing the occlusion of the aorta intermittently according to a periodic time. These techniques were developed to reduce major complications, including ischemia, associated with total occlusion of the aorta. Although clinical studies have not yet conclusively demonstrated a significant benefit, they continue to be a hot topic for future technology.

In p-REBOA, the aortic balloon catheter is partially inflated to generate a 50% blood pressure gradient, thereby minimizing ischemic injury while still controlling hemorrhage [42]. Some animal models have associated p-REBOA with reduced rebound hypertension and lower serum lactate [41]. However, human studies do not uniformly indicate increased survival compared with traditional REBOA, and the existing literature is primarily composed of case studies.

Similarly, i-REBOA involves cyclical balloon inflation and deflation to permit transient distal flow between aortic occlusions. Animal models have not demonstrated a survival benefit with i-REBOA. In a solid organ injury model, i-REBOA was associated with decreased survival compared to standard REBOA.

However, when effective, i-REBOA was linked to decreased acidosis and markers of end-organ injury [43]. Partial REBOA devices are currently undergoing clinical trials, requiring a 7Fr introducer sheath and possessing the capability to program and transduce blood pressure above and below the balloon occlusion using two separate monitoring units [44]. A recently FDA-approved balloon catheter compatible with a 4Fr introducer sheath is available for clinical use, designed for partial and/or intermittent REBOA [37]. Ongoing research will focus on optimizing the utilization of these devices in specific populations and determining their efficacy compared to traditional REBOA techniques.

CONCLUSION

There is consensus from many studies that torso hemorrhage with hypotension is the primary criterion for REBOA. Technological advancements, such as wire-free catheters, enhance efficiency. Precision in device placement, considering Zones 1 and 3, is crucial, guided by portable digital X-ray imaging. Time limitations post-aortic occlusion are emphasized, with partial and intermittent REBOA showing promise but requiring further research. This comprehensive overview underscores the evolving landscape of trauma management, blending technological advancements with the need for precision in clinical practice. Ongoing exploration of devices and techniques will shape REBOA’s future, influencing efficacy and safety in specific populations.

ACKNOWLEDGMENTS

None.

AUTHOR CONTRIBUTIONS

All work was done by KMR.

CONFLICT OF INTEREST

No potential conflict of interest relevant to this article was reported.

FUNDING

None.

DATA AVAILABILITY

None.

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