The role of REBOA in the control of exsanguinating torso hemorrhage.
Biffl WL, Fox CJ, Moore EE.

The management of patients with exsanguinating torso hemorrhage is challenging. Emergency surgery, with the occasional use of resuscitative thoracotomy for patient in extremis, is the current standard. Recent reports of REBOA (resuscitative endovascular balloon occlusion of the aorta) have led to discussions about changing paradigms in the management of patients in both civilian and military are nas. We submit that broad and liberal application of this technique is premature given the current data and in light of historical experience. We propose an algorithm for the management of patients with exsanguinating torso hemorrhage, as well as a set of research questions that we feel can help clarify the role of REBOA in modern trauma care in a variety of trauma settings.

Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta.
Saito N, Matsumoto H, Yagi T, Hara Y, Hayashida K, Motomura T, Mashiko K, Iida H, Yokota H, Wagatsuma Y.
J Trauma Acute Care Surg. 2015 May;78(5):897-904.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is one of the ultimately invasive procedures for managing a noncompressive torso injury. Since it is less invasive than resuscitative open aortic cross-clamping, its clinical application is expected.
METHODS: We retrospectively evaluated the safety and clinical feasibility of REBOA (intra-aortic occlusion balloon, MERA, Tokyo, Japan) using the Seldinger technique to control severe hemorrhage. Of 5,230 patients admitted to our trauma center in Japan from 2007 to 2013, we included 24 who underwent REBOA primarily. The indications for REBOA were a pelvic ring fracture or hemoperitoneum with hemodynamically instability and impending cardiac arrest. Emergency hemostasis was performed during REBOA in all patients.
RESULTS: All 24 patients had a blunt injury, the median age was 59 (interquartile range, 41-71 years), the median Injury Severity Score (ISS) was 47 (interquartile range, 37-52), the 30-day survival rate was 29.2% (n = 7), and the median probability survival rate was 12.5%. Indications for REBOA were hemoperitoneum and pelvic ring fracture in 15 cases and overlap in 8 cases. In 10 cases of death, the balloon could not be deflated in 5 cases. In 19 cases in which the balloon was deflated, the median duration of aortic occlusion was shorter in survivors than in deaths (21 minutes vs. 35 minutes, p = 0.05). The mean systolic blood pressure was significantly increased by REBOA (from 53.1 [21] mm Hg to 98.0 [26.6] mm Hg, p < 0.01). There were three cases with complications (12.5%), one external iliac artery injury and two lower limb ischemias in which lower limb amputation was necessary in all cases. Acute kidney injury developed in all three cases, but failure was not persistent.
CONCLUSION: REBOA seems to be feasible for trauma resuscitation and may improve survivorship. However, the serious complication of lower limb ischemia warrants more research on its safety.
LEVEL OF EVIDENCE: Therapeutic/care management, level V.

Treatment of intra-abdominal haemorrhagic shock by Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA).
Delamare L, Crognier L, Conil JM, Rousseau H, Georges B, Ruiz S.

Anaesth Crit Care Pain Med. 2015 Feb;34(1):53-5

PURPOSE: Haemorrhagic shock is commonly encountered in the emergency room and is associated with high morbidity and mortality. For intra-thoracic and intra-abdominal bleeding, treatment usually requires either surgery or an interventional radiologic procedure. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has already been described for pelvic fractures and intra-abdominal haemorrhages. In this case report, we present the use of REBOA in a patient admitted for haemorrhagic shock due to a ruptured splenic artery aneurysm.
CASE REPORT: We describe the case of a 35-year-old male with suspected massive pulmonary embolism. Prior to diagnostic confirmation by CT-scan, the patient suffered several cardiac arrests. CT-scan revealed a massive haemoperitoneum secondary to a ruptured aneurysm of the splenic artery. Because of refractory hypotension despite maximal conventional therapy, we used REBOA before patient transfer to the operating room for splenectomy.
CONCLUSIONS: This case underlines the feasibility of REBOA and discusses its role in uncontrollable intra-abdominal haemorrhagic shock.

Survival of severe blunt trauma patients treated with resuscitative endovascular balloon occlusion of the aorta compared with propensity score-adjusted untreated patients.
Norii T, Crandall C, Terasaka Y.
J Trauma Acute Care Surg. 2015 Apr;78(4):721-8

BACKGROUND: Despite a growing call for use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for critically uncontrolled hemorrhagic shock, there is limited evidence of treatment efficacy. We compared the mortality between patients who received a REBOA with those who did not, adjusting for the likelihood of treatment and injury severity, to measure efficacy.
METHODS: We analyzed observational prospective data from the Japan Trauma Data Bank (2004-2011) to compare the mortality between adult patients who received a REBOA with those who did not. To adjust for potential treatment bias, we calculated the likelihood of REBOA treatment via a propensity score (PS) using available pretreatment variables (vital signs, age, sex, as well as anatomic and physiologic injury severity) and matched treated patients to up to five similar PS untreated patients. We compared survival to discharge between treated and untreated groups using conditional logistic regression and Cox proportional hazards regression.
RESULTS: Of 45,153 patients who met inclusion, 452 patients (1.0%) received REBOA placement. These patients were seriously injured (median Injury Severity Score [ISS], 35) and had high mortality (76%). Patients who did not receive a REBOA had significantly lower injury severity (median ISS, 13; p < 0.0001) and lower mortality (16%). After matching REBOA patients with controls with similar PSs for treatment, the crude conditional odds ratio of survival by REBOA treatment was 0.30 (95% confidence interval, 0.23-0.40).
CONCLUSION: REBOA treatment is associated with higher mortality compared with similarly ill trauma patients who did not receive a REBOA. The higher observed mortality among REBOA-treated patients may signal “last ditch” efforts for severity not otherwise identified in the trauma registry.
LEVEL OF EVIDENCE: Epidemiologic study, level III; therapeutic study, level IV.

Functional outcome after resuscitative endovascular balloon occlusion of the aorta of the proximal and distal thoracic aorta in a swine model of controlled hemorrhage.
Long KN, Houston R 4th, Watson JD, Morrison JJ, Rasmussen TE, Propper BW, Arthurs ZM.

Ann Vasc Surg. 2015 Jan;29(1):114-21

BACKGROUND: Noncompressible torso hemorrhage remains an ongoing problem for both military and civilian trauma. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has been characterized as a potentially life-saving maneuver. The objective of this study was to determine the functional outcomes, paraplegia rates, and survival of 60-min balloon occlusion in the proximal and distal thoracic aorta in a porcine model of controlled hemorrhage.
METHODS: Swine (Sus scrofa, 70-110 kg) were subjected to class IV hemorrhagic shock and underwent 60 min of REBOA. Devices were introduced from the left carotid artery and positioned in the thoracic aorta in either the proximal location (pREBOA [n = 8]; just past takeoff of left subclavian artery) or distal location (dREBOA [n = 8]; just above diaphragm). After REBOA, animals were resuscitated with whole blood, crystalloid, and vasopressors before a 4-day postoperative period. End points included evidence of spinal cord ischemia (clinical examination, Tarlov gait score, bowel and bladder dysfunction, and histopathology), gross ischemia-reperfusion injury (clinical examination and histopathology), and mortality.
RESULTS: The overall mortality was similar between pREBOA and dREBOA groups at 37.5% (n = 3). Spinal cord-related mortality was 12.5% for both pREBOA and dREBOA groups. Spinal cord symptoms without death were present in 12.5% of pREBOA and dREBOA groups. Average gait scores improved throughout the postoperative period.
CONCLUSIONS: REBOA placement in the proximal or distal thoracic aorta does not alter mortality or paraplegia rates as compared with controlled hemorrhage alone. Functional recovery improves in the presence or the absence of REBOA, although at a slower rate after REBOA as compared with negative controls. Additional research is required to determine the ideal placement of REBOA in an uncontrolled hemorrhage model to achieve use compatible with survival outcomes and quality of life.

Resuscitative endovascular balloon occlusion of the aorta: a gap analysis of severely injured UK combat casualties.
Morrison JJ, Ross JD, Rasmussen TE, Midwinter MJ, Jansen JO.
Shock. 2014 May;41(5):388-93

The control of torso and junctional zone bleeding in combat casualties is particularly challenging because of its noncompressible nature. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has demonstrated promise in translational large animal and early clinical series as an effective resuscitation and hemorrhage control adjunct. However, it is unknown what proportion of combat casualties has an injury pattern and clinical course that is amenable to REBOA deployment. The prospective UK Joint Theatre Trauma Registry was used to retrospectively identify all UK military personnel who has sustained a severe combat injury, defined as an Abbreviated Injury Scale of three or greater, in the course of 10 years. Patients were then divided into three groups based on Abbreviated Injury Scale injury pattern: no indications for REBOA, contraindications (mediastinal, cervical, and axillary hemorrhage), and indications (torso and pelvic hemorrhage). From a total of 1,317 patients, 925 (70.2%) had no indication, 148 (11.2%) had a contraindication, and 244 (18.5%) had an indication for REBOA. Within the group with indications for REBOA, there were 174 deaths: 79 at the point of wounding, 66 en route to hospital, and 29 in-hospital deaths. The median (interquartile range) time to death in patients dying en route was 75 (42-109) min, and the median prehospital time for casualties admitted to hospital was 61 (34-89) min. One-in-five severely injured UK combat casualties have a focus of hemorrhage in the abdomen or pelvic junctional region potentially amenable to REBOA deployment. The UK military should explore REBOA as a potential en route hemorrhage control and resuscitation adjunct.

Basic endovascular skills for trauma course: bridging the gap between endovascular techniques and the acute care surgeon.
Brenner M, Hoehn M, Pasley J, Dubose J, Stein D, Scalea T.
J Trauma Acute Care Surg. 2014 Aug;77(2):286-91

BACKGROUND: The use of catheter-based skills is increasing in the field of vascular trauma. Virtual reality simulation (VRS) is a well-established means of endovascular skills training, and potentially lifesaving skills such as resuscitative endovascular balloon occlusion of the aorta (REBOA) may be obtained through VRS.
METHODS: Thirteen faculty members in the Division of Trauma and Critical Care performed REBOA six times on the Vascular Intervention System Training Simulator-C after a didactic and instructional session. Subjects were excluded if they had taken a similar endovascular training course, had additional training in endovascular surgery, or had performed this procedure in the clinical setting. Performance metrics included procedural time; accurate placement of guide wire, sheath, and balloon; correct sequence of steps; economy of motion; and safe use of endovascular tools. A precourse and postcourse test and questionnaire were performed by each subject.
RESULTS: Significant improvements in knowledge (p = 0.0013) and procedural task times (p < 0.0001) were observed at the completion of the course. No correlation was observed with endovascular experience in residency, number of central and arterial catheters placed weekly, or other parameters. All trainees strongly agreed that the course was beneficial, and the majority would recommend this training to other acute care surgeons.
CONCLUSION: Damage control endovascular procedures can be effectively taught using VRS. Significant improvements in procedural time and knowledge can be achieved regardless of endovascular experience in residency, years since residency, or other parameters. Novice interventionalists (acute care surgeons) can add a specific skill set (REBOA) to their existing core competencies, which has the potential to improve the survival and/or outcomes of severely injured patients.

The inflammatory sequelae of aortic balloon occlusion in hemorrhagic shock.
Morrison JJ, Ross JD, Markov NP, Scott DJ, Spencer JR, Rasmussen TE.
J Surg Res. 2014 Oct;191(2):423-31

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a hemorrhage control and resuscitative adjunct that has been demonstrated to improve central perfusion during hemorrhagic shock. The aim of this study was to characterize the systemic inflammatory response associated and cardiopulmonary sequelae with 30, 60, and 90 min of balloon occlusion and shock on the release of interleukin 6 (IL-6) and tumor necrosis factor alpha.
MATERIALS AND METHODS: Anesthetized female Yorkshire swine (Sus scrofa, weight 70-90 kg) underwent a 35% blood volume-controlled hemorrhage followed by thoracic aortic balloon occlusion of 30 (30-REBOA, n = 6), 60 (60-REBOA, n = 8), and 90 min (90-REBOA, n = 6). This was followed by resuscitation with whole blood and crystalloid over 6 h. Animals then underwent 48 h of critical care with sedation, fluid, and vasopressor support.
RESULTS: All animals were successfully induced into hemorrhagic shock without mortality. All groups responded to aortic occlusion with a rise in blood pressure above baseline values. IL-6, as measured (picogram per milliliter) at 8 h, was significantly elevated from baseline values in the 60-REBOA and 90-REBOA groups: 289 ± 258 versus 10 ± 5; P = 0.018 and 630 ± 348; P = 0.007, respectively. There was a trend toward greater vasopressor use (P = 0.183) and increased incidence of acute respiratory distress syndrome (P = 0.052) across the groups.
CONCLUSIONS: REBOA is a useful adjunct in supporting central perfusion during hemorrhagic shock; however, increasing occlusion time and shock results in a greater IL-6 release. Clinicians must anticipate inflammation-mediated organ

Use of resuscitative endovascular balloon occlusion of the aorta in a highly lethal model of noncompressible torso hemorrhage.
Morrison JJ, Ross JD, Houston R 4th, Watson JD, Sokol KK, Rasmussen TE.
Shock. 2014 Feb;41(2):130-7

Noncompressible torso hemorrhage is a leading cause of death in trauma, with many patients dying before definitive hemorrhage control. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an adjunct than can be used to expand the window of salvage in patients with end-stage hemorrhagic shock. The aim of this study was to evaluate the effect of continuous and intermittent REBOA (iREBOA) on mortality using a highly lethal porcine model of noncompressible torso hemorrhage. Male splenectomized pigs (70-90 kg) underwent a laparoscopic liver injury (80% resection of left lobe) followed by a 10-min free-bleed period. Animals were then divided into three groups (n = 8) for a 60-min intervention phase (n = 8): continuous occlusion (cREBOA), iREBOA, or no occlusion (nREBOA). Groups then underwent whole blood resuscitation, damage control surgery, and further critical care. Endpoints were mortality and hemodynamic and circulating measures of shock and resuscitation. Systolic blood pressure (in mmHg) at the end
of the free-bleed period for cREBOA, iREBOA, and nREBOA was 31 ± 14, 48 ± 28, and 28 ± 17, respectively (P = 0.125). Following the start of the intervention phase, systolic blood pressure was higher in the iREBOA and cREBOA groups compared with the nREBOA (85 ± 37 and 96 ± 20 vs. 42 ± 4; P < 0.001). Overall mortality for the cREBOA, iREBOA, and nREBOA groups was 25.0%, 37.5%, and 100.0% (P = 0.001). Resuscitative endovascular balloon occlusion of the aorta can temporize exsanguinating hemorrhage and restore life-sustaining perfusion, bridging critical physiology to definitive hemorrhage control. Prospective observational studies of REBOA as a hemorrhage control adjunct should be undertaken in appropriate groups of human trauma patients.

A clinical series of resuscitative endovascular balloon occlusion of the aorta for hemorrhage control and resuscitation.
Brenner ML, Moore LJ, DuBose JJ, Tyson GH, McNutt MK, Albarado RP, Holcomb JB, Scalea TM, Rasmussen TE.
J Trauma Acute Care Surg. 2013 Sep;75(3):506-11

BACKGROUND: A requirement for improved methods of hemorrhage control and resuscitation along with the translation of endovascular specialty skills has resulted in reappraisal of resuscitative endovascular balloon occlusion of the aorta (REBOA) for end-stage shock. The objective of this report was to describe implementation of REBOA in civilian trauma centers.
METHODS: Descriptive case series of REBOA (December 2012 to March 2013) used in scenarios of end-stage hemorrhagic shock at the University of Maryland, R. Adams Cowley Shock Trauma Center, Baltimore, Maryland, and Herman Memorial Hospital, The Texas Trauma Institute, Houston, Texas.
RESULTS: REBOA was performed by trauma and acute care surgeons for blunt (n = 4) and penetrating (n = 2) mechanisms. Three cases were REBOA in the descending thoracic aorta (Zone I) and three in the infrarenal aorta (Zone III). Mean (SD) systolic blood pressure at the time of REBOA was 59 (27) mm Hg, and mean (SD) base deficit was 13 (5). Arterial access was accomplished using both direct cutdown (n = 3) and percutaneous (n = 3) access to the common femoral artery. REBOA resulted in a mean (SD) increase in blood pressure of 55 (20) mm Hg, and the mean (SD) aortic occlusion time was 18 (34) minutes. There were no REBOA-related complications, and there was no hemorrhage-related mortality.
CONCLUSION: REBOA is a feasible and effective means of proactive aortic control for patients in end-stage shock from blunt and penetrating mechanisms. With available technology, this method of resuscitation can be performed by trauma and acute care surgeons who have benefited from instruction on a limited endovascular skill set. Future work should be aimed at devices that allow easy, fluoroscopy-free access and studies to define patients most likely to benefit from this procedure.

A novel fluoroscopy-free, resuscitative endovascular aortic balloon occlusion system in a model of hemorrhagic shock.
Scott DJ, Eliason JL, Villamaria C, Morrison JJ, Houston R 4th, Spencer JR, Rasmussen TE.
J Trauma Acute Care Surg. 2013 Jul;75(1):122-8

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a potentially lifesaving maneuver in the setting of hemorrhagic shock. However, emergent use of REBOA is limited by existing technology, which requires large sheath arterial access and fluoroscopy-guided balloon positioning. The objectives of this study were to describe a new, fluoroscopy-free REBOA system and to compare its efficacy to existing technology. An additional objective was to characterize the survivability of 60 minutes of REBOA using these systems in a model of hemorrhagic shock.
METHODS: Swine (70-88 kg) in shock underwent 60 minutes of REBOA using either a self-centering, one component prototype balloon system (PBS, n = 8) inserted (8 Fr) and inflated without fluoroscopy or a two-component, commercially available balloon system (CBS, n = 8) inserted (14 Fr) with fluoroscopic guidance. Following REBOA, resuscitation occurred for 48 hours with blood, crystalloid, and vasopressors. End points included accurate balloon positioning, hemodynamics, markers of ischemia, resuscitation requirements, and mortality.
RESULTS: Posthemorrhage mean arterial pressure (mm Hg) was similar in the CBS and PBS groups (35 [8] vs. 34 [5]; p = 0.89). Accurate balloon positioning and inflation occurred in 100% of the CBS and 88% of the PBS group. Following REBOA, mean arterial pressure increased comparably in the CBS and PBS groups (81 [20] vs. 89 [16]; p = 0.21). Lactate peaked in the CBS and PBS groups (10.8 [1.4] mmol/L vs. 13.2 [2.1] mmol/L; p = 0.01) 45 minutes following balloon deflation but returned to baseline by 24 hours. Mortality was similar between the CBS and PBS groups (12% vs. 25%, p = 0.50).
CONCLUSION: This study reports the feasibility and efficacy of a novel, fluoroscopy-free REBOA system in a model of shock. Despite a significant physiologic insult, 60 minutes of REBOA is tolerated and recoverable. Development of lower profile, fluoroscopy-free endovascular balloon occlusion catheters may allow proactive aortic control in patients at risk for hemorrhagic shock and cardiovascular collapse.

Physiologic tolerance of descending thoracic aortic balloon occlusion in a swine model of hemorrhagic shock.
Markov NP, Percival TJ, Morrison JJ, Ross JD, Scott DJ, Spencer JR, Rasmussen TE.
Surgery. 2013 Jun;153(6):848-56

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique in trauma; however, the physiologic sequelae have not been well quantified. The objectives of this study were to characterize the burden of reperfusion and organ dysfunction of REBOA incurred during 30 or 90 min of class IV shock in a survivable porcine model of hemorrhage.
METHODS: After induction of shock, animals were randomized into 4 groups (n = 6): 30 min of shock alone (30-Shock) or with REBOA (30-REBOA) and 90 min of shock alone (90-Shock) or with REBOA (90-REBOA). Cardiovascular homeostasis was then restored with blood, fluid, and vasopressors for 48 h. Outcomes included mean central aortic pressure (MCAP), lactate concentration, organ dysfunction, histologic evaluation, and resuscitation requirements.
RESULTS: Both REBOA groups had greater MCAPs throughout their shock phase compared to controls (P < .05) but accumulated a significantly greater serum lactate burden, which returned to control levels by 150 min in the 30-REBOA groups and 320 min in the 90-REBOA group. There was a greater level of renal dysfunction and evidence of liver necrosis seen in the 90-REBOA group compared to the 90-Shock group. There was no evidence of cerebral or spinal cord necrosis in any group. The 90-REBOA group required more fluid resuscitation than the 90-Shock
group (P = .05).
CONCLUSION: REBOA in shock improves MCAP and is associated with a greater lactate burden; however, this lactate burden returned to control levels within the study period. Ultimately, prolonged REBOA is a survivable and potentially life-saving intervention in the setting of hemorrhagic shock and cardiovascular collapse in the pig.

Aortic balloon occlusion is effective in controlling pelvic hemorrhage.
Morrison JJ, Percival TJ, Markov NP, Villamaria C, Scott DJ, Saches KA, Spencer JR, Rasmussen TE.

J Surg Res. 2012 Oct;177(2):341-7

BACKGROUND: The objective of this study was to evaluate the efficacy of resuscitative endovascular aortic balloon occlusion (REBOA) of the distal aorta in a porcine model of pelvic hemorrhage.
METHODS: Swine were entered into three phases of study: injury (iliac artery), hemorrhage (45 s), and intervention (180 min). Three groups were studied: no intervention (NI, n = 7), a kaolin-impregnated gauze (Combat Gauze) (CG, n = 7), or REBOA (n = 7). The protocol was repeated with a dilutional coagulopathy (CG-C, n = 7, and REBOA-C, n = 7). Measures of physiology, rates of hemorrhage, and mortality were recorded.
RESULTS: Rate of hemorrhage was greatest in the NI group, followed by the REBOA and CG groups (822 ± 415 mL/min versus 11 ± 13 and 0.2 ± 0.4 mL/min respectively; P < 0.001). MAP following intervention (at 15 min) was the same in the CG and REBOA groups and higher than in the NI group (70 ± 4 and 70 ± 11 mm Hg versus 5 ± 13 mm Hg respectively; P < 0.001). There was 100% mortality in the NI group, with no deaths in the CG or REBOA group. In the setting of coagulopathy, the rate of bleeding was higher in the CG-C versus the REBOA-C group (229 ± 295 mL/min versus 20 ± 7 mL/min, P = 0.085). MAP following intervention (15 min) was higher in the REBOA-C than the CG-C group (71 ± 12 mm Hg versus 28 ± 31 mm Hg; P = 0.005).
There were 5 deaths (71.4%) in the CG-C group, but none in the REBOA-C group (P = 0.010).
CONCLUSION: Balloon occlusion of the aorta is an effective method to control pelvic arterial hemorrhage. This technique should be further developed as an adjunct to manage noncompressible pelvic hemorrhage.