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ORIGINAL ARTICLES

Resuscitative endovascular balloon of the aorta is feasible in penetrating chest trauma with major hemorrhage: Proposal of a new institutional deployment algorithm

Ordoñez, Carlos A. MD; Rodríguez, Fernando MD; Parra, Michael MD; Herrera, Juan Pablo MD, MPH; Guzmán-Rodríguez, Mónica MD, MSc; Orlas, Claudia MD; Caicedo, Edgar Yaset MD; Serna, José Julián MD; Salcedo, Alexander MD; del Valle, Ana Milena MD; Meléndez, Juan José MD; Angamarca, Edison MD; García, Alberto MD, MSc; Brenner, Megan MD, MS

Author Information
Journal of Trauma and Acute Care Surgery: August 2020 - Volume 89 - Issue 2 - p 311-319
doi: 10.1097/TA.0000000000002773
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Abstract

Hemorrhage is the most common preventable cause of death in trauma patients and up to 67% of these deaths are related to noncompressible torso hemorrhage (NCTH).1 Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging treatment option for NCTH,2–4 its use has spread all over the world with growing evidence on its utility as a bridge to definitive open and/or endovascular repair.5–8 According to the American College of Surgeons Committee on Trauma and the American College of Emergency Physicians the indications for REBOA use are as follows: (1) trauma patients in hemorrhagic shock who are unresponsive or transiently responsive to resuscitation with traumatic life-threatening hemorrhage below the diaphragm and (2) patients arriving in arrest from injury due to presumed life-threatening hemorrhage below the diaphragm.9 The Pan-American Trauma Society recently created their first REBOA consensus which goes even further to include scenarios, such as penetrating thoracic trauma and non–trauma-related scenarios, such as women with abnormal placentation and patients with postintubation hypotension.10–14 Resuscitative endovascular balloon occlusion of the aorta is currently being performed routinely in many trauma centers all around the world in specific scenarios, such as abdominal and pelvic trauma.15–18 On the other hand, thoracic trauma is currently considered a contraindication for REBOA use. This contraindication is substantiated by the fact that its use will increase and/or exacerbate the blood loss via the injury proximal to the point of aortic occlusion (AO).19–22 We have previously published our initial experience of seven cases where we combined the use of a REBOA in zone 1 with a median sternotomy (MS), six of them survived with no adverse neurologic outcomes or deficits.23 The purpose of this study was to describe the use of REBOA as a resuscitative adjunct in penetrating trauma (PT) and major thoracic hemorrhage at a Level I trauma center and to propose a new REBOA management protocol for blunt trauma (BT) and penetrating chest trauma.

MATERIALS AND METHODS

Study Design

This was a prospective, observational, single-center study. Patient demographics, clinical course, procedural conditions and in-hospital outcome data were collected and recorded at our Level I university-affiliated trauma center in Cali, Colombia: Fundacion Valle del Lili (FVL). The FVL-REBOA Registry was created in 2014 and was designed to prospectively collect all data on all adult (age, >14 years) trauma patients that underwent open and/or endovascular AO. The study was approved by our institutional ethic and institutional review board committee (protocol 778-2014). Data were collected from January 2015 to December 2019. When a REBOA was placed, the trauma surgeon immediately informed the research assistant who would access all clinical records and extract data in real time. Any missing data points was addressed immediately by the research assistant and recorded according to the trauma surgeons input. Patient demographics, trauma mechanism, vital signs, laboratory results, REBOA deployment details, clinical outcomes, Injury Severity Score (ISS) was recorded in the FVL-REBOA Registry using BDClinic Software. Patients who met criteria for REBOA placement included those in hemorrhagic shock (systolic blood pressure [SBP] < 90 mm Hg) unresponsive to resuscitation, regardless of mechanism. We defined a chest-Abbreviated Injury Scale (AIS) score of 4 or 5 as thoracic trauma.

REBOA Procedure

Arterial access was established via the common femoral artery (CFA) by open surgical cutdown or percutaneously via ultrasound guidance. A 7-Fr or 11-Fr introducer sheath was inserted (depending on the availability), through which the REBOA catheter was placed in either zone 1 or zone 3. The balloon was deflated and repositioned from zone 1 to zone 3 in cases of both severe abdominal and pelvic trauma24,25 after abdominal hemorrhage was controlled.

Our institutional REBOA procedural protocol consists of two surgical teams which are simultaneously activated. Upon arrival to the operating room (OR), one surgical team is in charge of the placement of the REBOA catheter, and the other is in charge of the surgical intervention required to control the primary source of hemorrhage. Arterial femoral access is done in the emergency department (ED) or the OR, and the REBOA catheter is advanced to the desired aortic zone in the OR, but the balloon is only inflated if the patient's hemodynamics requires it. Resuscitative endovascular balloon occlusion of the aorta is inflated in the OR prior to the surgical intervention required to control the primary source of hemorrhage. The main goal of the REBOA use in these patients was threefold: first to prevent the typical cardiovascular collapse that occurs during anesthesia induction; second, to allow time for the surgical control of the primary source of hemorrhage while providing proximal control; and third, to sustain central perfusion to the brain and heart.

Statistical Analysis

Data were analyzed with R version 3.5.3.26 Variables with normal distribution are reported as mean (SD), and any variable skewed from normal distribution is reported as median and interquartile range. Categorical data are presented absolute and relative frequency. Fisher's exact test was used to compare proportions among groups, and Mann-Whitney U test was used to compare nonnormally distributed variables. All comparisons were evaluated with paired two-tailed tests. Significance was set at p < 0.05 (two-sided).

RESULTS

Baseline Characteristics

A total of 56 patients underwent REBOA placement, 37 had PT and 19 BT. Thirty (81.1%) PT patients were from gunshot wounds. Table 1 summarizes the patient's baseline characteristics. The injury severity did not have difference among groups (PT: ISS median 25; interquartile range [IQR], 25–34 vs. BT: ISS median, 25; IQR, 25–37; p = 0.31). Severe chest injuries were most common in PT patients (PT AIS score 4–5, 20 [54.1%] vs. BT no, 3 [15.8%]; p < 0.001). All patients were hemodynamically unstable upon arrival to the ED, and they had similar proportions of cardiac arrest (PT: 4 [10.8%] vs. BT: 2 [10.5%]). The BT patients required more fresh frozen plasma units at 24 hours (PT: median, 6; IQR, 4–9 vs. BT: median, 9; IQR, 6–12; p = 0.04) and more platelets (PT: median, 6; IQR, 0–6 vs. BT: median, 6; IQR, 6–14; p = 0.03). Red blood cell transfusion was not different among groups (PT: median, 6; IQR, 4–10 vs. BT: median, 8; IQR, 6–14 packed red blood cell units; p = 0.23) (Table 1).

TABLE 1
TABLE 1:
Baseline Characteristics

Overall REBOA Placement

All PT patients had their REBOAs placed in the OR, and the groin access technique most common was the surgical cut down (PT: 31(83.8%) vs. BT: 14(73.7%)). Resuscitative endovascular balloon occlusion of the aorta was deployed in zone 1 for all PT patients and 16 (84.2%) patients in the BT group. Resuscitative endovascular balloon occlusion of the aorta was repositioned from zone 1 to zone 3 in 16 (43.2%) PT patients and 11 (68.7%) BT patients. The median (IQR) duration of REBOA placement in PT patients was 40 minutes (26–55 minutes) and 35 minutes (21–61 minutes) in BT patients (Table 1). All the catheters were placed by the attending trauma surgeon. Complications related to groin access, such as femoral artery thrombosis (PT, 3 [8.1%] vs. BT, 1 [5.3%]), femoral artery dissection (PT, 1 [2.7%] vs. BT: 0), extremity ischemia (PT, 0 vs. BT, 1 [5.3%]) were similar among groups. Four (21.1%) BT patients and 3 (8.1%) PT patients required dialysis. Two patients develop systematic complications, one had gastrointestinal bleeding and the other had bowel ischemia. None of patients required limb amputation or had balloon rupture. No adverse neurologic outcomes or deficits were observed in survivors (Table 1).

PT Outcomes

Lung injury was reported in 11 (29.7%) PT patients and of these, five of them had an American Association of Surgery for Trauma (AAST) of 3 or less and 6 had an AAST of 4 to 5. Eleven patients had liver injuries: two cases with an AAST 3 or less and 9 had an AAST of 4 to 5. Thoracic vascular injury was presented in 12 (32.4%) patients, and of these, the pulmonary vein (4 [10.8%]) and pulmonary artery (3 [8.1%]) were the most common injured vessels. Abdominal vascular injury was presented in 13 (35.1%) patients. Twelve (32.4%) PT cases underwent a MS, 4 (10.8%) had a thoracotomy and 25 (67.6%) required a laparotomy. Abdominal damage control surgery was indicated in 23 (62.2%) patients. Twelve (75%) patients with thoracic PT survived (Table 2).

TABLE 2
TABLE 2:
Penetrating Trauma Patients

Thoracic Trauma Outcomes

Twenty-three patients had thoracic trauma, 20 (86.9%) were men and associated abdominal injury was seen in 11 (47.8%). The median (IQR) SBP pre-REBOA was 50 mm Hg (38–62 mm Hg), and the median (IQR) SBP post-REBOA was 98 mm Hg (86–120 mm Hg). All REBOA were performed by the attending trauma surgeon and placed in zone 1. Nine (39.1%) of them were inflated in zone 1 and then lowered to zone 3. The median (IQR) time of REBOA balloon inflation was 45 minutes (27–54 minutes). Twelve (52.1) patients had a MS, 4 (17.3%) had a thoracotomy, and 7 (30.4%) had a MS and a laparotomy. Damage control thoracic strategy was used in 13 (56.1%) patients and 9 (39.1%) had open abdomens. The intraoperative deaths were 4 (17.3%) and the in-hospital deaths were 8 (34.7%). Survival rate distribution was not different than the predicted survival distribution by Trauma and Injury Severity Score (TRISS) (65.2% [44.8–81.1] vs. 63.3% [24.5–87.3]) (Table 3).

TABLE 3
TABLE 3:
Thoracic Trauma Patients

Clinical Outcomes

In-hospital mortality was 16 (28.6%), eight suffered PT and eight suffered BT (death: 8 [21.6%] 37 vs. 8 [42.1%] 19; p = 0.1). Four patients died during surgery, and all of them suffered PT. Ten patients died between 24 hours and 72 hours after arrival, of these, seven had BT. Finally, two patients died between 9 days and 68 days after arrival. A significant difference was observed in the Sequential Organ Failure Assessment (SOFA) scale at the fifth day between patients with PT versus those that suffered BT (SOFA PT: median, 3; IQR, 2–5 vs. BT: median, 8; IQR, 4–10), p = 0.03) (Table 4).

TABLE 4
TABLE 4:
Clinical Outcomes

DISCUSSION

To our knowledge, this is the first reported description of a large experience with REBOA in Latin-America, and in many aspects, it has been strikingly different from that of our colleagues in the United States27 and elsewhere around the world. Sixty-six patients percentage of our patients presented with PT compared with similar published series in which 7% to 15% of the patients suffered this mechanism of trauma.28,29 All our patients presented with severe shock with a high ISS that required massive transfusions in the first 6 hours upon presentation, and unlike any other reported data, the most frequent injury associated was major thoracic hemorrhage. Most of our REBOAs were deployed in the OR (94.6%), as opposed to the ED which is where most REBOA procedures occur in the United States.28–30

These reported differences can be explained by the epidemiological fact that our city and surrounding region suffers, unfortunately, from significantly higher rates of PT. Also, many of our patients presented with multiples wounds in which combined injuries were encountered (major vascular injuries associated with solid organ involvement). The solid organ lesions were lung (29.7%), spleen (8.1%), liver (29.7%), and kidney (10.8%) in PT patients. These types of injuries required immediate surgical intervention in the OR,31 while simultaneously, another part of the team deployed the REBOA. We have learned over time that NCTH patients require an immediate response and an early surgical intervention to manage major injuries, as a result, it has been determined at our institution that the management of these patients be conducted by two teams: the first decides and initiates the appropriate surgical intervention for the specific patient, and the second, simultaneously places and inflates the REBOA.

Three of our patients who had severe liver trauma, required the placement of a resuscitative endovascular balloon of the vena cava. These patients had severe shock and active bleeding, the use of resuscitative endovascular balloon of the vena cava concomitantly to REBOA, allowed the surgeons to repair the liver injury. Two of them survived, and there are literature reports and animal models that support this use.32–34 We believe that this could be a valuable tool for the management of severe liver trauma. Our initial REBOA catheters were placed via large introducer sheaths (11–14 Fr) with multiple site–related complications that required in many instances open repair upon sheath removal (eight patients), which is comparable with other previously reported case series.10,18 With the introduction of the newly designed 7-Fr catheter devices, our adverse event rate has decreased significantly as in previously reported studies.23,35 Our recommendation is that a 7-Fr sheath REBOA catheter should be the preferred device used at any center that is thinking of adopting this new technology.36

A striking difference that stands out is our current reported experience of REBOA in thoracic trauma. Currently, many cases in which a REBOA is being used occur in patients with associated thoracic injuries, and its use does not worsen them because of the distal AO (lung contusions, rib fractures, pneumothorax, and hemothorax). We have previously published a case series describing the use of REBOA in conjunction with an MS, and in that article, we postulated that this was a feasible and effective means of hemorrhage control in patients with chest trauma that arrived hemodynamically unstable.37 The current REBOA guideline establishes thoracic hemorrhage as a relative contraindication for its use, and there are no publications to date except for ours, on the use of REBOA in patients with isolated intrathoracic hemorrhage. There are several reasons behind this. One is the theoretical and potential harm that could occur with a proximal arterial injury above AO, which could increase the blood loss via the primary source of injury. However, in settings such as ours, where REBOA occurs in the OR and two surgical teams are available and working concomitantly, REBOA can be used as a critical resuscitation device rather than for proximal control of hemorrhage.

Based on our experience and a thorough review of the existing literature,37,38 our institutional REBOA deployment algorithm was formulated (Figs. 1–2). Our newly devised algorithms addresses in four easy to understand steps, how to manage a hemodynamically unstable patient suffering from NCTH from BT or PT and are, or are, not transient responders to initial resuscitation efforts, these steps are described in Table 5. A transient responder is a trauma patient that has bled between 20% and 40% of his or her total blood volume and requires immediate blood and blood product replacement, in contrast to a nontransient responder who is a trauma patient who has bled greater than 40% of his or her total blood volume and requires immediate blood and blood product replacement and an immediate intervention to stop internal bleeding.

Figure 1
Figure 1:
Penetrating Trauma Management Algorithm which includes a REBOA.
Figure 2
Figure 2:
Blunt Trauma Management Algorithm which includes a REBOA.
TABLE 5
TABLE 5:
REBOA Management Algorithm

This newly devised algorithm requires that the patient be transferred immediately to an operating or hybrid room where all these interventions can be performed by a multidisciplinary team which includes a lead trauma surgeon, a supporting general surgeon/fellow/or senior surgical resident, an anesthesiologist, and competent trauma/OR nurses.39 The goal is that one team deploys the REBOA while the other is starting the surgical intervention for the early control of ongoing hemorrhage. This new algorithm expands the existing indications for the use of REBOA. To our knowledge, we are the first group to recommend the deployment of a REBOA in penetrating chest trauma and the first to describe a case series of chest trauma patients treated successfully with this technique.35 This is only advisable in settings such as ours where the patient is immediately transported to the OR for REBOA and simultaneous thoracotomy/sternotomy for control of proximal hemorrhage. We consider that the combined use of REBOA for resuscitation and a MS or thoracotomy is a feasible and effective alternative of hemorrhage control in patients with NCTH secondary to penetrating chest trauma when resources allow.38–40 This statement challenges the current recommendations41,42 due to differences in hospital settings and resources, but our results suggest that there are potential benefits for its use in patients with penetrating thoracic trauma with associated hemodynamic instability.

Our overall survival rate was 71.4%, which was similar to the calculated predicted survival rate of 69.19%. Specifically, the survival rate of patients suffering from PT was 78.4%, compared with 57.9% in those suffering from BT. These differences are probably due to the complexity of injuries associated with BT, especially complex pelvic fractures which are associated with significant hemorrhage that require immediate intervention. The intraoperative mortality was 17.3%, and overall mortality was 34.7%. There was no significant difference between the true and the predicted (TRISS) survival rates. We are aware that these results are preliminary and must be interpreted with caution, and further studies are needed to confirm our preliminary findings.

Limitations

Our study contains inherent limitations associated with its observational and descriptive design. First, although an institutional algorithm was established, the final decision to place a REBOA relied solely on the trauma surgeon. Second, as in other series of patients undergoing REBOA placement, there was no control group to compare them with, and the sample size was small. Finally, our findings may not be reproducible at other trauma centers with limited resources, given that having two available surgical teams is not always feasible at many trauma centers around the world. Despite these limitations, we believe that our results will add to the growing knowledge on REBOA and be the foundation for future research.

CONCLUSION

Resuscitative endovascular balloon occlusion of the aorta is a novel technique for NCTH control that can be used safely in both BT and PT. Resuscitative endovascular balloon occlusion of the aorta is also feasible for use in major thoracic hemorrhage as a resuscitative measure while concurrent surgical proximal control is obtained. We have proposed a new REBOA deployment algorithm for the use of REBOA in NCTH.

AUTHORSHIP

C.A.O. had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. C.A.O., M.P., C.O., J.P.H., and F.R. participated in the study concept and design. E.Y.C., C.O., M.G.-R., J.J.M., E.A., A.M.dV., A.S., M.P., A.G., C.A.O. participated in the acquisition, analysis, or interpretation of data. E.Y.C., C.O., M.G.-R., J.P.H. participated in the drafting of the article. C.A.O., M.B., M.P., F.R. participated in the critical revision of the article for important intellectual content. E.Y.C., C.O. participated in the statistical analysis. C.A.O., F.R., A.G. participated in the administrative, technical, or material support. C.A.O. participated in the study supervision. All authors approved the final article.

DISCLOSURE

The authors declare no funding or conflicts of interest.

Ethical statement: This study was approved by Fundación Valle del Lili's IRB, under the protocol number 778-2014.

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Keywords:

Resuscitative endovascular balloon occlusion of the aorta; penetrating and blunt trauma; noncompressible torso hemorrhage; hemodynamically unstable; protocol implementation

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