Journal of Trauma and Acute Care Surgery, Publish Ahead of Print

DOI: 10.1097/TA.0000000000002553

Abdominal Aortic and Junctional Tourniquet versus Zone III Resuscitative

Endovascular Balloon Occlusion of the Aorta in a Swine Junctional

Hemorrhage Model

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David W. Schechtman, MD1 (david.w.schechtman.mil@mail.mil)

David S. Kauvar, MD1,2,3 (david.s.kauvar.mil@mail.mil)

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Rodolfo De Guzman2 (rodolfo.j.deguzman.civ@mail.mil)

I. Amy Polykratis2 (irene.a.polykratis.civ@mail.mil)

M. Dale Prince2 (malcom.d.prince.civ@mail.mil)

Bijan S. Kheirabadi, PhD2 (bijan.s.kheirbadi.civ@mail.mil)

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Michael A. Dubick, PhD2 (michael.a.dubick.civ@mail.mil)

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Department of Surgery, Brooke Army Medical Center, JBSA Fort Sam Houston, TX
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2
U.S. Army Institute of Surgical Research, JBSA Fort Sam Houston, TX
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Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD
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The authors have no conflicts of interest to disclose. Funding was provided by U.S. Army
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Medical Research Development Command. The views expressed herein are the private views of

the authors and are not to be construed as representing those of the Department of the Army,

Department of the Air Force or Department of Defense.

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Address correspondence to:

Dr Michael Dubick

US Army Institute of Surgical Research

JBSA Fort Sam Houston, TX 78234

210-539-3680

Michael.a.dubick.civ@mail.mil

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Presented in part at the 2018 Military Health System Research Symposium, August 20-23, 2018

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in Kissimmee, Florida.
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Abstract

Background: Junctional hemorrhage is a leading contributor to battlefield mortality. The

Abdominal Aortic and Junctional Tourniquet (AAJT) and infrarenal (Zone III) Resuscitative

Endovascular Balloon Occlusion of the Aorta (REBOA) are emerging strategies for controlling

junctional hemorrhage, with AAJT currently available in select forward deployed settings and

increasing interest in applying REBOA in the military pre-hospital environment. This study

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compared the hemostatic, hemodynamic, and metabolic effects of these devices used for

junctional hemorrhage control.

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Methods: Shock was induced in anesthetized, mechanically ventilated swine with a controlled

hemorrhage (20 ml/kg) and closed femur fracture followed by uncontrolled hemorrhage from a

partial femoral artery transection (40% total hemorrhage volume). Residual femoral hemorrhage
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was recorded during 60-min AAJT (n=10) or Zone III REBOA (n=10) deployment and the

arterial injury was repaired subsequently. Animals were resuscitated with 15mL/kg autologous

whole blood and observed for 6 hours.

Results: One animal in each group died during observation. Both devices achieved hemostasis
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with mean residual femoral blood loss in the AAJT and REBOA groups of 0.38±0.59 mL/Kg

and 0.10±0.07 mL/Kg (p=0.16) respectively, during the 60-min intervention. AAJT and REBOA
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augmented proximal blood pressure equally with AAJT allowing higher distal pressure than
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REBOA during intervention (p<0.01). Following device deflation, AAJT animals had transiently

lower mean arterial blood pressure than REBOA pigs (39±6 vs 54±11 mmHg p=0.01). Both

interventions resulted in similar degrees of lactic acidemia which resolved during observation.

Similar cardiac and renal effects were observed between AAJT and REBOA.

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Conclusions: AAJT and REBOA produced similar hemostatic, resuscitative and metabolic

effects in this model of severe shock with junctional hemorrhage. Both interventions may have

utility in future military medical operations.

Level of Evidence:

Study Design: Animal Model

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Key Words: Junctional hemorrhage; REBOA; abdominal tourniquet; non-compressible torso

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hemorrhage; military.
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Introduction

Hemorrhage is a leading cause of death on the modern battlefield. Most of the potentially

preventable mortality occurs prior to casualties reaching surgical care in a population with

junctional and non-compressible torso hemorrhage (NCTH). Developing field-capable strategies

for addressing prehospital junctional and NCTH in austere military prehospital settings remains a

major goal in combat casualty care.1,2 The Abdominal Aortic and Junctional Tourniquet (AAJT)

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is an approved currently available device that is intended to provide a field-capable external

abdominal vascular occlusion to control pelvic and inguinal junctional hemorrhage. When

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placed in the infrarenal aortic (Zone III) position, resuscitative endovascular balloon occlusion of

the aorta (REBOA) may have similar utility and has been proposed for prehospital use on the

battlefield.3-8
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Both Zone III REBOA and abdominal AAJT application work on the principle of

limiting arterial blood flow below the level of the device. REBOA occludes only the aorta and is

thought to allow some distal flow through collateral circulation as well as permitting continued

venous circulation.9 The AAJT is placed around the lower abdomen and a pneumatic bladder
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extrinsically compresses all underlying structures including the aorta, vena cava, collateral

vessels, and abdominal viscera. Both devices have been shown to successfully limit distal
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arterial flow and be physiologically tolerated for periods up to one hour.10-12 The AAJT is
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simply applied externally, in contrast to REBOA which requires obtaining invasive femoral

arterial access and intravascular guidance and inflation. AAJT can be applied relatively easily
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and reliably following minimal training while REBOA placement is currently beyond the

capabilities of most prehospital combat casualty care providers.14 Because of their differing

mechanisms of action, there may be significant differences in the physiology produced by AAJT

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and REBOA. The comparative hemorrhage control efficacy and physiologic effects of AAJT

and REBOA in a large animal junctional hemorrhage model relevant to military field conditions

have undergone minimal investigation. The aim of this study was to compare the effects of

AAJT and Zone III REBOA in such a model. We tested the null hypothesis that there is no

difference in survival with the AAJT compared to aortic zone III REBOA in a swine

uncontrolled junctional hemorrhage model. Secondary endpoints of interest were blood loss and

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hemodynamic and metabolic effects between the 2 groups.

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Materials and Methods

This study was performed using Yorkshire crossbreed sexually immature female swine

weighing 50.5 ± 3.6 kg. This research was conducted in compliance with the Animal Welfare
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Act, the implementing Animal Welfare Regulations, and the principles of the Guide for the Care

and Use of Laboratory Animals, National Research Council. The facility's Institutional Animal

Care and Use Committee approved all research conducted in this study. The facility in which

this research was conducted is fully accredited by AAALAC.

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Animal Preparation

Figure 1 presents the experimental protocol. Swine were fasted overnight prior to
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surgery with free access to water. Anesthesia was induced with an injection of 8mg/kg of
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tiletamine-zolazepam (Telazol, 8 mg/kg, Wyeth, Fort Dodge, IA) and inhaled 5% isoflurane

(Forane, Baxter Healthcare, Deerfield, IL) in 100% oxygen via facemask. Animals were

intubated, mechanically ventilated, and maintained under anesthesia with inhaled 1-3%

isoflurane (Draeger Medical Apollo Gas anesthesia system, Telford, PA).

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 Catheters were inserted via cut down technique: the right femoral vein catheter was used

for fluid administration and the left femoral artery catheter for controlled hemorrhage and

advancement of the REBOA balloon. Catheters were placed into the left carotid artery for blood

sampling above the intervention and in the left internal jugular vein for Swan-Ganz catheter

measurement of continuous cardiac output (Opti-Qvue CCO System, Abbott Laboratories, North

Chicago, IL now Hospira, Inc., Lake Forest, IL. Millar Mikro-Tip pressure transducer-tipped

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catheters (Millar Instruments, Inc. Houston, TX) were positioned at the aortic bifurcation and in

the aortic arch to measure blood pressure below and above the interventions. The right femoral

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artery was isolated and prepared for injury. Splenectomy was then performed via laparotomy to

prevent autotransfusion and the abdominal incision was surgically closed.

Injury and interventions

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A controlled hemorrhage of 20ml/kg was performed at 100mL/min using a peristaltic

pump. Shed blood was collected in blood bags containing anticoagulant and stored. Hemorrhage

was paused if mean arterial pressure (MAP) dropped below 15 mmHg and resumed when MAP

increased above 20 mmHg. Immediately after controlled hemorrhage was completed the
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midshaft of the left femur was percutaneously fractured using a bolt stunner to add a traumatic

injury (compound open displaced comminuted bone fracture with muscle contusion) to the
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hemorrhage model. Next, a 50% circumferential laceration was made to the right femoral artery
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using iris scissors and the artery allowed to bleed freely over a fifteen-minute period until

8ml/kg of blood was lost at which point the artery was temporarily clamped. This brought the

animal’s total blood loss to 40% of estimated blood volume. The REBOA balloon (n = 10, 9 Fr

CODA balloon catheter, Cook Medical, Bloomington, IN) was positioned above the aortic

bifurcation in Zone III and inflated until there was a loss of pulsatile distal blood pressure below

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the balloon. The AAJT (n = 10, Compression Works, Birmingham, AL) was placed around the

abdomen and inflated to 250mmHg. Supplemental Digital Content, Figure 1,

(http://links.lww.com/TA/B514) depicts the devices used in the study. The femoral artery was

then unclamped just after AAJT or REBOA placement and the devices were left in place for 60

minutes. (Figure 1)

Intravenous blood transfusion and primary femoral artery repair were initiated 5 minutes

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prior to slow deflation of the REBOA balloon or AAJT over three minutes. Up to 15mL/kg of

autologous whole blood was administered to maintain a MAP of 65 ± 2 mmHg in both groups.

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Animals were monitored for six hours following the arterial injury. If hypotension (MAP <40)

developed during the observation period an infusion of norepinephrine (Levophed, Hospira Inc.,

Lake Forest, IL) was started at 4 µg/hr and titrated to a MAP of 65mmHg. Intermittent boluses of
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10µg of norepinephrine were also administered if animal was near cardiovascular collapse.

Outcomes and Analysis

Measured outcomes were survival, blood loss, hemodynamic performance, and

laboratory parameters to assess for physiological status and end organ injury. A power analysis
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determined that an n=10 per group would be sufficient to show that both the AAJT and REBOA

will extend the median survival time beyond 2 hr in a hemorrhage model with untreated survival
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times of 30-60 min based on historical data. At the end of the 6-hour experimental period,
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surviving animals were euthanized by IV infusion of a veterinary euthanasia solution (Fatal-Plus,

Vortech Pharmaceuticals, Dearborn, MI). Data were analyzed by repeated measures ANOVA

using SPSS version 22 (IBM Corp., Armonk, NY). Data are presented below as mean ± standard

deviation (SD). Differences were considered significant when P  .05. T-test was used for

continuous variables and Log-Rank test was used for survival time analysis.

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Results

Injury and Survival

There were no significant differences in baseline physiology or laboratory values

between groups as shown in Table 1. Both the AAJT and REBOA groups had similar

hemodynamic responses to the injury as well as shown in Figures 2 and 3.

All animals survived the hemorrhage and intervention period. One animal from each

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group died during observation, with the death in the AAJT group occurring 100 min and the

REBOA death 287 min following injury. Both AAJT and REBOA produced near-complete

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hemostasis, with AAJT and REBOA groups having residual blood loss of 0.38  0.59 mL/Kg vs.

0.10 ± 0.07 mL/Kg respectively during the intervention (P = .16). Residual blood loss during

REBOA balloon inflation ranged from 0.04 to 0.23 mL/Kg while AAJT animals’ blood loss
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during intervention ranged from 0.04 to 1.97 mL/Kg.

Hemodynamic Performance

Hemorrhage produced a significant decrease in mean arterial blood pressure (MAP)

measured in the aortic arch (Fig 2). The decrease was reversed by applying either the AAJT or
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REBOA in the absence of fluid resuscitation. Immediately following deflation, the AAJT

group’s mean MAP decreased to 39  6 mmHg, significantly lower than the 54  11 seen in the
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REBOA group (P =0.01). This distinction was transient with the groups maintaining similar
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blood pressures throughout the remainder of the observation period. During the intervention, the

AAJT’s group mean MAP measured at the aortic bifurcation was significantly higher than the

REBOA group (p<0.001), but not differing from the aortic arch pressure. The distal MAP was

negligible in the REBOA group. (Figure 2) In neither group did the MAP return to baseline after

the limited volume resuscitation. Heart rate increased modestly in both groups during

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intervention, with no intergroup differences observed and no return to baseline following

resuscitation. (Figure 3) Central venous pressure (CVP) was significantly higher in the AAJT

than the REBOA group during the intervention period, no differences were seen during the

observation period. (Figure 4) Cardiac output fell about 50% with hemorrhage, remained low

during intervention and improved similarly with resuscitation in both groups, but not to baseline

levels.

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Laboratory Values

Hemorrhage produced a metabolic acidosis in both the AAJT and REBOA groups that

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worsened during the respective interventions. Lactate and creatine kinase levels were similar in

both groups throughout the experiment although significantly higher than baseline. Both groups

had peak lactate 120 minutes after injury (45 minutes following intervention), reaching 8.3 ± 3.3
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mmol/L in the AAJT group and 9.0 ± 5.6 mmol/L in the REBOA group (P = .74). Lactate levels

did not normalize with the shed blood resuscitation in either group by the end of the experiment

and improved more slowly in the REBOA group. Potassium levels rose in both groups with

hemorrhage and intervention, doing so more precipitously in the AAJT group. Peak potassium
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levels were seen in the AAJT animals at 90 minutes following injury but not until 360 minutes in

the REBOA group. At the end of observation, potassium levels were significantly higher in the
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REBOA than the AAJT group (P = .02). Creatine kinase levels rose continuously after device
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release in both groups, with numerically higher levels reached in the REBOA group by the end

of the observation period. (Table 2)

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Discussion

In this combat casualty care relevant swine model of severe shock and junctional

hemorrhage, AAJT and Zone III REBOA conferred similar survival, junctional arterial

hemostasis, and physiologic impact. Proximal aortic MAP was restored to pre-hemorrhage

values during both interventions and the potentially deleterious effects of ischemia-reperfusion

were partially mitigated with volume-limited whole blood resuscitation. Both techniques did

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contribute to significant physiologic derangements including lactic acidosis and hyperkalemia

during and after intervention, suggesting that both AAJT and Zone III REBOA should be time-

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limited due to the consequences of distal ischemia and metabolic derangements caused by

reperfusion.

Previous large animal studies of AAJT and Zone III REBOA have demonstrated the
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individual efficacy of these devices in managing junctional arterial injuries similar to those in our

model, though the two devices were not compared head to head.10,15 The similarity in outcomes

between the groups in this investigation confirms the previous finding that 1 hr AAJT or Zone III

REBOA application has similar hemostatic capabilities and hemodynamic impact in junctional
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arterial trauma.6 In their study Rall et al.6 demonstrated a higher carotid MAP and lactate levels

during AAJT than REBOA application. After the subsequent two hour observation period, no
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sustained differences in metabolic derangement or abdominal organ pathology were noted

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between the two interventions. The present findings, although not entirely consistent with the

results of Rall et al6, expand on those results with an extended post-intervention observation

period, which may be more relevant in a military prolonged field care scenario.

Though both AAJT and Zone III REBOA augmented proximal MAP similarly in the

current study, distal blood pressure differed significantly between the two treatments, as

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anticipated. Aortic balloon occlusion does not inhibit distal venous outflow preventing the lower

extremity venous sequestration that is likely to occur with AAJT’s nonselective extrinsic

abdominal compression. The finding of elevated distal aortic pressure likely reflects the static

fluid pressure measurement of “trapped” intra-arterial blood in the AAJT group as has been

postulated previously.6 Additionally, AAJT extrinsic pressure increases intraabdominal pressure

while REBOA does not have this effect, a distinction which may have directly affected distal

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intra-aortic pressure measurements. Extrinsic abdominal visceral compression by the AAJT also

likely had a negative effect on renal perfusion and venous outflow which likely contributed to

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the more severe elevation in serum potassium levels seen in the AAJT group shortly following

device deflation. This effect appeared to be maintained for the remainder of the 6 hr study with

the both groups having comparable laboratory and hemodynamic measurements within an hour
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of balloon deflation. Central venous pressure elevation in the presence of AAJT likely resulted

from a decrease in circulating venous capacitance caused be compression of the inferior vena

cava and all potential collateral pathways, while a similar effect was not seen with Zone III

REBOA application, which preserves the venous circulation. In this model, the CVP reached
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almost twice the baseline value during AAJT inflation. This may have clinical hemodynamic

significance in the face of resuscitation and hemorrhage from injuries proximal to the device.
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Despite both AAJT and Zone III REBOA achieving adequate femoral hemostasis and
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proximal MAP restoration, in the absence of resuscitation, treatment with both devices resulted

in progressive lactic acidosis which did not begin to resolve until after deflation and whole blood

resuscitation. This result again highlights the great degree of tissue ischemia and reperfusion

metabolic derangement produced by these two interventions in the face of limited volume blood

resuscitation.6,10,15 We did not observe the higher lactate levels in the AAJT group during and in

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the hour following intervention that have been reported by Rall, et al.6 This likely has to do with

the mechanisms by which the two treatments produce lactic acidosis. Both AAJT and REBOA

cause arterial compression and reduction or elimination of arterial perfusion distal to their site of

placement. AAJT can also cause venous congestion and visceral ischemia as a result of direct

extrinsic compression, the degree of which may be related to the inflation pressure of the device.

Thus, the potential tissue crushing effects of the AAJT as a circumferential compression device

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should be considered in further study. For example the AAJTs in the Rall study were inflated to

300 mmHg, while we inflated the AAJT to 250 mmHg, with the former possibly causing a

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greater degree of visceral ischemia resulting in transiently higher lactate levels.6

The similar outcomes observed in this model between AAJT and Zone III REBOA

suggest that the selection of the most appropriate device for fielding in the austere battlefield
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setting should be based on other factors. Portability, ruggedness, simplicity of use, provider skill

level, and potential complication profile are all important considerations. In general, while

requiring significantly more training and skill to place, REBOA is a generally more flexible

intervention, with the advantage of providing more proximal aortic occlusion to serve as a
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resuscitation adjunct in patients with sub-diaphragmatic NCTH. In the lower trunk, AAJT is

indicated only for pelvic and severe inguinal hemorrhage. While in place, REBOA also offers
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the opportunity for invasive monitoring and surgical procedures on the abdomen that would be

precluded by the presence of an AAJT. The complication profiles of AAJT and Zone III
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REBOA are broadly similar, with most major potential complications resulting from prolonged

profound tissue ischemia. However, arterial access and proper positioning of the REBOA

balloon will require extensive training, especially if recommended by the military for use in

austere environments. The incidence and severity of these complications with AAJT are directly

related to the duration of treatment and while up to one hour application of the device appears to

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be safe in a number of animal models, longer occlusion times have been associated with severe

metabolic derangement and paraplegia.10,16 Zone III REBOA appears generally safer than AAJT

for up to one hour, but device-specific complications related to arterial access and balloon

placement are potentially severe.17

The principal limitation of this study is that it was designed to simulate a military combat

casualty care field environment and its overall findings are not generalizable to many civilian

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trauma scenarios. The model simulated a resource poor field care environment with limited or

no resuscitation during application of AAJT or Zone III REBOA and an observation period

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similar to that which might be seen at a forward surgical facility where there continue to be

constraints on resuscitation and critical care resources. Additionally, the animals in this study

were mechanically ventilated throughout the experiment and we were not able to observe the
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effect each device had on spontaneous respiratory efficiency. Despite these limitations, these

findings provide additional insight into the hemodynamic and metabolic effects of AAJT and

Zone III REBOA and will be of interest to military medical stakeholders.

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Conclusion

Both AAJT and REOBA augmented proximal MAP and promoted femoral hemostasis in
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this military-relevant model of junctional hemorrhage, tissue injury and severe shock. The

physiologic impacts of AAJT and Zone III REBOA when used for one hour were similar with no
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clear superior device for this injury pattern. However, slight differences in the metabolic

responses observed between these devices highlight the ischemia induced and may reflect the

unique application mode of each device. Further translational study of these devices will shed

light on their utility in various injury patterns and clinical settings.

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Author Contributions

David W. Schechtman, MD: Data analysis and interpretation, manuscript drafting.

David S. Kauvar, MD: Data analysis and interpretation, manuscript drafting and revision.

Rodolfo De Guzman: Performed experiments, data collection and analysis.

I. Amy Polykratis, BS: Experimental design, performed experiments, data collection.

M. Dale Prince, BS: Experimental design, performed experiments, data collection.

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Bijan S Kheirabadi, PhD: Literature search, experimental design, data interpretation, manuscript

revision.

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Michael A. Dubick, PhD: Literature search, experimental design, supervised experiments, data

analysis and interpretation, manuscript revision.

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Legend to Figures

Figure 1: Flow diagram of experimental procedure.

Figure 2: Mean Arterial Pressure above and below the device. -30 min represents baseline and

time 0 represents the splenic injury. Devices were inflated from 15-75 min. 45 and 75 min time

points above the balloon significantly higher than values below the balloon (p<0.05. Data

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expressed as mean + SD of 10 animals per group.

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Figure 3: Heart Rate. Devices were inflated from 15-75 min. Data expressed as mean + SD of 10

animals per group.

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Figure 4: Central Venous Pressure. Devices were inflated from 15-75 min. 45 min and 75 min

time points in AAJT group significantly higher than REBOA group (p<0.05). . Data expressed as

mean + SD of 10 animals per group.

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Table 1: Baseline Values from Swine Randomized to Treatment with REBOA or the AAJT

Table 1 - Baseline Characteristics

REBOA AAJT P-Value
Weight (Kg) 50.8 ± 3.6 50.3 ± 3.7 0.805
MAP - Carotid (mmHg) 73.4 ± 8.2 69.6 ± 7.0 0.278
MAP - Distal Aorta
76.4 ± 8.1 75.2 ± 7.7 0.735
(mmHg)

D
Heart Rate (BPM) 121 ± 14 110 ± 18 0.118
Hematocrit (Percent) 30.1 ± 3.0 28.6 ± 2.4 0.217
Lactate (mmol/L) 1.8 ± 0.8 1.7 ± 0.3 0.418

TE
Controlled Hemorrhage
20.1 ± 0.1 20.1 ± 0.1 0.807
(mL/Kg)
Total Uncontrolled
8.3 ± 0.5 8.5 ± 0.7 0.549
Hemorrhage (mL/Kg)
N=10/group, MAP (Mean Arterial Blood Pressure), Mean ± SD
EP
C
C
A

24

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

 Table 2: Laboratory Values from Hemorrhaged Swine treated with either REBOA or the AAJT

Table 2: Laboratory Values

Time(min) Lactate (mmol/L) Creatine kinase (U/L) Potassium (mmol/L)
REBOA AAJT P-Value REBOA AAJT P-Value REBOA AAJT P-Value
Baseline 1.8 ± 0.3 1.7 ± 0.3 0.418 566 ± 294 476 ± 121 0.388 4.0 ± 0..3 4.0 ± 0.2 0.747

D
15 3.2 ± 1.3 2.8 ± 0.8 0.358 523 ± 219 461 ± 128 0.446 4.3 ± 0.2 4.3 ± 0.3 0.889
45 4.6 ± 2.2 4.2 ± 1.5 0.655 571 ± 256 498 ± 140 0.443 4.2 ± 0.3 4.4 ± 0.4 0.437
75 6.4 ± 3.9 6.2 ± 3.5 0.936 594 ± 250 502 ± 134 0.319 4.5 ± 0.4 4.9 ± 1.1 0.215

TE
90 7.6 ± 3.8 8.3 ± 2.5 0.643 616 ± 259 493 ± 152 0.219 4.8 ± 0.6 5.5 ± 0.9 0.036
120 9.0 ± 5.6 8.3 ± 3.3 0.737 704 ± 246 676 ± 185 0.784 4.5 ± 0.9 4.5 ± 0.3 0.781
180 7.7 ± 4.9 6.4 ± 3.8 0.526 1096 ± 448 992 ± 327 0.578 5.1 ± 0.8 4.8 ± 0.3 0.247
240 6.4 ± 4.4 5.0 ± 3.9 0.463 1510 ± 923 1425 ± 424 0.805 5.7 ± 1.14 4.9 ± 0.3 0.082
360 4.7 ± 3.7 3.3 ± 2.9 0.388 4578 ± 4972 2299 ± 937 0.211 6.1 ± 0.8 5.3 ± 0.4 0.016
N=10/group, Dashed line signifies AAJT or REBOA inflation/deflation. Mean ± SD
EP
C
C
A

25

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Supplemental Digital Content, Figure 1

D
TE
EP
C
C
A

26

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.