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Preperitoneal balloon tamponade and resuscitative endovascular balloon occlusion of the aorta

Alternatives to open packing for pelvic fracture-associated hemorrhage

Do, Woo S. MD; Forte, Dominic M. MD; Sheldon, Rowan R. MD; Weiss, Jessica B. MD; Barron, Morgan R. MD; Sokol, Kyle K. MD; Black, George E. MD; Hegge, Sara R. DVM, MPH; Eckert, Matthew J. MD; Martin, Matthew J. MD

Journal of Trauma and Acute Care Surgery: July 2019 - Volume 87 - Issue 1 - p 18–26
doi: 10.1097/TA.0000000000002266
2019 EAST PODIUM PAPER
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Editor's Choice

BACKGROUND The objective of this study was to compare the efficacy of preperitoneal balloon tamponade (PPB), resuscitative endovascular balloon occlusion of the orta (REBOA), and open preperitoneal packing (OP) in a realistic animal model of pelvic fracture-associated hemorrhage.

METHODS Thirty-nine swine underwent creation of open-book pelvic fracture and iliac vascular injury. Animals were randomized to no intervention (n = 7), OP (n = 10), PPB (n = 9), zone 1 REBOA (n = 7), and zone 3 REBOA (n = 6) at a mean arterial pressure less than 40 mm Hg from uncontrolled hemorrhage. Primary outcome was survival at 1 hour. Secondary outcomes included survival in the immediate 10 m following intervention reversal, peak preperitoneal pressure (PP), blood loss, bleed rate, and peak lactate.

RESULTS Prior to injury, no difference was measured between groups for weight, hemodynamics, lactate, and hematocrit (all p = NS). The injury was uniformly lethal without intervention, with survival time (mean) of 5 m, peak PP of 14 mm Hg, blood loss of 960 g, bleed rate of 450 g/m, and peak lactate of 2.6 mmol/L. Survival time (m) was extended to 44 with OP, 60 with PPB, and 60 with REBOA (p < 0.01). Peak PP (mm Hg) was 19 with OP, 23 with PPB, 10 with zone 1 REBOA, and 6 with zone 3 REBOA (p < 0.05). Blood loss (g) was 850 with OP, 930 with PPB, 610 with zone 1 REBOA, and 370 with zone 3 REBOA (p < 0.01). Peak lactate (mmol/L) was 3.3 with OP, 4.3 with PPB, 13.4 with zone 1 REBOA, and 5.3 with zone 3 REBOA (p < 0.01). Only 33% of zone 1 REBOA animals survived the initial 10 m after balloon deflation, compared to 60% for OP, 67% for PPB, and 100% for zone 3 REBOA (p < 0.01).

CONCLUSION Preperitoneal balloon tamponade and zone 3 REBOA are effective alternatives to OP in this animal model of lethal pelvic fracture-associated hemorrhage. Zone 1 REBOA extends survival time but with high mortality upon reversal.

From the Departments of Surgery and Clinical Investigations (W.S.D., D.M.R., R.R.S., J.B.W., M.R.B., K.K.S., G.E.B., S.R.H., M.J.E., M.J.M.), Madigan Army Medical Center, Tacoma, Washington; and Trauma and Emergency Surgery Service (M.J.M.), Legacy Emanuel Medical Center, Portland, Oregon

Address for reprints: Matthew J. Martin, MD, Medical Corps, US Army Trauma and Emergency Surgery Service Legacy Emanuel Medical Center, 2801 North Gantenbein Avenue Portland, OR 97227; email: traumadoc22@gmail.com.

Meeting Presentation: 32nd EAST Annual Scientific Assembly, January 16, 2019.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.jtrauma.com).

Online date: April 25, 2019

Modern series of severe pelvic fractures have established a mortality rate exceeding 30% in well-resourced Level I trauma centers, and even higher rates (up to 85%) with blast injuries in the battlefield setting.1–4 For this critical subset of patients, current guidelines recommend immediate open preperitoneal packing (OP) and/or interventional radiology (IR) angiography.5–7 Select institutions have championed concurrent external fixation and OP with secondary IR.8–11 Still others have demonstrated success with minimally invasive techniques like resuscitative endovascular balloon occlusion of the aorta (REBOA) with or without IR.12 Outside of well-resourced centers, however, many trauma teams must combat pelvic fracture-associated hemorrhagic shock with severe limitations to their resources, infrastructure, or multidisciplinary capabilities. These limitations have propelled interest in developing techniques to provide rapid, early pelvic tamponade to extend the window of hemodynamic stability during transit to more definitive therapy.

One possible solution was inspired by a common minimally invasive general surgical procedure: the totally extraperitoneal laparoscopic inguinal hernia repair. Surgeons performing this procedure commonly utilize a balloon that is placed into the preperitoneal space and inflated to create an adequate working area to perform the hernia repair. Our group recently published the results of a small pilot study exploring the effectiveness of preperitoneal balloon tamponade (PPB) versus OP in a swine pelvic hemorrhage model that demonstrated promising results with the PPB.13 However, this experiment was limited by the small size, the lack of any associated pelvic fracture, and only compared PPB to OP. There are now multiple products or procedures that have been utilized or proposed to treat ongoing hemorrhage in the preperitoneal space. In addition to the options of PPB and OP, REBOA is emerging as a promising modality to address noncompressible truncal hemorrhage (NCTH) in both animal models14–19 and select human patients.20–27 In addition to the scarce clinical data, no large animal studies to date have tested REBOA in the setting of lethal pelvic fracture-associated hemorrhage.

In preparation for this study, our laboratory created a reproducible and highly lethal swine model combining an “open book” pelvic fracture with major arterial and venous pelvic hemorrhage. Our primary objective was to evaluate the efficacy of these four interventions (OP, PPB, zone 1 REBOA, and zone 3 REBOA) for enhancing survival after lethal pelvic fracture-associated hemorrhage. Additional objectives were to evaluate and compare the impacts of each intervention on hemodynamics, extraperitoneal tamponade pressures, blood loss, markers of ischemia-reperfusion, and any associated complications. We hypothesized that OP, PPB, zone 1 REBOA, and zone 3 REBOA would be equivalent in terms of survival, hemodynamics, extraperitoneal pressures, blood loss, ischemia-reperfusion, and associated complications.

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METHODS

This study was performed as part of a Department of Defense funded project to examine a variety of options for initial control of major pelvic-fracture associated hemorrhage in a prolonged field care setting (Fig. 1). The project was divided into two main phases, with the first being a comparison of PPB to two other manual compression methods—open packing and the recently fielded abdominal aortic junctional tourniquet device.28 This study represents the second phase of that project, comparing the PPB and OP with the endovascular hemorrhage control options of REBOA placement in either zone 1 or zone 3. As with all prior iterations, this study was performed at an Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited facility following protocol approval by the Institutional Animal Care and Use Committee. This protocol was designed to study a Food and Drug Administration (FDA) approved device (SpaceMaker Pro pelvic tissue expander balloon [Covidien Ltd, Ireland]) for a non–FDA-approved indication.

Figure 1

Figure 1

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Phase 1: Preparation

Forty-four castrated male Yorkshire swine weighing 35 kg to 55 kg were housed at the facility for at least 3 days of accommodation and fed ad libitum under the supervision of veterinary staff before usage. Animals were premedicated with atropine sulfate (0.04 mg/kg intramuscularly) and buprenorphine (0.01–0.05 mg/kg intramuscularly), and sedated with ketamine (15–33 mg/kg) and midazolam (400–500 μg/kg). Endotracheal intubation (5.0–7.5 ID tube) was performed by veterinary staff. General anesthesia was maintained using isoflurane (1–3%).

First, a central neck cutdown was performed. The left carotid artery was cannulated with a 5-Fr Micropuncture kit and right external jugular vein cannulated with a 9-Fr Cordis catheter to measure invasive arterial and venous pressures. A Swann-Ganz catheter was then placed through the 9-Fr Cordis catheter into the pulmonary artery and advanced until an adequate wedge pressure tracing was obtained.

Next, a limited groin cutdown was performed through a 6-cm incision along the right inguinal crease. This was deepened through the soft tissue until the femoral vessels were encountered. The femoral vessels were traced proximally to the point of emergence deep to the inguinal ligament. The inguinal ligament was retracted cephalad, facilitating access to the external iliac artery and vein. Using the Seldinger technique, 16-Fr vascular dilators were positioned in the iliac vessels. The use of dilators yielded an injury of reproducible size to the anterior wall of the artery and vein. The skin incision was then closed in a running fashion, from medial to lateral, leaving a tail at the lateral aspect, which could be tightened after pulling the vascular dilators.

Attention was then turned to the pelvis, where a midline cutdown was performed. The pubic symphysis was divided with a Lebsche knife. An open-book (Young-Burgess Anterior-Posterior Compression Type III) pelvic fracture was created using a Finochietto retractor. Seven rotations of the Finochietto reproducibly yielded an approximate 3-cm anterior diastasis and gross instability about the sacroiliac joints and posterior ligaments (by palpation and manual mobility check). Radiodense tacks were placed at the cut edges of the symphysis to facilitate identification on subsequent fluoroscopy. A 2.5-cm radiolucent (plastic) spacer was placed between the cut edges of the symphysis. A pressure transducer (5-Fr single-lumen catheter connected to an arterial line setup) was placed in the pelvic (extraperitoneal) space. The space was then inspected to confirm no immediate active hemorrhage due to the fracture procedure, which was confirmed in all animals. The skin was closed in a running fashion. The left proximal superficial femoral artery was then accessed percutaneously under ultrasound guidance. A 7-Fr introducer was placed using the Seldinger technique.

Significant care was taken to avoid violation of the peritoneum, which could interfere with (1) accurate compartment pressure measurements, (2) uniform preperitoneal dissection, and (3) post mortem assessment of peritoneal disruption. For this reason, select techniques described in other swine studies (i.e., splenectomy and suprapubic catheter placement) were intentionally avoided. According to recent evidence, splenectomy is not necessary and may confound results when using a fixed endpoint model with a moderate rate of acute hemorrhage and a mean arterial pressure (MAP) of 40 mm Hg.29 Of 44 swine, two experienced complications that resulted in their exclusion from the study after consultation and approval of the assigned study veterinarian.

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Phase 2: Intervention Setup

Animals (n = 42) were then randomized into five arms (control, OP, PPB, zone 1 REBOA, and zone 3 REBOA) using a standard block-randomization scheme. Randomization was performed using a random number generator for each batch of swine. If one study arm reached maximal capacity (n = 10), the excess animals were reallocated equally to the remaining study arms. Three REBOA balloons ruptured during the course of the experiments, and these were excluded from further analysis, making up the final cohort of 39 animals (Fig. 1).

An a priori power analysis was performed to calculate sample sizes (80% power and alpha = 0.05 with two-sided test) based on the effect sizes demonstrated in our prior pilot study. This analysis showed that four to six animals would be required to detect a difference in the primary outcome (survival time) between control versus OP and control versus PPB, respectively. Additionally, we calculated that nine animals would be required to detect a similar difference in the primary outcome (survival time) between OP versus PPB.

Animals in the control group received no further intervention. In the OP group, a 10-cm vertical incision was made just lateral to and above the pubic symphysis. This was carried down onto the right anterior rectus sheath, which was incised. A combination of blunt and sharp dissection was used to carefully develop the plane between the anterior sheath and rectus muscle, all the way until the preperitoneal space was exposed. The dissection was lateral enough that the vascular dilator could be felt just deep to one's fingers near the inguinal ligament. The fascia was then temporarily closed with Allis clamps and skin closed with towel clamps.

In the PPB group, a 2-cm transverse incision was made just lateral to the right side of the linea alba approximately 15 cm superior to the pubic symphysis (or one handbreadth inferior to the urethral meatus) and deepened to the anterior rectus sheath. The anterior rectus sheath was then incised and the plane between the sheath and rectus muscle was developed bluntly with simple finger dissection. As the peritoneum is flimsier in 35 kg to 55 kg swine than in adult humans, we found this technique to facilitate easier entry of the balloon into the preperitoneal space than the conventional method of developing the plane posterior to the rectus from a more cephalad position, such as the level of the umbilicus. The Spacemaker (with balloon deflated) was then inserted and secured to the skin using towel clamps. In the REBOA group, a Prytime REBOA catheter was introduced through the 7-Fr sheath previously placed in the left superficial femoral artery. The catheter was secured to the skin at 45 cm for zone 1 and 25 cm for zone 3. Baseline measurements were then obtained (see Table 1, http://links.lww.com/TA/B370 for variables). Immediately before injury, we confirmed that the vascular dilators were patent (i.e., easy to flush and draw back blood).

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Phase 3: Injury and Intervention

Start time for all experiments was designated as the initiation of hemorrhage. Therefore, each experiment began the moment we pulled the vascular dilators. Resuscitation (up to a 250-mL bolus of Hextend, in accordance with US militaryTactical Combat Casualty Care guidelines)30–32 was initiated at a trigger of MAP less than 40 mm Hg. Resuscitation was halted if MAP exceeded 40 mm Hg. An MAP of 40 mm Hg was also our trigger to deploy whichever intervention had been prepositioned. For animals in the OP arm, we packed with three standard nonhemostatic laparotomy pads (as recommended in the ASSET course) followed by closure of the rectus fascia and skin. The use of three packs deliberately targeted the site of injury (the right hemipelvis) but did not fill the contralateral side. For animals in the PPB arm, we inflated the balloon with 30 standard manual pumps, and full inflation was also confirmed visually by external inspection of the suprapubic abdominal wall. For animals in the REBOA arms, we inflated the balloon with 8 mL of saline.

Measurements (see Table 1, http://links.lww.com/TA/B370 for full list of variables) were obtained at 5 minutes, 30 minutes, and 60 minutes. Heart rate and MAP were additionally recorded every 10 seconds until 5 minutes, and then every minute until 10 minutes. We euthanized at a MAP of 20 mm Hg or 60 minutes postinjury, whichever occurred first.

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Phase 4: Intervention Reversal

In a subset of animals (three OP, three PPB, seven zone 1 REBOA and six zone 3 REBOA), we did not euthanize at 60 minutes to determine survival in the immediate 10 minutes following intervention reversal. At 60 minutes (while measurements were being collected), we opened the pelvic incision and extracted all blood and clot. Once measurements were obtained, we reversed the intervention (i.e., deflated the PPB/REBOA balloon or removed the OP packs) slowly over 1 minute. We recorded heart rate and MAP every 30 seconds for 10 minutes. Finally, we obtained additional laboratories at 10 minutes (or right before euthanasia if MAP fell below 20 mm Hg before 10 minutes.

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Phase 5: Post Mortem

Following euthanasia, laparotomy was performed on all animals to assess for peritoneal violation, intraperitoneal blood, and complications such as intra-abdominal organ injury. Blood and clot were extracted from the pelvic space and measured, both as estimated blood loss (mL) and total blood loss (TBL) by weight (g). Bleed rate (g/min) was calculated as TBL divided by survival time. Intravenous (IV) fluid consumption (ml/min) was calculated as total volume of Hextend divided by survival time.

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Statistical Analysis

Statistical analysis was performed using IBM SPSS version 21. Primary and secondary endpoints were compared between groups using χ2 testing for categorical variables and ANOVA with post hoc testing (Bonferroni and two-sided Dunnett using the control arm as the comparison group) for continuous variables. Survival was compared between groups with Kaplan-Meier curves using χ2 (log rank) testing (Fig. 2). Repeated measures were analyzed using ANOVA with adjustment for repeated measures, and comparisons for both within-group and between-group effects. Statistical significance was set at α = 0.05 (results not significant at this threshold are reported as p = NS). Numeric values are reported as mean ± standard deviation.

Figure 2

Figure 2

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RESULTS

Prior to injury, no significant baseline differences were seen between the five study groups (control vs. OP vs. PPB vs. zone 1 REBOA vs. zone 3 REBOA), including weight, hemodynamics, lactate, and hematocrit (Supplemental Digital Content, Table 1, http://links.lww.com/TA/B370). The pelvic fracture and hemorrhage model was uniformly lethal without intervention, with mean survival times of 4.7 ± 5.1 minutes, peak preperitoneal pressures (PP) of 13.7 ± 7.5 mm Hg, mean TBL of 956.6 ± 293.1 g, IV fluid consumption of 50.0 ± 28.3 mL/min, bleed rate of 447.1 ± 295.4 g/min, peak lactate of 2.6 ± 1.3 mmol/L, and minimum pH of 7.55 ± 0.09.

Survival times were significantly improved in all four intervention arms of the study versus the control group. Mean survival time was 41.8 ± 9.5 minutes with OP versus 60 ± 0 minutes for PPB, zone 1 REBOA, and zone 3 REBOA (all p < 0.01). Survival curves are shown in Figure 2, demonstrating the rapid lethality of the model and the prolonged survival times with intervention. Following intervention reversal (i.e., balloon deflation), only 33% of zone 1 REBOA animals survived the initial 10 minutes after balloon deflation, compared with 60% for OP, 67% for PPB, and 100% for zone 3 REBOA (p < 0.01).(Fig. 2).

Figure 3 depicts each secondary endpoint stratified by intervention arm. Peak PP in the control arm was not significantly different compared with the intervention arms, but on post hoc analysis, PPB achieved higher pressures than zone 3 REBOA (p = 0.022 by Bonferroni). Likewise, TBL was only significantly reduced in the zone 3 REBOA arm compared to controls (p = 0.017 by Bonferroni, p = 0.006 by two-sided Dunnett). While peak PP and TBL were largely equivalent across groups, bleed rate and IV fluid consumption were vastly reduced (over 10-fold from controls to PPB or REBOA (p < 0.01). However, zone 1 REBOA was associated with significantly greater markers of ischemia-reperfusion injury, including higher peak lactate levels and lower arterial pH (p < 0.01). In contrast, zone 3 REBOA did not appear to confer the same ischemia-reperfusion injury as zone 1 REBOA.

Figure 3

Figure 3

Figure 4 depicts the hemodynamic profiles stratified by intervention arm. Zone 1 REBOA generated significantly greater MAP, pulmonary capillary wedge pressure (PCWP), cardiac index (CI), and systemic vascular resistance (SVR) within the first 10 minutes. Over the subsequent 50 minutes, MAP, PCWP, and CI within the zone 1 REBOA arm approached the pressures generated by the other intervention arms; however, SVR continued to diverge.

Figure 4

Figure 4

Following euthanasia, an exploratory laparotomy and examination of intra-abdominal organs as well as the extraperitoneal space was performed. Necropsy revealed no evidence of frankly ischemic or necrotic bowel in any cases. In all animals, the peritoneum and separation of the intra and extraperitoneal spaces was intact, and there was no evidence of intraperitoneal accumulation of blood with any of the interventions.

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DISCUSSION

This is the first large-animal study to our knowledge to examine the use of either REBOA or the PPB in a large animal model of pelvic fracture and major pelvic hemorrhage, and to compare these interventions to the current standard of open preperitoneal pelvic packing. This is an important topic for both civilian and military researchers and clinicians, particularly in light of the continued high morbidity and mortality associated with severe pelvic fractures. Several additional factors that are unique to the current military setting make this a critical area for development of effective and less invasive adjuncts for hemorrhage control. First is the lack of angiography capabilities at the vast majority of forward deployed surgical units. Second is the increased operational activity in more remote locations and with significantly less robust medical support. This recognized need for the development of better interventions, capabilities, and resuscitation strategies for these scenarios has been the impetus behind the current focus on “prolonged field care,” and the Prolonged Field Care research program that funded the present study.33,34

The objective of this second phase of our project was to compare the efficacy of four interventions (OP, PPB, zone 1 REBOA, and zone 3 REBOA) for prolonging survival after lethal pelvic fracture-associated hemorrhage in a swine model, and to do so with a focus on the austere or resource limited setting. We demonstrated that all four interventions were effective at significantly extending survival time, with PPB, zone 1 REBOA, and zone 3 REBOA demonstrating significantly longer survival times and overall survival rates versus OP. In addition, both PPB and zone 3 REBOA demonstrated superior survival rates after removal or deflation as compared with only one third of zone 1 REBOA animals surviving the first 10 minutes after balloon deflation.

We emphasize that this was a highly lethal pelvic fracture and associated major vascular injury. Without intervention, death occurred within 5 minutes secondary to massive hemorrhage. Based on total blood volume estimates of 2,400 mL to 3,400 mL, approximately 20% of estimated blood volume would have been lost (i.e., class II hemorrhagic). While class II hemorrhagic shock is generally survivable, we suspect the rapidity of blood loss contributed to the overall lethality of this injury. Thus, it stands to reason that marked reductions in bleed rate (eightfold with OP, 28-fold with PPB, 45-fold with zone 1 REBOA, and 75-fold with zone 3 REBOA) would have significantly improved survival despite TBL being similar between groups.

In our group's prior series (porcine iliac artery and vein injury without pelvic fracture), PPB generated lower TBL, lower bleed rate, lower IV fluid requirements, and improved survival compared with OP and with control animals.13 In that series, PPB generated significantly higher extraperitoneal pressures compared to both OP and control groups. However, that initial pilot study did not create a concomitant pelvic fracture which would be expected to increase to pelvic volume and possibly alter the efficacy of the PPB (or other interventions). To more accurately model what would be seen in the clinical setting with NCTH from pelvic injuries, we developed this model that included an open-book pelvic fracture with marked widening of the pubic symphysis and posterior sacroiliac disruption (by palpation). While the extraperitoneal pressures in the prior pilot study are comparable to those in the present study, we suspect the overall difference between groups may have at least in part been nullified by the expanded volume of the pelvic space following creation of the open-book fracture.

Our data support the conclusion that the PPB approach is equally effective to either of these interventions and does not appear to carry the risks of direct compressive injuries or major distal ischemia-reperfusion injury. This discussion is particularly timely as the role of REBOA for NCTH is still being defined and debated, and with some data demonstrating improved outcomes with REBOA for thoracic and abdominal sources of NCTH, but not for pelvic sources.35 Importantly, this is the first animal model of lethal pelvic fracture-associated hemorrhage on which REBOA has been tested. Consistent with studies of the efficacy and safety profiles of REBOA in porcine models of NCTH (both due to vascular injury and solid organ injury), we again illustrate here that zone 1 confers a clinically significant detriment due to ischemia-reperfusion, which appears mitigated by positioning the REBOA in zone 3 without notable degradation of the mortality benefit.14,15 Although REBOA is primarily limited to in-hospital use by trauma surgeons at the present time, there is great interest in both the military and civilian communities for extending this intervention to the prehospital arena.20,36,37

This study does carry several important limitations that warrant discussion. We utilized a large animal model that may not entirely mimic human anatomy and physiology. This utilized a surgically created pelvic fracture and vascular hemorrhage that may not entirely replicate a traumatically induced pelvic fracture and associated bleeding. The rapid major hemorrhage used in this model may also be different than the slower continuous venous hemorrhage seen with many pelvic fractures. Although alternative models for creating a traumatic pelvic fracture using a mechanical press have been described,38 we elected to use a model that would reliably produce an expanded pelvic volume and disruption of the rigid pelvic bony ring. Because we measured pelvic pressures rather than packing to a set pressure, we are unable to comment on the efficacy of each intervention had equal pressures been obtained (a limitation that is particularly important for the OP arm). We also did not examine the impact (if any) of adjunctive measures such as pelvic sheeting or binder placement to manually reduce the pelvic volume. The resuscitation protocol utilized for this study reflected a prolonged field care scenario with limited resuscitation and limited blood products. This was designed with the austere military environment in mind and per our external funding source and may not reflect results with more robust resuscitation. As this study was primarily designed to examine the efficacy associated with each intervention and not the technique or ease of placement, we prepositioned our interventions, making each intervention ready for deployment right after MAP less than 40 mm Hg. Thus, we cannot comment on the time or skills required to perform each intervention. However, based on our previous pilot study we found that the mean time to perform the PPB was less than 3 minutes, and was significantly shorter than the time to perform OP.13 Although we propose that the PPB could be performed outside of the operating room as a bedside procedure, the actual success rates, patient tolerance, and impact of obesity or prior pelvic surgery are unknown and require further study.

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Clinical Implications

In this study, we explored adjuncts to extend the window of hemodynamic stability, theoretically allowing for transit to definitive care an hour out from injury. Notwithstanding the notable limitations of our model, we demonstrated the efficacy of PPB and zone 3 REBOA. From a standpoint of clinical relevance, PPB and REBOA are minimally invasive options that the modern acute care surgeon could feasibly perform even in an austere, resource-limited environment. Further steps are now warranted to refine the PPB technique/technology and determine whether the extended survival translates to meaningful survival after definitive care.

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Future Directions

Characterization of ideal pressures, balloon volumes, balloon conformations, and balloon materials could help optimize the balloon for the desired effect of hemorrhage control. Modifications to the design could help prevent interference with pelvic fixators. Determination of the pressure threshold at which contrast extravasation occurs could augment efforts to use PPB as a bridge to IR embolization. Exploration of the impact of partial versus intermittent balloon inflation (as has been described to confer a mortality benefit in numerous REBOA animal studies)16–18,39,40 could shed further light on the optimal use of these adjuncts for rapid, early hemorrhage control. Both PPB and REBOA carry the additional advantages of titratability, ease of removal without the need for additional surgery, and the ability to perform angiography and targeted angioembolization as needed without removal of the device. In the longer term, we hope this study will help set the foundation for a small, prospective human study of OP versus PPB in patients meeting very specific indications, who would otherwise be delayed in undergoing IR embolization. In an unstable patient with pelvic fracture-associated hemorrhage, we envision the use of PPB (placed at the bedside, with no need for anesthetic induction) to extend the window of hemodynamic stability until the balloon can be deflated in a controlled fashion in the IR suite, where contrast extravasation can be immediately targeted.

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CONCLUSION

In conclusion, we found that PPB and zone 3 REBOA are effective alternatives to OP in this animal model of lethal pelvic fracture-associated hemorrhage. Zone 1 REBOA extends survival time but with significant systemic physiologic disturbance and a high rate of immediate mortality upon reversal. We believe that both of these interventions warrant further evaluation, and potential fielding with forward military surgical units or austere teams that may be called upon to provide prolonged field care to patients with major pelvic fracture-associated hemorrhage.

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AUTHORSHIP

All authors conducted and contributed to the literature search. All authors contributed to study design. W.S.D., D.M.F., R.R.S., J.B.W., S.R.H., and K.K.S. collected the data. W.S.D., G.E.B., M.J.E., and M.J.M. interpreted the data. W.S.D., D.M.F., R.R.S., J.B.W., and M.J.M. wrote the article. All authors critically revised the final article.

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ACKNOWLEDGMENTS

This work would not have been possible without the effort and expertise of our Laboratory Animal Resources Service staff. We specifically wish to acknowledge the contributions of Branden Hubbard, Joanna Dandeneau, John Schaphorst, Juan Tercero, Audra Crans-Henderson, and Shannon Marko.

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DISCLOSURES

Prolonged Field Care Award DM167109, Congressionally Directed Medical Research Programs (CDRMP), US Army Medical Research & Materiel Command (USAMRMC).

The views expressed are those of the authors and do not reflect the official policy or position of the Army, the Department of Defense, or the US Government. The authors have no other conflicts of interest to disclose.

Animals involved in this study were maintained in accordance with the Guide for the Care and Use of Laboratory Animals published by the National Research Council/Institute of Laboratory Animal Research (ILAR).

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REFERENCES

1. Costantini TW, Coimbra R, Holcomb JB, et al. Current management of hemorrhage from severe pelvic fractures: results of an American Association for the Surgery of Trauma multi-institutional trial. J Trauma Acute Care Surg. 2016;80(5):717–723; discussion 723–5.
2. Costantini TW, Coimbra R, Holcomb JB, et al. Pelvic fracture pattern predicts the need for hemorrhage control intervention-results of an AAST multi-institutional study. J Trauma Acute Care Surg. 2017;82(6):1030–1038.
3. Cannon JW, Hofmann LJ, Glasgow SC, Potter BK, Rodriguez CJ, Cancio LC, Rasmussen TE, Fries CA, Davis MR, Jezior JR. Dismounted complex blast injuries: a comprehensive review of the modern combat experience. J Am Coll Surg. 2016;223(4):652–664.
4. Davis JM, Stinner DJ, Bailey JR, Aden JK, Hsu JR, Skeletal Trauma Research Consortium. Factors associated with mortality in combat-related pelvic fractures. J Am Acad Orthop Surg. 2012;20:S7–S12.
5. Davis JW, Moore FA, McIntyre RC Jr., Cocanour CS, Moore EE, West MA. Western trauma association critical decisions in trauma: Management of Pelvic Fracture with Hemodynamic Instability. J Trauma. 2008;65(5):1012–1015.
6. Tran TL, Brasel KJ, Karmy-Jones R, et al. Western trauma association critical decisions in trauma: management of pelvic fracture with hemodynamic instability—2016 updates. J Trauma Acute Care Surg. 2016;81(6):1171–1174.
7. Cullinane DC, Schiller HJ, Zielinski MD, et al. Eastern Association for the Surgery of Trauma Practice Management Guidelines for hemorrhage in pelvic fracture—update and systematic review. J Trauma. 2011;71(6):1850–1868.
8. Cothren CC, Osborn PM, Moore EE, Morgan SJ, Johnson JL, Smith WR. Preperitonal pelvic packing for hemodynamically unstable pelvic fractures: a paradigm shift. J Trauma. 2007;62(4):834–839; discussion 839–42.
9. Burlew CC, Moore EE, Smith WR, Johnson JL, Biffl WL, Barnett CC, Stahel PF. Preperitoneal pelvic packing/external fixation with secondary angioembolization: optimal care for life-threatening hemorrhage from unstable pelvic fractures. J Am Coll Surg. 2011;212(4):628.
10. Burlew CC. Preperitoneal pelvic packing for exsanguinating pelvic fractures. Int Orthop. 2017;41(9):1825–1829.
11. Burlew CC, Moore EE, Stahel PF, Geddes AE, Wagenaar AE, Pieracci FM, Fox CJ, Campion EM, Johnson JL, Mauffrey C. Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage due to unstable pelvic fractures. J Trauma Acute Care Surg. 2017;82(2):233–242.
12. Adnan SM, Wasicek PJ, Crawford A, Dubose J, Brenner M, Scalea TM, Morrison JJ. Endovascular control of pelvic Hemorrhage: concomitant use of REBOA and endovascular intervention. J Trauma Acute Care Surg. 2018.
13. Sokol KK, Black GE, Willey SB, Song MY, Marko ST, Eckert MJ, Inaba K, Martin MJ. Preperitoneal balloon tamponade for lethal closed retroperitoneal pelvic hemorrhage in a swine model. J Trauma Acute Care Surg. 2016;81(6):1046–1055.
14. Rall JM, Redman TT, Ross EM, Morrison JJ, Maddry JK. Comparison of zone 3 resuscitative endovascular balloon occlusion of the aorta and the abdominal aortic and Junctional tourniquet in a model of junctional hemorrhage in swine. J Surg Res. 2018;226:31–39.
15. Tibbits EM, Hoareau GL, Simon MA, Davidson AJ, DeSoucy ES, Faulconer ER, DuBose JJ, Neff LP, Grayson JK, Williams TK. Location is everything: the hemodynamic effects of REBOA in zone 1 versus zone 3 of the aorta. J Trauma Acute Care Surg. 2018;85(1):101–107.
16. Kuckelman J, Barron M, Moe D, Derickson M, Phillips C, Kononchik J, Lallemand M, Marko S, Eckert M, Martin MJ. Extending the Golden hour for zone 1 Reboa: improved survival and reperfusion injury with intermittent versus continuous Reboa in a porcine severe Truncal Hemorrhage model. J Trauma Acute Care Surg. 2018.
17. Morrison JJ, Ross JD, Houston R 4th, Watson JD, Sokol KK, Rasmussen TE. Use of resuscitative endovascular balloon occlusion of the aorta in a highly lethal model of noncompressible torso hemorrhage. Shock. 2014;41:130–137.
18. Russo RM, Williams TK, Grayson JK, Lamb CM, Cannon JW, Clement NF, Galante JM, Neff LP. Extending the golden hour: partial resuscitative endovascular balloon occlusion of the aorta in a highly lethal swine liver injury model. J Trauma Acute Care Surg. 2016;80(3):372–378.
19. Lallemand MS, Moe DM, McClellan JM, Smith JP, Daab L, Marko S, Tran N, Starnes B, Martin MJ. Resuscitative endovascular balloon occlusion of the aorta for major abdominal venous injury in a porcine hemorrhagic shock model. J Trauma Acute Care Surg. 2017;83(2):230–236.
20. Sadek S, Lockey DJ, Lendrum RA, Perkins Z, Price J, Davies GE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) in the pre-hospital setting: an additional resuscitation option for uncontrolled catastrophic haemorrhage. Resuscitation. 2016;107:135–138.
21. Pieper A, Thony F, Brun J, Rodière M, Boussat B, Arvieux C, Tonetti J, Payen J-F, Bouzat P. Resuscitative endovascular balloon occlusion of the aorta for pelvic blunt trauma and life-threatening hemorrhage: a 20-year experience in a level I trauma center. J Trauma Acute Care Surg. 2018;84(3):449–453.
22. Morrison JJ, Galgon RE, Jansen JO, Cannon JW, Rasmussen TE, Eliason JL. A systematic review of the use of resuscitative endovascular balloon occlusion of the aorta in the management of hemorrhagic shock. J Trauma Acute Care Surg. 2016;80(2):324–334.
23. Brenner M, Inaba K, Aiolfi A, DuBose J, Fabian T, Bee T, Holcomb JB, Moore L, Skarupa D, Scalea TM. Resuscitative endovascular balloon occlusion of the aorta and resuscitative thoracotomy in select patients with hemorrhagic shock: early results from the American Association for the Surgery of Trauma's aortic occlusion in resuscitation for trauma and acute care surgery registry. J Am Coll Surg. 2018;226(5):730–740.
24. Moore LJ, Martin CD, Harvin JA, Wade CE, Holcomb JB. Resuscitative endovascular balloon occlusion of the aorta for control of noncompressible truncal hemorrhage in the abdomen and pelvis. Am J Surg. 2016.
25. Borger van der Burg BLS, van Dongen TTCF, Morrison JJ, Hedeman Joosten PPA, DuBose JJ, Hörer TM, Hoencamp R. A systematic review and meta-analysis of the use of resuscitative endovascular balloon occlusion of the aorta in the management of major exsanguination. Eur J Trauma Emerg Surg. 2018;44:535–550.
26. Brenner M, Teeter W, Hoehn M, Pasley J, Hu P, Yang S, Romagnoli A, Diaz J, Stein D, Scalea T. Use of resuscitative endovascular balloon occlusion of the aorta for proximal aortic control in patients with severe hemorrhage and arrest. JAMA Surg. 2018;153(2):130.
27. Brenner M, Bulger EM, Perina DG, Henry S, Kang CS, Rotondo MF, Chang MC, Weireter LJ, Coburn M, Winchell RJ. Joint statement from the American College of Surgeons Committee on Trauma (ACS COT) and the American College of Emergency Physicians (ACEP) regarding the clinical use of resuscitative endovascular balloon occlusion of the aorta (REBOA). Trauma Surg Acute Care Open. 2018;3(1):e000154.
28. Do WS, Forte DM, Sheldon RR, Weiss JB, Barron MR, Sokol KK, Black GE, Hegge SR, Eckert MJ, Martin MJ. Minimally invasive preperitoneal balloon tamponade and abdominal aortic junctional tourniquet versus open packing for pelvic fracture-associated hemorrhage: not all extrinsic compression is equal. J Trauma Acute Care Surg. 2019;86:625–634.
29. Boysen SR, Caulkett NA, Brookfield CE, Warren A, Pang JM. Splenectomy versus sham splenectomy in a swine model of controlled hemorrhagic shock. Shock. 2016;46(4):439–446.
30. Butler FK, Holcomb JB, Schreiber MA, Kotwal RS, Jenkins DA, Champion HR, Bowling F, Cap AP, Dubose JJ, Dorlac WC. Fluid Resuscitation for Hemorrhagic Shock in Tactical Combat Casualty Care: TCCC Guidelines Change 14-01-2 June 2014. ARMY INST OF SURGICAL RESEARCH FORT SAM HOUSTON TX:2014.
31. Butler FK Jr. Fluid resuscitation in tactical combat casualty care: yesterday and today. Wilderness Environ Med. 2017;28(2):S74–S81.
32. Sheppard FR, Mitchell TA, Macko AR, Fryer DM, Schaub LJ, Ozuna KM, Glaser JJ. Whole blood and Hextend: bookends of modern tactical combat casualty care field resuscitation and starting point for multifunctional resuscitation fluid development. J Trauma Acute Care Surg. 2018;85(1S Suppl 2):S33–S38.
33. Keenan S. Prolonged field care working group update. J Spec Oper Med. 2016;16(2):105–106.
34. Keenan S, Riesberg JC. Prolonged field care: beyond the “golden hour”. Wilderness Environ Med. 2017;28(2S):S135–S139.
35. Chang R, Fox EE, Greene TJ, Eastridge BJ, Gilani R, Chung KK, DeSantis SM, DuBose JJ, Tomasek JS, Fortuna GR Jr. Multicenter retrospective study of noncompressible torso hemorrhage: anatomic locations of bleeding and comparison of endovascular versus open approach. J Trauma Acute Care Surg. 2017;83(1):11–18.
36. Lendrum R, Perkins Z, Chana M, Marsden M, Davenport R, Grier G, Sadek S, Davies G. Pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) for exsanguinating pelvic haemorrhage. Resuscitation. 2019;135:6–13.
37. Reva VA, Hörer TM, Makhnovskiy AI, Sokhranov MV, Samokhvalov IM, DuBose JJ. Field and en route resuscitative endovascular occlusion of the aorta: a feasible military reality? J Trauma Acute Care Surg. 2017;83(1 Suppl 1):S170–S176.
38. Krappinger D, Schubert H, Wenzel V, Rieger M, Stadlbauer K-H, Blauth M, Schmoelz W. A pelvic fracture model for the assessment of treatment options in a laboratory environment. Injury. 2007;38(10):1151–1157.
39. Russo RM, Neff LP, Lamb CM, Cannon JW, Galante JM, Clement NF, Grayson JK, Williams TK. Partial resuscitative endovascular balloon occlusion of the aorta in swine model of hemorrhagic shock. J Am Coll Surg. 2016.
40. Johnson MA, Davidson AJ, Russo RM, Ferencz SE, Gotlib O, Rasmussen TE, Neff LP, Williams TK. Small changes, big effects: the hemodynamics of partial and complete aortic occlusion to inform next generation resuscitation techniques and technologies. J Trauma Acute Care Surg. 2017;82(6):1106–1111.
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Editorial Critique

Pelvic fracture related hemorrhage remains a significant management challenge for well-resourced trauma centers, let alone a forward Role military care platform. The consistent high mortality reported with traditional methods of temporary fracture stabilization and angioembolization have led to alternative treatment strategies that can better control hemorrhage and reduce time to definitive hemostasis. There remains intense debate as to whether preperitoneal pelvic packing (OP) or REBOA is the more appropriate treatment strategy. Additionally, it is unknown whether other novel techniques such as preperitoneal balloon tamponade (PPB), previously described by these authors, can improve outcomes. D. Do and colleagues at Madigan Army Medical Center provide an excellent study comparing the use of OP, Zone I and III REBOA, and PPB, in a highly lethal combined open-book pelvis fracture and major arterial and venous hemorrhage animal model. They found Zone I and III REBOA and PPB to be superior to OP, with a post intervention survival advantage to Zone III REBOA and PPB. There are potential limitations in translating this study into patient care that warrant highlighting. The large diameter arterial and venous injury to the external iliac artery and vein may not be reflective of the venous and small branch arterial injury that occurs in civilian pelvic trauma, and may have favored REBOA. The anterior positioning of the TEP balloon, and narrow smaller volume swine pelvis, may have made it more effective at controlling an anteriorly placed external iliac injury compared to the medially placed OP which overlies the internal iliac vessels. The highly unstable pelvic fracture, without placement of a pelvic binder, may have decreased the effectiveness of OP. Additionally, it is unlikely that the current design of the inguinal hernia TEP balloon would be as effective in an adult human pelvis. This work is timely, progressive, and, with further refinement, has developed a model that can better help guide interventional studies. I look forward to this groups continued efforts in defining optimal management in pelvic fracture associated hemorrhage, and hope that their work can assist in reducing the high mortality and morbidity in this challenging patient population.

Ronald B. Tesoriero, MD

Keywords:

Preperitoneal balloon tamponade; REBOA; pelvic packing; pelvic fracture-associated hemorrhage; noncompressible truncal hemorrhage; hemorrhagic shock; hemodynamic instability

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