Anders J. Davidson

Extending resuscitative endovascular balloon occlusion of the aorta: Endovascular variable aortic control in a lethal model of hemorrhagic shock

BACKGROUND The duration of use and efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) is limited by distal ischemia. We developed a hybrid endovascular-extracorporeal circuit variable aortic control (VAC) device to extend REBOA duration in a lethal model of hemorrhagic shock to serve as an experimental surrogate to further the development of endovascular VAC (EVAC) technologies. METHODS Nine Yorkshire-cross swine were anesthetized, instrumented, splenectomized, and subjected to 30% liver amputation. Following a short period of uncontrolled hemorrhage, REBOA was instituted for 20 minutes. Automated variable occlusion in response to changes in proximal mean arterial pressure was applied for the remaining 70 minutes of the intervention phase using the automated extracorporeal circuit. Damage-control surgery and whole blood resuscitation then occurred, and the animals were monitored for a total of 6 hours. RESULTS Seven animals survived the initial surgical preparation. After 20 minutes of complete REBOA, regulated flow was initiated through the extracorporeal circuit to simulate VAC and provide perfusion to distal tissue beds during the 90-minute intervention phase. Two animals required circuit occlusion for salvage, while five animals tolerated sustained, escalating restoration of distal blood flow before surgical hemorrhage control. Animals tolerating distal flow had preserved renal function, maintained proximal blood pressure, and rapidly weaned from complete REBOA. CONCLUSION We combined a novel automated, extracorporeal circuit with complete REBOA to achieve EVAC in a swine model of uncontrolled hemorrhage. Our approach regulated proximal aortic pressure, alleviated supranormal values above the balloon, and provided controlled distal aortic perfusion that reduced ischemia without inducing intolerable bleeding. This experimental model serves as a temporary surrogate to guide future EVAC catheter designs that may provide transformational approaches to hemorrhagic shock.

Potential benefit of early operative utilization of low profile, partial resuscitative endovascular balloon occlusion of the aorta (P-REBOA) in major traumatic hemorrhage

A 28-year-old man with multiple gunshot wounds to the chest and upper extremities was transported by private vehicle to a community hospital with limited trauma capabilities. On arrival he developed pulseless electrical activity and cardiopulmonary resuscitation was initiated. He was intubated, transfused with 4 units of packed red blood cells, and resuscitated with 2 L of crystalloid prior to regaining spontaneous circulation. Left-sided tube thoracostomy immediately drained 1600 mL of bright red blood. He was transiently stable for a short transport to the nearest level 1 trauma center. On arrival the patient was normotensive with tachycardia. Chest X-ray demonstrated persistent left-sided hemothorax despite a well-positioned chest tube. Focused Assessment with Sonography for Trauma (FAST) examination was negative for pericardial fluid, but positive for intra-abdominal fluid. During the secondary examination the patient became hypotensive with systolic blood pressure (SBP) in the 70 s. A massive transfusion protocol was initiated, tranexamic acid was administered, and the patient was promptly transported to the operating room. The patient transiently responded to the massive transfusion. While instruments were being opened in the operating room, he again became hypotensive with SBP in the 50 s. The patient was acidotic (pH of 6.87, base excess −14.6), coagulopathic (international normalized ratio of 1.5) and …

Small changes, big effects: The hemodynamics of partial and complete aortic occlusion to inform next generation resuscitation techniques and technologies

BACKGROUND The transition from complete aortic occlusion during resuscitative endovascular balloon occlusion of the aorta can be associated with hemodynamic instability. Technique refinements and new technologies have been proposed to minimize this effect. In order to inform new techniques and technology, we examined the relationship between blood pressure and aortic flow during the restoration of systemic circulation following aortic occlusion at progressive levels of hemorrhage. METHODS An automated supraceliac aortic clamp, capable of continuously variable degrees of occlusion, was applied in seven swine. The swine underwent stepwise removal of 40% of their total blood volume in four equal aliquots. After each aliquot, progressive luminal narrowing to the point of complete aortic occlusion was achieved over 5 minutes, sustained for 5 minutes, and then released over 5 minutes. Proximal and distal blood pressure and distal aortic flow were continuously recorded throughout the study. RESULTS Upon release of the clamp, hyperemic aortic flow was observed following 10% and 20% hemorrhage (1,599 ± 785 mL/min, p < 0.01; and 1,070 ± 396 mL/min, p < 0.01, respectively). Proximal blood pressure exhibited a nonlinear relationship to aortic flow during clamp removal; however, distal blood pressure increased linearly with distal flow upon clamp opening across all hemorrhage volumes. CONCLUSIONS Hyperemic blood flow following return of circulation may contribute to cardiovascular collapse. Reintroduction of systemic blood flow after aortic occlusion should be guided by distal blood pressure rather than proximal pressure. Awareness of hemodynamic physiology during aortic occlusion is of paramount importance to the clinical implementation of next-generation resuscitative endovascular balloon occlusion of the aorta techniques and technologies.

Automated variable aortic control versus complete aortic occlusion in a swine model of hemorrhage

BACKGROUND Future endovascular hemorrhage control devices will require features that mitigate the adverse effects of vessel occlusion. Permissive regional hypoperfusion (PRH) with variable aortic control (VAC) is a novel strategy to minimize hemorrhage and reduce the ischemic burden of complete aortic occlusion (AO). The objective of this study was to compare PRH with VAC to AO in a lethal model of hemorrhage. METHODS Twenty-five swine underwent cannulation of the supraceliac aorta, with diversion of aortic flow through an automated extracorporeal circuit. After creation of uncontrolled liver hemorrhage, animals were randomized to 90 minutes of treatment: Control (full, unregulated flow; n = 5), AO (no flow; n = 10), and PRH with VAC (dynamic distal flow initiated after 20 minutes of AO; n = 10). In the PRH group, distal flow rates were regulated between 100 and 300 mL/min based on a desired, preset range of proximal mean arterial pressure (MAP). At 90 minutes, damage control surgery, resuscitation, and restoration of full flow ensued. Critical care continued for 4.5 hours or until death. Hemodynamic parameters and markers of ischemia were recorded. RESULTS Study survival was 0%, 50%, and 90% for control, AO, and VAC, respectively (p < 0.01). During intervention, VAC resulted in more physiologic proximal MAP (84 ± 18 mm Hg vs. 105 ± 9 mm Hg, p < 0.01) and higher renal blood flow than AO animals (p = 0.02). During critical care, VAC resulted in higher proximal MAP (73 ± 8 mm Hg vs. 50 ± 6 mm Hg, p < 0.01), carotid and renal blood flow (p < 0.01), lactate clearance (p < 0.01), and urine output (p < 0.01) than AO despite requiring half the volume of crystalloids to maintain proximal MAP ≥50 mm Hg (p < 0.01). CONCLUSION Permissive regional hypoperfusion with variable aortic control minimizes the adverse effects of distal ischemia, optimizes proximal pressure to the brain and heart, and prevents exsanguination in this model of lethal hemorrhage. These findings provide foundational knowledge for the continued development of this novel paradigm and inform next-generation endovascular designs.

Presenting hypertension, burn injury, and mortality in combat casualties

INTRODUCTION The effect of presenting hypertension is poorly studied in combat casualties. We hypothesized that elevated mean arterial pressure (MAP) on presentation to combat hospitals would be associated with poor outcomes. METHODS Data was obtained from the Department of Defense Trauma Registry and the Armed Forces Medical Examiner System. Variables analyzed included presenting vital signs to Role II-III military theater hospital, demographic variables, injury severity score (ISS), location and mechanism of injury, presence of traumatic brain injury (TBI), acute kidney injury (AKI), and mortality. Patients were stratified by decile of MAP and logistic regression analysis was employed to adjust for confounders. RESULTS A total of 4072 subjects injured from February 2002 to February 2011 were identified. Compared to patients in the middle deciles of presenting MAP, patients in the highest and lowest MAP deciles were the only groups that demonstrated a higher mortality on univariate analysis (OR 2.06, 95% CI 1.16-2.31 and OR 2.86, 95% CI 1.76-4.67, respectively), and this relationship persisted after adjustment for ISS, HR, temperature, presence of burn injury, TBI, and AKI. Burn injury was associated with mortality in the full multivariate analysis. However, further analysis limited to patients without burn injury did not demonstrate an association between high MAP and mortality (OR 0.84, 95% CI 0.36-1.99; p=0.70). Conversely, when limited to patients with burn injury, high MAP was associated with mortality (OR 3.78, 95% CI 1.74-8.20; p=0.001). CONCLUSION The relationship between mortality and presenting MAP appears to be U-shaped, demonstrating increased mortality in the lowest and highest deciles. However, mortality in the highest MAP decile appears to be limited to casualties with associated burn injury, even after adjustment for TBI, AKI, and ISS, which takes into account the severity of the burn injury. Physicians should recognize that burn patients presenting with an elevated MAP are at an increased risk for poor outcomes. LEVEL OF EVIDENCE III.

Direct site endovascular repair (DSER): A novel approach to vascular trauma.

ABSTRACT Peripheral vascular injuries carry significant risk for permanent functional impairment, limb loss, and death. Definitive correction of these injuries requires significant operative time and has traditionally been resource and skill set intensive. In the initial surgical treatment of the physiologically depleted trauma patient, faster techniques may prove more appropriate. Damage control techniques, including vascular shunting, rapidly restore distal flow but require additional vascular intervention and risk shunt thrombosis with prolonged use. To address these challenges, we present a technique, using an off-the-shelf endovascular device, for treatment of peripheral arterial injuries. Direct-site endovascular repair (DSER) is an open vascular surgical reconstruction technique using conventional endovascular stent grafts to create a “sutureless” anastomosis. We believe this technique to be a valuable adjunct to current repair options. The values of this technique are that it is (1) rapid, (2) of low technical complexity, (3) requires very little equipment, and (4) may offer extended durability in damage control scenarios. We describe three patients where this technique was used. In the first case, the technique was used to provide a temporary arterial shunt in a patient with a local infection and arterial disruption. In the second case, DSER was used for definitive repair of an injured artery after penetrating trauma. The third case involves DSER for definitive of both an artery and vein after penetrating trauma.

Endocrine Effects of Simulated Complete and Partial Aortic Occlusion in a Swine Model of Hemorrhagic Shock

INTRODUCTION Low distal aortic flow via partial aortic occlusion (AO) may mitigate ischemia induced by resuscitative endovascular balloon occlusion of the aorta (REBOA). We compared endocrine effects of a novel simulated partial AO strategy, endovascular variable aortic control (EVAC), with simulated REBOA in a swine model. MATERIALS AND METHODS Aortic flow in 20 swine was routed from the supraceliac aorta through an automated extracorporeal circuit. Following liver injury-induced hemorrhagic shock, animals were randomized to control (unregulated distal flow), simulated REBOA (no flow, complete AO), or simulated EVAC (distal flow of 100-300 mL/min after 20 minutes of complete AO). After 90 minutes, damage control surgery, resuscitation, and full flow restoration ensued. Critical care was continued for 4.5 hours or until death. RESULTS Serum angiotensin II concentration was higher in the simulated EVAC (4,769 ± 624 pg/mL) than the simulated REBOA group (2649 ± 429) (p = 0.01) at 180 minutes. There was no detectable difference in serum renin [simulated REBOA: 231.3 (227.9-261.4) pg/mL; simulated EVAC: 294.1 (231.2-390.7) pg/mL; p = 0.27], aldosterone [simulated EVAC: 629 (454-1098), simulated REBOA: 777 (575-1079) pg/mL, p = 0.53], or cortisol (simulated EVAC: 141 ± 12, simulated REBOA: 127 ± 9 ng/mL, p = 0.34) concentrations between groups. CONCLUSIONS Simulated EVAC was associated with higher serum angiotensin II, which may have contributed to previously reported cardiovascular benefits. Future studies should evaluate the renal effects of EVAC and the concomitant therapeutic use of angiotensin II.

Coagulopathy and Mortality in Combat Casualties: Do the Kidneys Play a Role?

Background Acute traumatic coagulopathy (ATC) is a common condition after traumatic injury and is known to be associated with an increase in morbidity and mortality in trauma patients. ATC has been implicated as a causative factor in both early hemorrhage and late organ failure in this population, yet the pathophysiology remains largely unknown. Additionally, acute kidney injury (AKI) is a common condition among critically injured trauma patients. AKI has been associated with an elevated International Normalized Ratio (INR) and warfarin use, but its development has not been well studied in the setting of ATC. We hypothesized that the presence of ATC influences the development of AKI and may mediate mortality in combat casualties. Methods Data were obtained from the Department of Defense Trauma Registry, Medical Data Store and Composite Healthcare System, and the Armed Forces Medical Examiner System. A retrospective review was conducted of US service members injured in Iraq or Afghanistan between February 1, 2002 and February 1, 2011, who required ICU level care and survived evacuation out of theater. Exclusions were made for missing data. Cox proportional hazard regression was performed to determine the effect of ATC (a priori defined as first INR > 1.3) on the development of AKI. Further analysis was conducted to determine the influence of these variables on 30-d mortality, and multiple sensitivity analyses were performed to determine the effect of ATC on both AKI and mortality. Results A total of 1,288 patients were identified for analysis. ATC was a risk factor for subsequent AKI after adjustment (HR 1.67, 95% CI 1.28-2.18; p < 0.001). However, ATC was not a risk factor for mortality after adjustment in the full model (HR 1.87, 95% CI 0.95-3.65; p = 0.069). On sensitivity analyses exploring alternate definitions of ATC, an INR of 1.2 remained associated with AKI (HR 1.46, 95% CI 1.13-1.88; p = 0.004) and an INR of 1.5 became significant for mortality (HR 1.76, 95% CI 1.32-2.35; p < 0.001). Conclusion ATC is independently associated with the development of AKI. Although ATC is associated with mortality in the unadjusted model, it is not significant after adjustment for AKI. This implies that the kidneys may play a role in the adverse outcomes observed after ATC. Increased awareness and monitoring for coagulopathy and the subsequent development of AKI in combat casualty patients may lead to earlier diagnosis and treatment of these conditions, possibly decreasing morbidity and mortality.

Negative pressure temporary abdominal closure without continuous suction: a solution for damage control surgery in austere and far-forward settings

The use of topical negative pressure dressings in temporary abdominal closure has been readily adopted worldwide; however, a method of continuous suction is typically required to provide a seal. We describe a method of temporary abdominal closure using readily available materials in the forward surgical environment which does not require continuous suction after application. This method of temporary abdominal closure provides the benefits of negative pressure temporary abdominal closure after damage control surgery without the need for continuous suction or specialised equipment. Its application in damage control surgery in austere or far-forward settings is suggested. The technique has potential applications for military surgeons as well as in humanitarian settings where the logistic supply chain may be fragile.

Comparison of direct site endovascular repair utilizing expandable polytetrafluoroethylene stent grafts versus standard vascular shunts in a porcine (Sus scrofa) model

INTRODUCTION The small diameter of temporary vascular shunts for vascular trauma management may restrict flow and result in ischemia or early thrombosis. We have previously reported a clinical experience with direct, open surgical reconstruction using expandable polytetrafluoroethylene stent grafts to create a “sutureless” anastomosis as an alternative to standard temporary vascular shunts. We sought to characterize patency and flow characteristics of these grafts compared with standard shunts in a survival model of porcine vascular injury. METHODS Twelve Yorkshire-cross swine received a 2-cm-long near-circumferential defect in the bilateral iliac arteries. A 14 Fr Argyle shunt was inserted into one randomly assigned artery, with a self-expanding expandable polytetrafluoroethylene stent deployed in the other. At 72 hours, conduit patency was evaluated by angiography. Arterial flow measurements were obtained at baseline, immediately after intervention, and after 72 hours via direct measurement with perivascular flow meters. Blood pressure proximal and distal to the conduits and arterial samples for histopathology were obtained during the terminal procedure. RESULTS Angiography revealed no difference in patency at 72 hours (p = 1.0). While there was no difference in baseline arterial flow between arteries (p = 0.63), the stent grafts demonstrated significantly improved blood flow compared with shunts both immediately after intervention (390 ± 36 mL/min vs. 265 ± 25 mL/min, p = 0.002) and at 72 hours (261 ± 29 mL/min vs. 170 ± 36 mL/min, p = 0.005). The pressure gradient across the shunts was greater than that of the stent grafts (11.5 mm Hg [interquartile range, 3–19 mm Hg] vs. 3 mm Hg [interquartile range, 3–5 mm Hg], p = 0.013). The speed of deployment was similar between the two devices. CONCLUSIONS Open “sutureless” direct site repair using commercially available stent grafts to treat vascular injury is a technically feasible strategy for damage control management of peripheral vascular injury and offers increased blood flow when compared with temporary shunts. Furthermore, stent grafts may offer improved durability to extend the window until definitive vascular repair. The combination of these traits may improve outcomes after vascular injury. LEVEL OF EVIDENCE Epidemiologic/Prognostic, level III.