Dataset Information

Fixed-Distance Model for Balloon Placement During Fluoroscopy-Free Resuscitative Endovascular Balloon Occlusion of the Aorta in a Civilian Population.

ABSTRACT:

Importance

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an innovative procedure in the treatment of noncompressible truncal hemorrhage. However, readily available fluoroscopy remains a limiting factor in its widespread implementation. Several methods have been proposed to perform REBOA without fluoroscopic guidance, and these methods were adapted predominantly from the military theater.

Objective

To develop a method for performing REBOA in a civilian population using a standardized distance from a set point of entry.

Design, setting, and participants

A retrospective study of whole-body computed tomographic (CT) scans from a cohort of 280 consecutive civilian trauma patients from University Hospitals of Lyon, France, was used to calculate the endovascular distances from both femoral arteries at the level of the upper border of the symphysis pubis to aortic zone I (descending thoracic aorta) and zone III (infrarenal aorta). These whole-body CT scans were performed between 2013 and 2015. Data were analyzed from July 16 to December 7, 2015.

Main outcomes and measures

Two segments (1 per zone) common to all CT scans were isolated, and their location, length, prevalence in the cohort, and predicted prevalence in the general population were calculated by inverting 99% certainty tolerance limits.

Results

Among the 280 trauma patients (140 men and 140 women) in this study, the mean (SD) height was 170.7 (8.7) cm, and the mean (SD) age was 38.8 (16.5) years. The common segment in zone I (414-474 mm) existed in all CT scans. The common segment in zone III (236-256 mm) existed in 99.6% and 97.9% of CT scans from the right and left femoral arteries, respectively. These segments are expected to exist in 98.7% (zone I) and 94.9% (zone III) of the general population.

Conclusions and relevance

Target distances for blind placement of REBOA exist with more than 94% prevalence in a civilian population. These findings support the expanded use of REBOA in emergency department and prehospital settings. Validation for safety and efficacy on cadaveric and clinical models is necessary.

SUBMITTER: Pezy P

PROVIDER: S-EPMC5470425 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.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.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.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.

Project description:Resuscitative endovascular balloon occlusion of the aorta (REBOA) for rapid hemorrhage control is increasingly being used in trauma management. Its beneficial hemodynamic effects on unstable patients beyond temporal hemostasis has led to growing interest in its use in other patient populations, such as during cardiac arrest from nontraumatic causes. The ability to insert the catheters without fluoroscopic guidance makes the technique available in the prehospital setting. However, in addition to correct positioning, challenges include reliably achieving aortic occlusion while minimizing the risk of balloon rupture. Without fluoroscopic control, inflation of the balloon relies on estimated aortic diameters and on the disappearing pulse in the contralateral femoral artery. In the case of cardiac arrest or absent palpable pulses, balloon inflation is associated with excess risk of overinflation and adverse events (vessel damage, balloon rupture). In this bench study, we examined how the pressure in the balloon is related to the surrounding blood pressure and the balloon's contact with the vessel wall in two sets of experiments, including a pulsatile circulation model. With this data, we developed a rule of thumb to guide balloon inflation of the ER-REBOA catheter with a simple disposable pressure-reading device (COMPASS). We recommend slowly filling the balloon with saline until the measured balloon pressure is 160 mmHg, or 16 mL of saline have been used. If after 16 mL the balloon pressure is still below 160 mmHg, saline should be added in 1-mL increments, which increases the pressure target about 10 mmHg at each step, until the maximum balloon pressure is reached at 240 mmHg (= 24 mL inflation volume). A balloon pressure greater than 250 mmHg indicates overinflation. With this rule and a disposable pressure-reading device (COMPASS), ER-REBOA balloons can be safely filled in austere environments where fluoroscopy is unavailable. Pressure monitoring of the balloon allows for recognition of unintended deflation or rupture of the balloon.

Project description:Background Few patients survive after out-of-hospital cardiac arrest and any measure that improve circulation during cardiopulmonary resuscitation is beneficial. Animal studies support that resuscitative endovascular balloon occlusion of the aorta (REBOA) during cardiopulmonary resuscitation might benefit patients suffering from out-of-hospital cardiac arrest, but human data are scarce. Methods and Results We performed an observational study at the helicopter emergency medical service in Trondheim (Norway) to assess the feasibility and safety of establishing REBOA in patients with out-of-hospital cardiac arrest. All patients received advanced cardiac life support during the procedure. End-tidal CO2 was measured before and after REBOA placement as a proxy measure of central circulation. A safety-monitoring program assessed if the procedure interfered with the quality of advanced cardiac life support. REBOA was initiated in 10 patients. The mean age was 63 years (range 50-74 years) and 7 patients were men. The REBOA procedure was successful in all cases, with 80% success rate on first cannulation attempt. Mean procedural time was 11.7 minutes (SD 3.2, range 8-16). Mean end-tidal CO2 increased by 1.75 kPa after 60 seconds compared with baseline (P<0.001). Six patients achieved return of spontaneous circulation (60%), 3 patients were admitted to hospital, and 1 patient survived past 30 days. The safety-monitoring program identified no negative influence on the advanced cardiac life support quality. Conclusions To our knowledge, this is the first study to demonstrate that REBOA is feasible during non-traumatic out-of-hospital cardiac arrest. The REBOA procedure did not interfere with the quality of the advanced cardiac life support. The significant increase in end-tidal CO2 after occlusion suggests improved organ circulation during cardiopulmonary resuscitation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03534011.

Project description:BackgroundIn this review, we assess the state of Resuscitative Endovascular Occlusion of the Aorta (REBOA) today with respect to out-of-hospital (OOH) vs. inhospital (H) use in blunt and penetrating trauma, as well as discuss areas of promising research that may be key in further advancement of REBOA applications.MethodsTo analyze the trends in REBOA use, we conducted a review of the literature and identified articles with human or animal data that fit the respective inclusion and exclusion criteria. In separate tables, we compiled data extracted from selected articles in categories including injury type, zone and duration of REBOA, setting in which REBOA was performed, sample size, age, sex and outcome. Based on these tables as well as more detailed review of some key cases of REBOA usage, we assessed the current state of REBOA as well as coagulation and histological disturbances associated with its usage. All statistical tests were 2-sided using an alpha=0.05 for significance. Analysis was done using SAS 9.5 (Cary, NC). Tests for significance was done with a t-test for continuous data and a Chi Square Test for categorical data.ResultsIn a total of 44 cases performed outside of a hospital in both military and civilian settings, the overall survival was found to be 88.6%, significantly higher than the 50.4% survival calculated from 1,807 cases of REBOA performed within a hospital (p<.0001). We observe from human data a propensity to use Zone I in penetrating trauma and Zone III in blunt injuries. We observe lower final metabolic markers in animal studies with shorter REBOA time and longer follow-up times.ConclusionsFurther research related to human use of REBOA must be focused on earlier initiation of REBOA after injury which may depend on development of rapid vascular access devices and techniques more so than on any new improvements in REBOA. Future animal studies should provide detailed multisystem organ assessment to accurately define organ injury and metabolic burden associated with REBOA application. Overall, animal studies must involve realistic models of injury with severe clinical scenarios approximating human trauma and exsanguination, especially with long-term follow-up after injury.

Project description:BackgroundResuscitative endovascular balloon occlusion of the aorta (REBOA) may be an adjunct treatment to cardiopulmonary resuscitation (CPR). Aortic occlusion may increase aortic pressure and increase the coronary perfusion pressure and the cerebral blood flow. Peripheral arterial blood pressure is often measured during or after CPR, however, changes in peripheral blood pressure after aortic occlusion is insufficiently described. This study aimed to assess changes in peripheral arterial blood pressure after REBOA in patients with out of hospital cardiac arrest.MethodsA prospective observational study performed at the helicopter emergency medical service in Trondheim (Norway). Eligible patients received REBOA as adjunct treatment to advanced cardiac life support. Peripheral invasive arterial blood pressure and end-tidal CO2 (EtCO2) was measured before and after aortic occlusion. Differences in arterial blood pressures and EtCO2 before and after occlusion was analysed with Wilcoxon Signed Rank test.ResultsFive patients were included to the study. The median REBOA procedural time was 11 min and median time from dispatch to aortic occlusion was 50 min. Two patients achieved return of spontaneous circulation. EtCO2 increased significantly 60 s after occlusion, by a mean of 1.16 kPa (p = 0.043). Before occlusion the arterial pressure in the compression phase were 43.2 (range 12-112) mmHg, the mean pressure 18.6 (range 4-27) mmHg and pressure in the relaxation phase 7.8 (range - 7 - 22) mmHg. After aortic occlusion the corresponding pressures were 114.8 (range 23-241) mmHg, 44.6 (range 15-87) mmHg and 14.8 (range 0-29) mmHg. The arterial pressures were significant different in the compression phase and as mean pressure (p = 0.043 and p = 0.043, respectively) and not significant in the relaxation phase (p = 0.223).ConclusionThis study is, to our knowledge, the first to assess the peripheral invasive arterial blood pressure response to aortic occlusion during CPR in the pre-hospital setting. REBOA application during CPR is associated with a significantly increase in peripheral artery pressures. This likely indicates improved central aortic blood pressure and warrants studies with simultaneous peripheral and central blood pressure measurement during aortic occlusion.Trial registrationThe study is registered in ClinicalTrials.gov ( NCT03534011 ).