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Resuscitative Endovascular Balloon Occlusion of the Aorta: Assessing Need in an Urban Trauma Center.

ABSTRACT: BACKGROUND:Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as a bridge to definitive hemostasis in select patients with noncompressible torso hemorrhage. The number of patients who might benefit from this procedure, however, remains incompletely defined. We hypothesized that we could quantify the number of patients presenting to our center over a 2-year period who may have benefited from REBOA. METHODS:All patients presenting to our trauma center from 2014 to 2015 were included. Potential REBOA patients were identified based on anatomic injuries. We used ICD-9 codes to identify REBOA-amenable injury patterns and physiology. We excluded patients with injuries contraindicating REBOA. We then used chart review by two REBOA-experienced independent reviewers to assess each potential REBOA candidate, evaluate the accuracy of our algorithm, and to identify a cohort of confirmed REBOA candidates. RESULTS:Four thousand eight hundred eighteen patients were included of which 666 had injuries potentially amenable to REBOA. Three hundred thirty-five patients were hemodynamically unstable, and 309 patients had contraindications to REBOA. Sixty-four patients had both injury patterns and physiology amenable to REBOA with no contraindications, and these patients were identified as potential REBOA candidates. Of these, detailed independent two physician chart review identified 29 patients (45%) as confirmed REBOA candidates (interrater reliability kappa = 0.94, P < 0.001). CONCLUSIONS:Our database query identified patients with indications for REBOA but overestimated the number of REBOA candidates. To accurately quantify the REBOA candidate population at a given center, an algorithm to identify potential patients should be combined with chart review. STUDY TYPE:Therapeutic study, level V.

SUBMITTER: Dumas RP

PROVIDER: S-EPMC6713903 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Resuscitative Endovascular Balloon Occlusion of the Aorta: Assessing Need in an Urban Trauma Center.

Dumas Ryan P RP Holena Daniel N DN Smith Brian P BP Jafari Daniel D Seamon Mark J MJ Reilly Patrick M PM Qasim Zaffer Z Cannon Jeremy W JW

The Journal of surgical research 20180918

<h4>Background</h4>Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as a bridge to definitive hemostasis in select patients with noncompressible torso hemorrhage. The number of patients who might benefit from this procedure, however, remains incompletely defined. We hypothesized that we could quantify the number of patients presenting to our center over a 2-year period who may have benefited from REBOA.<h4>Methods</h4>All patients presenting to our trauma center from ...[more]

PMID: 30502280

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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:BackgroundMultiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock.MethodsWe systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique.ResultsWe included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20-0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79-2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate.ConclusionsOur findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned.

Project description:ImportanceResuscitative 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.ObjectiveTo develop a method for performing REBOA in a civilian population using a standardized distance from a set point of entry.Design, setting, and participantsA 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 measuresTwo 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.ResultsAmong 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 relevanceTarget 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.

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.

Dataset Information

Resuscitative Endovascular Balloon Occlusion of the Aorta: Assessing Need in an Urban Trauma Center.

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Resuscitative Endovascular Balloon Occlusion of the Aorta: Assessing Need in an Urban Trauma Center.

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