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

ABSTRACT: 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.

SUBMITTER: Williams TK

PROVIDER: S-EPMC4961606 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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

Williams Timothy Keith TK Neff Lucas P LP Johnson Michael Austin MA Ferencz Sarah-Ashley SA Davidson Anders J AJ Russo Rachel M RM Rasmussen Todd E TE

The journal of trauma and acute care surgery 20160801 2

<h4>Background</h4>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.<h4>Methods</h4>Nine Yorkshire-cross swine were anesthetized, instrumented, splenect ...[more]

PMID: 27070441

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Project description:Background (rationale/purpose/objective)Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used to temporary control non-compressible truncal hemorrhage (NCTH) as bridge to definitive surgical treatment. The dependence on radiography for safe balloon positioning is one factor that limits the extended use of REBOA in civilian and military pre-hospital settings. We aimed to determine standardized sex and age-based variable-distance catheter insertion lengths for accurate REBOA placement without initial fluoroscopic confirmation.MethodsContrast enhanced CT-scans from a representative sample of a Dutch non-trauma population were retrospectively analyzed. Intravascular distances were measured from the bilateral common femoral artery access points (FAAP) to the middle of the aortic occlusion zones and accompanying boundaries. Means and 95% confidence intervals for the distances from the FAAPs to the boundaries and mid-zone III were calculated for all (combined) sex and age-based subgroups. Optimal insertion lengths and potentially safe regions were determined for these groups. Bootstrap analysis was performed in combination with a 40-mm long balloon introduction simulation to determine error-rates and REBOA placement accuracy for the general population.ResultsIn total, 1354 non-trauma patients (694 females) were included. Vascular distances increased with age and were longer in males. The iliofemoral trajectory was 7 mm longer on the right side. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion lengths showed up to 30 mm difference, ranging between 234 and 264 mm. Statistically significant and potentially clinically relevant differences were observed between the anatomical distances and necessary introduction depths for each subgroup.ConclusionThis is the first study to compare aortic morphology and intravascular distances between combined sex and age-based subgroups. As zone III length was consistent, length variability and elongation seem to mainly originate in the iliofemoral trajectory and zone II. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion ranged between 234 and 264 mm. These standardized variable-distance insertion lengths could facilitate safer fluoroscopy-free REBOA in austere, pre-hospital settings.

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: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.

Dataset Information

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

Publications

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

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