Dataset Information

Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank.

ABSTRACT:

Aim

To compare in-hospital mortality of severely injured trauma patients who underwent resuscitative endovascular balloon occlusion of the aorta (REBOA) or aortic cross-clamping (ACC).

Methods

In this multicenter, retrospective cohort study using data from a nationwide trauma registry of tertiary emergency medical centers in Japan (n = 280), trauma patients who underwent aortic occlusion at the emergency department from 2004 to 2019 were divided into two groups according to the treatment they received: patients treated with ACC and patients who underwent placement of a REBOA catheter. Multiple imputations were used to handle the missing data. In-hospital mortality of the patients who underwent REBOA or ACC was compared using a mixed-effect logistic regression analysis and a propensity score-matching analysis, in which the confounders, including baseline patient demographics and severity, were adjusted.

Results

Of 1,670 patients (1,137 with REBOA and 533 with ACC), 66% were male. The median age was 56 years, and the mortality rate was 55.2% in the REBOA group and 81.6% in the ACC group. The mixed-effect model regression analysis showed a significantly lower odds ratio for in-hospital mortality rate in the REBOA group (odds ratio 0.17; 95% confidence interval, 0.12-0.26). A similar odds ratio was observed in the propensity score matching analysis (odds ratio 0.27; 95% confidence interval, 0.18-0.40).

Conclusion

Compared with ACC, REBOA use was associated with decreased mortality in severely injured trauma patients.

SUBMITTER: Haruta K

PROVIDER: S-EPMC10014424 | biostudies-literature | 2023 Jan-Dec

REPOSITORIES: biostudies-literature

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Publications

Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank.

Haruta Koichi K Endo Akira A Shiraishi Atsushi A Otomo Yasuhiro Y

Acute medicine & surgery 20230101 1

<h4>Aim</h4>To compare in-hospital mortality of severely injured trauma patients who underwent resuscitative endovascular balloon occlusion of the aorta (REBOA) or aortic cross-clamping (ACC).<h4>Methods</h4>In this multicenter, retrospective cohort study using data from a nationwide trauma registry of tertiary emergency medical centers in Japan (<i>n</i> = 280), trauma patients who underwent aortic occlusion at the emergency department from 2004 to 2019 were divided into two groups according to ...[more]

PMID: 36936741

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Project description:ImportanceHemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care.ObjectiveTo establish whether prehospital zone 1 (supraceliac) partial resuscitative endovascular balloon occlusion of the aorta (Z1 P-REBOA) can be achieved in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination.Design, setting, and participantsThis was a prospective observational cohort study (Idea, Development, Exploration, Assessment and Long-term follow-up [IDEAL] 2A design) with recruitment from June 2020 to March 2022 and follow-up until discharge from hospital, death, or 90 days evaluating a physician-led and physician-delivered, urban prehospital trauma service in the Greater London area. Trauma patients aged 16 years and older with suspected exsanguinating subdiaphragmatic hemorrhage, recent or imminent hypovolemic traumatic cardiac arrest (TCA) were included. Those with unsurvivable injuries or who were pregnant were excluded. Of 2960 individuals attended by the service during the study period, 16 were included in the study.ExposuresZI REBOA or P-REBOA.Main outcomes and measuresThe main outcome was the proportion of patients in whom Z1 REBOA and Z1 P-REBOA were achieved. Clinical end points included systolic blood pressure (SBP) response to Z1 REBOA, mortality rate (1 hour, 3 hours, 24 hours, or 30 days postinjury), and survival to hospital discharge.ResultsFemoral arterial access for Z1 REBOA was attempted in 16 patients (median [range] age, 30 [17-76] years; 14 [81%] male; median [IQR] Injury Severity Score, 50 [39-57]). In 2 patients with successful arterial access, REBOA was not attempted due to improvement in clinical condition. In the other 14 patients (8 [57%] of whom were in traumatic cardiac arrest [TCA]), 11 successfully underwent cannulation and had aortic balloons inflated in Z1. The 3 individuals in whom cannulation was unsuccessful were in TCA (failure rate = 3/14 [21%]). Median (IQR) pre-REBOA SBP in the 11 individuals for whom cannulation was successful (5 [46%] in TCA) was 47 (33-52) mm Hg. Z1 REBOA plus P-REBOA was associated with a significant improvement in BP (median [IQR] SBP at emergency department arrival, 101 [77-107] mm Hg; 0 of 10 patients were in TCA at arrival). The median group-level improvement in SBP from the pre-REBOA value was 52 (95% CI, 42-77) mm Hg (P < .004). P-REBOA was feasible in 8 individuals (8/11 [73%]) and occurred spontaneously in 4 of these. The 1- and 3-hour postinjury mortality rate was 9% (1/11), 24-hour mortality was 27% (3/11), and 30-day mortality was 82% (9/11). Survival to hospital discharge was 18% (2/11). Both survivors underwent early Z1 P-REBOA.Conclusions and relevanceIn this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death.Trial registrationClinicalTrials.gov Identifier: NCT04145271.

Project description:ImportanceBleeding is the most common cause of preventable death after trauma.ObjectiveTo determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.Design, setting, and participantsPragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days.InterventionPatients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44).Main outcomes and measuresThe primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death.ResultsOf the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours.Conclusions and relevanceIn trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone.Trial registrationisrctn.org Identifier: ISRCTN16184981.

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.

Dataset Information

Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank.

Aim

Methods

Results

Conclusion

Publications

Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank.

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