When Every Minute Counts: REBOA Before Surgery Is Independently Associated With a 15-Minute Delay in Time to Definitive Hemorrhage Control.

INTRODUCTION: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a temporizing hemorrhage control intervention, but its inevitable effect on time to operating room (OR) has not been assessed. The aim of our study is to assess the impact of undergoing REBOA before surgery (RBS) on time to definitive hemorrhage control surgery. METHODS: In this retrospective analysis of 2017-2021 ACS-TQIP database, all adult (≥18 years) patients who underwent emergency hemorrhage control laparotomy (≤4 hours of admission) and received early blood products (≤4 hours) were included, and patients with severe head injury (Head-abbreviated injury score > 2) were excluded. Patients were stratified into those who did (RBS) vs those who did not undergo REBOA before surgery (No-RBS). Primary outcome was time to laparotomy. Secondary outcomes were complications and mortality. Multivariable linear and binary logistic regression analyses were performed to identify the independent associations between RBS and outcomes. RESULTS: A total of 32,683 patients who underwent emergency laparotomy were identified (RBS: 342; No-RBS: 32,341). The mean age was 39 (16) years, 78% were male, mean SBP was 107 (34) mmHg, and the median injury severity score was 21 [14-29]. The median time to emergency hemorrhage control surgery was 50 [32-85] minutes. Overall complication rate was 16% and mortality was 19%. On univariate analysis, RBS group had longer time to surgery (RBS 56 [41-89] vs No-RBS 50 [32-85] minutes, P < 0.001). On multivariable analysis, RBS was independently associated with a longer time to hemorrhage control surgery (ß + 14.5 [95%CI 7.8-21.3], P < 0.001), higher odds of complications (aOR = 1.72, 95%CI = 1.27-2.34, P < 0.001), and mortality (aOR = 3.42, 95%CI = 2.57-4.55, P < 0.001). CONCLUSION: REBOA is independently associated with longer time to OR for hemorrhaging trauma patients with an average delay of 15 minutes. Further research evaluating center-specific REBOA volume and utilization practices, and other pertinent system factors, may help improve both time to REBOA as well as time to definitive hemorrhage control across US trauma centers. LEVEL OF EVIDENCE: III. STUDY TYPE: Epidemiologic.

A PROMPT Update on Partial REBOA: Initial Clinical Data and Overview of the DoD-Funded Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) Study.

INTRODUCTION: Retrograde Endovascular Balloon Occlusion of the Aorta (REBOA) is an effective management for the transient responder, but the ischemic consequences of complete aortic occlusion currently limit its use. Multiple DoD-funded preclinical studies have clearly demonstrated that partial REBOA reduces distal ischemia to potentially extend safe occlusion times, while still providing effective temporization of noncompressible torso hemorrhage. Early versions of REBOA devices were designed to completely occlude the aorta and had little ability to provide partial occlusion. Recently, a new REBOA device (pREBOA-PRO) was designed specifically to allow for partial occlusion, with the hypothesis that this may reduce the complications of aortic occlusion and extend safe occlusion times while maintaining the benefits on cardiac and cerebrovascular circulation as well as reductions in resuscitation requirements. MATERIALS AND METHODS: To ascertain the impact of a new purpose-built partial REBOA device on the extension of safe occlusion time, the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) trial compared available data from the pREBOA-PRO with existing data from 200 clinical uses of pREBOA-PRO and available data in the AAST AORTA Registry were reviewed to design primary endpoints and clinical evidence for a prospective multi-center trial, the PROMPT Study. Together with the endpoints identified in preclinical studies of partial REBOA, primary endpoints for the PROMPT study were identified and power analyses were conducted to determine the target patient enrollment goals. RESULTS: Results from the clinical implementation of partial REBOA at a single trauma center were used to conduct the initial power analysis for the primary endpoint of Acute Kidney Injury (AKI) after prolonged occlusion. The rate of AKI after complete REBOA was 55% (12/20) compared to 33% (4/12) after partial REBOA (Madurska et al., 2021). With an alpha of 0.05 and power (ß) of 0.8, the projected sample size for comparison on a dichotomous outcome is 85 patients for the assessment of AKI. Initial power and endpoint analyses have been confirmed and extended with the ongoing analysis of partial and complete REBOA reported in the AORTA database. These analyses confirm preclinical findings which show that compared to complete REBOA, partial REBOA is associated with extended occlusion time in zone 1 (complete: 31 min vs. partial: 45 min, P = 0.003), lower rates of AKI after zone 1 occlusion (complete: 33% vs. partial: 19%, P = 0.05) and reduced resuscitation requirements (e.g., 25% reduction in pRBC administration: complete: 18 units vs. partial: 13 units, P = 0.02). CONCLUSIONS: The DoD-funded PROMPT study of partial REBOA will provide prospective observational clinical data on patients being treated with pREBOA-PRO. Outcomes will be stratified based on partial or complete occlusion to address whether partial REBOA has additional clinical benefits over complete REBOA, such as decreased distal ischemia, extension of safe occlusion time, improved hemodynamics during transition to and from occlusion, and reduced interoperative bleeding and blood product use. The results from this study are expected to confirm previous data demonstrating reduction of ischemic sequalae, improved transition to reperfusion, and reduced resuscitative requirements compared to complete REBOA.