Evaluation of Partial Flow Strategies in Hemorrhage and Traumatic Brain Injury with Endovascular Variable Aortic Control

Abstract

Resuscitative endovascular balloon occlusion of the aorta (REBOA) can stop bleeding and increase blood pressure to vital organs following severe trauma. Yet, there are major complications associated with even short periods of aortic occlusion due to lack of blood flow to the body below the balloon. Several methods to allow controlled blood flow past the balloon have been devised as a way to minimize these complications and extend the duration of therapy. Partial REBOA (pREBOA) is a balloon control strategy that makes small adjustments in the balloon volume to allow continuous small volume blood flow around the balloon to downstream organs. Intermittent REBOA (iREBOA) involves cyclical full inflation and full deflation of the REBOA balloon to allow downstream blood flow. Proponents of iREBOA site the ease of use in due to the presence of only two balloon states (deflated or inflated), whereas pREBOA requires careful titration of the balloon, making it more challenging and labor intensive. Conversely, it is suggested that iREBOA may lead to increased bleeding compared to pREBOA due to full deflation of the balloon. Animal studies of these two methods present conflicting conclusions regarding the ideal method to extend the duration of REBOA use. Furthermore, it is not clear which strategy is most beneficial in the context of a multiply injured Soldier that also has traumatic brain injury. Unfortunately, current clinical guidelines on this topic have been shaped based on unverified large animal data, which may lead to avoidable death of the injured Warfighter. Our group has extensive experience using automated balloon control, termed Endovascular Aortic Occlusion (EVAC), to streamline this process, enabling fully autonomous precision balloon control. This technique enables pREBOA and iREBOA to be performed without the need for continuous direct human oversight. The purpose of this proposal is the utilize the EVAC platform to compare pREBOA and iREBOA in a highly lethal injury model with hemorrhage, both with and without traumatic brain injury, to determine the optimal method for current manually controlled and next generation automated partial flow strategies. This proposal aligns with Focus Area 2 (Battlefield Resuscitation for Immediate Stabilization of Combat Casualties) by “exploring automated REBOA capabilities to enable interventions at the point of need” and Focus Area 3 (Neurotrauma) by exploring automated REBOA as an “innovative management of severely injured Warfighters with complex polytrauma conditions in the prehospital environments.” This study serves to advance the EVAC concept by identifying the ideal parameters for automated partial flow regulation, specifically iREBOA or pREBOA, to optimize outcomes for injured Warfighters. This automated technology also serves to minimize investigator bias and ensure increased fidelity in the results across all the intervention groups. Direct benefits of this research include the ability to extend the duration of treatment prior to undergoing surgery or stabilization in a hospital. This has broad applicability for military trauma care, where we are increasingly engaged in conflicts far removed from medical facilities with advanced surgical capabilities. This effort also seeks to address which strategy is best suited for those with associated brain injury, which has not been investigated to date. Given that the current Tactical Combat Casualty Care guidelines advocate for iREBOA use based on sparse and unvalidated animal research, this proposed research effort is essential to ensure these guidelines reflect optimal trauma care. We anticipate this work to occur over 18 months, with the knowledge products from this work able to immediately inform REBOA in both the forward deployed environments and in the U.S. civilian trauma centers. Additionally, the EVAC technology adds value to the Joint Program Committee 6 effort by generating the scientifically rigor

Document Details

Document Type
DoD Grant Award
Publication Date
Mar 10, 2021
Source ID
W81XWH2010864

Entities

People

  • Timothy Williams

Organizations

  • United States Army
  • Wake Forest University

Tags

Fields of Study

  • Medicine

Readers

  • Systems Analysis and Design
  • Trauma Surgery or Emergency Medicine.