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.

Managing Mesenteric-Side Small Bowel Perforation in the Setting of Non-ST Elevation Myocardial Infarction: A Dual Challenge.

Small bowel perforations are critical surgical emergencies, and those occurring on the mesenteric side are particularly uncommon. These perforations can lead to significant morbidity due to potential vascular compromise and the rapid spread of intraluminal contents. When a patient concurrently presents with a non-ST elevation myocardial infarction (NSTEMI), the clinical management becomes even more intricate. Balancing the urgency of surgical intervention for bowel perforation with the potential cardiac risks associated with surgery, especially in the context of a concurrent NSTEMI, poses a significant clinical challenge. An 86-year-old male with an extensive cardiac history presented with a complaint of abdominal pain, primarily localized to the left lower quadrant. Diagnostic investigations, including a contrast-enhanced computerized tomography (CT) scan, identified extraluminal air and pronounced inflammation adjacent to a loop of small bowel, consistent with perforation. Simultaneously, elevated troponin levels and specific electrocardiogram (ECG) changes confirmed an NSTEMI diagnosis. Following a multidisciplinary discussion, the patient underwent exploratory laparotomy, resulting in small bowel resection. Postoperative cardiac monitoring managed a brief episode of supraventricular tachycardia effectively. This case highlights the intricacies involved in managing a patient with a rare mesenteric-side small bowel perforation while also dealing with an NSTEMI. While the causes of spontaneous small bowel perforations can vary, this case presented an added layer of complexity without a clear predisposing factor. The presence of NSTEMI introduced challenges in determining the timing and approach to surgical intervention. The necessity for collaboration between surgical and cardiology teams was evident, ensuring a comprehensive assessment of the patient's cardiac risk and optimizing cardiac medications. Managing a patient with concurrent small bowel perforation and NSTEMI demands meticulous clinical judgment and inter-specialty collaboration. This case offers valuable insights into the considerations and challenges faced in such unique clinical scenarios, emphasizing the importance of individualized patient care.

Utility of an Emergency Department Observation Unit in Providing Care for Patients With Blunt Thoracic Trauma.

Background The use of Emergency Department Observation Units (EDOUs) to treat patients with a variety of complaints has grown over recent years. However, the treatment of patients with traumatic injuries in EDOUs is infrequently described. Our study sought to describe the feasibility of treating patients with blunt thoracic trauma in an EDOU in consultation with our trauma and acute care surgery (TACS) team. Together, our Emergency Department (ED) and TACS teams designed a protocol for the treatment of patients with specific blunt thoracic injuries (fewer than three rib fractures, nondisplaced sternal fractures) that we felt would require less than 24 hours of care in a hospital setting. Methods This study is an IRB-approved retrospective analysis comparing two groups before (pre-EDOU) and after (EDOU) the creation of the EDOU protocol, which was implemented in August 2020. Data was collected at a single, Level 1 trauma center with approximately 95,000 annual visits. Similar inclusion and exclusion criteria were used to select patients in both groups. We conducted two-sample t-tests and Chi-square testing to assess for significance. Primary outcomes include length of stay and bounce-back rate. Results A total of 81 patients were included in our data set across both groups. Forty-three patients were included in our pre-EDOU group while 38 patients were treated in our EDOU once the protocol was implemented. Patients in both groups were of similar age, gender and had similar Injury Severity Scores (ISS) ranging from 9 to 14. Hospital length of stay was shorter for the EDOU group (31.5 hours) compared to the pre-EDOU group (36.4 hours) although not statistically significant. When risk stratified by ISS, hospital length of stay did reach statistical significance and was found to be shorter for patients with ISS scores greater than or equal to 9 that were treated in the EDOU (29.1 hours vs. 43.8 hours, p = .028). Both groups had one patient each bounce back for repeat evaluation and additional care. Conclusion This study demonstrates the potential use of EDOUs to treat patients with mild to moderate blunt thoracic injuries. The availability of trauma surgeons for consultation along with ED provider experience may be rate-limiting steps in utilizing observation units to care for trauma patients. Additional research with more participants is needed to determine the impact of implementing such a practice at other institutions.