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Observational Study
. 2024 Sep 1;159(9):998-1007.
doi: 10.1001/jamasurg.2024.2254.

Prehospital Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Exsanguinating Subdiaphragmatic Hemorrhage

Affiliations
Observational Study

Prehospital Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Exsanguinating Subdiaphragmatic Hemorrhage

Robbie A Lendrum et al. JAMA Surg. .

Abstract

Importance: Hemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care.

Objective: To 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 participants: This 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.

Exposures: ZI REBOA or P-REBOA.

Main outcomes and measures: The 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.

Results: Femoral 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 relevance: In this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death.

Trial registration: ClinicalTrials.gov Identifier: NCT04145271.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Lendrum reported grants from National Health Service Scotland (research fellowship) during the conduct of the study as well as grants from the National Institute for Health Research (NIHR) for the UK Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) trial and other from Certus Critical Care Medical (advisory board) outside the submitted work. Dr Campbell reported grants from NIHR and Intuitive Surgical European Research Board for unrelated work outside the submitted work. Dr Tai reported employment at the UK Ministry of Defence, which trains and equips surgical teams with REBOA as well as participation in Ministry of Defense REBOA training as part of military duties and in the UK REBOA study (investigator), which reported in April 2023, and serving as editor of an international textbook on vascular trauma, published by Elsevier, which includes chapters on REBOA, and has received royalty payments from Elsevier. Dr Johnson reported personal fees from Certus Critical Care outside the submitted work; in addition, Dr Johnson had a patent for blood flow control devices, systems, and methods pending Certus Critical Care, a patent for calibration of solid-state sensors pending (Certus Critical Care), a patent for devices, systems, and methods for blood flow control pending (Certus Critical Care), a patent for blood flow control devices, systems, and methods issued (Certus Critical Care), a patent for blood pressure regulation system for the treatment of neurologic injuries pending (University of Utah), a patent for resuscitation and ventilation asynchrony monitor issued (Certus Critical Care), a patent for aortic flow meter and pump for partial-aortic occlusion issued (Certus Critical Care), and a patent for endovascular perfusion augmentation for critical care issued (Certus Critical Care). Dr Jansen reported grants from NIHR as chief investigator of the UK-REBOA trial during the conduct of the study as well as grants and personal fees from CSL Behring; grants from Infrascan, RevMedX, the National Institutes of Health, the US Department of Defense, and Medical Technology Enterprise Consortium; and personal fees from Octapharma outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Group-Level Hemodynamic Response to Zone 1 (Z1)–Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) and Partial (P)–REBOA
The horizontal lines indicate medians; boxes indicate IQRs, and whiskers show maximum values. BP indicates blood pressure; ED, emergency department.
Figure 2.
Figure 2.. Individual Hemodynamic Responses to Zone 1 (Z1)–Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) and Partial (P)-REBOA
C-REBOA indicates complete REBOA; LOS, length of stay; D-MAP, postinflation distal mean arterial pressure baseline; P1, proximal (aortic) mean arterial blood pressure and pulse pressure measured from the tip of the REBOA catheter; P2, distal (common femoral artery) mean arterial pressure measured from the side arm of the 8F access sheath; TCA, traumatic cardiac arrest. aExternal cardiac massage epinephrine, 100 μg. bSheath upsize 4F (early femoral access for arterial blood pressure measurement) to 8F (REBOA arterial access sheath).

Comment on

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