A contemporary assessment of devices for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): resource-specific options per level of care

Vrancken, Suzanne M; Burg, Boudewijn L S Borger van der; Vrancken, Paul J E M; Kock, Gert-Aldert H; Rasmussen, Todd E.; Hoencamp, Rigo

doi:10.1007/s00068-020-01382-5

Cited by 11 publications

(10 citation statements)

References 24 publications

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“…To our knowledge, this is the lowest profile aortic occlusion device ever reported 25 and we think that the 4 Fr COBRA-OS represents a significant improvement in REBOA technology by lowering the profile without compromising aortic occlusion ability. Due to the lower profile, we expect adoption for REBOA to increase when this device becomes widely available, similar to when there was a transition from 12 Fr to 7 Fr devices.…”

Section: Discussionmentioning

confidence: 91%

Size matters: first-in-human study of a novel 4 French REBOA device

Power

Parekh

Scallan

et al. 2021

Trauma Surg Acute Care Open

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BackgroundResuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the feasibility of a novel 4 French REBOA device called the COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System).MethodsThis study is the first-in-human feasibility trial of the COBRA-OS. Due to the difficulty of trialing the device in the trauma setting, we performed a feasibility study using organ donors (due to the potential usefulness of the COBRA-OS for normothermic regional perfusion) after neurological determination of death (NDD) prior to organ retrieval. Bilateral 4 French introducer sheaths were placed in both femoral arteries and the COBRA-OS was advanced up the right side and deployed in the thoracic aorta (Zone 1). Once aortic occlusion was confirmed via the left-sided arterial line, the device was deflated, moved to the infrarenal aorta (Zone 3), and redeployed.ResultsA total of 7 NDD organ donors were entered into the study, 71% men, with a mean age 46.6 years (range 26 to 64). The COBRA-OS was able to occlude the aorta in Zones 1 and 3 in all patients. The mean time of placing a 4 French sheath was 47.7 seconds (n=13, range 28 to 66 seconds). The mean time from skin to Zone 1 aortic occlusion was 70.1 seconds (range 58 to 105 seconds); mean balloon volumes were 15 mL for Zone 1 (range 13 to 20 mL) and 9 mL for Zone 3 (range 6 to 15 mL); there were no complications and visual inspection of the aorta in all patients revealed no injury.DiscussionThe COBRA-OS is a novel 4 French REBOA device that has demonstrated fast and safe aortic occlusion in this first-in-human feasibility study.Level of evidenceLevel V, therapeutic.

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Section: Discussionmentioning

confidence: 91%

Size matters: first-in-human study of a novel 4 French REBOA device

Power

Parekh

Scallan

et al. 2021

Trauma Surg Acute Care Open

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“…This statement is supported by recent gap analyses and case series on REBOA in austere environments 34–38 . Modern REBOA devices are specifically developed for trauma cases and carry features that make them suitable for application in austere, resource-limited environments 39 . However, techniques for lengthening balloon occlusion time have to be explored given the increasing shift to prolonged field care or for cases where the number of casualties exceeds the surgical capacity 30,40 .…”

Section: Discussionmentioning

confidence: 96%

Advanced bleeding control in combat casualty care: An international, expert-based Delphi consensus

Vrancken

Burg

DuBose

et al. 2022

J Trauma Acute Care Surg

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BACKGROUND: Hemorrhage from truncal and junctional injuries is responsible for the vast majority of potentially survivable deaths in combat casualties, causing most of its fatalities in the prehospital arena. Optimizing the deployment of the advanced bleeding control modalities required for the management of these injuries is essential to improve the survival of severely injured casualties. This study aimed to establish consensus on the optimal use and implementation of advanced bleeding control modalities in combat casualty care. METHODS:A Delphi method consisting of three rounds was used. An international expert panel of military physicians was selected by the researchers to complete the Delphi surveys. Consensus was reached if 70% or greater of respondents agreed and if 70% or greater responded. RESULTS:Thirty-two experts from 10 different nations commenced the process and reached consensus on which bleeding control modalities should be part of the standard equipment, that these modalities should be available at all levels of care, that only trained physicians should be allowed to apply invasive bleeding control modalities, but all medical and nonmedical personnel should be allowed to apply noninvasive bleeding control modalities, and on the training requirements for providers. Consensus was also reached on the necessity of international registries and guidelines, and on certain indications and contraindications for resuscitative endovascular balloon occlusion of the aorta (REBOA) in military environments. No consensus was reached on the role of a wound clamp in military settings and the indications for REBOA in patients with chest trauma, penetrating axillary injury or penetrating neck injury in combination with thoracoabdominal injuries. CONCLUSION: Consensus was reached on the contents of a standard bleeding control toolbox, where it should be available, providers and training requirements, international registries and guidelines, and potential indications for REBOA in military environments.

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“…Interestingly, both the devices have occlusion balloons with similar lengths (CODA 32 mm [3.7 cm] and IntraClude [3.75 cm]). 14 , 15 The preoperative CT scan was crucial in identifying a suitable landing zone for the CODA balloon in the ascending aorta graft proximal to the brachiocephalic artery. The estimated dimensions of the landing zone were of sufficient length and width to accommodate the inflated endoballoon device without occluding the coronary arteries proximally or the brachiocephalic artery distally.…”

Section: Discussionmentioning

confidence: 99%