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Size matters: first-in-human study of a novel 4 French REBOA device
  1. Adam Power1,
  2. Asha Parekh1,
  3. Oonagh Scallan1,
  4. Shane Smith1,
  5. Teresa Novick1,
  6. Neil Parry1,
  7. Laura Moore2
  1. 1Surgery, Western University, London, Canada
  2. 2Surgery, University of Texas McGovern Medical School, Houston, Texas, USA
  1. Correspondence to Dr Adam Power; adam.power{at}lhsc.on.ca

Abstract

Background Resuscitative 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).

Methods This 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.

Results A 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.

Discussion The 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 evidence Level V, therapeutic.

  • REBOA
  • COBRA-OS
  • organ donor
  • trauma
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors APo, OS, and TN were involved in study design and submission of the ITA application to Health Canada and Western University’s REB. APo, APa, OS, and TN were involved in data collection. All authors were involved in data analysis, data interpretation, and critical revisions. The first draft of the article was written by APo.

  • Funding This study was generously funded by Western University’s Department of Surgery Internal Research Fund 2019.

  • Competing interests A Power and A Parekh are co-founders and have an equity stake in Front Line Medical Technologies Inc. L J Moore is Chair of the Scientific Advisory board, has an equity stake, and receives consulting fees from Front Line Medical Technologies Inc.

  • Patient consent for publication Not required.

  • Data availability statement Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Further data are available through Trillium Gift of Life Network, 2020, Toronto, Ontario but must remain confidential due to the sensitive nature of organ donation.

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