19 Temmuz 2024 Cuma 11:37:39


LOW PROFILE REBOA CATHETERS AT A GLANCE

LOW PROFILE REBOA CATHETERS AT A GLANCE

You have a patient with acute bleeding on your ED shift and after going through the indications and contraindications list, you plan to inflate a REBOA balloon at an appropriate level in the aorta and save some time both for the patient and yourself. 

We mentioned in our previous post  that it would be useful to create a REBOA kit to do the procedure promptly. Let’s say you work in an extraordinarily fancy ED and you have all the balloons at hand that we listed down for you. Which one would suit best for your patient?

As we mentioned in our previous articles, some of the catheters used in the REBOA procedure are specially designed and produced for the REBOA procedure, which is called low-profile catheters owing to their relatively smaller diameters while some catheters are used for other indications and considered suitable for REBOA as well. In this article, we will focus on the differences, advantages, and disadvantages of these low-profile balloon catheters. These catheters are REBOA Medical's REBOA Balloon Kit, Tokai's Tokai Rescue Balloon, Prytime's ER-REBOA catheter, and Frontline's Frontline COBRA-OS balloon catheter. The common advantages of these catheters over other catheters are the adequacy of small sheath sizes, fewer complications due to smaller sheath usage, and ease of closure of the artery after the procedure.

 

  • REBOA Balloon Kit

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The most important feature of the REBOA Baloon Kit, a product of the Norway-based REBOA Medical company, is that it offers you all the equipment you will need while doing REBOA as a kit. This kit includes all the tools, including the REBOA catheter, sterile drapes, introducer sheath, and 0.035-inch guidewire. There are two different kits with different REBOA catheters, but the length of both catheters is 80 cm. The first of the REBOA catheters is compatible with a 6 Fr arterial sheath, with a balloon diameter of 15 mm and a balloon length of 30 mm. The balloon can be inflated with 8 ml of fluid. REBOA Medical offers another balloon catheter that is compatible with a 7 Fr arterial sheath, 20 mm in diameter and 30 mm in length, inflated with 15 ml of fluid. Both arterial sheaths are 23 cm long. The application is made with Seldinger’s technique and both of the catheters have a CE approval.

https://www.youtube.com/watch?v=hoHgYOVUkyQ&t

 

  • Tokai Rescue Balloon

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Tokai Rescue Balloon, a product of Tokai company based in Japan, is a REBOA balloon catheter compatible with a 0.025-inch guidewire and a 7 Fr sheath. The catheter is 80 cm long and can be inflated with 40 ml of liquid. The maximum balloon diameter can reach up to 40 mm. The catheter is purchased with its stiff guidewire. The radiopaque tip and marker allow proper positioning under fluoroscopy. If there is a lack of radiological equipment, it is recommended to position the marker under the xiphoid process for Zone I REBOA and at the level of the umbilicus for Zone III REBOA. CE certification is available. As of 2022, it is the only REBOA catheter available in Turkey.

 

  • ER-REBOA

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The ER-REBOA catheter, a product of Prytime Medical company in the USA, was first used in 2016 and continues to be used as ER-REBOA Plus with the renewal in 2021. The catheter has many features that facilitate REBOA administration and trauma management and reduce complications. The catheter has a special construction that does not require a guidewire for REBOA administration but is compatible with a 0.025-inch guidewire when intravascular intervention is required. The catheter is used with a 7 Fr introducer sheath, 6 Fr in size and 72 cm long, and the diameter of the balloon when fully inflated is 32 mm. It is recommended to inflate the catheter with 2 ml of liquid for Zone III REBOA and 8 ml of liquid for Zone I REBOA. With its double lumen structure, central-aortic pressure monitoring can be performed from the distal end of the balloon. Thus, central blood pressure can be closely monitored. At the tip of the catheter, there is a radiopaque structure called P-type, which prevents damage to the vessel wall. Proper placement can be achieved more easily with the measurement lines on both sides of the catheter. It has CE certification.

https://www.youtube.com/watch?v=oaqbGT0xvFc

 

  • Frontline COBRA-OS

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The Frontline COBRA-OS catheter is a product of Canada-based Frontline Medical Technologies. The prominent feature of Frontline COBRA-OS, which stands for Control Of Bleeding, Resuscitation, Arterial Occlusion System, is that it is compatible with 4 Fr sheath. The catheter, introduced with the motto of less size, less time, and fewer complications, does not require a guidewire for application but is compatible with a 0.018-inch guidewire for interventions that may be required. The maximum balloon diameter is 25 mm, the amount of fluid required to inflate the balloon is 13 ml, and the catheter length is 64.9 cm. The structure called “Safety Shoulder Reservoir” located proximal to the balloon acts as a reservoir as a result of over-inflating the balloon and prevents rupture of the balloon or the aortic wall. Catheter placement can be checked with radiopaque marker areas in the proximal and distal of the balloon, and the J-type tip prevents the catheter from damaging the vessel wall.

https://youtu.be/fDrNJMhADfU

When evaluated in general, all balloon catheters have pros and cons, ease of use, and prominent features. Balloon catheter selection is up to the clinician's discretion, but it is useful to consider the procedure experience, the patient's condition, and environmental conditions when making a decision.

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References

  1. REBOA Medical 2022, accessed 12.05.2022,
  2. Tokai Medical Products, accessed 12.05.2022, https://www.tokaimedpro.co.jp/english/products/endovascular/000081.html
  3. Chang, S. W., Kim, D. H., & Chang, Y. R. (2020). Educational Simulation Videos for Performing Resuscitative Endovascular Balloon Occlusion of the Aorta. Journal of Trauma and Injury, 33(3), 140-143.
  4. Shoji, T., Tarui, T., Igarashi, T., Mochida, Y., Morinaga, H., Miyakuni, Y., ... & Yamaguchi, Y. (2018). Resuscitative endovascular balloon occlusion of the aorta using a low-profile device is easy and safe for emergency physicians in cases of life-threatening hemorrhage. The Journal of emergency medicine, 54(4), 410-418.
  5. Prytime Medical, accessed 12.05.2022, < https://prytimemedical.com>
  6. Frontline Medical Technologies 2022, accessed 12.05.2022,
  7. Power, A., Parekh, A., Scallan, O., Smith, S., Novick, T., Parry, N., & Moore, L. (2021). Size matters: first-in-human study of a novel 4 French REBOA device. Trauma Surgery & Acute Care Open, 6(1), e000617.

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