Most emergency physicians are probably familiar, at least in theory, with resuscitative endovascular balloon occlusion of the aorta (REBOA), though the challenges associated with it have likely been deterrents to trying it in the emergency department. A new device, approved by the FDA in February, however, could be a real game-changer.
The concept, as previously outlined in the October 2015 edition of Emergency Medicine News (http://emn.online/1UdwkgG), relies on an endovascular balloon placed into the thoracic or lower abdominal aorta to control hemorrhage at non-compressible sites.
The challenges with the traditional method of REBOA, however, have been several-fold. The devices utilized were never really designed for trauma applications, and the wire required for placement is very lengthy and unwieldy. The CODA balloon, while very effective at achieving aortic occlusion, is likewise cumbersome, and the 12 French sheath required to deliver the CODA balloon into the aorta may represent the biggest challenge of all: The diameter of this device is likely to be occlusive in the common femoral artery of the majority of trauma victims, and may be more likely to cause significant arterial injury in attempted placement.
Even if the patient survives REBOA use, the large hole in the artery created by a 12 French sheath mandates subsequent open surgical repair of the common femoral artery at the earliest possible interval to avoid ischemic injury to the leg and even possible limb loss. Enthusiasm for REBOA has grown dramatically over the past year, but these sobering factors have proven challenging in actual implementation even at the most experienced of busy trauma centers.
Change for the Better
Now that the FDA approved the sale and distribution of ER-REBOA, the risk profile of REBOA placement changes significantly for the better. I am in no way affiliated, financially or otherwise, with this company, but in my opinion, this new device is a major advance for REBOA use in trauma. The key innovations that make this device attractive include the low-profile diameter, wireless catheter delivery system, and an integrated arterial monitoring port.
The diameter of the ER-REBOA at 7-French allows for placement with a smaller sheath, mitigating many of the risks associated with the larger sheath requirement for CODA placement. This smaller diameter may now make it possible simply to hold arterial pressure after device removal as one would a monitoring arterial line, as opposed to requiring universal open surgical repair of the arterial access site.
The ER-REBOA wireless catheter system, manufactured by Prytime Medical (formerly Pryor Medical), also significantly decreases the complexity of the procedure. The nitinol reinforced catheter is firm enough to resist retrograde pulsation and removes the need for long stiff wire placement, potentially making the procedure something one provider can accomplish, as opposed to the team effort it requires to introduce, position, and load a long rigid arterial wire. This device may also have the potential to be more safely placed without imaging guidance, though the FDA presently requires some additional study before it permits a “fluoroscopy free” indication. Any way you look at it, ER-REBOA can be performed with several fewer steps than older approaches. This easier and faster utilization should translate to more rapid aortic control, a key requirement for the types of patients typically considered for REBOA use.
Need for Caution
As a fellowship-trained surgeon in trauma/surgical critical care and vascular surgery, I view the ER-REBOA as a clear game-changer in REBOA for trauma indications. I have successfully salvaged hypotensive trauma victims at three different busy Level I trauma centers in my travels as an active duty military trauma surgeon. As the trauma surgeon on call at UC Davis in February, I was the fortunate to have this device available for a severely injured 28-year-old father of six, the first survivor after ER-REBOA use. (See photo. Also listen to me discuss this case with Scott Weingart, MD, on his EMCrit podcast at http://emcrit.org/podcasts/er-reboa.) I definitely consider this new device a dramatic improvement over the CODA for trauma use, and I firmly believe significant enthusiasm for increasing use of the ER-REBOA is justified.
I do believe, however, that a need for significant caution with REBOA use remains. Training is paramount to avoid most of the pitfalls. A number of courses are available; I would recommend the one-day Basic Endovascular Skills for Trauma (BEST) conducted at R Adams Cowley Shock Trauma Center. (Email BEST@umm.edu for information.) Key elements that should be reinforced in any training environment is that low-profile devices, while a clear advance, do not totally mitigate the risk for arterial injury if access is not achieved in the appropriate specific location (common femoral artery). My own experience, and that of an ongoing multicenter registry sponsored by the American Association for Surgery of Trauma (http://bit.ly/1oreTvd), suggests that this requires open cutdown in nearly half of all trauma patients for whom REBOA is utilized. Mastery of open common femoral artery exposure, then becomes an integral part of effective REBOA integration into practice regardless of device profile size.
Another important consideration moving forward will be that of the optimal environment in which to utilize REBOA. At present, I would not advise performing REBOA in any setting without the availability of immediate surgical support. I would suggest that anyone introducing this capability to their ED do so in close collaboration with surgical partners. REBOA utilization is and will continue to be a multidisciplinary team endeavor.
ER-REBOA is the first of many pending innovations in REBOA use that will continue to change practice. As with any innovation, the arrival of this device raises many questions about the who, when, and where of optimal REBOA use moving forward. The involvement of emergency medicine in answering these important questions will be paramount to success.
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