A new, lower profile device appears to be safe and effective for resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with blunt trauma, researchers report.
REBOA has been used for decades to control various types of hemorrhage below the diaphragm. The earliest experience with REBOA involved long platform guidewires and large introducer sheaths (12 Fr), but in 2015 a smaller profile device with a 7 Fr introducer sheath and no platform guidewire was approved.
Dr. Megan Brenner from University of California, Riverside and colleagues report their initial experience with this device in 60 consecutive patients who underwent REBOA, in most cases after blunt trauma (44/60, 73.3%).
Upon deployment of the device in the distal thoracic aorta (49 REBOAs) or distal abdominal aorta (11 REBOAs), mean systolic blood pressure increased significantly from 48.1 mmHg to 103.3 mmHg, according to the online report in The American Journal of Surgery.
Percutaneous cannulation was achieved in 41 patients, including 14 of the 31 who were in arrest at the time of REBOA. The remaining 19 patients required cannulation by open surgical cut down, including the other 17 patients in arrest.
ROSC after Ballon Inflation
Overall in-hospital survival was 43%, including 19% of patients in arrest and 69% of patients with refractory hypotension. Two-thirds of patients in arrest achieved return of spontaneous circulation (ROSC) after balloon inflation. This represents an improvement over the researchers' initial combined experience using the larger devices (37.5% overall survival, with 0% for patients in arrest at the time of REBOA).
Access and vascular procedural complications included iliac intimal injury requiring stent-graft (1), patch angioplasty of the common femoral artery (1), and balloon ruptures (3), and 5 amputations were required (2 due to initial injury and 3 delayed after unsuccessful efforts to salvage severely mangled extremities).
"Smaller introducer sheaths for REBOA are safe and effective alternatives to large-bore sheaths and may decrease arterial access complications, but do not eliminate the need for surgical common femoral artery access," the researchers conclude. "Patients who arrive in extremis, including those in arrest with ongoing CPR and those in arrest from non-hemorrhagic etiology, can benefit from REBOA with acceptable rates of ROSC and survival."
Dr. Joseph J. DuBose who recently reviewed risk factors and mitigation strategies related to REBOA, told Reuters Health by email, "Smaller diameter devices promise to mitigate the risk for access complications, but the present data suggest that specific expertise in the management of arterial access will continue to be required despite the advent of smaller intra-vascular devices."
"REBOA holds promise as a temporizing maneuver to deliver patients who do not respond to resuscitation rapidly to the operating room," he said. "REBOA represents a promising new evolution in technology. I look forward to ongoing research that continues to better define optimal utilization of this valuable tool."
Dr. Joseph Galante reported, "There are benefits from the smaller device, namely access. We will see the benefits of REBOA as physicians become more comfortable with its use, acquire the data to support which patients it benefits, and apply technological advances to make better devices, like this low profile REBOA."
Dr. Chad G. Ball reported, "REBOA is a powerful technology for the right patient at the right time…but it must also be engaged/used by someone who has a deep understanding of vascular anatomy and also has the ability to perform vascular reconstructions. Any additional use beyond this may lead to potentially preventable complications."