Pediatric Sized REBOA Catheter Testing in a Pulsatile Aortic Flow Model

Abstract

Background: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in the management of pediatric abdomino-pelvic hemorrhage from trauma or iatrogenic injury is limited by a lack of appropriately sized balloon catheters that can be delivered through a less than 7-Fr sheath.
Methods: We bench tested the occlusion capability of eight commercially available balloon catheters deliverable through 4-Fr, 5-Fr, and 6-Fr sheaths in an anatomic pulsatile flow model of the pediatric aorta with variable luminal diameters (5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, and 12 mm). Inflated balloon migration and the deflated balloon’s effect on aortic flow were recorded. The flow chamber was calibrated to an approximate size-appropriate physiologic aortic blood flow.
Results: Seven of the eight devices were able to occlude the test lumen diameter corresponding to their manufactured specifications. Deflated luminal flow restriction in the smallest test lumen was lowest in the Fogarty devices (0–3%) followed by Cordis (8–10%) and Numed (14–26%) devices. The Fogarty devices demonstrated the most distal migration (10–15 mm) followed by Numed (1–5 mm). Device migration was undetectable in the Cordis devices.
Conclusion: There are commercially available balloon catheters, deliverable through smaller than 7-Fr sheaths, which can occlude pediatric sized aortic test lumens in the setting of physiologic pulsatile flow. While the use of these catheters for occlusion represents off-label use, these results will help inform future research, device development, and practice in the field of pediatric REBOA.