Pediatric Sized REBOA Catheter Testing in a Pulsatile Aortic Flow Model
Keywords:pediatric REBOA, pulsatile flow model, trauma, balloon occlusion resuscitation
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 less than a 7 French sheath.
Methods – We bench tested the occlusion capability of eight commercially available balloon catheters deliverable through 4Fr, 5Fr and 6Fr sheaths in an anatomic pulsatile flow model of the pediatric aorta with variable luminal diameters (5mm, 6mm, 7mm, 8mm, 9mm, 10mm, and 12mm). Inflated balloon migration and the deflated balloon’s effect on aortic flow were recorded. The flow chamber was calibrated to approximate size-appropriate physiologic aortic blood flow.
Results – Seven of eight devices were able to occlude the test lumen diameter corresponding to their manufacture 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 (10-15mm) followed by Numed (1-5mm). Device migration was undetectable in the Cordis devices.
Conclusion – There are commercially available balloon catheters, deliverable through smaller than 7Fr sheaths which can occlude pediatric sized aortic test lumens in the setting of physiologic pulsatile flow. These results will help inform future research, device development and practice in the field of pediatric REBOA.