Feasibility Study of a Direct Endo-Aortic Clamp Balloon

We have developed a new end-aortic clamp balloon catheter intended to be inserted directly into, thereby occluding, the ascending aorta. We examined the performance of this catheter in a canine model. We evaluated the extent of migration tolerance of the catheter under cardiopulmonary bypass perfusion in 12 mongrel dogs, weighing 20 kg, under general anesthesia. After institution of cardiopulmonary bypass, this catheter was inserted into the ascending aorta, and the balloon was inflated to occlude the ascending aorta. After the canine heart was arrested following the administration of cardioplegic solution, balloon migration was examined over a period of 3 hours, with hourly increases in perfusion pressure from 50 mm Hg to 80 mm Hg and finally to 100 mm Hg. After the migration test, ascending aortic wall sections, where the balloon was inflated, were examined microscopically. At internal balloon pressure of 300 to 400 mm Hg, migration occurred at perfusion pressure of > or =90 to 100 mm Hg. No histological differences were observed with use of the balloon catheter, compared with an extra-aortic clamp forceps. Based on these results, this device is safe, feasible, and can adequately occlude the ascending aorta during cardiopulmonary bypass. We conclude that this device is effective in patients weighing 20 kg.