ABSTRACT
BACKGROUND: Several endovascular grafts are currently being evaluated for repair of abdominal aortic aneurysms (AAA). The goals of our study were twofold. First was to develop a new endovascular graft with several advantages over previous devices: (1) smaller size (16 fr), (2) recapturability (the device can be partially deployed and then recaptured and moved to a new location or entirely removed if needed), and (3) accuracy and ease of placement. Our second goal was to develop an animal model in which a full-scale prototype of the device could be tested. METHODS: Our final endovascular graft prototype was developed after extensive in-vitro testing, and trials of earlier prototypes in dog, pig, and female sheep models. Uncastrated male sheep, 75 to 100 kg, were chosen as the animal model in which to test the device. These animals had infrarenal aortas that were comparable to that of small humans, with diameters of 12 to 15 mm. Two models were used: (1) native infrarenal aorta, and (2) artificial infrarenal aneurysm. Pre-implant and postimplant angiography and intravascular ultrasound were used to evaluate graft placement, and were repeated prior to euthanasia and necropsy. RESULTS: The final prototype was implanted in 22 animals. Sixteen animals had the device placed in their native infrarenal aorta. Three animals were sacrificed immediately after implantation, and 6 more were euthanized after 2 weeks (n = 2), 6 weeks (n = 2), and 3 to 4 months (n = 2). In 7 animals the device is still in place. All procedures were successful. Pathology confirmed complete exclusion of the aorta and thrombosis of all lumbar branches covered by the graft. There was no evidence of graft malposition, migration, or perigraft leak, and no evidence of significant vessel injury on histology. Six animals had artificial aneurysms surgically created and then repaired with the device. A technical error resulted in a failure in 1 case; the remaining aneurysms were all successfully excluded. CONCLUSIONS: We report the development of a new endovascular prosthesis for the repair of AAA. Newer design features provide for smaller delivery size (16 fr), facilitate accurate placement, and provide the option when the device is partially deployed to recapture and reposition the device if necessary. In addition, we have developed an animal model in which this device, and future endovascular aortic devices, can be tested.
