Transfemoral placement of intraluminal polyurethane prosthesis for abdominal aortic aneurysm.

Because of the significant mortality associated with the conventional surgical approach to abdominal aortic aneurysms (AAA) in the high risk patients and in those with ruptured aneurysms, we have developed a new approach to this problem, intraluminal aneurysm exclusion. This was achieved by an intraluminal prosthesis which approximated the diameter of the aorta above and below the aneurysm and is inserted through the femoral artery. The prosthesis consisted of biomedical grade elastomeric polyurethane with a NITINOL and/or stainless steel frame and was designed in such a configuration that it could be compressed inside a 15 F catheter and then regain its original shape after being discharged inside the aorta. The polyurethane prosthesis tolerated static pressures in excess of 300 Torr. Aneurysmal aortas were created in three adult sheep using large knitted Dacron pathches (6 X 9 cm) sewn onto a longitudinal aortotomy. After 4-6 weeks, an intraluminal prosthesis was passed transfemorally to the location of the aortic aneurysm. Following satisfactory placement and expansion of the prosthesis, a laceration was produced in the aneurysmal wall. No bleeding developed, which confirmed the integrity of the prosthesis in excluding the aneurysm from the aorta proper. Pulsation in the iliac arteries indicated the presence of aortic blood flow through the prosthesis. Autopsy examination demonstrated directly that the prosthesis was open and that its two ends were fixed in the aorta above and below the aneurysm. The study has demonstrated that intraluminal AAA exclusion could be achieved with an intraluminal polyurethane prosthesis inserted through the femoral artery.