Purpose: To report the results of a two-center study of endovascular a
bdominal aortic aneurysm (AAA) exclusion using a polyester-covered nit
inol stent-graft. Methods: Candidates were evaluated with arteriograph
y and computed tomography. Criteria for endovascular therapy were a pr
oximal aortic neck > 10 mm in length and < 25 mm in diameter, no bilat
eral internal iliac artery involvement in the aneurysm, no markedly to
rtuous common iliac arteries (CIAs) or CIAs < 7 mm in diameter, and no
superior mesenteric artery occlusive disease. Patients were treated w
ith the Mialhe Stenter and Vanguard stent-grafts in either tube or bif
urcated versions. Results: Between August 1994 and November 1996, 149
patients (mean age 67 years, range 49 to 90) were admitted to the stud
y. Overall primary technical success (aneurysm exclusion without endol
eak) was 87% (130 patients): 78% (7 patients) for tube grafts and 88%
(123 patients) for bifurcated endografts. The rate of local, remote, o
r systemic complications was 10.8%, with a 30-day mortality rate of 0.
7%. During an average 13.5-month follow-up, there were no late deaths.
Four of 20 endoleaks sealed spontaneously, 14 were treated with endol
uminal techniques, and 2 remain untreated by patient request. Three gr
aft limb thromboses occurred; one was treated surgically, one with lyt
ic therapy, and one was untreated. Secondary patency was 96%. Conclusi
ons: Endoluminal repair of infrarenal AAAs using straight or bifurcate
d grafts is a feasible alternative to conventional surgical repair. Lo
nger follow-up and more experience with refined endograft models will
elucidate the durability of this endovascular approach to treating AAA
s.