Objective: The objective was to review the current results of endovascular
abdominal aortic aneurysm repair with the AneuRx stent graft and to determi
ne the effectiveness of the device in achieving the primary objective of pr
eventing aneurysm rupture.
Methods: The outcome of all patients treated during the past 4 years in the
U.S. AneuRx clinical trial was determined, and the worldwide clinical expe
rience was reviewed.
Results: A total of 1192 patients were treated with the AneuRx stent graft
during all phases of the U.S. Clinical Trial from June 1996 to November 199
9, with follow-up extending to June 2000. Ten (0.8%) patients have had aneu
rysm rupture, with most ruptures (n = 6) occurring in 174 (3.4%) patients t
reated with an early stiff bifurcation stent graft design used in phase I a
nd in the initial stages of phase II. Since the current, flexible, segmente
d bifurcation stent graft design was introduced, four (0.4%) ruptures have
occurred among 1018 patients treated. Of these, one was during implantation
, two were placed too far below the renal arteries, and one patient refused
treatment of a type I endoleak, Kaplan-Meier analysis of all 1192 patients
treated with the AneuRx stent graft including both stent graft designs rev
ealed the patient survival rate to be 93% at 1 year, 88% at 2 years, and 86
% at 3 years, freedom from conversion to open repair to be 98% at 1 year, 9
7% at 2 years, and 93% at 3 years, and freedom from secondary procedure to
be 94% at 1 year, 92% at 2 years, and 88% at 3 years. Freedom from aneurysm
rupture with the commercially available segmented bifurcation stent graft
was 99.7% at 1 year, 99.5% at 2 years, and 99.5% at 3 years. The presence o
r absence of endoleak on contrast computed tomography scanning after stent
graft placement was not found to be a significant predictor of long-term ou
tcome measures. Worldwide experience with the AneuRx device now approaches
10,000 patients.
Conclusions: Endovascular management of abdominal aortic aneurysms with the
AneuRx stent graft has markedly reduced the risk of aneurysm rupture while
eliminating the need for open aneurysm surgery in 98% of patients at 1 yea
r and 93% of patients at 3 years. The device was effective in preventing an
eurysm rupture in 99.5% of patients over a a-year period. The overall patie
nt survival rate was 93% at 1 year and 86% at 3 years.