Increased flexibility of AneuRx stent-graft reduces need for secondary intervention following endovascular aneurysm repair.
OBJECTIVE
To evaluate the impact of a change in the manufacturing of the AneuRx stent-graft on the long-term results of endovascular abdominal aortic aneurysm (AAA) repair.


METHODS
The first 70 AAA patients treated with the AneuRx stent-graft between October 1996 and December 1998 were reviewed. The early stiff bifurcated design (STIFF) was used in 23 patients (mean age 71.7 +/- 9.3 years, range 45-87) and the current flexible bifurcated design (FLEX) in 47 mean age 75.0 +/- 7.3 years, range 61-96). Data on patient demographics, aneurysm morphology, technical success, complications, secondary procedures, and outcomes were compared using Kaplan-Meier estimates to evaluate patient survival and freedom from surgical conversion, rupture, and secondary interventions at 6, 12, and 24 months.


RESULTS
The 2 groups were equally matched with regard to age, preoperative comorbidities, proximal neck dimensions, and aneurysm diameter. Mean follow-up times were 22.42 +/- 11.72 months (range 1-46) for the STIFF cohort and 18.08 +/- 6.14 months (range 1-30) for the FLEX (p = 0.057). Eleven (48%) of 23 STIFF patients required secondary interventions versus 6 (13%) of 47 FLEX patients (p < 0.05). There were no ruptures. At the 24-month interval, survival estimates were 86% for STIFF and 76% for FLEX (p = NS); freedom from surgical conversion was 100% for STIFF and 97% for FLEX (p = NS) and freedom from secondary interventions was 18% for STIFF and 90% for FLEX (p < 0.05) at 24 months.


CONCLUSIONS
The AneuRx stent-graft was effective in achieving the primary objective of preventing aneurysm rupture in all patients. However, increasing the flexibility of the bifurcated module significantly improved the primary success rate by reducing the need for subsequent secondary interventions.
Arko
F R
FR
Division of Vascular Surgery, Stanford University Medical Center, California 94305, USA.
Lee
W A
WA
Hill
B B
BB
Cipriano
P
P
Fogarty
T J
TJ
Zarins
C K
CK
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000628:therapy*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D004867:Equipment Design; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015607:Stents