Midterm results of a single-center experience with commercially available devices for endovascular aneurysm repair.

PURPOSE: To review the outcome of endovascular abdominal aortic aneurysm repair (EVAR) using commercial stent graft devices.

METHODS: Retrospective review of 167 EVAR procedures using different commercial devices at a single center between 1999 and 2003. Analysis included preoperative patient morbidities, operative and hospitalization data, postoperative complications, procedural outcome and midterm patient survival. Data are expressed as mean +/- SD and total number (%). P-values = 0.05 were considered significant.

RESULTS: A total of 153 men and 14 women (mean age 75.0 +/- 7.3 years, range 53.1-89.2 years) underwent EVAR. Technical success rate was 97.0%. Postoperative intensive care unit stay was 0.05 +/- 0.24 days and hospital stay was 4 +/- 1.84 days. Postoperative complications occurred in 25 patients (15.0%). Two patients had to be readmitted within 30 days. Median follow-up time was 16.0 months (0-48 months). Overall mortality rate was 9.6% and did not depend on the type of endograft used (p=0.287). No early or aneurysm-related deaths or aneurysm ruptures occurred. Clinical success rate was 91.6% (153 patients). Graft limb thrombosis occurred in 5 patients (3.0%), all with the AneuRx device (p=0.041). Graft migration was seen in 3 devices (1.8%). There were 36 endoleaks (20.4%), specifically 30 branch vessel (type II) and 6 junctional (type I) endoleaks. Early endoleaks occurred in 21 patients (12.5%) and late endoleaks in 15 (9.0%). Twenty-two patients (13.0%) required secondary procedures (75.0% catheter-based vs. 25.0% surgical). Three patients (1.8%) underwent conversion to open aortic repair, 2 (1.0%) within the first year after EVAR. Aneurysm sac stabilization or shrinkage (> or = 5 mm reduction in transverse aneurysm diameter) occurred in 98.2% of patients; aneurysm shrinkage rate was 39.6% at 1 year, 68.74% at 2 years and 79.96% at 3 years after the procedure. Time to aneurysm shrinkage was longest with the AneuRx (1.96 +/- 0.18 years) and Talent (1.67 +/- 0.53 years) devices, compared to the Zenith (1.01 +/- 0.13 years), Ancure (0.95 +/- 0.14 years) and Excluder (0.25 +/- 0.17 years) stent grafts (p=0.0001).

CONCLUSION: Endovascular aortic aneurysm repair using commercially manufactured devices is safe and effective, especially in patients at high risk for open aneurysm resection. While evolving endovascular experience has significantly decreased complication and secondary intervention rates, close long-term follow-up remains mandatory to detect late complications. Elective and unbiased use of all available surgical and interventional procedures is required to maintain long-term clinical success after EVAR.