Lifeline registry of endovascular aneurysm repair: long-term primary outcome measures.

PURPOSE: To determine the long-term outcome after endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms (AAA).
METHODS: Review the primary outcome measures of patients treated with endovascular grafts (EG) in the Lifeline Registry of EVAR. The registry contains data on 2,664 EG patients and 334 open surgical control (SC) patients collected under four multicenter Investigational Device Exemption (IDE) clinical trials that lead to United States Food and Drug Administration (FDA) approval with mandatory 5-year follow-up. Primary outcome measures include operative mortality, AAA-related death, all-cause mortality, aneurysm rupture, and surgical conversion.
RESULTS: Pooled data from IDE clinical trials revealed that EG patients were 3 years older (73 +/- 8 years) than SC patients (70 +/- 8 years, P < .01) and had significantly more cardiac comorbidities before treatment. However, there was no difference in 30-day operative mortality between EG (1.7%) and SC (1.4%) (P = .72). Both EG and SC were successful in preventing rupture, with freedom from aneurysm rupture in 99.8% of EG and 100% of SC patients at 1 year (P = .51). Freedom from rupture remained at 99% in years 1 to 6 after EG, with no increasing risk of late rupture. There was no significant difference in the AAA-related death rate at 1 year between EG (98.2%) and SC (98.6%) (P = .64). Freedom from AAA-related death remained at 98% in years 1 to 6 after EG, with no increasing risk of late AAA-related death. Kaplan-Meier analysis at 6 years revealed freedom from aneurysm rupture in 99%, freedom from AAA-related death in 98%, and freedom from surgical conversion in 95% of EG patients. There was no difference in survival at 4 years between EG (74%) and SC (71%) (P = .49). Overall EG patient survival at 5 years was 66% and at 6 years was 52%. Women had a higher risk of rupture (2.4%) than men (1.2%) (P = .01) and a higher rate of surgical conversion (8.3%) than men (3.8%) (P < .01) but had the same low AAA-related death rate (3.5%) as men (2.1%) (P = .16) at 5 years. Most secondary interventional procedures (85%) were performed < or =30 days after EVAR. Freedom from secondary intervention was 84% at 1 year and 78% at 5 years.
CONCLUSIONS: Endovascular aneurysm repair using FDA-approved devices is a safe, effective, and durable treatment for anatomically suited patients with infrarenal abdominal aortic aneurysms.