Fourteen-Year Outcomes of Abdominal Aortic Endovascular Repair With the Zenith Stent Graft

Objectives Long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR) are affected by graft design renewals that tend to improve performances of older generations but usually reset follow-up times to zero. The present study investigated long-term outcomes, up to 14 years, of EVAR using the Zenith graft (Cook Medical, Bloomington, Ind), still in use without major modification, in a single-center experience. Go Methods Between 2000 and 2011, 610 patients representing the study group underwent elective EVAR using the Zenith endograft. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late reintervention, late conversion to open repair, aneurysm sac enlargement >5.0 mm, and EVAR failure (a composite of AAA-related death, AAA rupture, AAA growth, and any reintervention). Go Results Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. Mean proximal neck length was 24.7 and diameter was 23.9 mm. There were 5 perioperative deaths (0.8%), and 3 intraoperative conversions. At a mean follow-up of 99.2 months (range 0-175), 7 AAA ruptures occurred, all fatal except one. Overall survival, by Kaplan-Meier analysis, was 92.8% ± 1.1% at 1 year, 37.8% ± 2.9% at 10 years, and 24% ± 4% at 14 years. Freedom from AAA rupture was 99.8% ± 0.02 at 1 year and 98.1% ± 0.07% at 10 and 14 years. Freedom from AAA-related death was 99.2% ± 0.4% at 1 year, and 97.3% ± 0.8% at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6% at 1 year, 87.7% ± 1.5% at 5 years, 75.7% ± 3.2% at 10 years, and 69.9% ± 5.2% at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 81.0% ± 3.4% at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 patients(21.6%) at 14 years. At multivariate analysis, independent predictors of EVAR failure were type I and III endoleak (hazard ratio [HR], 10.8; 95% confidence interval [CI], 7.2-16; P ≤ .001), type II endoleak (HR, 3.59; 95% CI, 2.5-5.5; P < .001), and ASA grade 4 (HR, 1.55; 95% CI, 1.0-2.6; P = .031). Go Conclusions Our 14-year experience shows that EVAR with Zenith graft provides a safe and durable repair. Risk of rupture and aneurysm-related death is low, while overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.