Background: To assess the long-term safety and effectiveness of endovascular aneurysm repair (EVAR) treatment with unibody endograft deployed on aortic bifurcation (anatomical fixation).
Methods: A retrospective, observational, single-center study of patients treated from 1999 to 2002 with unibody bifurcated endograft. Follow-up protocol required clinical and doppler-ultrasound at 1 and 6 months and annually thereafter, computed tomography angiography at 1-, 6- and 12-months and then every year. Primary endpoints included technical and treatment success, survival and freedom from late EVAR failure; secondary endpoints were freedom from late open conversion (LOC), freedom from late re-interventions and endoleaks.
Results: Seventy-three patients, mean age of 73±6 years were enrolled. Median follow-up was 6±0.5 years. Technical success was 98.6% (N.=71/73; causes of failure: 1 open conversion and 1 type Ib endoleak). A treatment success of 96% (N.=69/72) was recorded due to endoleaks (N.=2; 1 type Ia and 1 type Ib) and limb occlusion (N.=1). Survival at 1, 5, 10, 15 and 18 years was 90%, 58%, 40%, 32% and 23% respectively. One aneurysm-related death for infection of the endograft was registered. EVAR failure was 14% (N.=10/71). Three LOC were recorded and freedom from reinterventions at 1, 5, 10 and 18 years was 99%, 91%, 86% and 86%. Fourteen endoleaks were recorded: Ia (N.=6; 42.8%), Ia+Ib (N.=1; 7.1%), Ib (N.=2; 14.2%) and II (N.=5; 35.6%). Four endoleaks were observed, 9 endovascular correction and 1 LOC were required. Endoleaks free survival of 90% at 1-year and 75% at the end of the study. Aneurysm sac shrinkage was observed in 79% (N.=56/71).
Conclusions: This small, retrospective cohort of anatomically fixed EVAR demonstrated long-term safety and effectiveness. The design of the unibody graft did not substantially change and newer generation should guarantee the same performance.
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