Background/Objective: Durability is the main concern of aortic endografting, but it is not clear to what extent trial results
are applicable to “real world” patients. The purpose of this study was to assess the durability of a single model of aortic
endograft in an unselected population with core lab analysis of morphological changes.
Methods: Computed tomography (CT) images of patients treated with Talent Unidoc (Medtronic, Santa Rosa, Calif)
endografts from 2002 to 2006 in nine European centers with more than 1 year follow-up were centrally reviewed using
a dedicated software with multiplanar and volume reconstructions. Images were checked for aneurysm growth >5 mm,
neck enlargement >3 mm, graft migration >10 mm, endoleak, structural integrity. Morphological changes were defined
clinically relevant when associated with reintervention or aneurysm-related death.
Results: A total of 349 patients (mean age 73.8 years, 90% males) were available for analysis; 1187 CT examinations were
reviewed. Median abdominal aortic aneurysm (AAA) diameter was 56 mm (interquartile range [IQR] 49-62), neck
length 20 mm (IQR 16-30), and neck diameter 25 mm (IQR 23-26). Mean follow-up was 25 months (range 12-60
months). During the study period, 10 late deaths (1 aneurysm-related, 0.3%) with a survival rate of 89.2% at 48 months
and 33 reinterventions including 8 conversions (2.2%), 2 AAA ruptures (0.6%) and 1 (0.3%) loss of graft integrity were
recorded. Cumulative reintervention rate was 6%, 8%, 13%, and 16% at 1, 2, 3, and 4 years, respectively. According to core
lab analysis, 22 AAA grew, 169 were unchanged, and 158 shrunk, with a growing AAA rate of 3.1% patients/year. Five
growths required reintervention, one for rupture. Forty-seven (6.5% patients/year) neck enlargements, three clinically
relevant, 17 migrations (2.4% patients/year), five clinically relevant, and 70 endoleaks (9.7 % patients/year), 11 clinically
relevant, were detected.
Conclusion: Data from this real world experience monitored with a centralized imaging review show that endovascular
repair of abdominal aortic aneurysm with the latest generation of a single model of endograft is associated with low graft
thrombosis and graft fatigue, and low late aneurysm rupture and related death risks. Neck enlargement although
common after EVAR, is almost always without clinical consequences but a longer follow-up and prospective clinical
studies are advisable to confirm the present results.
