Introduction: Currently, there is a wide range of commercially available devices for endovascular aneurysm repair (EVAR) that differ in terms of both anatomical requirements and the technology and technique of deployment.
Aim: To assess the applicability of currently commercially available devices for EVAR in the treatment of an asymptomatic abdominal aneurysm (AAA).
Material and methods: The study group included 100 patients with infrarenal AAA with a maximum diameter ≥ 50 mm, qualified for invasive treatment at the University Hospital in 2013-2014. The aortoiliac morphological characteristics of the AAA were evaluated on preoperative computed tomography angiograms using the OsiriX DICOM viewer in the 3D-MPR mode. The morphological applicability of 14 types of CE-marked and FDA-approved stent grafts was determined based on their instructions for use (IFU).
Results: EVAR was feasible with at least one of the analysed devices in 68% of patients. The morphological applicability was as follows: Excluder Conformable (65%), Ovation iX (51%), Endurant II (47%), Treo (45%), Excluder C3 (45%), AFX 2 (45%), Incraft (44%), E-tegra (44%), Zenith Alfa (41%), Zenith Flex (40%), Anaconda (39%) Aorfix (37%), Altura (34%), and E-vita (20%). The differences in the stent graft applicability were statistically significant (p < 0.001). A wide diameter of the common iliac artery, angulated proximal neck, and diameter of proximal neck out of range constituted the most frequent causes of EVAR inapplicability.
Conclusions: The IFU-based applicability of currently available AAA stent graft systems differs significantly. Despite the constant evolution of EVAR technology, at least 32% of AAA will require a different therapeutic approach.
Keywords: endovascular aneurysm repair; infrarenal abdominal aortic aneurysms; instructions for use; stent graft.
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