Real-Life Experience with Ovation Stent Graft: Lesson Learned from the First One Hundred Fifty Treated Patients

The objective of the study was to report immediate and midterm results of an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) using the Ovation stent graft.

A double-center retrospective study was conducted on a prospectively collected database between 2012 and 2015. One hundred fifty-six elective patients were included. The outcome measures considered for analysis were primary technical success, 30-day and midterm reinterventions, and all-cause and AAA-related mortality rates. The presence of an aortic neck ≤10 mm, and of a noncylindrical aortic neck, as well as a narrowed aortic bifurcation was defined as an aortic bifurcation average diameter (AB_average) ≤ 18 mm or an AB_area ≤ 20 mm², and an external iliac artery diameter ≤5 mm was considered as independent factors potentially influencing the outcome.

Male patients totaled 128 (82.1%), and mean age was 74.83 ± 6.76 years (range: 56-91). Mean aortic diameter was 57.15 ± 8.77 mm, mean diameter at inferior renal artery level + 13 was 24.44 ± 3.31 mm, and mean aortic neck length was 18.77 ± 8.45 mm. Fifty-four patients (34.6%) had an aortic neck ≤10 mm, and cylindrical aortic neck shape was present in 34 patients (21.8%). Regarding the aortic bifurcation (AB), 31 patients (19.9%) presented AB_average ≤ 18 mm, and 35 (22.4%) an AB_area ≤ 20 mm². Technical success was achieved in all cases. At 30-day follow-up, 2 type I endoleaks (1.3%) were detected. One patient was successfully treated endovascularly by proximal aortic cuff implantation, while the other patient refused further treatment. Three-month unscheduled computed tomographic angiography shows endoleak resolution and complete aneurysm seal. One patient suffered from a limb graft occlusion, managed by medical treatment. At a mean follow-up time of 20.4 ± 8.8 (1-60) months, 6 reinterventions were reported, including 2 embolizations for type II endoleak and 4 for iliac and femoral vessel occlusive disease. Log-rank test on preoperative anatomical features showed no significant differences in terms of freedom from reinterventions, and P values were 0.653 for aortic neck length ≤10 mm, 0.309 for noncylindrical aortic neck length shape, 0.520 for AB_average ≤ 18 mm, 0.604 for AB_area ≤ 20 mm², and 0.421 for external iliac artery diameter ≤5 mm.

Our initial experience suggests that in an unselected patient population undergoing AAA repair, EVAR by Ovation stent graft can be performed safely with satisfactory immediate and midterm outcomes.