Ultra low profile polymer-filled stent graft for abdominal aortic aneurysm treatment: two-years follow-up

Purpose: To evaluate 2 years follow-up of the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs). Methods and Materials: This multicenter retrospective study included 36 patients (median age 73.6 yo) with AAAs (mean diameter, 5.65 cm) treated with the Ovation stent graft and a follow-up available at least of 2 years. Safety and effectiveness of the Ovation stent graft was evaluated. Indications for EVAR were the following: AAA ≥5 cm, neck lenght ≥ 7 mm, angulation ≤60o and diameter < 30 mm; the presence of neck calcification and thrombosis was not considered a contraindication; distal iliac landing zones length of 10 mm, and diameter between 5 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. Adverse events, clinical and imaging data and possible re-intervention were recorded. Results: Ovation stent graft was successfully implanted in 36 patients (100%). None of the patients required conversion to open surgery, none presented an aneurysm rupture. Endograft stent fracture or migration was not observed. No type I, III or IV endoleaks were observed; in 12 patients (33.3%) a type II endoleak was registered: with sac enlargement in one case not treated due to concomitant comorbidities and patient's decision. Conclusion: The 2-years results of the Ovation Stent Graft System demonstrated excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics.