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

PURPOSE: This study evaluated 2 years of follow-up of the Ovation Abdominal Stent Graft System (TriVascular Inc., Santa Rosa, CA, USA) for endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs). MATERIALS AND METHODS: This retrospective multicentre study included 36 patients (median age, 73.6 year) with AAAs (mean diameter, 5.65 cm) treated with the Ovation stent graft and followed up for at least 2 years. Safety and effectiveness of the Ovation stent graft were evaluated. Indications for EVAR were the following: AAA ≥5 cm, neck length ≥7 mm, angulation ≤60° and diameter <30 mm; the presence of neck calcification and thrombosis was not considered a contraindication; distal iliac landing zone 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 for 5 years. Adverse events, clinical and imaging data and possible re-intervention were recorded. RESULTS: The Ovation stent graft was implanted successfully in 36 patients (100 %). None of the patients required conversion to open surgery, and none presented with an aneurysm rupture. Endograft stent fracture or migration was not observed in any case. No type I, III or IV endoleaks were observed; in 12 patients (33.3 %), a type II endoleak was noted, in one case with sac enlargement but not treated due to concomitant comorbidities and the patient's decision. CONCLUSIONS: The 2-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in the treatment of patients with AAAs, particularly in those with challenging anatomical characteristics.