One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair.

OBJECTIVE: This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs).

METHODS: This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 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. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report.

RESULTS: The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three).

CONCLUSIONS: The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed.