Two-Year Outcomes From the Ovation Pivotal Study Presented

October 9, 2013—Manish Mehta, MD, presented the 2-year outcomes of the Ovation pivotal study at the VIVA 2013: Vascular Interventional Advances conference, being held October 8–11 in Las Vegas, Nevada.

The objective of the TriVascular (Santa Rosa, CA) Ovation pivotal study is to evaluate the safety and effectiveness outcomes of the ultra-low profile, 14-F outer diameter (OD) Ovation abdominal stent graft system for endovascular repair of abdominal aortic aneurysms (AAA). This prospective trial enrolled 161 patients from 36 sites in the United States, Germany, and Chile between November 2009 and May 2011.

The TriVascular Ovation abdominal stent graft system is tri-modular, consisting of two iliac limbs and a 14-F OD aortic body, the smallest profile of any currently commercially available stent graft. Ovation is designed to accommodate a broader range of anatomy by addressing the two most important issues in EVAR: access and seal.

All TriVascular Ovation study patients were treated under a common protocol. A clinical events committee adjudicated adverse events and an independent imaging core laboratory analyzed imaging. The main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner wall diameter between 16 and 30 mm, and iliac inner wall diameter between 8 and 20 mm in the distal sealing area.

Despite relatively broad inclusion criteria, results of the study were positive. Technical success was achieved in 100% of cases. Mean procedure time was 110 minutes, median procedural blood loss was 150 cc, and median hospital stay was 1 day. No AAA rupture or conversion to open surgery was reported. The imaging core laboratory reported no type I or III endoleak or migration. A further anatomically challenging subgroup analysis indicated that 39% (63/161) of the treated patients had aortic neck length of < 10 mm, access vessel of < 6 mm, or both. Remarkably, no differences in clinical or imaging outcomes were noted in patients with or without challenging aortic anatomy.

The 2-year outcomes with the Ovation stent graft are promising with excellent demonstrated safety and effectiveness in patients with AAA. These results were similarly impressive in patients with challenging anatomical characteristics who would be ineligible for treatment with other approved stent grafts. The ability of the Ovation stent graft to treat a broad range of aortoiliac anatomies may help to expand the patient population eligible for EVAR.