The Anaconda AAA stent graft system: 2-year clinical and technical results of a multicentre clinical evaluation.

ABSTRACT

INTRODUCTION: This study reports the technical and mid-term clinical results of the second-generation Anaconda AAA Stent Graft System endovascular device for treatment of abdominal aortic aneurysm (AAA). The design of the Anaconda AAA Stent Graft System is characterised by a three-piece system consisting of two proximal independent saddle-shaped nitinol self-expandable rings with hooks fixation, zero body support and vacuum-cleaner tube leg design. METHODS: From July 2002 to April 2005, a total of 61 patients with AAA were enrolled in a multicentre, prospective, non-randomised controlled design study. All patients received a second-generation Anaconda AAA Stent Graft System. They entered a standard follow-up protocol at discharge for 3, 6, 12 and 24 months. Follow-up data included survival; rupture-free survival; incidence of aneurysm rupture, death from aneurysm rupture, aneurysm-related death; freedom from aneurysm expansion; freedom from Types I and III endoleaks; endograft patency and technical and clinical success rates. RESULTS: Successful access to the arterial system was achieved in all patients. The primary technical success was 59 out of 61 and the primary assisted technical success was 60 out of 61. All endovascular grafts were patent without significant twists, kinks or obstructions. Migration was not observed in any of the grafts. During the first 30-day period, two serious adverse events (3%), both not related to the procedure, were observed. Nine patients (15%) needed a secondary intervention; two of these interventions were related to stent graft (3%). The mean aneurysm sac diameter decreased significantly from 57 mm pre-operative to 45mm after 24 months, without aneurysm growth. There was one Type I endoleak at initial implantation, which was corrected using a proximal extension cuff. In total, three Type II endoleaks were still present after 24 months without any signs of aneurysm growth. CONCLUSION: The design features of the second-generation Anaconda AAA Stent Graft System are effective in the treatment of AAAs on mid-term evaluation.