Background: The Anaconda prosthesis is a new endovascular device for abdominal aortic aneurysms repair.
Aim: of the study was to evaluate successful access to the arterial site, safety and efficacy of stent placement and fixation, assessment of endoleaks, patency of the graft due to twists, kinks or obstruction within the first 30 days after the procedure. Secondary objectives were the assessment of clinical success after 6 months due to graft patency and aneurysm exclusion without endoleak as well as the continuing clinical success without showing aneurysm expansion or any graft failure.
Patients and methods: Between 2003 and 2006 a total of 14 patients with infrarenal aortic aneurysm (median diameter prior to endovascular treatment: 56.7 mm (range: 50 to 70 mm) were treated with the Anaconda endovascular device. 8 of these patients were treated in accordance to a prospective Phase II clinical study protocol (Anaconda ANA 004). 6 more patients received the same endovascular device after CE-certification.
Results: Primary and secondary objectives were achieved in 12 of 14 patients after 6 months. In one patient insertion of the graft system was impossible due to kinking and circular calcification of the iliac arteries. Iliac access utilizing an alternative stent graft system (Cook, Zenith) was also unsuccessful. This patient underwent a conversion to open surgery and died. Another patient died 6 months after treatment unrelated to the procedure. A significant reduction of the median aneurysm diameter from 56.7 to 49.0 mm (range: 45 to 54 mm) was achieved after 6 months (p = 0.05). No endoleak was seen in the follow up.
Conclusions: Early results show that he Anaconda endovascular device for aneurysm repair is a safe and effective device for patients with suitable abdominal aortic aneurysms and proper distal access vessels which results in significant aneurysm diameter decrease and a low complication rate after 6 months of follow-up.