Stehr A, Schnitzbauer A A, Steinbauer M G, Töpel I, Pfister K, Schlitt H J, Kasprzak P M
Vascular and Endovascular Surgery, Department of Surgery, University of Regensburg, Germany.
Vasa. 2007 Aug;36(3):199-204. doi: 10.1024/0301-1526.36.3.199.
The Anaconda prosthesis is a new endovascular device for abdominal aortic aneurysms repair.
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.
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.
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.
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.
Anaconda假体是一种用于腹主动脉瘤修复的新型血管内装置。
本研究旨在评估动脉穿刺部位的成功入路、支架置入与固定的安全性和有效性、内漏评估、术后30天内移植物因扭曲、扭结或阻塞导致的通畅情况。次要目标是评估6个月后由于移植物通畅和无内漏的动脉瘤排除导致的临床成功率，以及持续的临床成功率，即未出现动脉瘤扩大或任何移植物失败。
2003年至2006年期间，共有14例肾下腹主动脉瘤患者（血管内治疗前中位直径：56.7mm（范围：50至70mm））接受了Anaconda血管内装置治疗。其中8例患者按照前瞻性II期临床研究方案（Anaconda ANA 004）进行治疗。另外6例患者在获得CE认证后接受了相同的血管内装置治疗。
6个月后，14例患者中的12例实现了主要和次要目标。1例患者由于髂动脉扭结和环状钙化，无法插入移植物系统。使用替代支架移植物系统（Cook，Zenith）进行髂动脉入路也未成功。该患者转为开放手术并死亡。另1例患者在治疗6个月后死亡，与手术无关。6个月后，中位动脉瘤直径从56.7mm显著减小至49.0mm（范围：45至54mm）（p = 0.05）。随访期间未见内漏。
早期结果表明，对于具有合适腹主动脉瘤和合适远端入路血管的患者，Anaconda血管内动脉瘤修复装置是一种安全有效的装置，在随访6个月后可导致动脉瘤直径显著减小且并发症发生率较低。
