Pauls Stradins Clinical University Hospital, Pilsonu iela 13, Rīga-1002, Latvia.
Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.
The study aimed to review the results of endovascular aneurysm repair (EVAR) using a novel sac-anchoring endoprosthesis in patients with favourable and adverse anatomy.
This is a prospective, multicentre, clinical trial.
The Nellix endoprosthesis consists of dual, balloon-expandable endoframes, surrounded by polymer-filled endobags, which obliterate the aneurysm sac and maintain endograft position.
The study reviewed worldwide clinical experience and Core Lab evaluation of computed tomography (CT) scans.
From 2008 to 2010, 34 patients (age 71 ± 8 years, abdominal aortic aneurysm (AAA) diameter 5.8 ± 0.8 cm) were treated at four clinical sites. Seventeen patients (50%) met the inclusion criteria for Food and Drug Administration (FDA)-approved endografts (favourable anatomy); 17 (50%) had one or more adverse anatomic feature: neck length <10 mm (24%), neck angle >60° (9%) and iliac diameter >23 mm (38%). Device deployment was successful in all patients; iliac aneurysm treatment preserved hypogastric patency. Perioperative mortality was 1/34 (2.9%); one patient died at 10 months of congestive heart failure (CHF); one patient had a secondary procedure at 15 months. During 15 ± 6 months follow-up, there were no differences in outcome between favourable and adverse anatomy patients. Follow-up CT extending up to 2 years revealed no change in aneurysm size or endograft position and no new endoleaks.
Favourable and adverse anatomy patients can be successfully treated using the Nellix sac-anchoring endoprosthesis. Early results are promising but longer-term studies are needed.
本研究旨在回顾使用新型囊锚定支架治疗具有有利和不利解剖结构的患者的血管内腹主动脉瘤修复（EVAR）的结果。
这是一项前瞻性、多中心临床试验。
Nellix 支架由两个球囊可扩张的内框组成，周围是充满聚合物的内袋，可消除动脉瘤囊并维持移植物位置。
本研究回顾了全球临床经验和计算断层扫描（CT）扫描的核心实验室评估。
2008 年至 2010 年，在四个临床中心治疗了 34 名患者（年龄 71±8 岁，腹主动脉瘤（AAA）直径 5.8±0.8cm）。17 名患者（50%）符合食品和药物管理局（FDA）批准的支架（有利解剖结构）的纳入标准；17 名患者（50%）有一个或多个不利解剖特征：颈长<10mm（24%）、颈角>60°（9%）和髂直径>23mm（38%）。所有患者的器械部署均成功；髂动脉瘤治疗保留了对支的通畅性。围手术期死亡率为 34/1（2.9%）；1 例患者在 10 个月时死于充血性心力衰竭（CHF）；1 例患者在 15 个月时进行了二次手术。在 15±6 个月的随访中，有利和不利解剖结构患者的结果没有差异。随访 CT 最长达 2 年，未发现动脉瘤大小或移植物位置变化，也未发现新的内漏。
有利和不利解剖结构的患者可以成功地使用 Nellix 囊锚定支架进行治疗。早期结果很有希望，但需要进行更长时间的研究。
