EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy.

OBJECTIVE

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.

DESIGN

This is a prospective, multicentre, clinical trial.

MATERIALS

The Nellix endoprosthesis consists of dual, balloon-expandable endoframes, surrounded by polymer-filled endobags, which obliterate the aneurysm sac and maintain endograft position.

METHODS

The study reviewed worldwide clinical experience and Core Lab evaluation of computed tomography (CT) scans.

RESULTS

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.

CONCLUSIONS

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.