title: EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy.
abstract: 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.
  
  
  METHODS
  This is a prospective, multicentre, clinical trial.
  
  
  METHODS
  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.
authors.affiliation: Pauls Stradins Clinical University Hospital, Pilsonu iela 13, Rīga-1002, Latvia.
authors.forename: D K
authors.initials: DK
authors.lastname: Krievins
authors.forename: A
authors.initials: A
authors.lastname: Holden
authors.forename: J
authors.initials: J
authors.lastname: Savlovskis
authors.forename: C
authors.initials: C
authors.lastname: Calderas
authors.forename: C E
authors.initials: CE
authors.lastname: Donayre
authors.forename: F L
authors.initials: FL
authors.lastname: Moll
authors.forename: B
authors.initials: B
authors.lastname: Katzen
authors.forename: C K
authors.initials: CK
authors.lastname: Zarins
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D003105:Colombia; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D007844:Latvia; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D018579:Patient Selection; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012086:Reoperation; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014687:Venezuela