title: Lombard Aorfix high angulation device, sac behavior following implantation.
abstract: Short neck length, and angulated infrarenal aortic necks, are historically associated with sac expansion following endovascular abdominal aortic aneurysm repair. Aorfix (Lombard Medical, Inc, Irvine, Calif), a conformable stent graft US Food and Drug Administration approved for highly angulated necks, was investigated in the US Pythagoras Trial. We investigated the incidence of, and factors related to, sac regression and expansion following implantation of the Aorfix device.
  
  
  
  Pythagoras trial data was assessed with mutivariable modeling for factors associated with sac regression or expansion (defined as change in maximum aneurysm diameter of ≥5 mm on annual follow-up computed tomography compared with last preoperative scan). All anatomic measurements were performed per protocol by a core laboratory (M2S; West Lebanon, NH).
  
  
  
  A total of 218 patients were enrolled; neck angle was ≥60° in 151 (69.3%), <60° in 67 (30.7%). Follow-up, including computed tomography imaging, was available at 1 year (n = 165), 2 years (n = 142), 3 years (n = 106), and 4 years (n = 70). Sac size decreased or was unchanged in 98.8% (1 year), 95.1% (2 years), 94.3% (3 years), and 92.9% (4 years). Mean neck length for the entire cohort was 22.3 mm; mean proximal neck angle was 71.4°. Maximum aneurysm diameter was 57.5 mm. Sac regression or expansion was not statistically associated with neck length, neck diameter, maximal aneurysm diameter, or patient sex (or 19 other demographic and medical history variables). Neck angle was not statistically associated with sac regression or expansion.
  
  
  
  In this study cohort, there is a low incidence of sac expansion with the Aorfix device. We were unable to demonstrate an association between neck length/angulation and sac expansion.
authors.affiliation: Department of Surgery, Brigham and Women's Hospital, Boston, Mass. Electronic address: mcgilled@cmhc.org.
authors.forename: Edward A
authors.initials: EA
authors.lastname: McGillicuddy
authors.affiliation: Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH.
authors.forename: Mark
authors.initials: M
authors.lastname: Fillinger
authors.affiliation: Department of Surgery, UMass Medical Center, Worcester, Mass.
authors.forename: William P
authors.initials: WP
authors.lastname: Robinson
authors.affiliation: Department of Surgery, Southern Illinois University, Springfield, Ill.
authors.forename: Kim
authors.initials: K
authors.lastname: Hodgson
authors.affiliation: Department of Surgery, University of Alabama, Birmingham, Ala.
authors.forename: William D
authors.initials: WD
authors.lastname: Jordan
authors.affiliation: Department of Surgery, University of Florida, Gainesville, Fla.
authors.forename: Adam W
authors.initials: AW
authors.lastname: Beck
authors.affiliation: Department of Surgery, Johns Hopkins University, Baltimore, Md.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Malas
authors.affiliation: Department of Surgery, Brigham and Women's Hospital, Boston, Mass.
authors.forename: Michael
authors.initials: M
authors.lastname: Belkin
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D000072226:Computed Tomography Angiography; D018450:Disease Progression; D057867:Endoleak / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D011446:Prospective Studies; D011474:Prosthesis Design; D019233:Retreatment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D066253:Vascular Remodeling