title: Initial clinical experience with a sac-anchoring endoprosthesis for aortic aneurysm repair.
abstract: OBJECTIVE
  All current aortic endografts depend on proximal and distal fixation to prevent migration. However, migration and rupture can occur, particularly in patients with aortic necks that are short or angulated, or both. We present our initial clinical experience with a new sac-anchoring endoprosthesis designed to anchor and seal the device within the aneurysm sac.
  
  
  METHODS
  The initial worldwide experience using a new endoprosthesis for the treatment of aortic aneurysms (Nellix Endovascular, Palo Alto, Calif) was reviewed. The endoprosthesis consists of dual balloon-expandable endoframes surrounded by polymer-filled endobags designed to obliterate the aneurysm sac and maintain endograft position. Clinical results and follow-up contrast computed tomography (CT) scans at 30 days and 6 and 12 months were reviewed.
  
  
  RESULTS
  The endograft was successfully deployed in 21 patients with infrarenal aortic aneurysms measuring 5.7 ± 0.7 cm (range, 4.3-7.4 cm). Two patients with common iliac aneurysms were treated with sac-anchoring extenders that maintained patency of the internal iliac artery. Infusion of 71 ± 37 mL of polymer (range, 19-158 mL) into the aortic endobags resulted in complete aneurysm exclusion in all patients. Mean implant time was 76 ± 35 minutes, with 33 ± 17 minutes of fluoroscopy time and 180 ± 81 mL of contrast; estimated blood loss was 174 ± 116 mL. One patient died during the postoperative period (30-day mortality, 4.8%), and one died at 10 months from non-device-related causes. During a mean follow-up of 8.7 ± 3.1 months and a median of 6.3 months, there were no late aneurysm- or device-related adverse events and no secondary procedures. CT imaging studies at 6 months and 1 year revealed no increase in aneurysm size, no device migration, and no new endoleaks. One patient had a limited proximal type I endoleak at 30 days that resolved at 60 days and remained sealed. One patient has an ongoing distal type I endoleak near the iliac bifurcation, with no change in aneurysm size at 12 months.
  
  
  CONCLUSIONS
  Initial clinical experience with this novel intrasac anchoring prosthesis is promising, with successful aneurysm exclusion and good short-term results. This new device platform has the potential to address the anatomic restrictions and limitations of current endografts. Further studies with a longer follow-up time are needed.
authors.affiliation: Harbor/UCLA Medical Center, Torrance, Calif 90502, USA. cdonayre@cox.net
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Donayre
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Zarins
authors.forename: Dainis K
authors.initials: DK
authors.lastname: Krievins
authors.forename: Andrew
authors.initials: A
authors.lastname: Holden
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Carlos
authors.initials: C
authors.lastname: Calderas
authors.forename: Jaime
authors.initials: J
authors.lastname: Velez
authors.forename: Rodney A
authors.initials: RA
authors.lastname: White
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001014:Aortic Aneurysm / 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; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000601:surgery; D007844:Latvia; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014687:Venezuela