title: Postapproval outcomes of juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft.
abstract: OBJECTIVE
  The objective of this study was to evaluate postapproval outcomes of patients with juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft (Cook Inc, Bloomington, Ind).
  
  
  METHODS
  We reviewed clinical data of consecutive patients treated with the Zenith fenestrated endovascular graft in the United States at seven institutions with early commercial access from July 2012 to December 2012. Clinical outcomes and compliance to anatomic guidelines were compared with results of the U.S. fenestrated trial (USFT).
  
  
  RESULTS
  Fifty-seven patients were treated. There were significantly more (P < .05) patients with coronary artery disease, myocardial infarction, and preoperative renal insufficiency than in the USFT. Thirty-six patients (63.2%) did not meet the USFT anatomic criteria of a >4-mm infrarenal neck, and there were significantly more mesenteric stents (13 vs 0; P < .05) used in this group than in the USFT, reflecting the higher anatomic complexity of these patients. The total operative time was 250.2 ± 14.8 minutes, the fluoroscopy time was 68.9 ± 4.47 minutes, and the average volume of contrast material was 108.6 ± 5.6 mL. Technical success was 100% in regard to aneurysm exclusion, although the left renal fenestration was not able to be aligned in two patients, and one patient had a kinked renal stent that was successfully restented. During this time period, there were a total of 10 endoleaks, of which two were type III and eight were type II.
  
  
  CONCLUSIONS
  Despite higher rates of comorbidities and more challenging anatomy, early 30-day outcomes of juxtarenal aortic aneurysms treated postapproval with the Zenith fenestrated endovascular graft compare well with USFT data. Future studies are needed to assess durability of this treatment modality as the technology diffuses and data mature.
authors.affiliation: Washington University in St. Louis, St. Louis, Mo. Electronic address: chanduvem@gmail.com.
authors.forename: Chandu
authors.initials: C
authors.lastname: Vemuri
authors.affiliation: Mayo Clinic, Rochester, Minn.
authors.forename: Gustavo S
authors.initials: GS
authors.lastname: Oderich
authors.affiliation: Stanford University, Palo Alto, Calif.
authors.forename: Jason T
authors.initials: JT
authors.lastname: Lee
authors.affiliation: University of North Carolina, Chapel Hill, NC.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Farber
authors.affiliation: Indiana University, Indianapolis, Ind.
authors.forename: Andres
authors.initials: A
authors.lastname: Fajardo
authors.affiliation: University of Pennsylvania, Philadelphia, Pa.
authors.forename: Edward Y
authors.initials: EY
authors.lastname: Woo
authors.affiliation: New York University, New York, NY.
authors.forename: Neal
authors.initials: N
authors.lastname: Cayne
authors.affiliation: Washington University in St. Louis, St. Louis, Mo.
authors.forename: Luis A
authors.initials: LA
authors.lastname: Sanchez
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D015897:Comorbidity; D018795:Device Approval; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D061646:Operative Time; D018579:Patient Selection; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States