title: Endovascular repair of descending thoracic aneurysms: results with "on-label" application in the post Food and Drug Administration approval era.
abstract: BACKGROUND
  Most studies of thoracic endovascular aortic repair (TEVAR) published since the technology gained US Food and Drug Administration (FDA) approval in March 2005 have included multiple applications including dissection, trauma, and "hybrid" approaches, all of which are currently "off-label." However, little post-approval data exist for the only FDA-approved application, namely descending thoracic aneurysm (DTA). The purpose of this study was to examine our experience with TEVAR for aneurysms limited to the descending thoracic aorta.
  
  
  METHODS
  Between March 23, 2005 (date of initial FDA approval) and April 6, 2009, 210 TEVAR procedures were performed at our institution. Of these, 79 (38%) were for saccular (n = 31) or fusiform (n = 48) DTA and form the basis of this report. Patients requiring "hybrid" approaches other than carotid-subclavian bypass were excluded. Devices utilized were Gore TAG (W. L. Gore Associates, Flagstaff, AZ) (n = 67; 85%), Zenith TX2 (Cook Medical Incorporated, Bloomington, IN) (n = 10; 13%), and Medtronic Talent (Medtronic, Inc, Santa Rosa, CA) (n = 5; 6%); 3 (4%) patients received more than one type of device.
  
  
  RESULTS
  Median patient age was 73 +/- 4 years; 35 (44%) were female. Mean aortic diameter was 5.8 +/- 1.8 cm. Twenty-four (30%) procedures were urgent-emergent. Thirty-day in-hospital rates of death, stroke, and permanent paraplegia-paresis were 5.1% (n = 4; 1.9% elective mortality), 2.5% (n = 2), and 1.3% (n = 1), respectively. The median postoperative length of stay was 3.0 days (25th and 75th percentiles = 2 and 6, respectively). At a mean follow-up of 23 +/- 17 months (range, 6 to 55), there were 2 (2.5%) late aortic deaths from graft infection (n = 1) and aneurysm rupture (n = 1). Overall actuarial midterm survival is 73% at 55 months, with an aorta-specific actuarial survival of 86% during this same time interval. Five patients (6.3%) required late (>30 days) secondary endovascular re-intervention for type I (n = 4) or type II (n = 1) endoleak; re-intervention was successful in 4 of 5.
  
  
  CONCLUSIONS
  Despite the advanced age, comorbid conditions, and significant incidence of urgent-emergent status of patients presenting with DTA, on-label application of TEVAR yields excellent 30-day and midterm outcomes, especially when compared with historic rates of morbidity and mortality with open repair. However, "on-label" applications represent a minority of current TEVAR use, likely due to the relative scarcity of DTA. These data appear to support the increasing utilization of TEVAR as a treatment strategy for this pathology.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA. gchad.hughes@duke.edu
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.forename: Sean M
authors.initials: SM
authors.lastname: Lee
authors.forename: Mani A
authors.initials: MA
authors.lastname: Daneshmand
authors.forename: Syamal D
authors.initials: SD
authors.lastname: Bhattacharya
authors.forename: Judson B
authors.initials: JB
authors.lastname: Williams
authors.forename: Sonny W
authors.initials: SW
authors.lastname: Tucker
authors.forename: Richard L
authors.initials: RL
authors.lastname: McCann
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001013:Aorta, Thoracic / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation; D018795:Device Approval; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration