title: Have thoracic endografting outcomes improved since US Food and Drug Administration approval?
abstract: BACKGROUND
  Thoracic endovascular aneurysm repair (TEVAR) is gaining acceptance since Food and Drug Administration approval in 2005. We hypothesize that, compared with open repair (OPEN), mortality and complication rate after TEVAR have continued to improve.
  
  
  METHODS
  All patients who underwent thoracic and (or) thoracoabdominal aneurysm repair from 2005 to 2007 in the Nationwide Inpatient Sample were examined. Patients were stratified by TEVAR or OPEN. Demographics, hospital characteristics, and outcomes were analyzed. Multivariable logistic regression models for complications and in-hospital mortality were developed.
  
  
  RESULTS
  A weighted total of 7,644 had TEVAR, while 32,948 patients underwent OPEN. The TEVAR utilization increased from 5.5% (2005) to 24.1% (2007). Mortality for all patients undergoing thoracic aneurysm repair decreased yearly (p<0.001). Mortality (TEVAR: 7.3%, OPEN: 9.8%, p<0.001) and complication rate (TEVAR: 24.3%, OPEN: 42.1%, p<0.001) were superior with TEVAR. The unadjusted annual mortality (7%) and complication rate (24%) after TEVAR did not improve each year; however, after risk adjustment, mortality after TEVAR steadily decreased annually. Moreover, risk-adjusted mortality for OPEN has improved since 2005. Multivariate analysis revealed age and ruptured aneurysm were highly predictive of death (p<0.001, respectively), while TEVAR lowered the adjusted odds of death by 18% (p<0.05).
  
  
  CONCLUSIONS
  Mortality in patients undergoing repair of thoracic aneurysms has decreased in the United States since Food and Drug Administration approval of stent grafts in 2005. This is due to wider adoption of TEVAR and improved mortality in patients undergoing TEVAR or open repair.
authors: Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia 22908, USA.
authors: Castigliano M
authors: CM
authors: Bhamidipati
authors: Damien J
authors: DJ
authors: LaPar
authors: Gaurav S
authors: GS
authors: Mehta
authors: John A
authors: JA
authors: Kern
authors: Irving L
authors: IL
authors: Kron
authors: Gilbert R
authors: GR
authors: Upchurch
authors: Gorav
authors: G
authors: Ailawadi
mesh_terms: D000328:Adult; D000368:Aged; D017542:Aneurysm, Ruptured / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy; D000792:Angiography / Q000379:methods; D017130:Angioplasty / Q000331:legislation & jurisprudence* / Q000379:methods / Q000401:mortality*; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D015331:Cohort Studies; D005260:Female; D017052:Hospital Mortality / Q000639:trends*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011183:Postoperative Complications / Q000401:mortality / Q000503:physiopathology; D058996:Quality Improvement; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D013908:Thoracotomy / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration