title: Impact of operative indication and surgical complexity on outcomes after thoracic endovascular aortic repair at National Surgical Quality Improvement Program Centers.
abstract: BACKGROUND
  Thoracic endovascular aortic repair (TEVAR) devices are increasingly being utilized to treat aortic pathologies outside of the original Food & Drug Administration (FDA) approval for nonruptured descending thoracic aorta aneurysms (DTAs). The objective of this study was to evaluate the outcomes of patients undergoing TEVAR, elucidating the role of surgical and pathologic variables on morbidity and mortality.
  
  
  METHODS
  National Surgical Quality Improvement Program (NSQIP) data were reviewed for all patients undergoing endovascular thoracic aorta repair from 2005 to 2007. The patients' operative indication and surgical complexity were used to divide them into study and control populations. Comorbid profiles were assessed utilizing a modified Charlson Comorbidity Index (CCI). Thirty-day occurrences of mortality and serious adverse events (SAEs) were used as study endpoints. Univariate and multivariate models were created using demographic and clinical variables to assess for significant differences in endpoints (P ≤ .05).
  
  
  RESULTS
  A total of 440 patients undergoing TEVAR were identified. When evaluating patients based on operative indication, the ruptured population had increased mortality and SAE rates compared to the nonruptured DTA population (22.6% vs 6.2%;P < .01 and 35.5% vs 9.1%;P < .01, respectively). Further analysis by surgical complexity revealed increased mortality and SAE rates when comparing the brachiocephalic aortic debranching population to the noncovered left subclavian artery population (23.1% vs 6.5%; P = .02 and 30.8% vs 9.1%; P < .01, respectively). Multivariate analysis demonstrated that operative indication was not a correlate of mortality or SAEs (odds ratio [OR], 0.95; P = .92 and OR, 1.42; P = .39, respectively); however, brachiocephalic aortic debranching exhibited a deleterious effect on mortality (OR, 8.75; P < .01) and SAE rate (OR, 6.67; P = .01).
  
  
  CONCLUSIONS
  The operative indication for a TEVAR procedure was not found to be a predictor of poor patient outcome. Surgical complexity, specifically the need for brachiocephalic aortic debranching and aortoiliac conduit, was shown to influence the occurrence of SAEs in a multivariate model. Comparative data, such as these, illustrate real-world outcomes of patients undergoing TEVAR outside of the original FDA-approved indications. This information is of paramount importance to various stakeholders, including third-party payers, the device industry, regulatory agencies, surgeons, and their patients.
authors.affiliation: Department of Cardiovascular Sciences, East Carolina University, Greenville, NC 27858-4354, USA.
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Ehlert
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Durham
authors.forename: Frank M
authors.initials: FM
authors.lastname: Parker
authors.forename: William M
authors.initials: WM
authors.lastname: Bogey
authors.forename: Charles S
authors.initials: CS
authors.lastname: Powell
authors.forename: Michael C
authors.initials: MC
authors.lastname: Stoner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001013:Aorta, Thoracic; D001018:Aortic Diseases / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation; D015331:Cohort Studies; D057510:Endovascular Procedures; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D018579:Patient Selection; D058996:Quality Improvement; D016896:Treatment Outcome; D014481:United States