title: Aneurysm-related death: primary endpoint analysis for comparison of open and endovascular repair.
abstract: OBJECTIVE
  The purpose of this study was to utilize an objective endpoint analysis of aneurysm treatment, which is based on the primary objective of aneurysm repair, and to apply it to a consecutive series of patients undergoing open and endovascular repair.
  
  
  METHODS
  Aneurysm-related death was defined as any death that occurred within 30 days of primary aneurysm treatment (open or endovascular), within 30 days of a secondary aneurysm or graft-related treatment, or any death related to the aneurysm or graft at any time following treatment. We reviewed 417 consecutive patients undergoing elective infrarenal aortic aneurysm repair: 243 patients with open repair and 174 patients with endovascular repair.
  
  
  RESULTS
  There was no difference between the groups (open vs endovascular) with regard to mean age +/- standard deviation (73 +/- 8 years vs 74 +/- 8 years) or aneurysm size (64 +/- 2 mm vs 58 +/- 10 mm) (P = not significant [NS]). The 30-day mortality for the primary procedure after open repair was 3.7% (9/243) and after endovascular repair was 0.6% (1/174, P <.05). The 30-day mortality for secondary procedures after open repair was 14% (6/41) compared to 0% after endovascular repair (P <.05). The aneurysm-related death rate was 4.1% (10/243) after open surgery and 0.6% (1/174) after endovascular repair (P <.05). Mean follow-up was 5 months longer following open repair (P <.05). Secondary procedures were performed in 41 patients following open surgery and 27 patients following endovascular repair (P = NS). Secondary procedures following open repair were performed for anastomotic aneurysms (n = 18), graft infection (n = 6), aortoenteric fistula (n = 5), anastomotic hemorrhage (n = 4), lower extremity amputation (n = 4), graft thrombosis (n = 3), and distal revascularization (n = 1). Secondary procedures following endovascular repair consisted of proximal extender cuffs (n = 11), distal extender cuffs (n = 11), limb thrombosis (n = 3), and surgical conversion (n = 2). The magnitude of secondary procedures following open repair was greater with longer operative time 292 +/- 89 minutes vs 129 +/- 33 minutes (P <.0001), longer length of stay 13 +/- 10 days vs 2 +/- 2 days (P <.0001) and greater blood loss 3382 +/- 4278 mL vs 851 +/- 114 mL (P <.0001).
  
  
  CONCLUSIONS
  The aneurysm-related death rate combines early and late deaths and should be used as the primary outcome measure to objectively compare the results of open and endovascular repair in the treatment of infrarenal abdominal aortic aneurysms. In our experience, endovascular aneurysm repair reduced the overall aneurysm-related death rate when compared to open repair. Secondary procedures are required after both open and endovascular repair. However, the magnitude, morbidity, and mortality of secondary procedures are reduced significantly with endovascular repair.
authors.affiliation: Division of Vascular Surgery, Stanford University School of Medicine, Stanford, CA 94305, USA.
authors.forename: Frank R
authors.initials: FR
authors.lastname: Arko
authors.forename: W Anthony
authors.initials: WA
authors.lastname: Lee
authors.forename: Bradley B
authors.initials: BB
authors.lastname: Hill
authors.forename: Cornelius
authors.initials: C
authors.lastname: Olcott
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Dalman
authors.forename: E John
authors.initials: EJ
authors.lastname: Harris
authors.forename: Paul
authors.initials: P
authors.lastname: Cipriano
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Fogarty
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Zarins
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality* / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016019:Survival Analysis