title: Lifeline registry of endovascular aneurysm repair: open repair surgical controls in clinical trials.
abstract: OBJECTIVE
  The improvement of available endovascular aortic aneurysm repair (EVAR) devices is critical for the advancement of patient care in vascular surgery. The goal of this article is to report a highly detailed, closely monitored, audited, pooled multicenter cohort of open surgical abdominal aortic aneurysm (AAA) repairs that has potential for use in future EVAR studies as a control data set.
  
  
  METHODS
  Open surgical AAA repair data from four investigational device exemption clinical aortic endograft trials were tested for poolability, merged, and analyzed for the intervals of 0 to 30 days and 31 to 365 days.
  
  
  RESULTS
  The data set includes 323 open patients (83% men; mean age, 70 years). Operative mortality at 30 days was 2.8%. The mean age of women was 3 years older than men, and mortality at 30 days for women was 5.7% compared with 2.2% for men (P = .18). Operative mortality for patients with large AAAs (>/=5.5 cm, 3.6%) was not different than for patients with small aneurysms (<5.5 cm, 2.4%, P = .54). All-cause mortality at 1 year was 6.7%, with significant predictors including age, sex, and renal failure. Women had 2.6-fold greater 1-year all-cause mortality rate (13.2%) than men (5.4%, P = .04), but statistical significance was lost after correction for age. Two additional AAA-related deaths occurred between days 31 and 365, resulting in a 1-year AAA-related mortality of 3.5%.
  
  
  CONCLUSIONS
  This data set provides a tightly controlled, thoroughly detailed, and audited experience that has the potential to serve as an open control group for future EVAR trials.
authors.affiliation: Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Zwolak
authors.forename: Anton N
authors.initials: AN
authors.lastname: Sidawy
authors.forename: Roy K
authors.initials: RK
authors.lastname: Greenberg
authors.forename: Marc L
authors.initials: ML
authors.lastname: Schermerhorn
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Shackelton
authors.forename: Flora S
authors.initials: FS
authors.lastname: Siami
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D015897:Comorbidity; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012042:Registries / Q000706:statistics & numerical data; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome