Lifeline registry of endovascular aneurysm repair: Open repair surgical controls in clinical trials
Received 19 March 2008; accepted 24 April 2008. published online 24 July 2008.
Purpose
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%.
Conclusion
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.
aSection of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH
bDepartment of Surgery, Washington VA Medical Center, Washington, DC
cDepartment of Vascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio
dDepartment of Surgery, Beth Israel Deaconess Medical Center, Boston, Mass
eNew England Research Institutes Inc, Watertown, Mass
Reprint requests: Flora Sandra Siami, MPH, RAC, Principal Research Scientist/Director, Regulatory Affairs, New England Research Institutes Inc, 9 Galen St, Watertown, MA 02472
The analysis of the Lifeline Registry of Endovascular Aneurysm Repair data set for surgical controls was supported exclusively by funds from the Society for Vascular Surgery (SVS).
Competition of interest: none.
⁎ A list of SVS Outcome Committee members is in the Appendix.
ABSTRACT