Lifeline registry of endovascular aneurysm repair: Open repair surgical controls in clinical trials
Journal of Vascular Surgery
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. © 2008 The Society for Vascular Surgery.
Zwolak, R., Sidawy, A., Greenberg, R., Schermerhorn, M., Shackelton, R., & Siami, F. (2008). Lifeline registry of endovascular aneurysm repair: Open repair surgical controls in clinical trials. Journal of Vascular Surgery, 48 (3). http://dx.doi.org/10.1016/j.jvs.2008.04.056