Aortic aneurysm repair with endovascular grafts: developing a graft surveillance program.

The objective of this study was to describe the development of a comprehensive surveillance program for monitoring the long-term follow-up of endoluminal stent graft (ELG) patients. Despite high procedural success rates, ELG patients remain at ongoing risk for aneurysm sac expansion, rupture, and other adverse events that make long-term surveillance imperative. As they perform more ELG, practitioners face increased logistical difficulty performing appropriate patient follow-up. A computer-based data ELG registry was created using Epi Info, a program developed by the Centers for Disease Control and Prevention that enables users to design a data entry form, enter data, and perform statistical analyses. The database has been used to track 259 patients (214 men and 45 women) who underwent ELG between November 1999 and October 2003. One-year follow-up was available for 182 patients, 2-year follow-up for 104 patients, and 3-year surveillance data for 40 patients, which represent follow-up rates of 89.6%, 78.8%, and 61.5%, respectively. There were 25 late deaths. The Kaplan-Meier estimate for 1-year survival was 92.5%. Twenty-one patients underwent 24 secondary angiographic procedures at a mean 8.6 +/- 10.3 months (range, 1-37.6) after stent-graft repair. No mortality was observed in association with a secondary intervention. There were no late conversions to open aneurysm repair. The Kaplan-Meier estimate for freedom from secondary intervention for all patients at 1 year was 91.0%. A computer-based registry facilitates appropriate and timely patient follow-up and may improve the long-term outcome from ELG.