Lost to follow-up: A potential under-appreciated limitation of endovascular aneurysm repair

Objective It has long been evident that lifetime follow-up after endovascular aneurysm repair (EVAR) is necessary to identify late complications. The purpose of this study is to test the hypothesis that late follow-up rates for EVAR in routine practice are inferior to those reported from protocol-driven clinical trials, consequently contributing to avoidable events associated with poor long-term outcome. Methods From February 1999 to December 2005, 302 EVARs were performed and eligible for follow-up. Of these, 47 were performed as part of an industry-sponsored clinical trial (study patients). Responsibility for follow-up was assigned to a research nurse for study patients and to office clerical staff for nonstudy patients. Follow-up compliance was classified as either frequent ( 2 missed scheduled appointments). Overall survival and complication rates were analyzed. Results Of the 302 patients, 203 (67.2%) had frequent follow-up and 99 (32.8%) had incomplete follow-up. The mean follow-up was significantly better in the frequent follow-up group (34.7 ± 22 months) vs the incomplete follow-up group (18.8 ± 18.6 months, P P = .006), with nearly half of these patients dying perioperatively. There was no difference in measured outcomes for study patients compared with nonstudy patients. However, mean follow-up was significantly longer for study patients vs nonstudy patients (44.8 ± 23.7 months vs 26.8 ± 20.9 months; P Conclusions Follow-up surveillance after EVAR is less intense in practice environments outside of clinical trials. Patients with incomplete follow-up have higher fatal complication rates than patients with frequent follow-up. These data expose a potential under-appreciated limitation of EVAR, questioning whether the findings in clinical trials defining the efficacy of EVAR can be routinely extrapolated to ordinary practice.