Objectives: To assess the mid-term outcomes up to 5 years following endovascular repair of abdominal aortic aneurysms (EVAR), following its initial introduction into practice in the UK.
Design: A prospective voluntary Registry of Endovascular Treatment of Aneurysms (RETA) collected demographic and risk factor data, short term (30 day) outcomes and follow up outcomes up to 5 years from the 41 centres that initially undertook EVAR in the UK.
Results: Short term outcomes (30 days): 90.4% of aneurysms were successfully excluded, 6.1% had persistent endoleaks and 5.8% of patients had died. Follow up was obtained from 30 days up to 5 years (mean 3.1 years). Returns rates for requested follow up data were 87% at 1 year and 77, 65, 52 and 51% at 2, 3, 4 and 5 years, respectively. Ninety percent of deaths at follow up were unrelated to the stent-graft or aneurysm. Persistent proximal type I endoleak was associated with significant mortality both from attempted open repair or from rupture if untreated. Other endoleaks were more benign. Complications related to the aneurysm or device occurred at an average rate of 15% per annum. The most common complications were secondary endoleaks or graft migration. Endovascular treatment was preferred if treatment was necessary for graft complications. The cumulative freedom from secondary procedure (Kaplan-Meier) were 87, 77, 70, 65 and 62% at 1, 2, 3, 4 and 5 years of follow up, respectively.
Conclusions: Registry data provides useful information to guide the design of more formal trials. Collecting follow up from voluntarily submitted data is difficult. The registry data remains well ahead of the trial data, but indicate that long term follow up is required in these trials, because of the high rate of complications seen at follow up.