Endovascular aneurysm repair: the need for randomized controlled trials

Abstract

Abstract Background An audit of endovascular aneurysm repair (EVAR) was undertaken in order to assess the efficacy of this new approach in the treatment of abdominal aortic aneurysm. Methods An international register of EVAR was started in 1996, with emphasis on close follow-up. Results Data have now been accumulated for 895 cases. The 30-day mortality rate is low at 3 per cent; patients who died generally had major co-morbidity. At discharge 14 per cent were identified as having an endoleak (persistent blood flow outside the lumen of the endoluminal graft but within the aneurysm sac) and another 18 per cent developed new endoleaks during the first year of follow-up. Continued expansion of the aneurysm was observed in 22 per cent. This occurred in 53 per cent of patients with an identified endoleak compared with 11 per cent of those in whom no endoleak was demonstrated (P < 0·01). Aneurysm rupture after EVAR occurred in six patients, three of whom died. Conclusion That EVAR is technically feasible is beyond doubt. Close follow-up has identified problems specific to the minimally invasive approach. The significance of endoleaks in particular remains unclear, but the strong association with continued aneurysm expansion is of concern. The primary purpose of EVAR, however, is to prolong life and in this study the cumulative 2-year survival rate (including operative deaths) was 85 per cent. In patients without any complications the benefits of the minimally invasive approach are readily apparent. Thus, while there is no place for unrealistic optimism, there certainly appears to be a role for EVAR. To prevent inappropriate widespread application of this new approach, or indeed unwarranted condemnation, randomized controlled trials comparing EVAR with conventional management are essential.