Lessons learnt from the EUROSTAR registry on endovascular repair of abdominal aortic aneurysm repair.

OBJECTIVE: The EUROSTAR project is a multicentred database of the outcome of endovascular repair of infra-renal aortic aneurysms. To date 92 European centres of vascular surgery have contributed. The purpose of the article here is to review the medium term (up to 4 years) results of endovascular aneurysm repair as reported to Eurostar.

PATIENTS AND METHODS: Patients intended for endovascular aneurysm repair were notified to the EUROSTAR Data Registry Centre before treatment in order to eliminate bias due to selective reporting. The following data was collected on all patients: (1) their demographic details and the anatomical characteristics of their aneurysms, (2) details of the endovascular device used, (3) procedural complications and the immediate outcome, (4) results of contrast enhanced CT imaging at 3, 6, 12 and 18 months after operation and at yearly intervals thereafter, (5) all adverse events. Life table analysis was performed to determine the cumulative rates of: (1) death from all causes, (2) secondary intervention. Risk factors for rupture and late conversion were identified by regression analysis.

RESULTS: By July 2000, 2862 patients had been registered and their median duration of follow-up was 12 mo (range 0-72). Successful deployment was achieved in 2812 patients with a perioperative (30 day) mortality of 2.9%. In 2464 patients enrolled by March 2000 late rupture of the aneurysm occurred in 14 patients for an annual cumulative rate of 1%. The significant factors were proximal type I endoleak (P=0.001), midgraft (type III) endoleak (P=0.001), graft migration (P=0.001) and post-operative kinking of the endograft (P=0.001). Forty-one patients had late conversion to open repair for an annual cumulative rate (risk) of approximately 2.1%. Risk factors (indications) for late conversion were: proximal type I endoleak (P=0.001), midgraft (type III) endoleak (P=0.001), type II endoleak (P=0.003), graft migration (P=0.001), graft kinking (P=0.001) and distal type I endoleak (P=0.001).

CONCLUSIONS: Endovascular repair of infra-renal aortic aneurysms using the first and second-generation devices that predominated in this study was associated with a risk of late failure of 3% per year, based upon an analysis of observed primary endpoints of rupture and conversion. Eurostar continues to provide responsible evaluation of the technique for the benefit of both physicians and the industry.