Incidence and risk factors of late rupture, conversion, and death after endovascular repair of infrarenal aortic aneurysms: The EUROSTAR experience

Objective: The EUROSTAR (European Collaborators on Stent/graft techniques f or aortic aneurysm repair) Registry was established in 1996 to collect data on the outcome of treatment of patients with infrarenal aortic aneurysms w ith endovascular repair. To date, 88 European centers of vascular surgery h ave contributed. The purpose of the study was to evaluate the results of th is treatment in the medium term (up to 4 years) according to the analysis o f "hard" or primary end points of rupture, late conversion, and death. Patients and Methods: Patients with aortic aneurysms suitable for endovascu lar aneurysm repair were notified to the EUROSTAR Data Registry Centre befo re treatment to eliminate bias due to selective reporting. The following in formation was collected on all patients: (1) demographic details and the an atomic characteristics of their aneurysms, (2) details of the endovascular device used, (3) complications encountered during the procedure and the imm ediate outcome, (4) results of contrast enhanced computed tomographic imagi ng at 3, 6, 12, and 18 months after operation and at yearly intervals there after, and (5) all adverse events. Life table analysis was performed to det ermine the cumulative rates of (1) death from all causes, (2) rupture, and (3) late conversion to open repair. Risk factors for rupture and late conve rsion were identified through regression analysis. Results: By March 2000, 2464 patients had been registered, and their mean d uration of follow-up was 12.19 months (SD, 12.3 months). There were 14 pati ents with confirmed rupture of their aneurysms. The cumulative rate (risk) of rupture was approximately 1% per year. Emergency surgery was undertaken in 12 (86%) patients, of whom five (41.6%) survived. Two patients who were not treated surgically also died, which resulted in an overall death rate o f 64.5% (9/14) of the patients. Significant risk factors for rupture were p roximal type I endoleak (P = .001), midgraft (type III) endoleak (P = .001) , graft migration (P = .001), and postoperative kinking of the endograft (P = .001). Forty-one patients underwent late conversion to open repair with a perioperative mortality rate of 24.4% (10/41). The cumulative rate (risk) of late conversion was approximately 2.1% per year. Risk factors (indicati ons) for late conversion were proximal type I endoleak (P = .001), midgraft (type III) endoleak (P = .001), type II endoleak (P = .003), graft migrati on (P = .001), graft kinking (P = .001), and distal type I endoleak (P = .0 01). Conclusions: Endovascular repair of infrarenal aortic aneurysms with t he first- and second-generation devices that predominated in this study was associated with a risk of late failure, according to an analysis of observ ed hard end points of 3% per year. Action taken to address the risk factors identified by the study may improve results in the future.