Mid-term results of a second generation bifurcated endovascular graft for abdominal aortic aneurysm repair: the French Vanguard trial.

PURPOSE: The purpose of this study was to evaluate prospectively the results of the bifurcated Vanguard endovascular graft for abdominal aortic aneurysm (AAA) repair. METHODS: Seventy-five patients, with a median age of 69.6 years (range, 48 to 88 years) and asymptomatic AAAs, were recruited in 14 French vascular institutions. An independent committee validated the indications for endovascular repair, and all the implantations were supervised by a well-trained medico-technical assistant. Further independent committees reviewed patient data, clinical data, and imaging follow-up examination. The main endpoints were implantation success, mortality, morbidity, reinterventions, and aneurysm evolution assessed with serial computed tomographic (CT) scanning. RESULTS: All the grafts were successfully implanted, resulting in a 100% success rate on an intent-to-treat basis. At discharge, there were no deaths, six significant local complications (8%) that necessitated surgery, no vascular complications, and six systemic complications (8%). The average durations of intensive care unit and hospital stays were 26 +/- 6 hours and 6 +/- 2.54 days, respectively. Predischarge CT scan results showed five type I and 18 type II endoleaks (total, 30%). At the end of the follow-up period (mean duration, 18.35 +/- 4.12 months; range, 17 days to 24 months), seven patients (9%) had died: one from sepsis, five from unrelated causes, and one from aneurysm rupture. The 2-year cumulative survival rate was 86% +/- 5.9%. Twenty-one subsequent endovascular or vascular procedures were necessitated (28%) in 17 patients (23%) to treat graft limb occlusion or stenosis (n = 9 patients) or to seal an endoleak (n = 8 patients). The 2-year cumulative survival rate free of reintervention was 67% +/- 7%. On CT scans, the mean AAA diameter decreased from 54 mm +/- 8.9 (range, 45 to 80 mm) before surgery to 51.6 mm +/- 9.1 at 6 months and to 43.4 mm +/- 4.4 at the end of the follow-up period (P =.001). Persistent endoleak was significantly associated with an increase in diameter (4 of 5 [80%] vs 1 of 47 [2%]; P =.001). CONCLUSION: In selected patients, the bifurcated Vanguard endovascular graft may be implanted with a low mortality and morbidity rate and a favorable mid-term survival rate. The decrease of the aneurysm size is a strong argument in favor of the efficiency of the device. However, lasting endoleaks with increased aneurysm diameter and occurrence of limb graft stenosis or occlusion raise concerns and justify a careful long-term follow-up monitoring of all patients who undergo treatment with endovascular technique.