Purpose: To evaluate the safety and efficacy of the Talent stent-graft (TSG) system in the endoluminal treatment of infrarenal abdominal aortic aneurysms (AAAs).
Patients and methods: Endoluminal treatment of an AAA was attempted in 30 men with a mean age of 70.5 years (range, 51-83 years). Seven patients had AAAs suitable for treatment with a tube graft. In the other patients, treatment with a bifurcated TSG was planned. All procedures were performed as a combined surgical-radiologic procedure in an angiographic room.
Results: Primary technical success was achieved in 25 of 30 patients (83%). Technical failures were due to misplacement of the TSG (n = 2) with proximal leakage as a consequence, inability to gain access via the iliac arteries (n = 1), and a distal leakage (n = 2). Secondary interventions (n = 2) and spontaneous thrombosis of a distal leak (n = 1) increased the secondary technical success rate to 93% (28 of 30). Two procedures were converted to open surgery (conversion rate = 6%). One patient died during the first 30 days after uncomplicated stent-graft insertion because of myocardial infarction (30-day mortality = 5%). No complications occurred during a mean follow-up of 15.4 months (range, 6-19 months). The maximum diameter of the AAA decreased in eight patients and remained unchanged in the remaining patients. No increase in diameter was observed. No late endoleak or migration of the TSG was observed.
Conclusion: The TSG-system revealed satisfactory initial and early follow-up results. Treatment of AAAs with this stent-graft system is feasible. The technical success rate in carefully selected patients should be 90% or more. However, long-term observations are necessary to determine if the encouraging early results of this type of therapy can be preserved during long-term follow-up.