Purpose: To describe a newly designed bifurcated modular stent-graft and assess the feasibility and safety of its use in the treatment of abdominal aortic aneurysms (AAA).
Methods: Thirteen patients (10 men; mean age 61.2+/-16 years, range 57-78) with AAAs underwent treatment with a bifurcated stent-graft consisting of 4 components: an unsupported bifurcated stent-graft, an inner bare stent, and 2 stent-grafts. The system was placed sequentially through a percutaneously introduced 12-F sheath; the preloaded bifurcated main body of the stent-graft was deployed first, followed by the inner bare stent and individual stent-graft limbs through separate 10-F sheaths. Spiral computed tomography (CT) was performed before treatment and at 1 week, 3 months, and then at 6-month intervals.
Results: The stent-grafts were successfully deployed in all patients, although 3 types of procedure-related adverse events occurred: left limb kinking in 1, postimplantation syndrome (fever, leukocytosis, and decreased platelet count) in 5, and a small access site arteriovenous fistula in 1. Postprocedural angiography and 1-week follow-up CT scanning did not identify any endoleaks. At a mean 9.2+/-4.6-month follow-up, all devices were intact, with complete exclusion of the aneurysms and no endoleaks.
Conclusions: This newly designed bifurcated modular stent-graft appears to be effective for percutaneous AAA repair; further investigation is warranted.