Flemish experience using the Advanta V12 stent-graft for the treatment of iliac artery occlusive disease.

AIM

The aim of this study was to evaluate the technical feasibility and safety of implanting a polytetrafluoroethylene (PTFE) covered balloon expandable stent to treat iliac artery stenoses and occlusions. Additionally, the primary patency and clinical and hemodynamic efficacy at 1 year were analysed.

METHODS

This nonrandomized, prospective study involved patients with claudication and iliac artery occlusive disease at 2 participating centres. Patients with suitable lesions determined by clinical examination, ankle-brachial indices (ABIs), colour-flow duplex ultrasound (CFDU), magnetic resonance angiogram (MRA) and confirmed with biplanar digital subtraction angiography (DSA) were treated with PTFE-covered stainless steel stents. Procedural and 30-day periprocedural complications were recorded prospectively. According to in-hospital standards, follow-up with clinical ischemia category determination, ABI and CFDU was performed at 1, 6 and 12 months to determine treatment efficacy and primary limb patency.

RESULTS

In total, 91 limbs were treated in 65 patients (51 male; mean age 65 years). Stent-graft deployment was successful in 91 (100%) limbs. There were no limbs with residual stenosis >30%. There were no procedural or 30-day complications. The clinical ischemia category distribution improved significantly at 1, 6 and 12 months. The mean ABI rose significantly from 0.59 before treatment to 0.98, 0.98 and 0.99 at 1, 6 and 12 months after the procedure. Primary limb patency at 1-year was 91.1%

CONCLUSIONS

Implantation of Advanta V12 PTFE-covered stent for iliac occlusive disease shows to be safe and feasible with excellent clinical results at 1 year in the investigated patient cohort.