Endovascular treatment of femoropopliteal stenoses/occlusions with a SilverHawk directional atherectomy device: immediate results and 12-month follow-up.

PURPOSE

This paper reports our immediate and 12-month follow-up results in the treatment of arterial stenoses/occlusions of the femoropopliteal region with the use of the SilverHawk directional atherectomy device (EV3, USA).

MATERIALS AND METHODS

In an 18-month period, we treated 18 patients (13 men, five women, age range 39-81 years) with the SilverHawk directional atherectomy device. Inclusion criteria were symptomatic femoropopliteal stenosis/insufficiency, nonresponsiveness to medical therapy, and Rutherford categories 3-5. Exclusion criteria were based on the preliminary colour Doppler ultrasound (US) assessment and were plaque with a calcified component >50% and inadequate upstream and/or downstream vascular bed. Patients with severe vascular impairment, classified as TransAtlantic Inter-Society Consensus (TASC) D, were also excluded.

RESULTS

The procedure was successfully completed in all cases, with evident recanalisation and sufficient wall remodelling. No major complication was observed. At assessment immediately after the procedure and over the following days, an improvement in clinical symptoms and in the Rutherford scale was observed. Follow-up at 2 and 12 months identified one case of distal reocclusion subsequently treated with amputation, and two cases of restenosis (primary patency 79%) successfully treated with a repeat procedure (secondary patency 96%).

CONCLUSIONS

The SilverHawk directional atherectomy device proved to be an effective and safe tool in all our patients treated for femoropopliteal stenosis/occlusion, with a significant improvement in both imaging findings and clinical signs and symptoms.