Purpose: To report a prospective study to evaluate safety, effectiveness, and midterm patency of self-expanding stent-grafts in patients with femoropopliteal occlusive disease.
Materials and methods: Sixty-three Hemobahn stent-grafts were used in 52 patients for treatment of medium- or long-segment (>3 cm) occlusions (82.7%) and stenoses (17.3%) of the femoropopliteal artery. The mean length of vessel segments covered was 10.9 cm +/- 5.13. Follow-up with documentation of clinical symptoms, assessment of Rutherford clinical stage of peripheral vascular disease, and color-coded duplex sonography was performed at discharge, at 1, 3, 6, 12, 18, and 24 months after implantation, and yearly thereafter. Mean follow-up duration was 23.8 months +/- 6.9 (range, 8-36 mo). Follow-up data at 12 and 24 months after treatment were available for 47 of 52 (90.4%) and 31 of 52 patients (59.6%), respectively.
Results: Device implantation was technically successful in all 52 patients, yielding an overall technical success rate of 100%. Procedure-related complications were observed in 12 of 52 patients (23.1%) and consisted of distal embolization (n = 4, 7.7%), minor groin hematoma (n = 7, 13.5%), and arteriovenous fistula (n = 1, 1.9%), but prolonged hospitalization and further medical, interventional, or surgical measures were not required. Stent-graft placement induced an initial improvement of the mean resting ankle-brachial index from 0.54 +/- 0.12 to 0.89 +/- 0.14 (P <.01). Primary patency rates at 12 and 24 months were 78.4% +/- 5.8 and 74.1% +/- 6.2, respectively. Primary assisted patency rates were 82.4% +/- 5.3 at 12 months and 80.3% +/- 5.6 at 24 months. Secondary patency rates at 12 and 24 months were 88.3% +/- 4.5 and 83.2% +/- 5.5, respectively. There was no significant difference (log-rank test, P >.3) between primary patency rates in patients grouped according to lengths of implanted grafts (ie, length of the treated lesions).
Conclusion: Endovascular placement of Hemobahn stent-grafts for percutaneous treatment of medium- to long-segment high-grade stenoses and occlusions of the femoropopliteal artery is a safe procedure with excellent initial success rates and promising midterm results.