Efficacy of Hemobahn® in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia:: A comparative study with claudicants

Purpose. To assess the results of covered stents in the treatment of superficial femoral artery (SFA) occlusive disease. Method. From July 2000 till June 2003, 32 patients (34 limbs) were scheduled for procedures including Hemobahn (R) deployment in the SFA. Indication for treatment was claudication (group I, N = 15 patients and 16 limbs, 31.2% occlusions) or critical and acute ischemia (group II, N = 17 patients and 18 limbs, 61.1% occlusions). TASC D SFA lesions were excluded. No limb artery was patent pre-operatively in 19% and 89% of limbs in groups I and II, respectively (p = 0.00001). Results. Outflow procedures were performed simultaneously in one limb in group I and 12 in group 11 (p = 0.0003). The technical, hemodynamic and clinical success rates were 100, 100 and 94.1%, respectively. Mean follow-up was 18.1 months. Primary patency rates at 12 months were 81.3 +/- 10.6% in group I and 88.6 +/- 9.0% in group It (p = 0.547). At 12 months, the secondary patency and limb salvage rates were, respectively, 87.5 +/- 8.9 and 100% in group I and 87.5 +/- 8.93 and 94.45 +/- 6.71% in group II. Conclusion. Treatment of SFA occlusive lesions (excluding TASC D lesions) with the Hemobahn (R) covered stent yielded good results for both claudicants with good outflow and patients with critical or acute ischemia with bad outflow, if concomitant outflow-improving procedures were performed.