Percutaneous treatment of long superficial femoral artery occlusive disease: efficacy of the Hemobahn stent-graft.

Purpose: To assess the efficacy of the Hemobahn stent-graft in the percutaneous treatment of long occlusive lesions of the superficial femoral artery (SFA).

Methods: Fifty-nine limbs in 54 patients (42 men; mean age 73.3+/-8.2 years, range 55.2-91.3) with 59 symptomatic SFA occlusions >10 cm in length were selected for percutaneous treatment with the Hemobahn stent-graft. The treated SFA was assessed for patency and degree of stenosis by color-flow duplex ultrasound prior to discharge and at 1, 3, and 6 months and yearly thereafter. The actuarial life-table method was used to derive primary and secondary patency rates.

Results: Primary technical success was achieved in 56 (95%) of 59 limbs on an intention-to-treat basis (2 access and 1 device failures). In the first 30 days, 4 (6.8%) stent-graft thromboses and 5 (8.5%) minor technical difficulties occurred. Up to 1 year, there were 15 (25.4%) primary occlusions, 7 (11.9%) of which were associated with restenosis. Cumulative primary patencies were 88%, 67%, and 58% at 1, 6, and 12 months, respectively; secondary patencies were 92%, 82%, and 73% at the same intervals. There was no statistically significant difference (p<0.05) in patency (primary or secondary) with respect to presenting symptoms, lesion length, stent-graft length, or distal runoff.

Conclusions: Symptomatic long occlusive lesions of the SFA treated percutaneously with the Hemobahn stent-graft achieved good outcomes initially with a low complication rate. Primary and secondary patencies were similar to those reported for open synthetic femoropopliteal bypass procedures.