Purpose: To evaluate the long-term efficacy of Hemobahn/Viabahn endoprostheses (HVE) in patients with femoral arterial occlusive disease.
Methods: During a 6-year period, 57 patients (46 men; mean age 62.7+/-9.3 years, range 44-82) were treated with 82 Hemobahn or Viabahn endoprostheses for stenoses (13%) or occlusions (87%) of the superficial femoral artery (SFA) in 60 limbs. The average length of the treated lesions was 10.7 cm (range 3-34), and the mean length of the HVE was 15.9 cm (3-33). Patients had chronic limb ischemia in Rutherford stages 2/3 (92%), 4 (2%), and 5 (7%). The crossover method was used to deploy the stent-graft in 31 cases and the ipsilateral technique in 29.
Results: Endoprosthesis deployment was technically successful in 59 (98%) of 60 limbs. In 2 cases, major complications (1 deployment failure and 1 thromboembolism) required additional surgery. Early thrombosis (within 30 days) occurred in 6 (10%) femoral arteries. The mean follow-up was 55 months (8-78). Late thrombosis or reocclusion was observed in 22 (37%) arteries up to 5 years after prosthesis placement (14 in the first year). Primary/ secondary patency rates were 90%/95% at 30 days (n=59), 67%/81% at 1 year (n=58), 57%/ 80% after 3 years (n=49), and 45%/69% after 5 years (n=32). In a subgroup analysis of 48 patients with "optimal" conditions for implantation (no heavy calcifications, popliteal obstruction, or complete superficial femoral artery occlusion; minimum 1-vessel runoff; and adequate antiplatelet therapy or anticoagulation), the primary/secondary patency rates were 80%/91% after the first year (n=46), 71%/89% after 3 years (n=38), and 62%/90% after 5 years (n=21).
Conclusion: HVE seems to be suitable for femoral arterial occlusive disease so long as ideal indications and prophylaxis against secondary thrombosis are strictly observed.