Femorodistal bypass using cryopreserved venous allografts for limb salvage

Critical ischemia due to extensive femoropopliteal occlusive disease often leads to amputation in patients in whom an autologuous vein is unavailable for reconstruction. The purpose of this nonrandomized prospective study is to evaluate the usefulness of cryopreserved venous allografts (CPVA) as an arterial substitute in these cases. Between October 1990 and March 1993, long bypass to a tibial or a foot artery using a CPVA was performed in 25 consecutive patients with ulcerations or gangrene. There were 19 women and six men with a mean age of 72 years (range: 51-90). The indication for allograft reconstruction was absence (17 cases) or unsuitability (eight cases) of an autologous vein graft. Greater saphenous vein allografts were harvested from multiple organ donors and frozen at -80 degrees C with 12% dimethylsulfoxide (DMSO). Sixteen patients had undergone one or more previous unsuccessful limb salvage attempts. The plantar arch was absent or incomplete in 16 patients (64%). Patients were followed up prospectively for a mean of 21 months (range: 3-32). One patient died early (32 days) and three patients died late with patent bypasses. Cumulative survival rate was 77% at 1 year and 72% at 2 years. Cumulative secondary patency rate (Kaplan-Meier) was 88% at 1 month, 72% at 6 months, and 52% at 1 year. The cumulative limb salvage rate was 78% at 2 years. When an autologous vein is unavailable, long bypass using a CPVA is a simple, quick, minimally traumatic, economical, and effective method to achieve limb salvage in patients with severe distal arterial occlusive disease. However, CPVA causes immunoreaction and there is a risk of proximal postanastomotic stenosis. Doppler ultrasound surveillance of a subcutaneous graft allows accurate assessment and repair of the abnormalities with no increase in mortality or morbidity.