Fifteen years of infrapopliteal arterial reconstructions with cryopreserved venous allografts for limb salvage.

OBJECTIVE: The availability of autologous vein grafts remains the limiting factor in infragenual bypass surgery in many patients with critical limb ischemia (CLI). Alternatives such as prosthetic conduits are known to have a poor outcome and most are not resistant to infection. Based on previous experimental work, we started to use cryopreserved saphenous vein allografts for this indication 15 years ago. To evaluate their outcome, we performed a retrospective study of those bypasses with distal anastomosis on a crural or pedal vessel.
METHODS: Between November 1991 and December 2005, 108 cryopreserved great saphenous vein allografts were implanted for in 92 patients (42 women, 50 men) with a mean age of 71 years (range, 39-88 years). All patients received low-dose immunosuppressive therapy for up to 1 year after intervention. Follow-up was conducted until amputation, death, or the end of the study in March 2007.
RESULTS: Nondiabetic atherosclerosis the cause of CLI in 57%, 41% had diabetes, and 2% had Buerger disease. Forty-one conduits were performed for primary reconstructions and 67 for redo reconstructions. During a mean follow-up of 26.4 months, 69 occlusions occurred. Primary and secondary patency rates were 56% and 73% at 1 year, 32% and 60% at 3 years, and 17% and 38.5% at 5 years. Survival rates were 87.4% at 1 year and 64.5% at 5 years. At multivariate analysis, the intake of statins was predictive for improved patency (hazard ratio [HR], 0.09; P = .024) and for prolonged survival (HR, 0.335; P = .045). The presence of diabetes showed a trend for inferior patency (HR, 2.325; P = .116) and for decreased amputation risk (HR, 0.592; P = .078).
CONCLUSION: Cryopreserved saphenous vein allografts are a valuable alternative to prosthetic materials when autologous veins are not available. Our limb salvage and patency rates are higher then those described for prosthetic grafts at the infrapopliteal level in most studies. Moreover, these grafts are resistant to infection when performed for revascularization in patients with an infected ulcer. Better graft and patient selection, better graft surveillance and immunologic matching, and standard use of statins could possibly improve the results even further. Shortage in availability might be a limiting factor for their widespread use.