Outcomes of cold-stored venous allograft for below-knee bypasses in patients with critical limb ischemia

Objective: Critical limb ischemia (CLI), the most advanced form of peripheral arterial disease, is associated with strikingly high morbidity and mortality rates. Autogenous single-segment great saphenous vein (GSV) remains the optimal conduit for infrainguinal revascularization. Unfortunately, GSV is unavailable in up to 20% of patients. There is no consensus about the alternative graft that should be used for infragenicular bypass grafting when the GSV is unavailable. Currently, there are no outcome data for cold-stored venous allograft use in regard to recent safety and efficacy objective performance goals described by the Society for Vascular Surgery.

Methods: This is a retrospective analysis of 118 infragenicular revascularizations performed for CLI with cold-stored venous allografts obtained from varicose vein stripping surgery in a single institution from November 2002 to August 2013.

Results: Mean age (± standard deviation) was 75 ± 12 years (male, 76%; diabetes, 73%; dialysis, 16%), and 38% (n = 45) had a history of failed ipsilateral revascularization. None had suitable autogenous conduit for even composite vein bypass. The distal anastomosis was performed to an infrapopliteal artery in 85 cases (72%). At 30 days, perioperative death rate was 6.8%, major adverse cardiovascular event rate was 7.6%, and major adverse limb event rate was 11.9%. Mean follow-up was 34 ± 29 months (range, 1-113 months). At 1 year, freedom from major adverse limb event or perioperative death, limb salvage, survival, amputation-free survival, and secondary patency rates were, respectively, 64.9%, 82.5%, 85.4%, 73.3%, and 58.3%. Ejection fraction <45% and dialysis were the most significant factors predicting failure of revascularization.

Conclusions: Cold-stored venous allografts may be used for performing infragenicular revascularization for CLI with acceptable safety and efficacy results despite poor long-term patency. Their level of performance remains inferior to autologous vein sources but seems comparable to alternative allografts or prosthetic conduit. Their availability is a major advantage compared with other biologic alternative sources.