Early experience with cryopreserved saphenous vein allografts as a conduit for complex limb-salvage procedures.

Purpose: The lack of a suitable alternative to autogenous vein is often the limiting factor for complex lower extremity vascular reconstruction, especially when previously placed grafts have failed. Cryopreserved saphenous vein allografts have been used as an alternative conduit. This report reviews our early experience with this conduit in a series of complex redo revascularization procedures for limb salvage when no suitable autogenous vein was available.

Methods: Thirty-five patients underwent 39 lower extremity bypass grafts on 36 limbs. These patients had undergone a combined total of 72 prior revascularization procedures on the symptomatic limb, an average of two procedures per patient. Only five bypasses were performed as a primary procedure. There were 18 men and 17 women with a mean age of 71 years. Sixteen of the patients had diabetes. Thirty-four bypasses were performed for rest pain or ulceration, four for disabling claudication, and one for replacement of an aneurysmal vein graft. There were 35 femorotibial, three below-knee femoropopliteal, and one femoropedal reconstruction. Twenty-five grafts were constructed with cryopreserved vein only, whereas 14 were composite grafts; 10 were constructed with polytetrafluoroethylene, one with Dacron, and three with spliced native saphenous vein. The mean follow-up was 9 months (range 1 to 25 months).

Results: There was one early death (< 30 days) and two late deaths. Two patients died with a patent graft. There have been 12 early graft closures and an additional 17 late failures, resulting in primary cumulative graft patency rates of 67%, 56%, 43%, 28%, and 14% at 1, 3, 6, 12, and 18 months, respectively. Surgically correctable causes, including technical error and anastomotic stenosis, could be identified in 13 of the 29 graft failures. Salvage of failed grafts resulted in secondary cumulative graft patency rates of 87%, 77%, 61%, 46%, and 37% at these same intervals. There was no significant difference in primary or secondary graft patency rates related to diabetes, ABO graft compatibility, graft composition or orientation, indication for surgery, state of the outflow tract, or site of distal anastomosis. Limb salvage was attained in 24 (67%) of the 36 limbs. Two amputations were necessary despite patent grafts.

Conclusions: Because of the poor overall graft patency rates, cryopreserved saphenous vein allografts should be used only as a last resort when no alternative autogenous conduit is available. Unless patency rates superior to those achievable with currently available prosthetic or biologic conduits can be attained by adjunctive measures such as routine anticoagulation or immunosuppressive therapy, the use of cryopreserved saphenous vein allografts for lower extremity revascularization should be deferred until improved preparation techniques provide a more durable conduit.