Early results of a prospective randomized trial of spliced vein versus polytetrafluoroethylene graft with a distal vein cuff for limb-threatening ischemia

Abstract

Objective: Single-piece vein remains the conduit of choice in patients who need bypass grafting for limb salvage. When this option is not available, two of the remaining options are prosthetic bypass graft or several segments of vein spliced together. In this study, we compare spliced vein bypass grafting versus polytetrafluoroethylene grafting with a distal vein cuff in patients with limb-threatening ischemia. Methods: Between 1996 and 2000, 39 bypass grafting procedures in 36 patients were performed for limb-threatening ischemia. These procedures were prospectively randomized to either spliced vein bypass grafting (spliced group, 19 bypass grafts) or polytetrafluoroethylene grafting with a distal vein cuff (cuff group, 20 bypass grafts). All the patients in the cuff group underwent anticoagulation therapy with warfarin sodium after surgery. The inclusion criteria included: no single-piece vein option for bypass grafting, adequate vein for splice, no composite sequential option, and limb-threatening ischemia. The demographics were similar between the two groups. Results: The primary patency rate at 2 years was 44% and 49% for the spliced and cuff groups, respectively. In the spliced group, seven of 19 bypass grafts underwent revision in the follow-up period, and two of 20 cuffed bypass grafts were successfully revised. The secondary patency rate was 87% and 59% (P <.05), with limb salvage rates of 94% and 85% for spliced and cuff groups, respectively. Four patients in the spliced vein group needed reoperation for wound complications related to vein harvest. One polytetrafluoroethylene graft needed removal for infection. Two early mortalities occurred in the spliced group, one from myocardial infarction and one from stroke. The overall survival rate at 2 years between the two groups was 67% and 100% for the spliced and cuff groups, respectively (P <.05). Conclusion: Although this is a preliminary report, it appears that both spliced vein bypass grafting and polytetrafluoroethylene bypass grafting with a distal vein cuff produce acceptable limb salvage rates. The secondary patency rate for spliced vein is better, but these bypass grafts more often need revision or reoperation for wound complications. (J Vasc Surg 2002;35:299-306.)