Randomized clinical trial of distal anastomotic interposition vein cuff and infrainguinal polytetrafluoroethylene (PTFE) bypass grafting

Abstract

Conclusion: Three-year patency rates for femoral to below-knee popliteal polytetrafluoroethylene (PTFE) bypasses are improved with use of a Miller cuff. Miller cuffs have no effect on patency rates for femoral to above-knee popliteal bypasses at 5 years, and do not improve limb salvage in either above-knee or below-knee PTFE bypasses. Summary: The authors examined the effect of a Miller vein cuff at the distal anastomosis of a PTFE graft on median to long-term patency of femoral to above-knee and femoral to below-knee bypasses. Outcome measures were bypass graft patency and limb salvage. This was a prospective, randomized clinical trial with 261 bypass operations originally randomized. Data were available for 235 bypasses (120 with a Miller cuff, 115 without). Mean age of patients in the cuff group was 67.2 years, and in the non-cuff group was 69.3 years (P < .72). The indication for operation was limb salvage in 89% of each group. Cumulative 5-year patency for above-knee bypasses with a Miller cuff was 40%, compared with 42% for the non-cuffed bypasses (P < .702). Cumulative 3-year patency for below-knee bypasses with a Miller cuff was 45%, compared with 19% for non-cuffed bypasses (P < .018). The Miller cuff had no significant effect on limb salvage for either above-knee or below-knee bypasses. Comment: When PTFE bypass is indicated to the below-knee popliteal artery in a primarily limb salvage population, a Miller cuff should be used. The results also suggest that PTFE bypass to the popliteal artery for limb salvage, whether above or below the knee, has relatively poor long-term patency.