Randomized clinical trial of distal anastomotic interposition vein cuff in infrainguinal polytetrafluoroethylene bypass grafting

Abstract

Background: The aim was to examine the effect of a Miller vein cuff at the distal anastomosis on the medium- to long-term patency and limb salvage rates of femoral to above-knee and femoral to below-knee popliteal artery polytetrafluoroethylene (PTFE) bypasses.

Methods: This study involved extended follow-up of the original cohort of patients included in a previously reported multicentre randomized clinical study. Outcome measures were bypass graft patency and limb salvage.

Results: Two hundred and sixty-one bypass operations were originally randomized. For this study, full data were available on 235 (120 with a Miller cuff, 115 without). The cumulative 5-year patency rate for above-knee bypasses with a Miller cuff was 40 per cent, compared with 42 per cent for non-cuffed bypasses (P = 0.702). The cumulative 3-year patency rate for below-knee bypasses with a Miller cuff was 45 per cent, compared with 19 per cent for non-cuffed bypasses (P = 0.018). A Miller cuff had no significant effect on limb salvage for above-knee or below-knee bypasses.

Conclusion: Three-year patency rates of femoral to below-knee popliteal PTFE bypasses were improved by a Miller cuff. Miller cuffs had no effect on patency rates for femoral to above-knee popliteal bypasses at 5 years and did not improve limb salvage in either group.