Objectives: To evaluate the utility and efficacy of colour-coded duplex scanning as an adjunct to clinical surveillance of infrainguinal vein bypass surgery.
Design: Prospective controlled randomised trial.
Methods: The trial included 179 consecutive patients undergoing 185 primary infrainguinal vein graft reconstructions during a 3-year period. Patients alive without amputation and with open graft at 1 month were randomised to a surveillance program based on clinical examination and ankle-brachial pressure index measurement (ABI group) or additional duplex scanning (DD group). All patients were scheduled for surveillance at 1, 3, 6, 9 and 12 months after operation.
Results: Surveillance identified four failing grafts in the ABI group and 11 in the DD group which were revised. The number of occluded grafts was seven in ABI group and 12 in DD group. At 1-year overall cumulative assisted primary patency rates in the ABI group and in the DD group were 74% and 65% respectively (p = 0.21), corresponding secondary patency rates were 84% and 71% (p = 0.04) and limb salvage rates 88% versus 81% (p = 0.23) respectively.
Conclusions: This study failed to show any beneficial effect of duplex scanning in a surveillance program, which was difficult to accomplish as a part of routine clinical work. However, the main difference in outcome appeared during the first postoperative month before the commencement of the surveillance program.