Background: The purpose of this study was to assess the benefits of duplex compared with clinical vein graft surveillance in terms of amputation rates, quality of life, and healthcare costs in patients after femoropopliteal and femorocrural vein bypass grafts.
Methods and results: This was a multicenter, prospective, randomized, controlled trial. A total of 594 patients with a patent vein graft at 30 days after surgery were randomized to either a clinical or duplex follow-up program at 6 weeks, then 3, 6, 9, 12, and 18 months postoperatively. The clinical and duplex surveillance groups had similar amputation rates (7% for each group) and vascular mortality rates (3% versus 4%) over 18 months. More patients in the clinical group had vein graft stenosis at 18 months (19% versus 12%, P=0.04), but primary patency, primary assisted patency, and secondary patency rates, respectively, were similar in the clinical group (69%, 76%, and 80%) and the duplex group (67%, 76%, and 79%). There were no apparent differences in health-related quality of life, but the average health service costs incurred by the duplex surveillance program were greater by 495 pound sterling (95% CI 83 pound sterling to 807 pound sterling) per patient.
Conclusions: Intensive surveillance with duplex scanning did not show any additional benefit in terms of limb salvage rates for patients undergoing vein bypass graft operations, but it did incur additional costs.