Aims. This prospective, non-randomised study is designed to assess the short and medium-term results of using Carbograft® carbon-coated polyester vascular prostheses in the surgical revascularisation of the lower extremities. Methods. Between January 1997 and September 1998 60 patients (43 male, 15 female, mean age 68.2 years) were monitored after femoro-popliteal bypass procedures using Carbograft® prostheses. The indication to surgery was invalidating claudication in 65% and critical ischaemia in 35% of cases. All patients were subjected to preoperative angiography which revealed optimum run-off in 11 cases (18.3%), good run-off in 4 (68.4%) and minimal run-off in 8 (13.3%). A supragenicular femoropopliteal bypass operation was therefore performed on 49 patients (81.7%) and a subgenicular procedure on 11 (18.3%). Results. Mean follow-up lasted 314±207 days. Early complications (medium 30 days) included 5 cases of graft thrombosis (8.5%) requiring surgery and 1 case (1.7%) of aseptic periprosthetic effusion around the graft. Tardive complications included 8 cases (13.1 pt/yr) of graft thrombosis caused by stenosis of distal anastomosis and treated by PTA and 2 cases (3.3% pt/yr) of graft infection. There were no perioperative deaths. The probability of primary patency at one year was assessed using the Kaplan- Meier method and came to 70.0±7.1% (67.9±8.3% for supragenicular bypass cases and 80.2±12.6% for subgenicular procedures). The secondary patency figure was 88.8±4.4%. A statistically significant difference was noted in primary patency between patients with good/excellent and patients with poor run-off: the primary patency rates were 76.1±7.3% and 35.7±17.5%, respectively. Conclusions. The satisfactory results achieved in this series justify future randomised clinical studies designed to confirm the long-term advantages of using Carbograft® prostheses in infra-inguinal revascularisation procedures.
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