Congress of the European Society for Vascular Surgery - Copenhagen 1999

Femoro-Distal PTFE bypass grafting for severe ischemia: results of a prospective clinical study using a new distal anastomosis with optimized hemodynamics.

• Rueckert RI, Settmacher U, Krueger U, Scholz H
• Humbolt University Medical School (Charité), Department of Surgery, Campus Mitte, Campus Virchow, Ev. Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany

Introduction and aim:

Although the saphenous vein is the conduit of choice for infrainguinal bypass procedures, in the absence of vein polytetrafluoroethylene (PTFE) has been established as an alternative bypass graft material. Several methods have been described to improve the patency of below-knee PTFE arterial grafts including venous cuff techniques or adjunctive arteriovenous fistula at the distal anastomosis. Owing to the importance of hemodynamics for the development of intimal hyperplasia a new type of distal end-to-side anastomosis was developed, the design of which is characterized by a bifurcated double bulb. In vitro experiments and numerical simulation clearly demonstrated improved hemodynamics within the newly shaped anastomotic site as compared to all other types of anastomoses. The purpose of this study was to evaluate the feasibility and the clinical results using the new anastomotic design in femoro-infragenicular PTFE reconstructions for severe ischemia.

Material and Methods:

A prospective non-randomized study was performed between 6/92 and 7/98 including 135 bypasses in 127 patients. There were 91 men and 36 women with a mean age of 65.1 +/- 9.9 years. Indication for surgery was critical ischemia. All patients were included in the study in whom there was no greater saphenous vein available. The proximally tapered, 8/5 mm ringed PTFE grafts were positioned extraanatomically with the newly designed distal end-to-side anastomosis being constructed entirely from PTFE. Patients were discharged on coumadin with follow-up at 1 month, 6 months, and annually. Patency of the bypass grafts was confirmed by clinical investigation and color-coded Doppler sonography. Statistical analysis of cumulative primary (PPR) and secondary patency rates (SPR) and limb salvage as well as patient survival rates was performed using the Kaplan-Meier method.

Results:

Median follow-up was 45 months ranging from 3 to 72 months. PPR and SPR at 1, 2, 3, 4, and 5 years were 67.7%, 53.0%, 45.1%, 40.5% and 33.7% and 76.1%, 56.7%, 46.7%, 43.6%, and 38.2%, respectively. Recipient arteries included popliteal (21), anterior (46) and posterior (52) tibial, and peroneal (16). There was no significant difference in PPR or SPR depending on the recipient artery. The cumulative limb salvage rates were 86.8%, 79.2%, and 77.5% at 1, 3, and 5 years, respectively. There was no perioperative mortality with a cumulative patient survival of 87.6%, 76.3%, and 67.8% at 1, 3, and 5 years, respectively. Graft infection occurred in 8 patients (5.8%) requiring explantation in all cases.

Conclusions:

These results indicate that PTFE grafting can be a worthwhile option in patients without a usable vein. The new anastomotic design was feasible and resulted in acceptable long-term patency rates of femoro-distal PTFE bypass grafts. While the new anastomotic shape is not necessarily confined to the use of PTFE, it demonstrates another successful adjunct to improve patency of femoro-distal bypass allografts.