InterGard silver bifurcated graft: features and results of a multicenter clinical study.

OBJECTIVES: Recent research in vascular surgery has focused on development of infection-resistant prosthetic grafts. This article describes the results of a multicenter study to evaluate safety, patency, and infection rates after implantation of the InterGard Silver bifurcated polyester graft coated with collagen and silver.

METHODS: Between October 2000 and February 2002, 289 consecutive patients were implanted with a collagen and silver acetate-coated polyester bifurcated graft at 16 French vascular surgery centers. Mean patient age was 65.3 +/- 10.9 years. The indication for prosthetic bypass was aortic aneurysm in 160 patients (55.4%) and symptomatic aortoiliac occlusive disease in 129 (44.6%). All but four patients received prophylactic antibiotic therapy. Patency was assessed at 30 days, 1 year, 2 years, and 3 years, primarily by duplex scan.

RESULTS: Two patients (0.7%) died during the first 30 days. Median duration of hospitalization was 11 days. The Kaplan-Meier survival rate at 3 years was 85.7% +/- 4.1%. Primary and secondary patency rates at 3 years were 94.9% +/- 2.6% and 97.5% +/- 1.8%. Thrombectomy was performed successfully in seven patients, and a major amputation was required in two patients with patent grafts. Postoperative complications, including 39 nosocomial infections, were observed in 107 patients (37.0%). Eleven patients presented with 12 wound infections that were classified Szilagyi grade I in eight cases, grade II in two cases, and grade III with graft infection in two cases (0.7%). Among the 149 patients undergoing aortofemoral bypass, eight (5.4%) presented with wound infection, including two graft infections (1.3%). Among the 140 patients undergoing aortoiliac bypass, only three patients (2.1%) presented wound infection and none with graft infection (P = .15). Three (16.7%) of 18 patients who had undergone previous femoral revascularization and eight (3%) of 271 patients without previous femoral revascularization presented with wound infection. This difference was statistically significant (P = .03), with a relative risk of 5.6 (95% confidence interval [CI], 1.6 to 19.5). Five (11.9%) of 42 diabetic patients and six (2.4%) of 247 nondiabetic patients presented with wound infection. This difference was also statistically significant (P = .01), with a relative risk of 3.4 (95% CI, 1.7 to 6.9). Lymphorrhea or lymphocele developed in the groin of 25 patients (8.6%) with negative culture.

CONCLUSION: This multicenter prospective study shows that the InterGard Silver graft is safe with no side effects. The primary patency rate was excellent, and the graft infection rate was low, despite a high incidence of nosocomial infections.