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.