Results from the First in Man German Pilot Study of the Silver Graft, a Vascular Graft Impregnated with Metallic Silver

Abstract

The purpose of this study was to assess the safety of a novel vascular prosthesis in 50 patients who underwent inguinal and infrainguinal vascular reconstructions. The safety data were based on ultrasound Doppler data at 2 and 18 months to quantify the graft-tissue integration in this patient cohort. Between August 9, 2005, and January 25, 2006, 50 patients underwent inguinal or infrainguinal reconstructions with the Silver Graft (SG; B. Braun Melsungen AG, B. Braun Aesculap AG, Tuttlingen, Germany) in six vascular centers. All participating centers received the metallic silver-coated polyester graft (SG) with a diameter of 8 mm and a total length of 60 cm, which was length adjusted to fit the patient's anatomy and the planned vascular reconstruction. The mean patient age was 69.1 ± 9.0 years, the male inclusion rate was 72.0%, and the Fontaine classifications were stage IV (16%), stage III (14%), stage IIb (66%), and stage IIa (4%), whereas aneurysm repairs amounted to 4%. In-hospital results revealed the presence of minimal perigraft fluid in 14.0% of all cases (7 of 50). At the 2-month follow-up, perigraft fluid was detected in one patient (1 of 50). At 18 months, a single case of minimal perigraft fluid was detected in an asymptomatic patient. Wound healing was accomplished at discharge in 96% of all patients, whereas at the 2-month follow-up, no signs of wound infection or irritation could be detected. The accumulated primary patency rates were 94% at 2 months and 88% at 18 months. The available clinical data on perigraft fluid as a marker for graft-tissue incorporation at 2 and 18 months, patency, and wound healing are comparable to those of other relevant clinical results with polyester grafts and support the safety of the metallic SG in the studied patient population with inguinal and infrainguinal reconstructions. However, it cannot be guaranteed that all graft infections can be avoided with the SGs.