Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft.

The purpose of this postmarket surveillance registry was to document the efficacy of a vascular prosthesis coated with metallic silver in high-risk patients undergoing vascular reconstructions. Patency (primary endpoint) and freedom from graft infection (secondary endpoint) data were assessed at a minimum of 12 months in patients with significant co-morbidity and/or confirmed graft infections or infected native vessels. Between November 2006 and December 2009, 230 patients with high-risk factors underwent aortic,peripheral and/or extra-anatomic reconstructions with Silver Graft® (SG) in six German, one French and one Polish vascular center.All participating centers used the metallic silver-coated polyester graft (SG) in various diameters and lengths including tubular and bifurcate vascular grafts. Doppler ultrasound follow-ups to determine graft patency were planned at 12 months or done at an earlier time in case the patient became symptomatic. A total of 230 patients were studied. Ten of these 230 patients had graft infections at baseline whereas the remaining 220 subjects had significant risk factors such as coronary artery disease (62.7%, 138/220), vascular access in scar tissue (27.3%, 60/220), Fontaine III/IV (38.2%, 84/220), chronic renal insufficiency (26.8%, 59/220) and diabetes (21.0%,46/220). The long-term follow-up at 15.5 ± 8.3 months revealed a secondary patency rate of 93.2% (205/220) and an 'all cause' mortality rate of 18.6% (41/220). There was a freedom from de novo graft infection rate of 95.9% (211/220) in the high-risk group without graft infections at baseline. One regraft infection occurred distal of the revisional reconstruction in the 10 patients with graft infection at baseline. The presence of perigraft fluid at follow-up and Fontaine III/IV at baseline were found to be predictors for graft patency whereas perigraft fluid presence was the only predictor for de novo graft infections. This registry revealed favorable patency and freedom from de novo infections rates in a 'high-risk' population with significant co-morbidities.

Results from the first in man german pilot study of the silver graft, a vascular graft impregnated with metallic silver.

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.