title: Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft.
abstract: 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.
authors.affiliation: Department of Vascular and Thoracic Surgery, KrankenhausNordwest, Frankfurt a. M, Germany. zegelman.max@khnw.de
authors.forename: Max
authors.initials: M
authors.lastname: Zegelman
authors.forename: Gisela
authors.initials: G
authors.lastname: Guenther
authors.forename: Matthias
authors.initials: M
authors.lastname: Waliszewski
authors.forename: Fryderyk
authors.initials: F
authors.lastname: Pukacki
authors.forename: Michal Goran
authors.initials: MG
authors.lastname: Stanisic
authors.forename: Philippe
authors.initials: P
authors.lastname: Piquet
authors.forename: Marius
authors.initials: M
authors.lastname: Passon
authors.forename: Zuhir
authors.initials: Z
authors.lastname: Halloul
authors.forename: Jörg
authors.initials: J
authors.lastname: Tautenhahn
authors.forename: Luc
authors.initials: L
authors.lastname: Claey
authors.forename: Claudia
authors.initials: C
authors.lastname: Agostinho
authors.forename: Dragos
authors.initials: D
authors.lastname: Simici
authors.forename: Dinah
authors.initials: D
authors.lastname: Doebrich
authors.forename: Carsten
authors.initials: C
authors.lastname: Mueller
authors.forename: Kai
authors.initials: K
authors.lastname: Balzer
mesh_terms: D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D015897:Comorbidity; D005060:Europe; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000503:physiopathology / Q000601:surgery; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011091:Polyesters; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000382:microbiology / Q000601:surgery; D012042:Registries; D012086:Reoperation; D012307:Risk Factors; D012834:Silver / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D014654:Vascular Patency
chemical_list: D000890:Anti-Infective Agents; D020099:Coated Materials, Biocompatible; D011091:Polyesters; D012834:Silver