First clinical experience with a mechanical valve with silver coating

Background and aim of the study: The interface between the annulus and sewi ng cuff is the infectious center of prosthetic valve endocarditis (PVE). To decrease the incidence of PVE, the sewing cuff of the St. Jude Medical(R) (SJM) mechanical heart valve was permanently coated with elemental silver ( Silzone(R) coating). In vitro data have supported the antimicrobial efficac y of this coating. Methods: To study any adverse effects of the silver coating in humans, seru m silver levels were determined (by graphite furnace atomic absorption spec trometry) before (baseline) and at five intervals after operation: day 1, d ay 3, discharge, one month, and two months. Between January and August 1997 1 38 patients (71% males) underwent surgical implant of a SJM Masters Serie s valve with Silzone coating for the aortic valve (n = 29), mitral valve (n = 6), or both valves (n = 3). Five patients (13%) underwent concomitant pr ocedures. Two patients (5%) presented with native active valve endocarditis . Results: There was no hospital mortality or valve-related hospital morbidit y. Blood silver concentrations peaked shortly after surgery and then decrea sed during the postoperative period. Average levels were consistently below 4 parts per billion (ppb). Levels below 10 ppb are considered normal. Foll ow up was 95% complete. There were no recurrent or new cases of endocarditi s. Conclusion: These clinical data indicate that the SJM Masters Series valve with Silzone coating performs well. No adverse effects of the silver coatin g could be detected, and there were no valve-related complications.