Document Detail


Silzone-coated St. Jude Medical valves: six-year experience in 46 patients.
MedLine Citation:
PMID:  17315381     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND AIM OF THE STUDY: The Silzone-coated St. Jude Medical valve was developed to reduce prosthetic valve endocarditis, but in the Artificial Valve Endocarditis Trial (AVERT) was recalled following reports of major paravalvular leaks. A separate study suggested an increased risk of thromboembolic complications associated with the Silzone valve. Herein is reviewed the present authors' experience in patients with Silzone valves. METHODS: Between April 1998 and November 1999, 46 patients (28 males, 18 females; mean age 62.6 years; range: 41-78 years) received a total of 49 Silzone valves. Seven of the patients were in NYHA class IV, and 29 in class III; four patients had active endocarditis. Twenty-one patients underwent aortic valve replacement, 22 mitral valve replacement, and three had both mitral and aortic valve replacement. Concomitant procedures were performed in nine patients. RESULTS: The 30-day mortality was 6.5 % (n = 3). At post-mortem examination, the valves were found to be seated well, with no evidence of malfunction, thrombotic occlusion or infection. Follow up examinations were conducted initially at six months after surgery, and annually thereafter. All patients underwent transthoracic echocardiography. Follow up was 100% complete; the mean follow up period was 73.5 months (range: 62-81 months). Six late deaths have occurred; five deaths were due to non-cardiac causes, and one cardiac death was unrelated to the valve prosthesis. No cases of paravalvular leak have been identified. Two patients had postoperative thromboembolic complications, but echocardiography did not demonstrate the presence of thrombus or paravalvular leakage. CONCLUSION: In this single-center, non-randomized study of 46 patients, the findings of increased paravalvular leak with the Silzone valve, as identified in AVERT study, could not be confirmed. Moreover, the incidence of thromboembolic complications reported was modest.
Authors:
Uday P Dandekar; Max Baghai; Maninder Kalkat; Paul D Ridley
Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  The Journal of heart valve disease     Volume:  16     ISSN:  0966-8519     ISO Abbreviation:  J. Heart Valve Dis.     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-02-23     Completed Date:  2007-03-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9312096     Medline TA:  J Heart Valve Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  37-41     Citation Subset:  IM    
Affiliation:
Department of Cardiothoracic Surgery, University Hospital of North Staffordshire, Stoke-on-Trent, United Kingdom. udandekar@yahoo.co.uk
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Endocarditis / surgery
Female
Heart Valve Diseases / surgery*
Heart Valve Prosthesis / adverse effects*
Heart Valve Prosthesis Implantation / adverse effects*,  instrumentation*,  mortality
Humans
Male
Middle Aged
Postoperative Complications

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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