Document Detail

The Edwards MIRA heart valve prosthesis: a 2-year study.
MedLine Citation:
PMID:  15151649     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The Edwards MIRA mechanical heart valve is designed to optimize hemodynamics, reduce thrombogenicity, and avoid mechanical failure with a special hinge mechanism. The purpose of the study was to investigate the clinical performance and postoperative hemodynamic results of the first European patients receiving Edwards MIRA mechanical heart valves. METHODS: From March 1998 to March 1999 a total of 54 Edwards MIRA valves model numbers 3600 (aortic, n = 44) and 9600 (mitral, n = 10) were implanted in 52 (36 male, 16 female; mean age 61 +/- 10.1 years) consecutive patients undergoing mechanical valve replacement in a prospective study. Follow-up of the patients including physical examination, ECG, blood tests, and Doppler were performed prior to discharge, at 6 months, at 1 year, and at least 2 years postoperatively. RESULTS: Through October 2001 a total of 172 follow-up examinations were completed (51 patients at discharge, 46 patients at 6 months, 43 patients at 12 months, 32 patients at 2 years or beyond). All patients were in NYHA class I and II at the 6-month and 2+-year follow-up. All the patients stated an improved quality of life. Hospital mortality was 1.9%. There were no complications related to anticoagulation. Mean international normalized ratio at 6 months was 3.2 (range 1.9 to 4.3); lactate dehydrogenase was slightly increased with 264 +/- 103 U/L on average (normal value 80 to 240 U/L). No signs of valvular dysfunction or paravalvular leakage were observed. Mean pressure gradients were related to valve diameter: after mitral valve replacement (size 27, 29, 31 mm: 4.8, 3.2, 2.1 mmHg); after aortic valve replacement (size 19, 21, 23, 25 mm: 12.1, 13.1, 9.3, 8.2 mmHg). CONCLUSIONS: These preliminary data suggest good hemodynamic function and a low rate of valve-related complications of the Edwards-MIRA mechanical prosthesis.
Rudolf Driever; Stefan Fuchs; Markus Meissner; Edgar Schmitz; Herbert O Vetter
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Journal of cardiac surgery     Volume:  19     ISSN:  0886-0440     ISO Abbreviation:  J Card Surg     Publication Date:    2004 May-Jun
Date Detail:
Created Date:  2004-05-20     Completed Date:  2004-11-06     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8908809     Medline TA:  J Card Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  226-31     Citation Subset:  IM    
Department of Cardiothoracic Surgery, Heart Center, University of Witten/Herdecke, Wuppertal, Germany.
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MeSH Terms
Aged, 80 and over
Aortic Valve / pathology,  surgery,  ultrasonography
Follow-Up Studies
Germany / epidemiology
Heart Valve Diseases / epidemiology,  surgery,  ultrasonography
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation
Middle Aged
Mitral Valve / pathology,  surgery,  ultrasonography
Postoperative Complications / etiology,  mortality,  ultrasonography
Prosthesis Design*
Survival Analysis
Time Factors
Treatment Outcome

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

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