Literature DB >> 11388203

Mosaic valve international clinical trial: early performance results.

G J Fradet1, N Bleese, J Burgess, P C Cartier.   

Abstract

BACKGROUND: A new third generation porcine bioprosthesis was developed in an attempt to improve on hemodynamic performance and durability of current prostheses.
METHODS: One thousand, two hundred, sixty patients underwent aortic valve replacement and 366 patients underwent mitral valve replacement between February 1994 and September 2000. The cumulative follow-up was 3,696.3 patient-years for aortic valve replacement and 880.1 patient-years for mitral valve replacement. Follow-up was complete for 95.5% of aortic valve replacement patients and 97.5% of mitral valve replacement patients.
RESULTS: For aortic valve replacement, freedom from valve-related adverse events at 1 year was 96.5%+/-0.5% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 5 years was 93.8%+/-2.6% for antithromboembolic-related hemorrhage and 99.3%+/-0.9% for structural valve deterioration. For mitral valve replacement, freedom from valve-related adverse events at 1 year was 96.0%+/-1.1% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 4 years was 92.1%+/-3.7% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration.
CONCLUSIONS: These results support the claim that the Mosaic bioprosthetic valve is efficacious and safe, but continued follow-up is mandatory to determine mid- and long-term performance.

Entities:  

Mesh:

Year:  2001        PMID: 11388203     DOI: 10.1016/s0003-4975(01)02539-5

Source DB:  PubMed          Journal:  Ann Thorac Surg        ISSN: 0003-4975            Impact factor:   4.330


  5 in total

1.  Factors affecting survival after mitral valve replacement in patients with prosthesis-patient mismatch.

Authors:  Abdulhameed Aziz; Jennifer S Lawton; Hersh S Maniar; Michael K Pasque; Ralph J Damiano; Marc R Moon
Journal:  Ann Thorac Surg       Date:  2010-10       Impact factor: 4.330

Review 2.  Diagnostic evaluation of left-sided prosthetic heart valve dysfunction.

Authors:  Jesse Habets; Ricardo P Budde; Petr Symersky; Renee B van den Brink; Bas A de Mol; Willem P Mali; Lex A van Herwerden; Steven A Chamuleau
Journal:  Nat Rev Cardiol       Date:  2011-05-17       Impact factor: 32.419

3.  Prediction of valve prosthesis-patient mismatch prior to aortic valve replacement: which is the best method?

Authors:  Sabine Bleiziffer; Walter B Eichinger; Ina Hettich; Ralf Guenzinger; Daniel Ruzicka; Robert Bauernschmitt; Ruediger Lange
Journal:  Heart       Date:  2006-12-12       Impact factor: 5.994

4.  The Mosaic Mitral Valve Bioprosthesis: A Long-Term Clinical and Hemodynamic Follow-Up.

Authors:  Michele Celiento; Stefania Blasi; Andrea De Martino; Stefano Pratali; Aldo D Milano; Uberto Bortolotti
Journal:  Tex Heart Inst J       Date:  2016-02-01

5.  Antithrombotic Strategies After Bioprosthetic Aortic Valve Replacement: A Systematic Review.

Authors:  Joel N Papak; Joseph C Chiovaro; North Noelck; Laura D Healy; Michele Freeman; Jacquelyn A Quin; Robin Paynter; Allison Low; Karli Kondo; Owen J T McCarty; Devan Kansagara
Journal:  Ann Thorac Surg       Date:  2018-11-17       Impact factor: 4.330

  5 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.