| Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years. | |
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MedLine Citation:
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PMID: 19695889 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and alpha-amino oleic acid (AOA) antimineralisation treatment to improve haemodynamic performance and durability. This single-centre study reports the clinical results, including haemodynamic performance, of the Mosaic bioprosthesis after implant in aortic or mitral position. METHODS: Between February 1994 and October 1999, 255 patients with aortic valve replacement (AVR; mean age: 67 years, range: 23-82 years) and 47 patients with mitral valve replacement (MVR; mean age: 67 years, range: 41-84 years) were enrolled in this prospective non-randomised clinical trial. Follow-up visits were performed 30 days and 6 months after implant and annually thereafter. The cumulative follow-up was 1976.2 patient-years (pt-yrs) after AVR (median: 8.3 years, maximum: 14.0 years) and 336.9 pt-yrs after mitral valve replacement (MVR) (median: 8.2 years, maximum: 13.3 years). RESULTS: After AVR, mean systolic gradient and effective orifice area at 4, 8 and 13 years follow-up were 13.3+/-5.6, 15.5+/-7.7 and 16.0+/-7.2 mmHg and 1.8+/-0.5, 1.8+/-0.5 and 1.7+/-0.4 cm(2). After MVR, respective data were 4.7+/-2.1, 4.3+/-1.2 and 5.0 mmHg (only one recording) and 2.2+/-0.7, 2.3+/-0.6 and 1.8 cm(2). Transvalvular regurgitation at 13-year follow-up was mild or less in both the AVR and MVR patients. Thirteen-year survival was 63.1+/-4.5% in the AVR group and 51.2+/-13.6% in the MVR group. Early mortality after AVR and MVR was 1.2% and 0.0%, respectively; late mortality was 3.2%pt-yr(-1) and 3.3%pt-yr(-1), including a valve-related/unexplained mortality of 1.1%pt-yr(-1) and 0.9%pt-yr(-1). Freedom from adverse events in the AVR and MVR group was permanent neurological event: 97.4+/-1.2% and 96.0+/-3.9%; valvular thrombosis: 97.8+/-1.1% and 100%; structural valve deterioration: 84.8+/-7.8% and 93.8+/-6.1%; explant: 73.3+/-7.3% and 89.3+/-6.5%. CONCLUSIONS: The Mosaic bioprosthesis demonstrates excellent clinical performance and safety after 13 years of follow-up. Continued follow-up will determine whether this new design will provide increased durability. |
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Authors:
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Friedrich-Christian Riess; Eva Cramer; Lorenz Hansen; Sandra Schiffelers; Gunther Wahl; Jürgen Wallrath; Stephan Winkel; Peter Kremer |
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Publication Detail:
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Type: Evaluation Studies; Journal Article Date: 2009-08-19 |
Journal Detail:
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Title: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery Volume: 37 ISSN: 1873-734X ISO Abbreviation: Eur J Cardiothorac Surg Publication Date: 2010 Jan |
Date Detail:
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Created Date: 2010-02-03 Completed Date: 2011-01-11 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8804069 Medline TA: Eur J Cardiothorac Surg Country: Germany |
Other Details:
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Languages: eng Pagination: 145-53 Citation Subset: IM |
Copyright Information:
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Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved. |
Affiliation:
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Albertinen Heart Center, Department of Cardiac Surgery, Hamburg, Germany. Friedrich-Christian.Riess@albertinen.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Anticoagulants / therapeutic use Aortic Valve / surgery*, ultrasonography Bioprosthesis* Epidemiologic Methods Female Heart Valve Diseases / surgery* Heart Valve Prosthesis* / adverse effects Heart Valve Prosthesis Implantation / methods Humans Male Middle Aged Mitral Valve / surgery*, ultrasonography Postoperative Care / methods Prosthesis Design Prosthesis Failure Treatment Outcome Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Anticoagulants |
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