Document Detail


Hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis up to ten years.
MedLine Citation:
PMID:  17383332     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The Mosaic bioprosthesis (Medtronic, Minneapolis, MN) is a third-generation stented porcine bioprosthesis combining physiologic fixation and amino oleic acid antimineralization treatment to improve hemodynamic performance and durability. The findings of this single-center experience with this valve were evaluated to determine the clinical and hemodynamic performance. METHODS: Between February 1994 and October 1999, we enrolled 255 patients with aortic valve replacement (AVR) with a mean age of 67 years (range, 23 to 82 years) and 47 patients with mitral valve replacement (MVR) with a mean age of 67 years (range, 41 to 84 years) in this post-United States Food and Drug Administration approval prospective and nonrandomized clinical trial. Patients were followed-up, including serial echocardiographic assessment, within 30 days, at 6 months, and annually thereafter. The cumulative follow-up was 1540 patient-years for AVR (mean, 6.1 years; maximum, 10 years) and 250 patient-years for MVR (mean, 5.4 years, maximum; 10 years). RESULTS: Early mortality after AVR (<30 days) was 0.8%; late mortality per patient-year was 3.5%, including a valve-related/unexplained mortality of 1.1%. Early mortality after MVR (<30 days) was 0.0%; late mortality per patient-year was 2.8%, including a valve-related/unexplained mortality of 1.2%. Median postoperative gradient and effective orifice area for all valves after AVR were (early, n = 252; 5 years, n = 161; 9 years, n = 43) 13.7, 12.3, and 11.7 mm Hg and 1.9, 1.8, and 1.8 cm2 at early, 5 years, and 9 years, respectively. With MVR respective data were (early, n = 46; 5 years, n = 25; 7 years, n = 13) 4.6, 4.1, and 3.9 mm Hg and 1.8, 2.2, and 2.3 cm2. At 10 years, freedom from adverse events in the AVR group and MVR group was, respectively, thromboembolism, 86.6% +/- 6.6% and 86.3% +/- 9.8%; permanent neurologic event, 91.2% +/- 6.8% and 90.9% +/- 8.7%; valve thrombosis, 98.2% +/- 0.8% and 100%; structural valve deterioration, 87.1% +/- 6.7% and 100%. CONCLUSIONS: Our midterm results demonstrate clinical safety and good performance of the Mosaic bioprosthesis. Continued follow-up will determine if this new design will provide increased durability.
Authors:
Friedrich-Christian Riess; Ralf Bader; Eva Cramer; Lorenz Hansen; Bèr Kleijnen; Gunther Wahl; Jürgen Wallrath; Stephan Winkel; Niels Bleese
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article    
Journal Detail:
Title:  The Annals of thoracic surgery     Volume:  83     ISSN:  1552-6259     ISO Abbreviation:  Ann. Thorac. Surg.     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-03-26     Completed Date:  2007-04-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  15030100R     Medline TA:  Ann Thorac Surg     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  1310-8     Citation Subset:  AIM; IM    
Affiliation:
Albertinen Heart Center, Hamburg, Germany. friedrich-christian.riess@albertinen.de
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Animals
Aortic Valve / physiopathology,  surgery*
Bioprosthesis*
Cardiac Output / physiology
Echocardiography, Doppler
Female
Follow-Up Studies
Heart Valve Diseases / mortality*,  surgery*,  ultrasonography
Heart Valve Prosthesis Implantation / adverse effects,  methods*
Humans
Linear Models
Male
Middle Aged
Mitral Valve / physiopathology,  surgery*
Postoperative Care
Postoperative Complications
Probability
Prospective Studies
Prosthesis Design
Prosthesis Failure
Risk Assessment
Severity of Illness Index
Survival Rate
Swine
Treatment Outcome

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


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