Document Detail


A randomized comparison of the MCRI On-X and CarboMedics Top Hat bileaflet mechanical replacement aortic valves: early postoperative hemodynamic function and clinical events.
MedLine Citation:
PMID:  16153925     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: This study compared hemodynamic function and clinical events in consecutive patients randomly assigned to receive a wholly supra-annular replacement valve or a valve with an intra-annular component. METHODS: Fifty-two patients with an average age of 62 years (range 40-74 years) were sized for both a CarboMedics Top Hat valve (CarboMedics Inc, Austin, Tex) and an MCRI On-X valve (Medical Carbon Research Institute, LLC, Austin, Tex) before random assignment to receive either valve type. Echocardiographic and clinical assessments were performed in the immediate postoperative period and at 1 year. RESULTS: The mean effective orifice areas were 1.41 +/- 0.42 cm2 for the Top Hat and 2.17 +/- 0.78 cm2 for the On-X (P < .0001). The mean pressure differences were 12.2 +/- 4.4 mm Hg and 6.9 +/- 3.6 mm Hg, respectively (P < .0001). New York Heart Association functional class was better with the On-X than the Top Hat valves, but there were no differences in clinical events, regression of left ventricular mass, or measures of hemolysis. CONCLUSION: The partially intra-annular MCRI On-X valve was hemodynamically superior to the wholly supra-annular CarboMedics Top Hat valve. However, there were no differences in early clinical outcomes between the two valve types.
Authors:
J Chambers; J Roxburgh; C Blauth; J O'Riordan; F Hodson; H Rimington
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of thoracic and cardiovascular surgery     Volume:  130     ISSN:  0022-5223     ISO Abbreviation:  J. Thorac. Cardiovasc. Surg.     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-09-12     Completed Date:  2005-11-03     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0376343     Medline TA:  J Thorac Cardiovasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  759-64     Citation Subset:  AIM; IM    
Affiliation:
Valve Study Group, Guy's and St Thomas Hospitals, London, United Kingdom. jboydchambers@aol.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aortic Valve / surgery*
Aortic Valve Insufficiency / physiopathology,  surgery
Aortic Valve Stenosis / physiopathology,  surgery
Cholesterol, LDL / blood
Echocardiography
Female
Follow-Up Studies
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation* / mortality
Hemodynamics
Humans
Male
Middle Aged
Postoperative Complications
Prosthesis Design
Chemical
Reg. No./Substance:
0/Cholesterol, LDL

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


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