| Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. | |
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MedLine Citation:
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PMID: 18703359 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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INTRODUCTION: Percutaneous mitral repair with the MitraClip device ("clip") is currently being evaluated in a Phase II clinical trial (EVEREST II). This device was evaluated in an animal model prior to use in humans. MATERIALS AND METHODS: Twenty-one excised clips with accompanying leaflet tissue from pigs were examined at 4, 12, 17, 24, and 52 weeks. Sixteen specimens were available for hematoxylin and eosin and Movat pentachrome staining, and five were sent for scanning electron microscopy. The devices were examined grossly for tissue growth on flow and nonflow surfaces, thrombus, and vegetations. Microscopic evaluation focused on the presence of tissue growth around the device, the inflammatory response, and the presence of thrombus, infective endocarditis, and hematoma. RESULTS: Tissue growth on both flow and nonflow surfaces was seen in all specimens with variation of tissue thickness proportional to the duration of device implantation. Evidence of endothelialization, fibrous encapsulation, and organization of tissue between the aortic and mitral leaflets was observed. Adjacent chordae tendinae were incorporated into the healing tissue growth around the device as early as 4 weeks, in 33% of clips implanted for that time period, increasing to 67% of clips at 12 weeks, and 100% of clips at 17, 24, and 52 weeks. Two animals were diagnosed with infective endocarditis during life. CONCLUSIONS: Mechanical coaptation of the mitral leaflets in an animal model demonstrates adequate tissue response and healing with complete encapsulation of the device by 12 weeks and ongoing healing response proportional to duration of implantation. Infective endocarditis remains a potential complication in the animal model and for all implanted prosthetic devices. |
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Authors:
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Adriana Luk; Jagdish Butany; Eric Ahn; James I Fann; Fred St Goar; Troy Thornton; Liz McDermott; Chrysbe Madayag; Jan Komtebedde |
Publication Detail:
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Type: Journal Article Date: 2008-08-13 |
Journal Detail:
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Title: Cardiovascular pathology : the official journal of the Society for Cardiovascular Pathology Volume: 18 ISSN: 1879-1336 ISO Abbreviation: Cardiovasc. Pathol. Publication Date: 2009 Sep-Oct |
Date Detail:
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Created Date: 2009-09-07 Completed Date: 2009-11-17 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9212060 Medline TA: Cardiovasc Pathol Country: United States |
Other Details:
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Languages: eng Pagination: 279-85 Citation Subset: IM |
Affiliation:
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Department of Pathology, Toronto General Hospital, Toronto, Canada. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Animals Disease Models, Animal Heart Valve Prosthesis* / adverse effects Heart Valve Prosthesis Implantation / instrumentation* Mitral Valve Insufficiency / surgery* Swine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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