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Pathological healing response of explanted MitraClip devices.

Abstract：

BACKGROUND:The safety and effectiveness of the MitraClip device (Abbott Vascular, Menlo Park, CA) is being evaluated in the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) clinical studies. The healing response after device implantation has not previously been characterized in humans. METHODS AND RESULTS:A total of 67 explanted devices (implantation duration, 1 to 1878 days) from 50 patients were submitted for histological evaluation. Explants were analyzed in 4 implantation intervals: acute (≤30 days; n=7), subacute (31 to 90 days; n=23), chronic (91 to 300 days; n=18), and long term (>300 days; n=19). The acute healing response consisted of platelet/fibrin deposition. The subacute response exhibited granulation tissue with early fibrous encapsulation (pannus). The chronic response was characterized by various degrees of tissue bridging between the device arms. The long-term healing response demonstrated collagen-rich matrix (by type I collagen), incorporating the device components with complete encapsulation by organized, fibrous growth. In long-term devices with minimal surgical disruption, a fibrous tissue bridge (mean area, 7.39±4.3 mm(2)) was observed over and between the device arms, resulting in atrial tissue continuity between the 2 valve leaflets. Devices demonstrated no evidence of endocarditis, mechanical wear, component fracture, or corrosion up to the time of explantation (median, 119 days; first and third quartiles, 42 and 365 days). CONCLUSIONS:In all patients, device mechanical integrity was maintained up to the time of explantation. Four phases of physiological healing were observed: platelet and fibrin deposition, inflammation, granulation tissue, and finally, fibrous encapsulation. Long-term device fibrous encapsulation with extension over adjacent mitral leaflets and tissue bridge formation adds structural stability. Clinical Trial Registration- URL: http://clinicaltrials.gov/show/NCT00209274. Unique identifiers: NCT00209339 and NCT00209274.

journal_name

Circulation

journal_title

Circulation

authors

Ladich E,Michaels MB,Jones RM,McDermott E,Coleman L,Komtebedde J,Glower D,Argenziano M,Feldman T,Nakano M,Virmani R,Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators.

doi

10.1161/CIRCULATIONAHA.110.978130

subject

Has Abstract

pub_date

2011-04-05 00:00:00

pages

1418-27

issue

eissn

0009-7322

issn

1524-4539

pii

CIRCULATIONAHA.110.978130

journal_volume

123

pub_type

杂志文章,随机对照试验

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Pathological healing response of explanted MitraClip devices.