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Use of Human Perivascular Stem Cells for Bone Regeneration
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Pathological healing response of explanted MitraClip devices
Elena Ladich1, Mary Beth Michaels, Russell M Jones
1Medical Director/President, CVPath Institute, Inc, 19 Firstfield Rd, Gaithersburg, MD 20878, USA. rvirmani@cvpath.org
Circulation
|March 23, 2011
Summary
The MitraClip device shows excellent mechanical integrity and develops a stable fibrous encapsulation over time. This healing process, observed in human studies, involves tissue bridging and contributes to structural stability.
Area of Science:
- Cardiovascular research
- Medical device technology
- Histopathology
Background:
- The Endovascular Valve Edge-to-Edge Repair Study (EVEREST) evaluates the MitraClip device.
- Human healing response after MitraClip implantation was previously uncharacterized.
Purpose of the Study:
- To characterize the human healing response after MitraClip device implantation.
- To assess the long-term histological integration of the MitraClip device.
Main Methods:
- Histological evaluation of 67 explanted MitraClip devices from 50 patients.
- Analysis of explants across four implantation intervals: acute, subacute, chronic, and long-term.
Main Results:
- Acute response: platelet/fibrin deposition. Subacute response: granulation tissue and early pannus formation.
- Chronic response: tissue bridging between device arms. Long-term response: collagen-rich matrix with complete fibrous encapsulation.
- No evidence of endocarditis, mechanical wear, fracture, or corrosion observed in explanted devices.
Conclusions:
- MitraClip device mechanical integrity is maintained up to explantation.
- Four distinct phases of physiological healing observed: deposition, inflammation, granulation, and encapsulation.
- Long-term fibrous encapsulation and tissue bridging enhance structural stability and leaflet continuity.
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