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Pathological healing response of explanted MitraClip devices.

Publication ,  Journal Article
Ladich, E; Michaels, MB; Jones, RM; McDermott, E; Coleman, L; Komtebedde, J; Glower, D; Argenziano, M; Feldman, T; Nakano, M; Virmani, R ...
Published in: Circulation
April 5, 2011

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.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

April 5, 2011

Volume

123

Issue

13

Start / End Page

1418 / 1427

Location

United States

Related Subject Headings

  • Wound Healing
  • Surgical Instruments
  • Mitral Valve Insufficiency
  • Mitral Valve
  • Middle Aged
  • Male
  • Humans
  • Heart Valve Prosthesis Implantation
  • Female
  • Cardiovascular System & Hematology
 

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Ladich, E., Michaels, M. B., Jones, R. M., McDermott, E., Coleman, L., Komtebedde, J., … Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators, . (2011). Pathological healing response of explanted MitraClip devices. Circulation, 123(13), 1418–1427. https://doi.org/10.1161/CIRCULATIONAHA.110.978130
Ladich, Elena, Mary Beth Michaels, Russell M. Jones, Elizabeth McDermott, Leslie Coleman, Jan Komtebedde, Donald Glower, et al. “Pathological healing response of explanted MitraClip devices.Circulation 123, no. 13 (April 5, 2011): 1418–27. https://doi.org/10.1161/CIRCULATIONAHA.110.978130.
Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, et al. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418–27.
Ladich, Elena, et al. “Pathological healing response of explanted MitraClip devices.Circulation, vol. 123, no. 13, Apr. 2011, pp. 1418–27. Pubmed, doi:10.1161/CIRCULATIONAHA.110.978130.
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. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418–1427.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

April 5, 2011

Volume

123

Issue

13

Start / End Page

1418 / 1427

Location

United States

Related Subject Headings

  • Wound Healing
  • Surgical Instruments
  • Mitral Valve Insufficiency
  • Mitral Valve
  • Middle Aged
  • Male
  • Humans
  • Heart Valve Prosthesis Implantation
  • Female
  • Cardiovascular System & Hematology