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J Thorac Cardiovasc Surg 2001;121:428-430
© 2001 The American Association for Thoracic Surgery

Editorials

Calcification of bioprosthetic heart valves and its assessment

From Medtronic Heart Valves, Santa Ana, Calif.

Received for publication Dec 6, 2000. Accepted for publication Dec 12, 2000. Address for reprints: Jeffrey M. Gross, PhD, Medtronic Heart Valves, 1851 East Deere Ave, Santa Ana, CA 92705 (E-mail: grossj1@medtronic.com).

For related article, see p. 500.

Be not the first by whom the new are tried,
Nor yet the last to lay the old aside.
—Alexander Pope, An Essay on Criticism

This quotation befits the surgical community as it collectively ponders how much technology to embrace with respect to current and future bioprosthetic heart valve designs. It can be argued that current regulatory guidance document governing development of these prostheses adequately safeguards against the potential for catastrophic structural failures decoupled from biologic influence, for example, stent fracture and tissue dehiscence. The current state of preclinical assessment for the "biologic degradation" of the valvular components is not as predictive given the inherent variability and complexity of the human biologic system into which these devices are implanted. Granted, preclinical evaluation in a variety of animal models is used to access a valve design's functionality and resistance to calcification; however, it is often difficult to extrapolate such data to the long-term human experience.

The intent of this editorial is to provide a broad overview of what is thought to be the mechanisms of calcification in bioprosthetic heart valves, list the current fixation processes in the literature, and examine how prostheses are evaluated for their antimineralization efficacy. Above all, it is my hope that this editorial will spur thought and challenge industrial, clinical, and academic scientists to seek better techniques for the evaluation of new tissue fixation processes.

Glutaraldehyde-fixed heart valves were first implanted in 1967 after it was determined that glutaraldehyde stabilized collagenous biomaterials. ^1,2 Although valves thus treated were nonthrombogenic, they failed because of calcific degeneration. ^3,4 Much has been written yet little has been proven as to the mechanisms for this calcification. It has been postulated that calcium phosphate crystals containing sodium, magnesium, and carbonate nucleate due to devitalization of the cells . . . [Full Text of this Article]

Related Article

Dynamic in vitro calcification of bioprosthetic porcine valves: Evidence of apatite crystallization

Elena Pettenazzo, Michael Deiwick, Gaetano Thiene, Gianmario Molin, Birgit Glasmacher, Fedora Martignago, Tomaso Bottio, Helmut Reul, and Marialuisa Valente
J. Thorac. Cardiovasc. Surg. 2001 121: 500-509. [Abstract] [Full Text] [PDF]

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