Clinical Studies of Prosthetic Heart Valves Using Historical Controls

  • Gary L. Grunkemeier

Abstract

Beginning in 1960, replacement of diseased heart valves has dramatically lowered the death rate and improved the functional class of patients compared with the natural history of heart valve disease. Experience has proven that acceptable replacement devices for diseased heart valves can be produced and evaluated clinically in single-arm studies, without using randomized or other concurrent controls. The elements of this successful development have been thoughtful design and engineering, carefully controlled manufacturing specifications, thorough laboratory pulse-duplicator and wear testing, animal implantation, and limited initial clinical use with thorough and complete hemodynamic and clinical follow-up.

Keywords

Heart Valve Guidance Document Prosthetic Heart Valve Ball Valve Diseased Heart Valve 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Gary L. Grunkemeier

There are no affiliations available

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