The Long-Term Clinical Assessment of Heart Valve Substitutes

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Abstract
This paper describes the organization and routine management of the UK Multicentre Valve Trial. Details are given of the present data bank comprising information on 9859 artificial valve implants collected from 44 surgeons in 22 centres. The paper discusses various analyses of the long term performances of different valves. The validity of these analyses and this approach to valve performance assessment is discussed with reference to: (i) the limitations of the present statistical techniques, (ii) the inherent variability of data arising from differences in patient/prosthesis selection and surgical techniques amongst the various participating centres, and (iii) a new approach for the estimation of the failure rates of valve implants taking such inherent variability of the data into consideration.

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