Valve data collection: problems and pitfalls.

Since 1981, the Department of Medical Physics and Clinical Engineering at the University of Sheffield has been responsible for the organization, management and data collection associated with the largest multicentre heart valve implant patient follow-up study in the Western world. At the present time, the database comprises information on over 16,000 valve implants, which have been provided by 57 surgeons working at 22 centres in the UK. All this data is available for in-depth statistical analysis. Over 30 individual valve models presently are included in the Study and these can be categorized into five main types: ball, disc, porcine, pericardial and homograft. Analysis includes descriptive statistics as well as valuable information on the various performances of the different valves. Survival and event-free survival graphs are obtained by actuarial methods and individual valve types can be studied in depth in terms of freedom from thromboembolic complications and valve dysfunction. Whilst this approach provides interesting and valuable survival data, it does not take account of the wide variation in prognostic factors which occur within large groups of patients. This latter problem can be addressed by the use of proportional hazards analysis and this paper provides details of this approach and typical results obtained from the use of this method. These include the comparative performances of the major types of valves currently in use in terms of the event-free survival of the patients.