The effect of DICOM on QCA and clinical trials.

Almost without any exemption, new cardiac catheterization laboratories are entirely digital without 35 mm cinefilm as the storage medium. In addition, existing laboratories are increasingly converting to the digital world. Aside from the organizational aspects, this has significant implications for the daily diagnostic review process of the procedures, and for the quantitative analysis of selected frames by QCA. The DICOM standard has now been well accepted in the catheterization laboratories. In stead of mechanical cine projectors, a department must decide on so-called DICOM-Viewers or 'digital Tagarno's'. In this paper the effects of DICOM on image quality and therefore on the visual interpretation of these images, as well as on QCA are discussed. Since the digital images can be enhanced, these look sharper than the conventional cinefilm images. However, edge enhancement has an effect on QCA, reason why the digital data must be stored in raw format. With the enormous amounts of digital data produced in a catheterization laboratory, image compression is of great importance. Currently, an international study is being carried out to determine which compression level is still acceptable from a visual interpretation and QCA point of view. Finally, the implications of the digital era on clinical trials are discussed. One of the important conclusions is that one should be encouraged not to switch from cinefilm to digital in the course of a trial, while a mixed population from the beginning is no problem, as long as the proper statistical calculations are carried out. In conclusion, despite the fact that there are still a number of items to be checked and possibly modified in the standard, the existing DICOM standard has succeeded in bringing widespread utilization of QCA in cardiac angiography closer than ever.