QUALITY ASSURANCE IN PTCA

The special need for quality assurance in PTCA results from increasing numbers of procedures, which are due to the prevalence of disease, high primary success rates, progressive simplicity of the basic procedure, but guaranteed financing in Germany. Quality assurance programs first have to take into account the procedural quality, which includes preparation, performance, result, and also overall appropriateness (the indication) of PTCA, and secondly, the structural quality, including personnel, organization, cardiac laboratory facilities and technical equipment. In spite of numerous publications addressing special issues relating to PTCA, these items have been largely neglected in research, and it is uncertain which parameters and methods are meaningful for the improvement of clinical quality and effectiveness. Two examples for general and for internal quality control are demonstrated. In a first extensive quality assurance project of the ALKK study group, all PTCA procedures of a complete group of hospitals are prospectively registered on an intention-to-treat basis, data are controlled by visiting monitors, and appropriateness is examined in a representative sample of procedures by evaluating complete patient files. As an example for an internal quality control system a software program (CLAIM, cardiac laboratory angiography investigation management) is presented. The program yields clinical data but also investigator-related parameters such as fluoroscopy time, investigation time, contrast use, balloon consumption, etc. Such studies by themselves should improve quality awareness and the acquired data may serve as a basis for the continuous definition and control of generally accepted standards. At present, methods for a comprehensive quality assessment and improvement are still in their infancy.