Developments in Cardiovascular Medicine

primary goal of all forms of therapy is not just prolonging life, but improving the quality of life, has forced analysis of what constitutes quality of life, a concept whose structure pervades all walks of life and eludes definition. Global well being, happiness, morale, vitality, fullness of social life, and satisfaction must be integrated and assessed for the effects of the disease and the therapy, in the context of specific personality traits, attitudes to life, family situation, and socio-economic and political freedom. A growing inter est in research on this subject has led to a clearer understanding of the components which come to determine quality of a patient's life, and how they can be measured in a reproducible manner so that valid comparisons can be made. Keeping these recommendations of analysing quality of life within the context of patients who have undergone open heart surgery, it seemed appro priate to me to separate the influence of various forms of open heart surgery into five aspects of life which can comprehensively reflect the quality of life outcome of the operation. These five 'components' are (1) Physiological state, which summarises the traditionally reported incidence of operative mortality and morbidity, objectively and subjectively measured physical ca pacity, and the residual symptoms, treatment and long-term survival. (2) Intellectual functioning relates to the psychoneurolgocial deficit in memory, reasoning or judgement because of cerebral microembolism and hypo perfusion during cardiopulmonary bypass.

With the beginning of the 1980's it was becoming increasingly evident that the lack of approval of new cardiovascular agents for use by clinicians in the United States for the treatment of cardiovascular disorders was becoming a problem. Patients requiring medical therapy for hypertension, angina pectoris, arrhythmias, congestive heart failure, and vasospastic disorders of the coronary arteries could receive in the United States only a small number of the drugs available to physicians in the rest of the world. In fact, as the 1980's began, there was only one available beta blocking agent released by The Food and Drug Administration; and even as of this writing, no oral calcium antagonist agent. This lag, in part, has been due to the confusion of proper and expeditious methods to define safety and efficacy of such agents so that the United States regulatory agency (Food and Drug Administration) could approve the use of such agents by clinicians. The vast number of new beta blocker and calcium antagonist agents being developed, as well as the long-term use abroad of many new drugs, has raised important questions as to how relative safety and efficacy of such agents can be determined to facilitate availability in the United States.