Impact of the Implantable Defibrillator on Mortality: The Axiom of Overall Implantable Cardioverter-Defibrillator Survival

As soon as it was established that the implantable cardioverter-defibrillator (ICD) effectively prevents sudden death, it became axiomatic that whether the ICD will prolong overall survival depends entirely on the population of patients to which it is applied. This axiom of overall ICD survival immediately reveals the only vital question that remains regarding usage of the ICD; namely, How does one select those patients in whom prevention of sudden death by the ICD will also prolong life? This axiom also reveals the essential futility of randomized trials now being conducted for the purpose of discerning the true efficacy of the ICD. Claims to the scientific high ground notwithstanding, if a study asks the wrong question from the beginning, then the design of that study (including whether the study is randomized or nonrandomized), is completely irrelevant. Ideally, funds now being spent on these randomized trials should be diverted to the design and initiation of more appropriate trials, trials that will teach us to select patients for the ICD more effectively. At the very least, however, we should recognize the problems inherent in the ongoing trials, so that when their results are finally published (and are loudly touted by whichever faction feels vindicated by them), we will not be carried away into inappropriate clinical behavior. (Am J Cardiol 1996;78(suppl 5A):57–61)