Derivation of a defibrillator implant criterion based on probability of successful defibrillation

Common criteria for implant of a cardioverter defibrillator include verification of a 2:1 energy safety margin or a fixed safety margin of 10 joules. These criteria have been established empirically. We present a statistical model based on defibrillation efficacy curves which may be used to establish a criterion which would meet a predetermined target. As an example, an implant criterion is derived based on a goal of 1-year sudden cardiac death survival of at least 99% by selecting an expected first-shock efficacy to meet that target. Logistic regression was performed on data from over 1,500 defibrillator implants including successful epicardial and transvenous electrode system implants as well as data from unsuccessful implants. A random sample from these curves was used to generate a representative sample of 1,000 potential implant candidates. By assuming successful defibrillation using a series of shocks at specified energies, i.e., choosing an implant criterion, the probability of successful defibrillation of the patient by a single shock at a predetermined maximum output can be established. Independent data are used to validate the model's accuracy in predicting defibrillation efficacy within the derived example.