The story of the implantable cardioverter-defibrillator (ICD) as an effective tool for reducing sudden death and improving survival in appropriately selected patients has never been simple and since the pioneering era of Michel Mirowski 1 has always been the subject of debate and controversy. In the last 15 years, randomized clinical trials and, as a consequence, evidence-based international guidelines have extended the clinical application of ICDs to increasingly broad patient populations, not only in the setting of secondary prevention of sudden cardiac death, but also in the setting of primary sudden cardiac death prevention (i.e. for patients who are identified as being at risk of life-threatening ventricular tachyarrhythmias, despite no previous history of these events). 2,3 However, primary prevention is a particularly challenging area, as many years may pass before the benefits of the intervention can be perceived within the targeted population, and the financial burden of widespread implementation of such indications may constitute an important limitation in some economic settings. 3,4 Recently, the results of the DANISH trial, 5 focused on ICD implant for primary prevention in patients with non-ischaemic cardiomyopathy, appear to increase the uncertainty on the role of ICD for extending survival and stimulated a new debate on ICD benefit.
Implantable cardioverterdefibrillators in the setting of ischaemic and non-ischaemic cardiomyopathiesThe benefits of ICDs implanted for primary prevention of sudden death in patients with left ventricular dysfunction were with previous myocardial infarction (MADIT I, MUSTT, MADIT II trials), 3 and were then extended to patients with left ventricular dysfunction and heart failure [New York Heart Association (NYHA) classes II and III] of either ischaemic or non-ischaemic aetiology on the basis of the results of the SCD-HeFT trial. 2,6 In all these studies, the primary endpoint was all-cause mortality and this appears absolutely justified as no doubts can arise from using a hard endpoint that is independent of definitions and not affected by the availability or non-availability of specific data related to the terminal event.Moreover, the assumption that prevention of arrhythmic death translates in reduction in all-cause mortality is not always true, as demonstrated in the two trials that evaluated the ICD in the setting of a recent myocardial infarction (IRIS and DINAMIT). 7,8 Both in IRIS and DINAMIT the reduction in sudden death in ICD patients was completely offset by increased non-arrhythmic deaths, thus resulting in no impact on all-cause mortality. 7,8 Between 2002 and, in the phase of validation of ICD therapy for primary prevention of sudden cardiac death with randomized controlled trials (RCTs), the setting of non-ischaemic cardiomyopathy was not prioritized in comparison with the setting of ischaemic heart disease. Indeed, CAT and AMIOVIRT were studies with a small sample size (<120 patients in each study) and were underpowered to demonstrate a mortality benefit...