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The MADIT II and COMPANION studies: will they affect uptake of device treatment?
  1. J M Morgan
  1. Correspondence to:
    Dr John M Morgan
    Wessex Cardiothoracic Centre, Southampton University Hospitals, Tremona Road, Southampton SO16 6YD, UK; jmmcardiology.co.uk

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Primary prophylaxis of sudden cardiac death by implantable cardioverter-defibrillator (ICD) treatment will greatly increase ICD implant numbers. This will have major cost and infrastructure consequences. Those studies that have demonstrated the clinical need have been industry driven. Whether their conclusions should now expand ICD indications is debated, but it would be perverse to suggest that hesitancy in ICD treatment expansion relates to reservation about the clinical science rather than to concern about cost and resource implications

It is accepted that sudden cardiac death, often caused by ventricular arrhythmia, is a major cause of western population mortality.1–,2 Immediate defibrillation is the only remedy for arrhythmic sudden death caused by haemodynamically compromising ventricular tachycardia and ventricular fibrillation,3 although pace termination of ventricular tachycardia may prevent the arrhythmic cascade to ventricular fibrillation.4–,6 Immediate defibrillation shock treatment delivery by the implantable cardioverter-defibrillator (ICD) is highly efficacious in preventing sudden cardiac death.7,8 Though the ICD has been in clinical use for 23 years,9 indications for its use have broadened in the 1990s as clinical acceptability of ICD treatment has increased (with the advent of small devices capable of pectoral implantation, using per venous defibrillation leads).10,11

IMPLANTATION GUIDELINES

Implantation guidelines based on outcomes of well designed studies have become widely accepted.12,13 These have mainly defined implantation practice in patients who have already suffered ventricular arrhythmia from which they have been rescued—that is, “secondary prevention” of sudden cardiac death. However, the burden of sudden cardiac death mortality rests with those patients who die at the time that they suffer their first ventricular arrhythmia.14 Thus the greater challenge has been identification and treatment of these patients before their arrhythmic catastrophe.

Studies of risk factors for sudden cardiac death have allowed risk stratification of such patients …

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