Criteria that led to exclusion from the ICD efficacy trials and hence constitute markers of off-label use included patients undergoing simultaneous percutaneous coronary intervention or coronary artery bypass surgery, and patients with a recent acute MI, renal failure, liver failure, neurologic failure, solid tumor, or dementia, as well as patients on dialysis, and patients aged 75 or older or aged 19 or younger.
Dr. Kato and his associates on the study said that they had no disclosures.