Purpose: To estimate the incidence of idarubicin (IDA)-related cardiomyopathy in acute myeloid leukemia (AML) and myelodysplasia (MDS). Patients end Methods: We analysed a group of 127 AML/MDS patients who received IDA-based induction and postremission or salvage therapy and achieved a complete remission (CR) that lasted greater than or equal to 12 weeks for the development of IDA-related congestive heart failure (CHF), CHF was defined as definite if a resting left ventricular ejection fraction (LVEF) of less than or equal to 45% measured by radionuclide ventriculogram (RV) accompanied the clinical diagnosis of CHF, which had to be made during or within 6 months of receiving IDA and for which no other cause was apparent; without RV confirmation, the diagnosis was considered probable. Patients who had RVs performed were evaluated for decreasing LVEF. Older age (greater than or equal to 70 years), prior/sequential anthracycline/mitoxantrone (anthraquinone) therapy, and cardiac disease/hypertension were evaluated as risk factors for the development of CHF. Results: One hundred fifteen patients were assessable (median age, 40 years; median dose, 96 mg/m(2)), Sixty-five had RVs performed during therapy; 43 had risk factors, The probability of IDA-related cardiomyopathy was 5% at a cumulative IDA dose of 150 to 290 mg/m(2), with 18 patients receiving doses greater than 150 mg/m(2). At a cumulative IDA dose of 150 mg/m(2), the probability of a mild or greeter asymptomatic decrease in LVEF (greater than or equal to 10% to a level less than or equal to 50%) was 18%, whereas the probability of a moderate or greater asymptomatic decrease in LVEF (greater than or equal to 15% to a level less than or equal to 45%) was 7%. No patient with asymptomatic LVEF decreases developed CHF, CHF was more frequent in patients with prior/sequential exposure to anthracyclines/mitoxantrone (P = .01). Conclusion: In this patient group, IDA-related cardiomyopathy was uncommon with cumulative IDA doses of up to 290 mg/m(2). Asymptomatic LVEF decreases were more frequent, but their predictive value for the development of CHF is unclear. (C) 1995 by American Society of Clinical Oncology.