Why the study?
Does routine implantation of artificial implantable defibrillator cardioverter devices reduce mortality in patients aged 75 years and older with prior myocardial infarction and left ventricular ejection fraction <=30%?
Does routine implantation of artificial implantable defibrillator cardioverter devices reduce mortality in patients aged 75 years and older with prior myocardial infarction and left ventricular ejection fraction <=30%?
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Caution is warranted before routinely implanting ICDs in elderly patients (>=75 years) with prior MI and LVEF <=30%, as the pivotal trial populations were significantly younger and predominantly male.
The Multicenter Automatic Defibrillator Implantation Trial (MADIT II) investigators assert that their results justify the placement of artificial implantable defibrillator cardioverter devices in patients aged 75 years and older with prior myocardial infarction and left ventricular dysfunction (ejection fraction of 30 or less). The authors claim that the results of the trial do not justify this conclusion. The majority of patients were male (84%) and aged 64+/-10 years. Also, 2.8% of patients assigned to the defibrillator group and 1.5% had their device removed. Of the latter subgroup, nine patients (1.3%) received a heart transplant. Twelve had their artificial implantable defibrillator cardioverter device deactivated mostly because of terminal illness. Although the study results show a significant reduction in mortality over the control group (absolute reduction=5.6%), almost the same percentage required hospitalization because of manifestation of congestive heart failure (absolute value 5%; p=0.09). Also, 1.8% had lead problems, 0.7% had infections, and the benefits were only seen after the first year. Caution is needed before the results of this study are applied to a much older cohort comprised mainly of women in whom heart transplant is contraindicated and who have multiple health problems, including cognitive impairment. Artificial implantable cardioverter/defibrillator devices are expensive and this study's results need to be duplicated in other comparable cohorts.
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Lofty L. Basta (2003) studied this question.
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