Features October 2012 Issue

Study Shows ICD Advisories Not Linked to Higher Mortality Rates

Cleveland Clinic researchers find that patient age and heart health are the biggest factors determining outcomes.

Hearing that a safety advisory has been issued for your implantable cardioverter-defibrillator (ICD) could be a frightening piece of news. But a recent study by Cleveland Clinic researchers suggests that an advisory from the Food and Drug Administration (FDA) is not associated with a significantly higher mortality rate than what would otherwise be expected in a patient with such a device. In the study, published in a recent issue of HeartRhythm, the mortality rate of people who whose devices were never the subject of an advisory was 52 percent over a period of 5.5 years, while the mortality rates of those whose devices were subject to a Class I advisory by the FDA was 54.1 percent, and 43.6 percent in patients with devices that received Class II advisories. The FDA divides medical devices into three classes: Class I and II devices are generally considered lower-risk, while Class III devices are higher risk and/or first-of-a-kind items.

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