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Feds Investigate Use of Implantable Heart Devices

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The U.S. Justice Department is looking into the use – or overuse – of implantable heart defibrillators. In a statement issued Friday, the Heart Rhythm Society said it was aware of the ongoing federal investigation “and has agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making.”

“HRS is reviewing information that does not include either identifiable patient or facility level data,” the group said. “Rather, we are providing insight on the field of electrophysiology to the DOJ. Because this is an ongoing investigation, HRS is not available for further comment.”

Implantable defibrillators administer an electrical shock to a heart that is beating erratically to jolt it back into a normal rhythm. Practice guidelines do not recommend use of such defibrillators for primary prevention in patients recovering from a heart attack or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure.

In a study published earlier this month in the Journal of the American Medical Association (JAMA) found that about 20 percent of patients receiving implantable defibrillators don’t meet evidence-based guidelines for their use. What’s more, those patients had a significantly higher risk of in-hospital death than individuals who met criteria for receiving an implantable defibrillator.

It is not clear if the Justice Department probe was prompted by the JAMA study.

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