Implantable Defibrillator Use Subject of DOJ Probe

The use of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">implantable heart defibrillators is being investigated by the U.S. Department of Justice. The Heart Rhythm Society, the leading professional group for doctors who implant defibrillators, said Friday it is cooperating with the federal probe.

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.

As we reported previously, 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. For the study, the researchers examined a registry of implants maintained by the American College of Cardiology that covers an estimated 95 percent of all U.S. implants.

The risk of in-hospital death was significantly higher in patients who received a non-evidence-based device than in patients who received an evidence-based device (0.57 percent vs. 0.18 percent). The risk of any post-procedure complication was significantly higher in the non-evidence-based ICD group at 3.23 percent compared with 2.41 percent in the evidence-based group.

Any adverse event and death were significantly higher in patients who received a non-evidence-based device, according to the study. The median (midpoint) length of hospital stay was significantly longer for patients who received a non-evidence-based ICD compared with patients who received an evidence-based ICD (3 days vs. 1 day).

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

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.”

According to a report in The Wall Street Journal, the defibrillator market could slow if device-implanting electrophysiologists try to hew more closely to guidelines, or are concerned about scrutiny from the Justice Department.

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