DoJ launches probe into ICD practices; HRS to assist
The Heart Rhythm Society (HRS) has agreed to assist the Department of Justice (DoJ) in its ongoing civil investigation of implantable cardioverter-defibrillator (ICD) implant practices, according to an announcement Jan. 21 by the HRS.
HRS will act in an advisory role "to lend expertise concerning proper guidelines for clinical decision making."
The society said it is reviewing information that does not include either identifiable patient or facility level data and is "providing insight on the field of electrophysiology to the DOJ."
Earlier this month, a report in the Journal of the American Medical Association found that more than 20 percent of patients who received ICDs did not meet evidence-based guidelines for the devices, putting them at a higher risk of in-hospital death. Al-Khatib et al had reviewed the American College of Cardiology's National Cardiovascular Data Registry-ICD Registry to gather their data.
It's unlikely, though, the two are related, given the time it takes for the government to mount an investigation.
Comments around the blogosphere suggest electrophysiologists might be hesitant to provide appropriate care if it means deviating from evidence-based guidelines.
In its statement, the society said, "HRS upholds the highest ethical and patient standards for the field of electrophysiology. We strive to support clinicians provide quality patient care and further demonstrate that commitment by acting as advisors in the investigation."
HRS will act in an advisory role "to lend expertise concerning proper guidelines for clinical decision making."
The society said it is reviewing information that does not include either identifiable patient or facility level data and is "providing insight on the field of electrophysiology to the DOJ."
Earlier this month, a report in the Journal of the American Medical Association found that more than 20 percent of patients who received ICDs did not meet evidence-based guidelines for the devices, putting them at a higher risk of in-hospital death. Al-Khatib et al had reviewed the American College of Cardiology's National Cardiovascular Data Registry-ICD Registry to gather their data.
It's unlikely, though, the two are related, given the time it takes for the government to mount an investigation.
Comments around the blogosphere suggest electrophysiologists might be hesitant to provide appropriate care if it means deviating from evidence-based guidelines.
In its statement, the society said, "HRS upholds the highest ethical and patient standards for the field of electrophysiology. We strive to support clinicians provide quality patient care and further demonstrate that commitment by acting as advisors in the investigation."