WASHINGTON, January 21, 2011 — The Heart Rhythm Society (HRS) is aware of the ongoing Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants 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. 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 cardiac defibrillators (ICDs) are 99 percent effective in stopping life-threatening arrhythmias and are the most successful therapy to treat ventricular fibrillation, the major cause of sudden cardiac arrest. HRS advocates for evidence-based medicine and supports multicenter clinical trials to better define the safety and efficacy of cardiac devices, such as ICDs.
For decades, HRS has individually and collaboratively issued consensus statements and clinical documents outlining guidelines and best practices for clinicians, as well as supporting quality improvement initiatives, such as the National ICD Registry. The National ICD Registry includes data that spans over four years and is the largest repository for ICD implantation data. It is also a quality benchmarking tool to help clinicians and hospitals deliver high quality and appropriate care. The information collected in the Registry provides a rich source of data to evaluate trends in clinical practice and identify opportunities to advance adherence to evidence-based practice. HRS is dedicated to improving the care of patients by promoting research, education and optimal health care policies and standards.
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.