RICHMOND, Va. -- When the FDA issues an advisory or recall on an implanted cardioverter-defibrillator (ICD) or pacemaker, physicians must decide whether to replace it immediately or monitor it closely until the scheduled replacement time.
RICHMOND, Va., July 26 -- When the FDA issues an advisory or recall on an implanted cardioverter-defibrillator (ICD) or pacemaker, physicians must decide whether to replace it immediately or monitor it closely until the scheduled replacement time.
In most cases, the less risky option is monitoring, according to a decision-making model created by Kenneth A. Ellenbogen, M.D., of the Medical College of Virginia here, and colleagues.
But when both the reported device failure rate and the risk of death from device failure are high, replacement often becomes the safer choice, according to recommendations from Dr. Ellenbogen and colleagues appearing in the July 26 issue of the Journal of the American Medical Association.
"An increasing number of device recalls and advisories has led to heightened awareness of device failure," the authors said. For example, in 2005 the FDA issued advisories affecting more than 200,000 devices, they said.
They cited a 2006 survey by the European Heart Rhythm Association showing the lack of consensus about optimal clinical management in situations involving recalled devices. In the survey "physicians were replacing more than 30% of the devices under advisory, although the percentage varied widely from 0% to 100% among individual physicians."
Earlier this year, the Heart Rhythm Society called for independent watchdog committees to monitor both the manufacturing and regulation of pacemakers and implantable cardioverter-defibrillators.
Using published data on device failure rates, mortality rates from replacement procedures, mortality rates due to device failure, and other factors, the JAMA authors constructed a computer-based decision making model to help guide physicians to the best choice in a variety of situations.
"Recognizing that the decision to replace a device will be made on a case-by-case basis, this analysis provides a framework for rational discussions with and risk stratification for individual patients," the JAMA authors said.
The analysis takes physicians through some likely scenarios:
Mortality rates from the replacement procedure ranged from .003% to .005% across all scenarios.
"The clinical situations favoring device replacement are likely more limited than most physicians estimate, and indiscriminate device replacement may result in more deaths than lives saved," the authors said.
However, "our model did not estimate the psychological burden resulting from the knowledge that a device may fail," they added. "This is likely to be a factor in many cases, and more studies are needed to appropriately quantify this impact."
Dr. Ellenbogen participate in device-related clinical research supported by grants from Medtronic, Guidant, St. Jude, and Cameron Health. Dr Ellenbogen reported having received honoraria from Medtronic, Guidant, St. Jude, and Sorin Biomedica. None of the outside companies that are mentioned were in any way involved with this work, he reported.