New guidelines will help physicians decide the best option for each patient when an advisory or recall is issued for a pacemaker or implantable cardioverter-defibrillator, according to an article in the July 26 issue of the Journal of the American Medical Association.

“There is limited information to direct patient management after an implantable device has been subject to an FDA advisory,” said Kenneth Ellenbogen, MD, senior author of the study. “These guidelines can give physicians a better understanding of the risks and benefits of device replacement compared to continued clinical follow-up.”

In the analysis, the American researchers, led by Mitesh S. Amin, MD, considered potential outcomes in deciding whether to immediately replace a device under advisory or to continue follow-up without replacement.

In determining the best management approach, the researchers constructed a decision analysis model to evaluate the risks and benefits associated with device replacement or continued monitoring.

The study considered variables including indications for device implantation, anticipated course following device failure, device failure rates from the advisory, and device replacement mortality rates per procedure.

According to Ellenbogen, the findings suggest device replacement in the setting of an advisory is not inconsequential and frequently has a greater risk than continued device follow-up.

The decision to replace a recalled device should be based primarily on the device failure rate, the degree of patient dependency, and the anticipated mortality from device replacement.

“We ultimately want the best care for patients with implantable devices and having a rational mechanism to approach these patients is critical to patient care,” said Ellenbogen.

According to the study, there are approximately 2 million patients with implanted cardioverter-defibrillators and pacemakers worldwide. Advisories typically arise from unanticipated device failures that are identified after product release and widespread clinical use.