A team of medical experts led by a Virginia Commonwealth University researcher has established a set of clinical guidelines to help physicians determine how to best care for patients with pacemakers or implantable cardioverter-defibrillators (ICDs) that are the subject of an advisory or recall.

The research team, led by Mitesh S. Amin, M.D., a resident in the Department of Internal Medicine at the VCU School of Medicine, developed the guidelines, which appear 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, M.D., director of VCU’s cardiac electrophysiology lab and 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 researchers considered the 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.

Ellenbogen and Amin collaborated with Mark Wood, M.D., VCU professor of internal medicine, and David Matchar, M.D., professor of medicine at Duke University.

According to the study, there are approximately 2 million patients with ICDs and pacemakers worldwide that often are implanted for life threatening conditions -  pacemakers for patients with complete heart block and ICDs to provide therapy for patients at risk for cardiac arrest. Advisories typically arise from unanticipated device failures which are identified after product release and widespread clinical use.

Virginia Commonwealth University