Focus on management of pacemaker and ICD advisories, recalls, and alerts

Abstract

Because the number of implantable cardiac devices has dramatically increased, device alerts and advisories have become a part of routine clinical practice. When a physician is faced with the management of a patient with an implanted device that has been the subject of a recall or advisory, the major concern facing the clinician is how to manage the patient and whether the device needs to be replaced. A rational approach to evaluating patients with a device or lead that is the subject of a US Food and Drug Administration advisory requires evaluating the competing risks of elective device or lead replacement versus keeping the recalled device or lead in place. It is important to keep in mind that the risks of replacing devices are not insignificant and may outweigh the risks of death from device malfunction. Ultimately, this decision should be based on the estimated device (lead) malfunction rate, device (lead) dependency, and an individual center's procedural risk for complications from generator (lead) removal, and should also factor in patient preferences.