The effect of device advisories on implantable cardioverter-defibrillator therapy.
Implantable cardioverter-defibrillators have been shown to improve survival by terminating life-threatening ventricular tachyarrhythmias. As the devices have become more complex, there has been an increase in the incidence of device and lead malfunction. The device manufacturers issue advisories and recalls to alert physicians of the potential for malfunction. When patients are faced with a recalled device or lead, the initial question is whether or not to replace it. A rational approach to evaluating these patients and the associated advisory can help gauge the competing risks of elective device removal or extraction versus keeping the device in place. It is important to keep in mind that the risks of replacing devices or extracting leads are not insignificant and may outweigh the risks of death from malfunction. Despite the increasing number of advisories and attention to device and lead failure, the overall reliability and efficacy of these devices for appropriate patients remains high. In general, patients should be counseled prior to implant of the potential for device and lead malfunction, and careful consideration must be employed when decisions are made to replace generators or extract leads.
Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University Medical Center, P. O. Box 980053, Richmond, VA 23298-0053, USA.
Mitesh S
MS
Amin
Kenneth A
KA
Ellenbogen
D000465:Algorithms; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004566:Electrodes; D004868:Equipment Failure; D004869:Equipment Safety / Q000295:instrumentation; D006801:Humans; D008390:Markov Chains; D057052:Medical Device Recalls; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration