title: Should recent defibrillator and lead advisories affect decisions to refer patients for implantable cardioverter-defibrillator therapy?
abstract: OBJECTIVE
  Implantable cardioverter-defibrillators (ICDs) have been shown to improve survival by terminating life-threatening ventricular arrhythmias. As ICDs have become more complex, there has been an increase in the incidence of device and lead malfunctions. Advisories and recalls are issued by device manufacturers to alert physicians to potential malfunction, but the management is typically left to the physician. We reviewed recent data on ICD and lead advisories, in addition to studies evaluating associated consequences, to determine whether advisories affect the benefit of device therapy and how best to manage device advisories.
  
  
  RESULTS
  Despite the increasing number of advisories and attention to device and lead failure, the overall reliability and efficacy of ICDs for appropriate patients remain high. Careful consideration must be employed when decisions are made to replace generators or extract leads, as these additional procedures can lead to more significant adverse complications compared with the advisory and potential for malfunction.
  
  
  CONCLUSIONS
  Patients continue to benefit from ICD implantation despite recent advisories for potential device and lead malfunction. The decision for ICD implantation should still be based on the patient's risk of experiencing a life-threatening arrhythmia. Patients should be counseled prior to implant of the potential for device and lead malfunction, and careful consideration must be employed in the setting of an advisory prior to replacing an affected device or lead.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, Virginia Commonwealth University Medical Center, Richmond, Virginia 23298-0053, USA.
authors.forename: Mitesh S
authors.initials: MS
authors.lastname: Amin
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Ellenbogen
mesh_terms: D000075202:Contraindications; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000523:psychology; D004868:Equipment Failure; D006801:Humans; D018570:Risk Assessment