title: Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model.
abstract: BACKGROUND
  Limited information exists to direct clinical management after an implantable device has been put under advisory. A better understanding of the risks and benefits of device replacement compared with continued clinical follow-up would be helpful to clinicians.
  
  
  OBJECTIVE
  Using the tools of decision analysis, to determine the best management approach (immediate device replacement vs continued monitoring) in the setting of a device advisory.
  
  
  METHODS
  A decision model was constructed to evaluate the risks and benefits associated with immediate device replacement compared with continued monitoring.
  
  
  METHODS
  Variables considered included indications for device implantation, anticipated course following device failure, device failure rates from the advisory ranging from 0.0001% to 1.0% per year, and device replacement mortality rates ranging from 0.10% to 1.00% per procedure. Device replacement was preferred to continued follow-up when replacement led to greater patient survival.
  
  
  RESULTS
  The decision to replace a recalled device depends primarily on the advisory's estimated device failure rate and the likely effects of device failure on mortality. Procedural mortality is an important secondary factor, while patient age and remaining generator life have the least influence on the decision. For pacemaker-dependent patients, advisory device failure rates exceeding 0.3% warrant device replacement in most situations. In patients with implantable cardioverter-defibrillators for primary or secondary prevention, a failure rate associated with an advisory of 3.0% is needed to favor replacement in most cases, decreasing to close to 1.0% as procedural mortality rates decrease to 0.1% or risk of fatal arrhythmias increase to near 20% per year. In cases of pacemaker implantation for non-life-threatening situations (eg, carotid sinus hypersensitivity), most device advisories do not warrant device replacement.
  
  
  CONCLUSIONS
  The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.
authors.affiliation: Department of Internal Medicine, Virginia Commonwealth University Medical Center, Richmond, USA.
authors.forename: Mitesh S
authors.initials: MS
authors.lastname: Amin
authors.forename: David B
authors.initials: DB
authors.lastname: Matchar
authors.forename: Mark A
authors.initials: MA
authors.lastname: Wood
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Ellenbogen
mesh_terms: D003661:Decision Support Techniques; D017147:Defibrillators, Implantable / Q000009:adverse effects; D018795:Device Approval; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D008390:Markov Chains; D009026:Mortality; D010138:Pacemaker, Artificial / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment / Q000379:methods