title: Perspectives of patients with cardiovascular implantable electronic devices who received advisory warnings.
abstract: OBJECTIVE
  To learn the perspectives of patients with cardiovascular implantable electronic devices (CIEDs) who received device-related advisories.
  
  
  BACKGROUND
  CIEDs are placed under advisory because of potential malfunctions.
  
  
  METHODS
  Qualitative methods were used. Focus groups were conducted of 10 patients who had CIEDs under advisory. Audio recordings of the focus group discussions were transcribed and analyzed for content in accordance with qualitative analysis methods, specifically thematic analysis.
  
  
  RESULTS
  Major themes were identified: patients' attitudes toward their devices under advisory, education about advisories, emotional responses to advisories, impact on loved ones, and what affected patients would say to the chief executive officers of CIED manufacturers. Although the patients felt "fortunate and blessed" to have their devices, they reported a range of emotional responses to the advisories (from no concern to "outrage"). Patients preferred to learn about advisories from their physicians, not from news media. Loved ones had as many, if not more, advisory-related concerns than the patients. Patients had recommendations for chief executive officers of CIED manufacturers regarding advisories, including providing timely and comprehensible information and emotional support, taking responsibility, and collaborating with health care providers. Patients wanted to know what prompted the advisory and what will be done to fix the problem.
  
  
  CONCLUSIONS
  The experiences and perspectives of patients with CIEDs under advisory not only encompass their emotional responses to advisories, but also their views on how the advisory notification process can be improved. These findings should be informative to CIED manufacturers and clinicians.
authors.affiliation: Program in Professionalism and Ethics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. ottenberg.abigale@mayo.edu
authors.forename: Abigale L
authors.initials: AL
authors.lastname: Ottenberg
authors.forename: Luke A
authors.initials: LA
authors.lastname: Mueller
authors.forename: Paul S
authors.initials: PS
authors.lastname: Mueller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000523:psychology / Q000628:therapy*; D001364:Awareness; D003376:Counseling / Q000941:ethics*; D017147:Defibrillators, Implantable; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D010349:Patient Compliance / Q000523:psychology; D010353:Patient Education as Topic / Q000941:ethics* / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012189:Retrospective Studies