title: Decision-making, emotional distress, and quality of life in patients affected by the recall of their implantable cardioverter defibrillator.
abstract: OBJECTIVE
  We sought to investigate whether patients with implantable cardioverter defibrillators (ICDs) were suffering from emotional distress related to the recent United States Food and Drug Administration (FDA) recalls, to better understand their decision process related to device replacement, and to assess any impact of recall on quality of life (QOL).
  
  
  RESULTS
  Thirty-one patients experiencing device recalls answered questions regarding their knowledge about the recall and their decision whether to replace the device. Fifty patients whose devices were not recalled reported demographic data. In both groups, psychological factors were assessed. No significant differences were found for psychological factors. Most patients reported being informed of their recall by their physician. Most estimated the risk of device failure to be low or very low, but they overestimated the fail rate. Thirty-six per cent of patients reported feeling anxious about the recall.
  
  
  CONCLUSIONS
  No significant differences existed in psychological factors and QOL between patients whose ICDs were recalled compared with those whose devices were not. The majority of patients whose ICDs are the subject of an FDA advisory/recall have a realistic understanding of the risks of device failure. Prompt information, support, and reassurance provided by healthcare professionals may allay patient distress.
authors.affiliation: Virginia Commonwealth University School of Medicine, 1200 East Broad Street, PO Box 980268, Richmond, VA 23298-0268, USA. dgibson@mcvh-vcu.edu
authors.forename: Douglas P
authors.initials: DP
authors.lastname: Gibson
authors.forename: Kristin K
authors.initials: KK
authors.lastname: Kuntz
authors.forename: James L
authors.initials: JL
authors.lastname: Levenson
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Ellenbogen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D003657:Decision Making; D017147:Defibrillators, Implantable / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D011358:Product Surveillance, Postmarketing; D011788:Quality of Life; D013315:Stress, Psychological / Q000523:psychology*; D011795:Surveys and Questionnaires; D014768:Virginia