title: Psychological distress in patients with ICD recall.
abstract: BACKGROUND
  Multiple clinical trials have shown that a properly functioning implantable cardioverter-defibrillator (ICD) is capable of interrupting sudden death caused by ventricular tachyarrhythmias. However, ICDs are complex medical devices, and they do not always perform as expected or they may fail completely. Exposure of ICD recipients to professional or media reports that their specific device type is potentially malfunctioning could negatively influence their psychological status.
  
  
  METHODS
  This study aimed to evaluate and quantify psychological distress in patients implanted with an ICD-recall device. Thirty patients implanted with ICD-recall devices (ICD-recall group) and 25 patients with unaffected ICD devices (ICD-control group) were interviewed using the Brief Symptom Inventory (a psychological self-report symptom scale).
  
  
  RESULTS
  Mean values of all primary psychiatric distress symptom dimensions and global indices were within the normal range for both the ICD-recall and the ICD-control group. New York Heart Association (NYHA)class was a predictor of higher distress symptoms in all categories, independently of the ICD group. NYHA II group patients tended toward higher stress levels than the NYHA I group, but only somatization was significantly different. An upward, but not significant, trend in 7 of the 12 scales was associated with symptomatic shock experience.
  
  
  CONCLUSIONS
  This study demonstrates that psychological distress was not significantly increased in patients recently informed about a potential malfunction of their device.
authors.affiliation: Department of Cardiology, Kantonsspital Luzern, Switzerland.
authors.forename: Florim
authors.initials: F
authors.lastname: Cuculi
authors.forename: Werner
authors.initials: W
authors.lastname: Herzig
authors.forename: Richard
authors.initials: R
authors.lastname: Kobza
authors.forename: Paul
authors.initials: P
authors.lastname: Erne
mesh_terms: D017147:Defibrillators, Implantable / Q000523:psychology* / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D013315:Stress, Psychological / Q000175:diagnosis / Q000453:epidemiology*; D013557:Switzerland / Q000453:epidemiology