title: The psychological impact of implantable cardioverter-defibrillator recalls and the durable positive effects of counseling.
abstract: BACKGROUND
  It is known that patients with lifesaving devices such as implantable cardioverter-defibrillators (ICDs) may be alarmed and worried by recalls or alerts related to their ICDs.
  
  
  OBJECTIVE
  This study aimed to determine whether counseling has any short- or long-term benefits, and to look for characteristics that identify those most worried and those most in need of counseling.
  
  
  METHODS
  Among 100 patients with recall or alert ICDs, 14 were pacer dependent; 50 had ICDs for 1 degrees prevention and 22 were women. Patients completed a survey indicating how worried they were on learning of the recall or alert (0-10 scale). After counseling and advice in accordance with manufacturer guidelines, patients were asked to indicate their level of worry, and were again asked after 6 months.
  
  
  RESULTS
  For all patients, the "worry level" at the initial interview was 5.0+/-3.7, falling to 2.2+/-3.0 after counseling (P < 0.001) and 1.4+/-2.3 after 6 months (P < 0.001 vs both earlier levels). There were no significant differences between those implanted for 1 degrees versus 2 degrees prevention or for pacer dependency. Women were initially more worried than men, but not for the long term. The 49 patients whose ICDs could be managed by reprogramming or software fix had significant reduction in worry after counseling and at 6 months compared to others. The 18 patients recommended for operative intervention remained more concerned after counseling (3.5+/-3.3 vs 1.9+/-2.9, P = 0.043).
  
  
  CONCLUSIONS
  Patients' concerns resulting from ICD recalls or alerts can be reduced by appropriate counseling. Those patients whose ICDs could be reprogrammed to safer parameters had the most reduction in worry levels.
authors: Department of Medicine, Cardiology Division, Arrhythmia Service, Bronx, New York 10467, USA. jfisher@montefiore.org
authors: John D
authors: JD
authors: Fisher
authors: Konstantinos P
authors: KP
authors: Koulogiannis
authors: Linda
authors: L
authors: Lewallen
authors: Daniel
authors: D
authors: Katz
authors: Soo G
authors: SG
authors: Kim
authors: Kevin J
authors: KJ
authors: Ferrick
authors: Jay N
authors: JN
authors: Gross
authors: Andrew K
authors: AK
authors: Krumerman
authors: Debra R
authors: DR
authors: Johnston
authors: Bridget C
authors: BC
authors: Mercaldi
mesh_terms: D001145:Arrhythmias, Cardiac / Q000453:epidemiology / Q000517:prevention & control / Q000523:psychology*; D001294:Attitude to Health; D017147:Defibrillators, Implantable / Q000523:psychology* / Q000706:statistics & numerical data*; D037001:Directive Counseling / Q000706:statistics & numerical data*; D030881:Disclosure; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D009518:New York / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D013315:Stress, Psychological / Q000453:epidemiology* / Q000517:prevention & control*