title: Psychological impact of surveillance in patients with a defibrillator lead under advisory: a prospective evaluation.
abstract: BACKGROUND
  Implantable cardioverter defibrillator (ICD) leads are subject to technical failures and the impact of the resulting public advisories on patient welfare is unclear. The psychological status of patients who received an advisory for their Medtronic Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and followed either by self-surveillance for alarm or home monitoring with CareLink was evaluated prospectively and compared to patients with ICDs not under advisory.
  
  
  METHODS
  One hundred sixty consecutive consenting patients (90 alarms, 24 Carelinks, 46 controls) were recruited within 1.5 years of advisory notification. Advisory patients were seen immediately before being told that the automatic lead surveillance utilized since the advisory had been inadequate in warning of impending fracture, as well as 1 and 6 months after programming was optimized. Depression, anxiety, quality of life (QoL), and ICD-related concerns were assessed.
  
  
  RESULTS
  Symptoms of depression and state anxiety were experienced by 31% and 48% of patients, respectively. QoL was impaired on all subscales. No significant group differences in distress and ICD-related concerns emerged at baseline or at follow-up. At baseline, alarm patients reported greater limitations because of body pain compared to controls (P < 0.05). All patients showed a significant reduction in body pain-related QoL at the final versus first two evaluations (P < 0.001). Advisory patients were significantly less satisfied with surveillance at follow-up than at baseline (P < 0.05).
  
  
  CONCLUSIONS
  There was limited evidence for worse psychosocial functioning in those at risk for ICD lead fracture, irrespective of surveillance method. However, many control and advisory patients experienced chronic distress for which counseling may prove beneficial.
authors.affiliation: Research Centre, Montreal Heart Institute/Université de Montréal, Montréal, Canada. bianca.d.antono@umontreal.ca
authors.forename: Bianca
authors.initials: B
authors.lastname: D'Antono
authors.forename: Maria
authors.initials: M
authors.lastname: Goldfarb
authors.forename: Crina
authors.initials: C
authors.lastname: Solomon
authors.forename: Marcio
authors.initials: M
authors.lastname: Sturmer
authors.forename: Giuliano
authors.initials: G
authors.lastname: Becker
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.forename: Tomy
authors.initials: T
authors.lastname: Hadjis
authors.forename: Ewa
authors.initials: E
authors.lastname: Gizicki
authors.forename: Jonathan St
authors.initials: JS
authors.lastname: Gelais
authors.forename: Georgeta
authors.initials: G
authors.lastname: Sas
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Côté
authors.forename: Teresa
authors.initials: T
authors.lastname: Kus
mesh_terms: D000368:Aged; D001007:Anxiety / Q000453:epidemiology* / Q000523:psychology; D056902:Clinical Alarms / Q000706:statistics & numerical data; D015897:Comorbidity; D017147:Defibrillators, Implantable / Q000523:psychology* / Q000706:statistics & numerical data*; D003863:Depression / Q000453:epidemiology* / Q000523:psychology; D004567:Electrodes, Implanted / Q000523:psychology* / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011792:Quebec / Q000453:epidemiology; D018570:Risk Assessment; D012307:Risk Factors