Psychological Impact of Surveillance in Patients with a Defibrillator Lead under Advisory: A Prospective Evaluation

• Published in: Pacing and clinical electrophysiology 2013-02, Vol.36 (2), p.221-230
• Main Authors: D'ANTONO, BIANCA, GOLDFARB, MARIA, SOLOMON, CRINA, STURMER, MARCIO, BECKER, GIULIANO, ESSEBAG, VIDAL, HADJIS, TOMY, GIZICKI, EWA, GELAIS, JONATHAN ST, SAS, GEORGETA, CÔTÉ, MARIE-CLAUDE, KUS, TERESA
• Format: Article
• Language: English
• Subjects: advisory; Aged; anxiety; Anxiety - epidemiology; Anxiety - psychology; Clinical Alarms - statistics & numerical data; Comorbidity; Defibrillators, Implantable - psychology; Defibrillators, Implantable - statistics & numerical data; depression; Depression - epidemiology; Depression - psychology; Electrodes, Implanted - psychology; Electrodes, Implanted - statistics & numerical data; Equipment Failure - statistics & numerical data; Female; Humans; Implantable cardioverter defibrillator; Incidence; Longitudinal Studies; Male; Middle Aged; Product Surveillance, Postmarketing - statistics & numerical data; quality of life; Quebec - epidemiology; Risk Assessment; Risk Factors; surveillance method
• ISSN: 0147-8389; 1540-8159
• DOI: 10.1111/pace.12040

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.