Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification

• Published in: Europace (London, England) England), 2011-09, Vol.13 (9), p.1292-1298
• Main Authors: Pedersen, Susanne S, Versteeg, Henneke, Nielsen, Jens C, Mortensen, Peter T, Johansen, Jens B
• Format: Article
• Language: English
• Subjects: Aged; Defibrillators, Implantable - adverse effects; Defibrillators, Implantable - psychology; Denmark; Electrodes, Implanted - psychology; Equipment Failure; Female; Humans; Male; Middle Aged; Self Report; Treatment Outcome
• ISSN: 1099-5129; 1532-2092
• DOI: 10.1093/europace/eur157

Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether patients with a lead subject to a device advisory report poorer PROs than non-advisory controls. Patients (n= 207) implanted with an ICD at Aarhus University Hospital, Denmark, with a Sprint Fidelis lead subject to an advisory and a non-advisory control group (n= 510), completed a set of standardized PRO measures. A Bonferroni correction was applied to all statistical PRO comparisons to adjust for multiple comparisons, with a P-value of 0.0038 (0.05/13 PROs) indicating statistical significance. Device advisory patients did not differ significantly on PROs according to mode of notification (all P-values >0.0038). They also did not differ significantly from controls on mean scores of depression, anxiety, device acceptance, and health status (all P > 0.0038). Differences were only found on ICD concerns (P< 0.0001) and on mental health status (P = 0.003), with advisory patients reporting fewer ICD concerns and a better mental health status than non-advisory controls. The mode used to inform ICD patients about the advisory was not associated with PROs, nor was the overall well-being of device advisory patients impaired compared to non-advisory controls. These results indicate that ICD patients are generally able to cope with a device advisory.