Background The St Jude Medical Riata lead advisory was issued owing to insulation failures. The impact of this advisory on patients' well-being is unknown. Objectives The objectives of this study were to describe the acute impact of the Riata advisory on patients' well-being and psychological functioning and to examine changes over time.Methods Patients with active Riata leads completed standardized and validated patient-reported outcomes (PROs) in connection with a nationwide fluoroscopic screening with 12-month follow-up. They were matched (1:1) on age, sex, and implant indication with nonadvisory controls for baseline comparisons. Cohen's effect size d was used to determine the clinical relevance of the estimated adjusted mean differences (small, d = 0.20; moderate, d = 0.50; large, d ≥ 0.80).Results Of all Riata patients, 86% (256 of 299) completed baseline PROs and 70% (210 of 299) follow-up PROs. Riata patients reported poorer device acceptance (d = -0.28; P =.001) and increased device-related concerns (d = 0.29; P <.001) as compared with matched nonadvisory controls. There were no differences in symptoms of depression (d = 0.13; P =.13). Female sex was an independent predictor of a high advisory impact on general well-being as assessed with a purpose-designed question (odds ratio 2.24; P =.04). Device-related concerns decreased over time (d = -0.17; P =.002), but no changes were seen for other PROs.Conclusion The Riata advisory is associated with a persistent small reduction in device acceptance and a small increase in device-related concerns with minimal improvement over time. Female sex is a predictor of a high negative advisory impact on general well-being. A need for counseling may arise in vulnerable subsets of patients.

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Heart Rhythm
Department of Cardiology

Larsen, J., Riahi, S., Johansen, J., Nielsen, J. C., Petersen, H. H., Haarbo, J., & Pedersen, S. (2014). The patient perspective on the Riata defibrillator lead advisory: A Danish nationwide study. Heart Rhythm, 11(12), 2148–2155. doi:10.1016/j.hrthm.2014.09.008