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.
Heart Rhythm, 2014, Vol 11, Issue 12, p. 2148-2155
Comparative Study; Journal Article; Research Support, Non-U.S. Gov't