The Patient Perspective on the Riata Defibrillator Lead Advisory: a Danish Nationwide Study

BACKGROUND: The St. Jude Medical Riata lead advisory was issued due to insulation failures. The impact of this advisory on patients' well-being is unknown.

OBJECTIVE: To describe the acute impact of the Riata advisory on patients' well-being and psychological functioning, and 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 months follow-up. They were matched 1:1 on age, sex and implant indication with non-advisory controls for baseline comparisons. Cohen's effect size d determined clinical relevance of estimated adjusted mean differences (0.20 = small; 0.50 = moderate; ≥0.80 = large).

RESULTS: Of all Riata patients, 86% (256/299) completed baseline PROs and 70% (210/299) follow-up PROs. Riata patients reported poorer device acceptance (d = -0.28, p=0.001) and increased device-related concerns (d = 0.29, p<0.001) as compared to matched non-advisory controls. There were no differences on symptoms of depression (d = 0.13, p=0.13). 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=0.04). Device-related concerns decreased over time (d = -0.17, p=0.002), but no changes were seen for other PROs.

CONCLUSIONS: 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.