The patient perspective on the Riata defibrillator lead advisory: A Danish nationwide study
Larsen,Jacob M. Riahi,Sam Johansen,Jens B. Nielsen,Jens C. Petersen,Helen H. Haarbo,Jens Pedersen,S.S.
Larsen,Jacob M.
Riahi,Sam
Johansen,Jens B.
Nielsen,Jens C.
Petersen,Helen H.
Haarbo,Jens
Pedersen,S.S.
Abstract
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. ObjectivesThe 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.
Description
Date
2014
Journal Title
Journal ISSN
Volume Title
Publisher
Research Projects
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Journal Issue
Keywords
Advisory, Recall, Leads, Implantable cardioverter-defibrillator, Psychology, Distress, Patient-reported outcome, Riata
Citation
Larsen, J M, Riahi, S, Johansen, J B, Nielsen, J C, Petersen, H H, Haarbo, J & Pedersen, S S 2014, 'The patient perspective on the Riata defibrillator lead advisory : A Danish nationwide study', Heart Rhythm, vol. 11, no. 12, pp. 2148-2155. https://doi.org/10.1016/j.hrthm.2014.09.008
License
info:eu-repo/semantics/closedAccess