title: The patient perspective on the Riata defibrillator lead advisory: a Danish nationwide study.
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.
  
  
  OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Cardiology and Center for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark. Electronic address: jaml@rn.dk.
authors.forename: Jacob M
authors.initials: JM
authors.lastname: Larsen
authors.affiliation: Department of Cardiology and Center for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Sam
authors.initials: S
authors.lastname: Riahi
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Jens B
authors.initials: JB
authors.lastname: Johansen
authors.affiliation: Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.
authors.forename: Jens C
authors.initials: JC
authors.lastname: Nielsen
authors.affiliation: Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Helen H
authors.initials: HH
authors.lastname: Petersen
authors.affiliation: Department of Cardiology, Gentofte Hospital, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Haarbo
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Department of Psychology, University of Southern Denmark, Odense, Denmark.
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Pedersen
mesh_terms: D000223:Adaptation, Psychological; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000628:therapy*; D016022:Case-Control Studies; D003253:Consultants; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000523:psychology*; D003718:Denmark; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005471:Fluoroscopy / Q000379:methods; D006801:Humans; D016015:Logistic Models; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D015999:Multivariate Analysis; D010358:Patient Participation; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012307:Risk Factors; D011795:Surveys and Questionnaires
keywords: Advisory; Distress; Implantable cardioverter-defibrillator; Leads; Patient-reported outcome; Psychology; Recall; Riata