The patient perspective on the Riata defibrillator lead advisory: A Danish nationwide study

被引:3
作者
Larsen, Jacob M. [1 ]
Riahi, Sam [1 ]
Johansen, Jens B. [2 ]
Nielsen, Jens C. [3 ]
Petersen, Helen H. [4 ]
Haarbo, Jens [5 ]
Pedersen, Susanne S. [2 ,6 ,7 ,8 ]
机构
[1] Aalborg Univ Hosp, Ctr Cardiovasc Res, Dept Cardiol, Aalborg, Denmark
[2] Odense Univ Hosp, Dept Cardiol, DK-5000 Odense, Denmark
[3] Aarhus Univ, Hosp Skejby, Dept Cardiol, Aarhus, Denmark
[4] Copenhagen Univ Hosp, Rigshosp, Dept Cardiol, Copenhagen, Denmark
[5] Copenhagen Univ Hosp, Gentofte Hosp, Dept Cardiol, Copenhagen, Denmark
[6] Erasmus MC, Thoraxctr, Dept Cardiol, Rotterdam, Netherlands
[7] Tilburg Univ, Dept Med & Clin Psychol, NL-5000 LE Tilburg, Netherlands
[8] Univ Southern Denmark, Dept Psychol, Odense, Denmark
关键词
Advisory; Recall; Leads; Implantable cardioverter-defibrillator; Psychology; Distress; Patient-reported outcome; Riata; IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR; QUALITY-OF-LIFE; PSYCHOLOGICAL IMPACT; DEVICE ACCEPTANCE; OUTCOMES; ANXIETY; RECALL;
D O I
10.1016/j.hrthm.2014.09.008
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:2148 / 2155
页数:8
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