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

Jacob M. Larsen, Sam Riahi, Jens B. Johansen, Jens C. Nielsen, Helen H. Petersen, Jens Haarbo, S.S. Pedersen

Research output: Contribution to journalArticleScientificpeer-review

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.
Original languageEnglish
Pages (from-to)2148-2155
JournalHeart Rhythm
Volume11
Issue number12
DOIs
Publication statusPublished - 2014

Keywords

  • Advisory
  • Recall
  • Leads
  • Implantable cardioverter-defibrillator
  • Psychology
  • Distress
  • Patient-reported outcome
  • Riata

Cite this

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, 11(12), 2148-2155. https://doi.org/10.1016/j.hrthm.2014.09.008
Larsen, Jacob M. ; Riahi, Sam ; Johansen, Jens B. ; Nielsen, Jens C. ; Petersen, Helen H. ; Haarbo, Jens ; Pedersen, S.S. / The patient perspective on the Riata defibrillator lead advisory : A Danish nationwide study. In: Heart Rhythm. 2014 ; Vol. 11, No. 12. pp. 2148-2155.
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title = "The patient perspective on the Riata defibrillator lead advisory: A Danish nationwide study",
abstract = "BackgroundThe 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.MethodsPatients 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).ResultsOf 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.ConclusionThe 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.",
keywords = "Advisory, Recall, Leads, Implantable cardioverter-defibrillator, Psychology, Distress, Patient-reported outcome, Riata",
author = "Larsen, {Jacob M.} and Sam Riahi and Johansen, {Jens B.} and Nielsen, {Jens C.} and Petersen, {Helen H.} and Jens Haarbo and S.S. Pedersen",
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language = "English",
volume = "11",
pages = "2148--2155",
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Larsen, JM, Riahi, S, Johansen, JB, Nielsen, JC, Petersen, HH, Haarbo, J & Pedersen, SS 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

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.

In: Heart Rhythm, Vol. 11, No. 12, 2014, p. 2148-2155.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - The patient perspective on the Riata defibrillator lead advisory

T2 - A Danish nationwide study

AU - Larsen, Jacob M.

AU - Riahi, Sam

AU - Johansen, Jens B.

AU - Nielsen, Jens C.

AU - Petersen, Helen H.

AU - Haarbo, Jens

AU - Pedersen, S.S.

PY - 2014

Y1 - 2014

N2 - BackgroundThe 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.MethodsPatients 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).ResultsOf 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.ConclusionThe 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.

AB - BackgroundThe 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.MethodsPatients 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).ResultsOf 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.ConclusionThe 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.

KW - Advisory

KW - Recall

KW - Leads

KW - Implantable cardioverter-defibrillator

KW - Psychology

KW - Distress

KW - Patient-reported outcome

KW - Riata

U2 - 10.1016/j.hrthm.2014.09.008

DO - 10.1016/j.hrthm.2014.09.008

M3 - Article

VL - 11

SP - 2148

EP - 2155

JO - Heart Rhythm

JF - Heart Rhythm

SN - 1547-5271

IS - 12

ER -

Larsen JM, Riahi S, Johansen JB, Nielsen JC, Petersen HH, Haarbo J et al. The patient perspective on the Riata defibrillator lead advisory: A Danish nationwide study. Heart Rhythm. 2014;11(12):2148-2155. https://doi.org/10.1016/j.hrthm.2014.09.008