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Bispebjerg Hospital - en del af Københavns Universitetshospital
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The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial

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  • Johan S Bundgaard
  • Jens J Thune
  • Jens C Nielsen
  • Regitze Videbæk
  • Jens Haarbo
  • Niels E Bruun
  • Lars Videbæk
  • David Aagaard
  • Eva Korup
  • Gunnar Jensen
  • Per Hildebrandt
  • Flemming H Steffensen
  • Hans Eiskjær
  • Axel Brandes
  • Anna M Thøgersen
  • Thomas M Melchior
  • Ole D Pedersen
  • Finn Gustafsson
  • Kenneth Egstrup
  • Christian Hassager
  • Jesper H Svendsen
  • Dan E Høfsten
  • Christian Torp-Pedersen
  • Susanne S Pedersen
  • Steen Pehrson
  • Lars Køber
  • Ulrik M Mogensen
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AIM: The Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators (ICD) in Patients with Non-ischaemic Systolic Heart Failure (HF) on Mortality (DANISH) found no overall effect on all-cause mortality. The effect of ICD implantation on health-related quality of life (HRQoL) remains to be established as previous trials have demonstrated conflicting results. We investigated the impact of ICD implantation on HRQoL in patients with non-ischaemic systolic HF, a prespecified secondary endpoint in DANISH.

METHODS AND RESULTS: In DANISH, a total of 1116 patients with non-ischaemic systolic HF were randomly assigned (1:1) to ICD implantation or usual clinical care (control). Patients completed disease-specific HRQoL as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ; 0-105, high indicating worse). Changes in HRQoL 8 months after randomization were assessed with a mixed-effects model. At randomization, MLHFQ was completed by 935 (84%) patients (n = 472 in the ICD group and n = 463 in the control group) and was reassessed in 274 (58%) and 292 (63%) patients, respectively after 8 months for the primary analysis. Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8 months [least square mean -7.0 vs. -4.2 (P = 0.13)]. A clinically relevant improvement (decrease ≥5) in the MLHFQ overall score at 8 months was observed in 151 patients in the ICD group and 148 patients in the control group [55% vs. 51%, respectively (P = 0.25)].

CONCLUSION: Implantable cardioverter-defibrillator implantation in patients with non-ischaemic systolic HF did not significantly alter HRQoL compared with patients randomized to usual clinical care.

OriginalsprogEngelsk
TidsskriftEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
Vol/bind21
Udgave nummer6
Sider (fra-til)900-908
Antal sider9
ISSN1099-5129
DOI
StatusUdgivet - 1 jun. 2019

Bibliografisk note

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.

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