The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial

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 HassagerJesper H Svendsen, Dan E Høfsten, Christian Torp-Pedersen, Susanne S Pedersen, Steen Pehrson, Lars Køber, Ulrik M Mogensen

Research output: Contribution to journalJournal articleResearchpeer-review

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
JournalEuropace
Volume21
Issue number6
Pages (from-to)900-908
Number of pages9
ISSN1099-5129
DOIs
Publication statusPublished - Jun 2019

Keywords

  • Cardiovascular disease
  • Heart failure
  • Implantable cardioverter-defibrillator
  • Quality of life

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