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Randomized Controlled Trial
. 2019 Jun 1;21(6):900-908.
doi: 10.1093/europace/euz018.

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

Johan S Bundgaard  1 , Jens J Thune  1   2 , Jens C Nielsen  3 , Regitze Videbæk  1 , Jens Haarbo  4 , Niels E Bruun  5   6   7 , Lars Videbæk  8 , David Aagaard  1 , Eva Korup  9   10 , Gunnar Jensen  5 , Per Hildebrandt  5   11 , Flemming H Steffensen  12 , Hans Eiskjær  3 , Axel Brandes  8 , Anna M Thøgersen  9   10 , Thomas M Melchior  5 , Ole D Pedersen  5 , Finn Gustafsson  1 , Kenneth Egstrup  8 , Christian Hassager  1 , Jesper H Svendsen  1 , Dan E Høfsten  1 , Christian Torp-Pedersen  9   10 , Susanne S Pedersen  8   13 , Steen Pehrson  1 , Lars Køber  1 , Ulrik M Mogensen  1   5
Affiliations
Randomized Controlled Trial

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

Johan S Bundgaard et al. Europace. .

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.

Keywords: Cardiovascular disease; Heart failure; Implantable cardioverter-defibrillator; Quality of life.

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