The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial. Issue 6 (22nd February 2019)

• Record Type: Journal Article
• Authors: Bundgaard, Johan S; Thune, Jens J; Nielsen, Jens C; Videbæk, Regitze; Haarbo, Jens; Bruun, Niels E; Videbæk, Lars; Aagaard, David; Korup, Eva; Jensen, Gunnar; Hildebrandt, Per; Steffensen, Flemming H; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna M; Melchior, Thomas M; Pedersen, Ole D; Gustafsson, Finn; Egstrup, Kenneth; Hassager, Christian; Svendsen, Jesper H; Høfsten, Dan E; Torp-Pedersen, Christian; Pedersen, Susanne S; Pehrson, Steen; Køber, Lars; Mogensen, Ulrik M
• Is Part Of: Europace. Volume 21:Issue 6(2019)
• Page Start: 900
• Page End: 908
• Publication Date: 2019-02-22
• Subjects: Quality of life -- Heart failure -- Implantable cardioverter-defibrillator -- Cardiovascular disease; Arrhythmia -- Treatment -- Periodicals; Cardiac pacing -- Periodicals; Catheter ablation -- Periodicals; Heart -- Physiology -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1093/europace/euz018
• Languages: English
• ISSNs: 1099-5129

Abstract

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.