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

• Published in: Europace (London, England) England), 2019-06, Vol.21 (6), p.900-908
• Main 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
• Format: Article
• Language: English
• ISSN: 1099-5129; 1532-2092
• DOI: 10.1093/europace/euz018

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.