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

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 8months 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 8months for the primary analysis. Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8months [least square mean -7.0 vs. -4.2 (P=0.13)]. A clinically relevant improvement (decrease 5) in the MLHFQ overall score at 8months 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.