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. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
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. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Johan S Bundgaard; Kasper Iversen; Mia Pries-Heje; Nikolaj Ihlemann; Sabine U Gill; Trine Madsen; Hanne Elming; Jonas A Povlsen; Niels E Bruun; Dan E Høfsten; Kurt Fuursted; Jens J Christensen; Martin Schultz; Flemming Rosenvinge; Jannik Helweg-Larsen; Lars Køber; Christian Torp-Pedersen; Emil L Fosbøl; Niels Tønder; Claus Moser; Henning Bundgaard; Ulrik M Mogensen Journal: Qual Life Res Date: 2022-03-29 Impact factor: 3.440
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Authors: Bruce L Wilkoff; Giuseppe Boriani; Suneet Mittal; Jeanne E Poole; Charles Kennergren; G Ralph Corey; Andrew D Krahn; Edward J Schloss; Jose L Gallastegui; Robert A Pickett; Rudolph F Evonich; Steven F Roark; Denise M Sorrentino; Darius P Sholevar; Edmond M Cronin; Brett J Berman; David W Riggio; Hafiza H Khan; Marc T Silver; Jack Collier; Zayd Eldadah; Reece Holbrook; Jeff D Lande; Daniel R Lexcen; Swathi Seshadri; Khaldoun G Tarakji Journal: Circ Arrhythm Electrophysiol Date: 2020-09-11