Resumé
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Europace |
| Vol/bind | 21 |
| Udgave nummer | 6 |
| Sider (fra-til) | 900-908 |
| ISSN | 1099-5129 |
| DOI | |
| Status | Udgivet - jun. 2019 |
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The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial. / 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.
I: Europace, Bind 21, Nr. 6, 06.2019, s. 900-908.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
TY - JOUR
T1 - The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial
AU - Bundgaard, Johan S
AU - Thune, Jens J
AU - Nielsen, Jens C
AU - Videbæk, Regitze
AU - Haarbo, Jens
AU - Bruun, Niels E
AU - Videbæk, Lars
AU - Aagaard, David
AU - Korup, Eva
AU - Jensen, Gunnar
AU - Hildebrandt, Per
AU - Steffensen, Flemming H
AU - Eiskjær, Hans
AU - Brandes, Axel
AU - Thøgersen, Anna M
AU - Melchior, Thomas M
AU - Pedersen, Ole D
AU - Gustafsson, Finn
AU - Egstrup, Kenneth
AU - Hassager, Christian
AU - Svendsen, Jesper H
AU - Høfsten, Dan E
AU - Torp-Pedersen, Christian
AU - Pedersen, Susanne S
AU - Pehrson, Steen
AU - Køber, Lars
AU - Mogensen, Ulrik M
N1 - Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.
PY - 2019/6
Y1 - 2019/6
N2 - 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.
AB - 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.
KW - Cardiovascular disease
KW - Heart failure
KW - Implantable cardioverter-defibrillator
KW - Quality of life
U2 - 10.1093/europace/euz018
DO - 10.1093/europace/euz018
M3 - Journal article
VL - 21
SP - 900
EP - 908
JO - Europace
JF - Europace
SN - 1099-5129
IS - 6
ER -