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

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@article{cf557945d3244e83bbcb6f7b85adc167,
title = "The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial",
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.",
author = "Bundgaard, {Johan S} and Thune, {Jens J} and Nielsen, {Jens C} and Regitze Videb{\ae}k and Jens Haarbo and Bruun, {Niels E} and Lars Videb{\ae}k and David Aagaard and Eva Korup and Gunnar Jensen and Per Hildebrandt and Steffensen, {Flemming H} and Hans Eiskj{\ae}r and Axel Brandes and Th{\o}gersen, {Anna M} and Melchior, {Thomas M} and Pedersen, {Ole D} and Finn Gustafsson and Kenneth Egstrup and Christian Hassager and Svendsen, {Jesper H} and H{\o}fsten, {Dan E} and Christian Torp-Pedersen and Pedersen, {Susanne S} and Steen Pehrson and Lars K{\o}ber and Mogensen, {Ulrik M}",
note = "Published on behalf of the European Society of Cardiology. All rights reserved. {\textcopyright} The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.",
year = "2019",
month = jun,
day = "1",
doi = "10.1093/europace/euz018",
language = "English",
volume = "21",
pages = "900--908",
journal = "Europace",
issn = "1099-5129",
publisher = "Oxford University Press",
number = "6",

}

RIS

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 - 2019/6/1

Y1 - 2019/6/1

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.

U2 - 10.1093/europace/euz018

DO - 10.1093/europace/euz018

M3 - Journal article

C2 - 30796456

VL - 21

SP - 900

EP - 908

JO - Europace

JF - Europace

SN - 1099-5129

IS - 6

ER -

ID: 57384860