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

Johan S Bundgaard*, Jens J Thune, Jens C Nielsen, Regitze Videbæk, Jens Haarbo, Niels E Bruun, Lars Videbæk, David Aagaard, Eva Korup, Gunnar Jensen, Per Hildebrandt, Flemming H Steffensen, Hans Eiskjær, Axel Brandes, Anna M Thøgersen, Thomas M Melchior, Ole D Pedersen, Finn Gustafsson, Kenneth Egstrup, Christian HassagerJesper H Svendsen, Dan E Høfsten, Christian Torp-Pedersen, Susanne S Pedersen, Steen Pehrson, Lars Køber, Ulrik M Mogensen

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalEuropace
Volume21
Issue number6
Pages (from-to)900-908
ISSN1099-5129
DOIs
Publication statusPublished - Jun 2019

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Implantable Defibrillators
Quality of Life
Systolic Heart Failure
Random Allocation
Control Groups
Least-Squares Analysis

Keywords

  • Cardiovascular disease
  • Heart failure
  • Implantable cardioverter-defibrillator
  • Quality of life

Cite this

Bundgaard, J. S., Thune, J. J., Nielsen, J. C., Videbæk, R., Haarbo, J., Bruun, N. E., ... Mogensen, U. M. (2019). The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial. Europace, 21(6), 900-908. https://doi.org/10.1093/europace/euz018
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. / The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial. In: Europace. 2019 ; Vol. 21, No. 6. pp. 900-908.
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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.",
keywords = "Cardiovascular disease, Heart failure, Implantable cardioverter-defibrillator, Quality of life",
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. {\circledC} The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.",
year = "2019",
month = "6",
doi = "10.1093/europace/euz018",
language = "English",
volume = "21",
pages = "900--908",
journal = "Europace",
issn = "1099-5129",
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Bundgaard, JS, Thune, JJ, Nielsen, JC, Videbæk, R, Haarbo, J, Bruun, NE, Videbæk, L, Aagaard, D, Korup, E, Jensen, G, Hildebrandt, P, Steffensen, FH, Eiskjær, H, Brandes, A, Thøgersen, AM, Melchior, TM, Pedersen, OD, Gustafsson, F, Egstrup, K, Hassager, C, Svendsen, JH, Høfsten, DE, Torp-Pedersen, C, Pedersen, SS, Pehrson, S, Køber, L & Mogensen, UM 2019, 'The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial', Europace, vol. 21, no. 6, pp. 900-908. https://doi.org/10.1093/europace/euz018

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.

In: Europace, Vol. 21, No. 6, 06.2019, p. 900-908.

Research output: Contribution to journalJournal articleResearchpeer-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

C2 - 30796456

VL - 21

SP - 900

EP - 908

JO - Europace

JF - Europace

SN - 1099-5129

IS - 6

ER -