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 Hassager & 7 andre Jesper H Svendsen, Dan E Høfsten, Christian Torp-Pedersen, Susanne S Pedersen, Steen Pehrson, Lars Køber, Ulrik M Mogensen

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

OriginalsprogEngelsk
TidsskriftEuropace
Vol/bind21
Udgave nummer6
Sider (fra-til)900-908
ISSN1099-5129
DOI
StatusUdgivet - jun. 2019

Fingeraftryk

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

Citer dette

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. I: Europace. 2019 ; Bind 21, Nr. 6. s. 900-908.
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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.",
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",
publisher = "Heinemann",
number = "6",

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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, bind 21, nr. 6, s. 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.

I: Europace, Bind 21, Nr. 6, 06.2019, s. 900-908.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer 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 -