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; Jesper H Svendsen; Dan E Høfsten; Christian Torp-Pedersen; Susanne S Pedersen; Steen Pehrson; Lars Køber; Ulrik M Mogensen

doi:10.1093/europace/euz018

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

Research output: Contribution to journal › Journal article › Research › peer-review

10 Citations (Scopus)

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 language	English
Journal	Europace
Volume	21
Issue number	6
Pages (from-to)	900-908
Number of pages	9
ISSN	1099-5129
DOIs	https://doi.org/10.1093/europace/euz018
Publication status	Published - Jun 2019

Keywords

Cardiovascular disease
Heart failure
Implantable cardioverter-defibrillator
Quality of life

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Bundgaard, J. S., Thune, J. J., Nielsen, J. C., Videbæk, R., Haarbo, J., Bruun, N. E., Videbæk, L., Aagaard, D., Korup, E., Jensen, G., Hildebrandt, P., Steffensen, F. H., Eiskjær, H., Brandes, A., Thøgersen, A. M., Melchior, T. M., Pedersen, O. D., Gustafsson, F., Egstrup, K., ... 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. Advance online publication. https://doi.org/10.1093/europace/euz018

@article{688da9f8e1904525981b7ca5006c6407,

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}",

year = "2019",

month = jun,

doi = "10.1093/europace/euz018",

language = "English",

volume = "21",

pages = "900--908",

journal = "Europace",

issn = "1099-5129",

publisher = "Oxford University Press",

number = "6",

}

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

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

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

UR - http://www.scopus.com/inward/record.url?scp=85067117894&partnerID=8YFLogxK

U2 - 10.1093/europace/euz018

DO - 10.1093/europace/euz018

M3 - Journal article

C2 - 30796456

SN - 1099-5129

VL - 21

SP - 900

EP - 908

JO - Europace

JF - Europace

IS - 6

ER -

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

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