Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

Lars Køber, Jens J Thune, Jens C Nielsen, Jens Haarbo, Lars Videbæk, Eva Korup, Gunnar Jensen, Per Hildebrandt, Flemming Hald Steffensen, Niels E Bruun, Hans Eiskjær, Axel Brandes, Anna M Thøgersen, Finn Gustafsson, Kenneth Egstrup, Regitze Videbæk, Christian Hassager, Jesper H Svendsen, Dan E Høfsten, Christian Torp-Pedersen & 2 andre Steen Pehrson, DANISH Investigators

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Resumé

Background The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT). Methods In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death. Results After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29). Conclusions In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).

OriginalsprogEngelsk
TidsskriftThe New England Journal of Medicine
Vol/bind375
Udgave nummer13
Sider (fra-til)1221-1230
ISSN0028-4793
DOI
StatusUdgivet - 2016

Fingeraftryk

Systolic Heart Failure
Implantable Defibrillators
Coronary Artery Disease
Cardiac Resynchronization Therapy
Control Groups
Cause of Death
Confidence Intervals

Citer dette

Køber, L., Thune, J. J., Nielsen, J. C., Haarbo, J., Videbæk, L., Korup, E., ... DANISH Investigators (2016). Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. The New England Journal of Medicine, 375(13), 1221-1230. https://doi.org/10.1056/NEJMoa1608029
Køber, Lars ; Thune, Jens J ; Nielsen, Jens C ; Haarbo, Jens ; Videbæk, Lars ; Korup, Eva ; Jensen, Gunnar ; Hildebrandt, Per ; Hald Steffensen, Flemming ; Bruun, Niels E ; Eiskjær, Hans ; Brandes, Axel ; Thøgersen, Anna M ; Gustafsson, Finn ; Egstrup, Kenneth ; Videbæk, Regitze ; Hassager, Christian ; Svendsen, Jesper H ; Høfsten, Dan E ; Torp-Pedersen, Christian ; Pehrson, Steen ; DANISH Investigators. / Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. I: The New England Journal of Medicine. 2016 ; Bind 375, Nr. 13. s. 1221-1230.
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title = "Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure",
abstract = "Background The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT). Methods In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35{\%}) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58{\%} of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death. Results After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6{\%}) in the ICD group and in 131 patients (23.4{\%}) in the control group (hazard ratio, 0.87; 95{\%} confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3{\%}) in the ICD group and in 46 patients (8.2{\%}) in the control group (hazard ratio, 0.50; 95{\%} CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9{\%}) in the ICD group and in 20 patients (3.6{\%}) in the control group (P=0.29). Conclusions In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).",
keywords = "Journal Article",
author = "Lars K{\o}ber and Thune, {Jens J} and Nielsen, {Jens C} and Jens Haarbo and Lars Videb{\ae}k and Eva Korup and Gunnar Jensen and Per Hildebrandt and {Hald Steffensen}, Flemming and Bruun, {Niels E} and Hans Eiskj{\ae}r and Axel Brandes and Th{\o}gersen, {Anna M} and Finn Gustafsson and Kenneth Egstrup and Regitze Videb{\ae}k and Christian Hassager and Svendsen, {Jesper H} and H{\o}fsten, {Dan E} and Christian Torp-Pedersen and Steen Pehrson and {DANISH Investigators}",
note = "From [The New England Journal of Medicine, K{\o}ber L., Thune J.J., Nielsen J.C., et al., Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure , Volume No. 375, Page No. 1221-1230 Copyright {\circledC} (2016) Massachusetts Medical Society. Reprinted with permission.",
year = "2016",
doi = "10.1056/NEJMoa1608029",
language = "English",
volume = "375",
pages = "1221--1230",
journal = "The New England Journal of Medicine",
issn = "0028-4793",
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Køber, L, Thune, JJ, Nielsen, JC, Haarbo, J, Videbæk, L, Korup, E, Jensen, G, Hildebrandt, P, Hald Steffensen, F, Bruun, NE, Eiskjær, H, Brandes, A, Thøgersen, AM, Gustafsson, F, Egstrup, K, Videbæk, R, Hassager, C, Svendsen, JH, Høfsten, DE, Torp-Pedersen, C, Pehrson, S & DANISH Investigators 2016, 'Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure', The New England Journal of Medicine, bind 375, nr. 13, s. 1221-1230. https://doi.org/10.1056/NEJMoa1608029

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. / Køber, Lars; Thune, Jens J; Nielsen, Jens C; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Jensen, Gunnar; Hildebrandt, Per; Hald Steffensen, Flemming; Bruun, Niels E; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna M; Gustafsson, Finn; Egstrup, Kenneth; Videbæk, Regitze; Hassager, Christian; Svendsen, Jesper H; Høfsten, Dan E; Torp-Pedersen, Christian; Pehrson, Steen; DANISH Investigators.

I: The New England Journal of Medicine, Bind 375, Nr. 13, 2016, s. 1221-1230.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

AU - Køber, Lars

AU - Thune, Jens J

AU - Nielsen, Jens C

AU - Haarbo, Jens

AU - Videbæk, Lars

AU - Korup, Eva

AU - Jensen, Gunnar

AU - Hildebrandt, Per

AU - Hald Steffensen, Flemming

AU - Bruun, Niels E

AU - Eiskjær, Hans

AU - Brandes, Axel

AU - Thøgersen, Anna M

AU - Gustafsson, Finn

AU - Egstrup, Kenneth

AU - Videbæk, Regitze

AU - Hassager, Christian

AU - Svendsen, Jesper H

AU - Høfsten, Dan E

AU - Torp-Pedersen, Christian

AU - Pehrson, Steen

AU - DANISH Investigators

N1 - From [The New England Journal of Medicine, Køber L., Thune J.J., Nielsen J.C., et al., Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure , Volume No. 375, Page No. 1221-1230 Copyright © (2016) Massachusetts Medical Society. Reprinted with permission.

PY - 2016

Y1 - 2016

N2 - Background The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT). Methods In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death. Results After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29). Conclusions In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).

AB - Background The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT). Methods In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death. Results After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29). Conclusions In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).

KW - Journal Article

U2 - 10.1056/NEJMoa1608029

DO - 10.1056/NEJMoa1608029

M3 - Journal article

VL - 375

SP - 1221

EP - 1230

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

IS - 13

ER -