Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

Lars Køber; Jens Jakob Thune; Jens C. Nielsen; Jens Haarbo; Lars Videbaek; Eva Korup; Gunnar Myrup Jensen; Per Hildebrandt; Flemming Hald-Steffensen; Niels Eske Bruun; Hans Eiskjær; Axel Brandes; Anna Margrethe Thøgersen; Finn Gustafsson; Kenneth Egstrup; Regitze Videbæk; Christian Hassager; Jesper H Svendsen; Dan Eik Hoefsten; Christian Torp-Pedersen; Steen Pehrson; DANISH Investigators

doi:10.1056/nejmoa1608029

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

Lars Køber, Jens Jakob Thune, Jens C. Nielsen, Jens Haarbo, Lars Videbaek, Eva Korup, Gunnar Myrup Jensen, Per Hildebrandt, Flemming Hald-Steffensen, Niels Eske Bruun, Hans Eiskjær, Axel Brandes, Anna Margrethe Thøgersen, Finn Gustafsson, Kenneth Egstrup, Regitze Videbæk, Christian Hassager, Jesper H Svendsen, Dan Eik Hoefsten, Christian Torp-PedersenSteen Pehrson, DANISH Investigators

Institut for Klinisk Medicin

768 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	New England Journal of Medicine
Vol/bind	375
Udgave nummer	13
Sider (fra-til)	1221-1230
Antal sider	10
ISSN	0028-4793
DOI	https://doi.org/10.1056/nejmoa1608029
Status	Udgivet - 29 sep. 2016

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Køber, L., Thune, J. J., Nielsen, J. C., Haarbo, J., Videbaek, L., Korup, E., Jensen, G. M., Hildebrandt, P., Hald-Steffensen, F., Bruun, N. E., Eiskjær, H., Brandes, A., Thøgersen, A. M., Gustafsson, F., Egstrup, K., Videbæk, R., Hassager, C., Svendsen, J. H., Hoefsten, D. E., ... DANISH Investigators (2016). Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. New England Journal of Medicine, 375(13), 1221-1230. https://doi.org/10.1056/nejmoa1608029

Køber, L, Thune, JJ, Nielsen, JC, Haarbo, J, Videbaek, L, Korup, E, Jensen, GM, Hildebrandt, P, Hald-Steffensen, F, Bruun, NE, Eiskjær, H, Brandes, A, Thøgersen, AM, Gustafsson, F, Egstrup, K, Videbæk, R, Hassager, C, Svendsen, JH, Hoefsten, DE, Torp-Pedersen, C, Pehrson, S & DANISH Investigators 2016, 'Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure', New England Journal of Medicine, bind 375, nr. 13, s. 1221-1230. https://doi.org/10.1056/nejmoa1608029

@article{252ac339a8614d9aaea517d94012d319,

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.",

keywords = "Aged, Cardiac Pacing, Artificial, Cardiovascular Diseases, Death, Sudden, Cardiac, Defibrillators, Implantable, Electrocardiography, Female, Follow-Up Studies, Heart Failure, Systolic, Humans, Male, Middle Aged, Mortality, Stroke Volume, Journal Article, Multicenter Study, Randomized Controlled Trial",

author = "Lars K{\o}ber and Thune, {Jens Jakob} and Nielsen, {Jens C.} and Jens Haarbo and Lars Videbaek and Eva Korup and Jensen, {Gunnar Myrup} and Per Hildebrandt and Flemming Hald-Steffensen and Bruun, {Niels Eske} and Hans Eiskj{\ae}r and Axel Brandes and Th{\o}gersen, {Anna Margrethe} and Finn Gustafsson and Kenneth Egstrup and Regitze Videb{\ae}k and Christian Hassager and Svendsen, {Jesper H} and Hoefsten, {Dan Eik} and Christian Torp-Pedersen and Steen Pehrson and {DANISH Investigators}",

year = "2016",

month = sep,

day = "29",

doi = "10.1056/nejmoa1608029",

language = "English",

volume = "375",

pages = "1221--1230",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "13",

}

TY - JOUR

T1 - Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

AU - Køber, Lars

AU - Thune, Jens Jakob

AU - Nielsen, Jens C.

AU - Haarbo, Jens

AU - Videbaek, Lars

AU - Korup, Eva

AU - Jensen, Gunnar Myrup

AU - Hildebrandt, Per

AU - Hald-Steffensen, Flemming

AU - Bruun, Niels Eske

AU - Eiskjær, Hans

AU - Brandes, Axel

AU - Thøgersen, Anna Margrethe

AU - Gustafsson, Finn

AU - Egstrup, Kenneth

AU - Videbæk, Regitze

AU - Hassager, Christian

AU - Svendsen, Jesper H

AU - Hoefsten, Dan Eik

AU - Torp-Pedersen, Christian

AU - Pehrson, Steen

AU - DANISH Investigators

PY - 2016/9/29

Y1 - 2016/9/29

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.

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.

KW - Aged

KW - Cardiac Pacing, Artificial

KW - Cardiovascular Diseases

KW - Death, Sudden, Cardiac

KW - Defibrillators, Implantable

KW - Electrocardiography

KW - Female

KW - Follow-Up Studies

KW - Heart Failure, Systolic

KW - Humans

KW - Male

KW - Middle Aged

KW - Mortality

KW - Stroke Volume

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

U2 - 10.1056/nejmoa1608029

DO - 10.1056/nejmoa1608029

M3 - Journal article

C2 - 27571011

SN - 0028-4793

VL - 375

SP - 1221

EP - 1230

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 13

ER -

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

Abstract

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