Cited by 1,763Cardiac pacing and defibrillation studiesCardiac Arrest and ResuscitationHeart Failure Treatment and Management

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Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

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Køber, Lars, Thune, Jens J., Nielsen, Jens C., Haarbo, Jens, Videbæk, Lars, Korup, Eva, Jensen, Gunnar, Hildebrandt, Per, Steffensen, Flemming H., 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·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1608029

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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 .).

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Corrigendum to: 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC.
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Authors: Køber, L., Thune, J. J., Nielsen, J. C., Haarbo, J., Videbæk, L., Korup, E., Jensen, G., Hildebrandt, P., Steffensen, F. H., Bruun, N. E., Eiskjær, H., Brandes, A., Thøgersen, A. M., Gustafsson, F., Egstrup, K., Videbæk, R., Hassager, C., Svendsen, J. H., Høfsten, D. E., Torp-Pedersen, C., & Pehrson, S.
Affiliations: University of Copenhagen (DK)
ORCID: Køber, Lars
Thune, Jens J.
Nielsen, Jens C.
Videbæk, Lars
Steffensen, Flemming H.
Bruun, Niels E.
Eiskjær, Hans
Brandes, Axel
Thøgersen, Anna M.
Gustafsson, Finn
Egstrup, Kenneth
Hassager, Christian
Svendsen, Jesper H.
Høfsten, Dan E.
Torp-Pedersen, Christian
Pehrson, Steen
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-09-29
Volume: 375
Issue: 13
Pages: 1221-1230
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1608029
OpenAlex: W2518530324
Cited by: 1,763
References: 18
Citations by year: 2026: 104 · 2025: 138 · 2024: 139 · 2023: 170 · 2022: 182 · 2021: 177 · 2020: 196 · 2019: 212 · 2018: 200 · 2017: 213 · 2016: 28
FWCI: 179.55
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, other-oa)
Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Scopus (Elsevier) (submittedVersion)
VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
Funders: Bristol-Myers Squibb
Pfizer
AstraZeneca
Sanofi
Gilead Sciences
Hjerteforeningen
Boston Scientific Corporation
TrygFonden
Servier
St. Jude Medical
Biosense Webster
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
Health Sciences › Medicine › Emergency Medicine › Cardiac Arrest and Resuscitation
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Keywords: implantable cardioverter-defibrillator, prophylactic ICD, heart failure with reduced ejection fraction, non-ischemic heart failure, sudden cardiac death, all-cause mortality, cardiac resynchronization therapy, device-related infection, left ventricular ejection fraction, DANISH trial
MeSH terms: Aged, Cardiac Pacing, Artificial, Cardiovascular Diseases, Electrocardiography, Female, Follow-Up Studies, Humans, Male, Middle Aged, Mortality, Stroke Volume, Death, Sudden, Cardiac, Defibrillators, Implantable, Heart Failure, Systolic

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Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

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