Defibrillator implantation in patients with nonischemic systolic heart failure
Open accessAbstract
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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A large prospective study of transplanted patients indicated a decreased likelihood of 10-year survival in those with diabetes.
“Heart transplantation could be considered in end-stage HF, but a large, prospective study of transplanted patients indicated a decreased likelihood of 10-year survival in those with diabetes.526”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [526]
In the DANISH trial, there was no significant difference in treatment effect in patients with and without T2DM (HRs 0.92 and 0.85, respectively, interaction P=0.60).
“In pre-specified subgroup analysis, there was no significant difference in treatment effect in patients with and without T2DM (HRs 0.92 and 0.85, respectively, interaction P=0.60).”
From Type 2 diabetes mellitus and heart failure: A position statement from the Heart Failure Association of the European Society of Cardiology (2018) · cites this paper as [166]
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Self-citation
- 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
- 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
- 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 · 2015: 1
- 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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