{"id":"26e9b1c7b098","type":"article","url":"https://hartvaat.nl/2016/09/29/icd-implantatie-bij-niet-ischemisch-systolisch-hartfalen-nejm-danish-trial/","title":"ICD-implantatie bij niet-ischemisch systolisch hartfalen: NEJM DANISH-trial","title_en":"Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1608029","source_url":"https://doi.org/10.1056/NEJMoa1608029","authors":["Lars Køber","Jens J Thune","Jens C Nielsen","Jens Haarbo","Lars Videbæk","Eva Korup","Gunnar Jensen","Per Hildebrandt","Flemming H 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","Steen Pehrson"],"significance":10,"published":"2016-09-29","source_date":"2016-09-29","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/icd-bij-hartfalen/","https://hartvaat.nl/kennis/diagnostiek/cardiale-mri/"],"congress":"","summary_en":"The DANISH trial found that prophylactic ICD implantation did not significantly reduce all-cause mortality in patients with nonischemic systolic heart failure, though there was a reduction in sudden cardiac death. This result challenged the routine use of primary prevention ICDs in dilated cardiomyopathy and reshaped clinical decision-making for device therapy.","created":"2026-07-03T10:26:19Z","updated":"2026-07-03T13:25:39Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Landmark NEJM DANISH-trial die onderzocht of ICD-implantatie de mortaliteit vermindert bij patiënten met niet-ischemisch systolisch hartfalen. Bepalend voor de ICD-indicatiestelling bij dilaterande cardiomyopathie.","abstract_original":"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 .)."}