title: Implantable cardioverter/defibrillators for primary prevention in dilated cardiomyopathy post-DANISH: an updated meta-analysis and systematic review of randomized controlled trials.
abstract: BACKGROUND
  Sudden cardiac death (SCD) is frequent in patients with heart failure due to dilated cardiomyopathy (DCM). Implantable cardioverter/defibrillator (ICD) device therapy is currently used for primary prevention. However, publication of the DANISH trial has recently given reason for doubt, showing no significant improvement in all-cause mortality in comparison to contemporary medical therapy.
  
  
  METHODS
  We performed a meta-analysis of all randomized controlled trials comparing ICD therapy to medical therapy (MT) for primary prevention in DCM. The primary outcome was all-cause mortality; secondary analyses were performed on sudden cardiac death, cardiovascular death and non-cardiac death.
  
  
  RESULTS
  Five trials including a total of 2992 patients were included in the pooled analysis. Compared to contemporary medical treatment there was a significant mortality reduction with ICD device therapy [odds ratio (OR) 0.77, 95% confidence interval (CI) 0.64-0.93; p = 0.006]. SCD was decreased significantly (OR 0.43, CI 0.27-0.69; p = 0.0004), while cardiovascular death and non-cardiac death showed no differences. Sensitivity analyses showed no influence of amiodarone therapy on overall results. Analysis of MT details revealed the DANISH population to adhere the most to current guideline recommendations. In addition, it was the only study including a substantial amount of CRT devices (58%).
  
  
  CONCLUSIONS
  Our meta-analysis of all available randomized evidence shows a survival benefit of ICD therapy for primary prevention in DCM. DANISH results suggest an attenuation of this ICD advantage when compared to contemporary medical and cardiac resynchronization therapy. Until larger trials have confirmed this finding, ICD therapy should remain the recommendation for primary prevention of SCD in DCM.
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany. georg.wolff@med.uni-duesseldorf.de.
authors.forename: Georg
authors.initials: G
authors.lastname: Wolff
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Yingfeng
authors.initials: Y
authors.lastname: Lin
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karathanos
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Brockmeyer
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Wolters
authors.affiliation: Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Nowak
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.|Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Fürnkranz
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Hisaki
authors.initials: H
authors.lastname: Makimoto
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Malte
authors.initials: M
authors.lastname: Kelm
authors.affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Schulze
mesh_terms: D002311:Cardiomyopathy, Dilated / Q000150:complications / Q000175:diagnosis / Q000628:therapy; D002423:Cause of Death / Q000639:trends; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D017147:Defibrillators, Implantable; D005858:Germany / Q000453:epidemiology; D006333:Heart Failure / Q000150:complications / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D015994:Incidence; D011322:Primary Prevention / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D015996:Survival Rate / Q000639:trends
keywords: Dilated cardiomyopathy; Heart failure; ICD; Implantable defibrillator; Meta-analysis