AIMS: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. METHODS AND RESULTS: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). CONCLUSION: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.

Arrhythmia Department Skane University Hospital Lund Sweden

Biotronik Berlin Germany

Department of Cardiology Uppsala University Uppsala Sweden

Department of Internal Medicine 1 Cardiology Faculty Hospital Olomouc Olomouc Czech Republic

Department of Internal Medicine 3 Cardiology and Angiology University Hospital Schleswig Holstein Campus Kiel Kiel Germany

Department of Internal Medicine Cardiology DRK Hospital Mölln Ratzeburg Ratzeburg Germany

Department of Medical Biometry and Epidemiology University Medical Center Hamburg Eppendorf Hamburg Germany

Heart Center Department of Cardiology Rigshospitalet Copenhagen University Hospital Copenhagen Denmark Danish Arrhythmia Research Centre University of Copenhagen Copenhagen Denmark

Heart Center Rostock Department of Internal Medicine 1 Divisions of Cardiology University Hospital Rostock Ernst Heydemann Str 6 Rostock 18057 Germany

Medical Clinic 2 Cardiology Angiology and Intensive Care Medicine University Hospital Schleswig Holstein Campus Lübeck Lübeck Germany

Nat Rev Cardiol. 2015 Sep;12(9):501. doi: 10.1038/nrcardio.2015.111. PubMed

Eur Heart J. 2015 Oct 1;36(37):2508-9. doi: 10.1093/eurheartj/ehv324. PubMed

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