title: Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Heart Center Rostock, Department of Internal Medicine I, Divisions of Cardiology, University Hospital Rostock, Ernst-Heydemann-Str. 6, Rostock 18057, Germany dietmar.baensch@med.uni-rostock.de.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Bänsch
authors.affiliation: Department of Internal Medicine III Cardiology and Angiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Bonnemeier
authors.affiliation: Arrhythmia Department, Skane University Hospital, Lund, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Brandt
authors.affiliation: Medical Clinic II Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Bode
authors.affiliation: Heart Center, Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark Danish Arrhythmia Research Centre, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jesper Hastrup
authors.initials: JH
authors.lastname: Svendsen
authors.affiliation: Department of Internal Medicine I Cardiology, Faculty Hospital Olomouc, Olomouc, Czech Republic.
authors.forename: Miloš
authors.initials: M
authors.lastname: Táborský
authors.affiliation: Department of Internal Medicine, Cardiology, DRK Hospital Mölln-Ratzeburg, Ratzeburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Kuster
authors.affiliation: Department of Cardiology, Uppsala University, Uppsala, Sweden.
authors.forename: Carina
authors.initials: C
authors.lastname: Blomström-Lundqvist
authors.affiliation: Biotronik, Berlin, Germany.
authors.forename: Angelika
authors.initials: A
authors.lastname: Felk
authors.affiliation: Biotronik, Berlin, Germany.
authors.forename: Tino
authors.initials: T
authors.lastname: Hauser
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Suling
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
mesh_terms: D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000592:standards*; D004554:Electric Countershock / Q000009:adverse effects / Q000592:standards*; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000379:methods* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013610:Tachycardia / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
keywords: Defibrillation testing; Implantable cardioverter-defibrillator