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  • Baensch, DietmarUniv Hosp Rostock, Dept Internal Med 1, Div Cardiol, Heart Ctr Rostock, D-18057 Rostock, Germany. (author)

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators : the NORDIC ICD randomized clinical trial

  • Article/chapterEnglish2015

Publisher, publication year, extent ...

  • 2015-06-25
  • Oxford University Press (OUP),2015
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-265831
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-265831URI
  • https://doi.org/10.1093/eurheartj/ehv292DOI
  • https://lup.lub.lu.se/record/7477846URI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • 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 210%). 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.

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  • Bonnemeier, HendrikUniv Hosp Schleswig Holstein, Dept Internal Med Cardiol & Angiol 3, Kiel, Germany. (author)
  • Brandt, JohanLund University,Lunds universitet,Thoraxkirurgi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Thoracic Surgery,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skane Univ Hosp, Arrhythmia Dept, Lund, Sweden.(Swepub:lu)thor-jbr (author)
  • Bode, FrankUniv Hosp Schleswig Holstein, Med Clin Cardiol Angiol & Intens Care Med 2, Lubeck, Germany. (author)
  • Svendsen, Jesper HastrupCopenhagen Univ Hosp, Rigshosp, Dept Cardiol, Ctr Heart, Copenhagen, Denmark.;Univ Copenhagen, Danish Arrhythmia Res Ctr, Copenhagen, Denmark. (author)
  • Taborsky, MilosFac Hosp Olomouc, Dept Internal Med Cardiol 1, Olomouc, Czech Republic. (author)
  • Kuster, StefanDRK Hosp Molln Ratzeburg, Dept Internal Med, Cardiol, Ratzeburg, Germany. (author)
  • Blomström-Lundqvist, CarinaUppsala universitet,Kardiologi-arrytmi(Swepub:uu)carinabl (author)
  • Felk, AngelikaBiotronik, Berlin, Germany. (author)
  • Hauser, TinoBiotronik, Berlin, Germany. (author)
  • Suling, AnnaUniv Med Ctr Hamburg Eppendorf, Dept Med Biometry & Epidemiol, Hamburg, Germany. (author)
  • Wegscheider, KarlUniv Med Ctr Hamburg Eppendorf, Dept Med Biometry & Epidemiol, Hamburg, Germany. (author)
  • Univ Hosp Rostock, Dept Internal Med 1, Div Cardiol, Heart Ctr Rostock, D-18057 Rostock, Germany.Univ Hosp Schleswig Holstein, Dept Internal Med Cardiol & Angiol 3, Kiel, Germany. (creator_code:org_t)

Related titles

  • In:European Heart Journal: Oxford University Press (OUP)36:37, s. 2500-25070195-668X1522-9645

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