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

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

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

Bonnemeier, Hendrik (author): Univ Hosp Schleswig Holstein, Dept Internal Med Cardiol & Angiol 3, Kiel, Germany.

Brandt, Johan (author): Lund 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.

Bode, Frank (author): Univ Hosp Schleswig Holstein, Med Clin Cardiol Angiol & Intens Care Med 2, Lubeck, Germany.

Svendsen, Jesper Hastrup (author): Copenhagen Univ Hosp, Rigshosp, Dept Cardiol, Ctr Heart, Copenhagen, Denmark.;Univ Copenhagen, Danish Arrhythmia Res Ctr, Copenhagen, Denmark.

Taborsky, Milos (author): Fac Hosp Olomouc, Dept Internal Med Cardiol 1, Olomouc, Czech Republic.

Kuster, Stefan (author): DRK Hosp Molln Ratzeburg, Dept Internal Med, Cardiol, Ratzeburg, Germany.

Blomström-Lundqvist, Carina (author): Uppsala universitet,Kardiologi-arrytmi

Felk, Angelika (author): Biotronik, Berlin, Germany.

Hauser, Tino (author): Biotronik, Berlin, Germany.

Suling, Anna (author): Univ Med Ctr Hamburg Eppendorf, Dept Med Biometry & Epidemiol, Hamburg, Germany.

Wegscheider, Karl (author): Univ Med Ctr Hamburg Eppendorf, Dept Med Biometry & Epidemiol, Hamburg, Germany.

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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)

2015-06-25
2015
English.
In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 36:37, s. 2500-2507

Related links:: https://doi.org/10.1...; show more...; http://www.ncbi.nlm....; https://academic.oup...; https://portal.resea... (primary) (free); http://www.ncbi.nlm.... (free); http://dx.doi.org/10... (free); https://urn.kb.se/re...; https://doi.org/10.1...; https://lup.lub.lu.s...; show less...

Journal article (peer-reviewed)

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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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By the author/editor: Baensch, Dietmar; Bonnemeier, Hend ...; Brandt, Johan; Bode, Frank; Svendsen, Jesper ...; Taborsky, Milos; show more...; Kuster, Stefan; Blomström-Lundqv ...; Felk, Angelika; Hauser, Tino; Suling, Anna; Wegscheider, Kar ...; show less...

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cardiac and Card ...

Articles in the publication: European Heart J ...

By the university: Uppsala University; Lund University

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

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