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. / Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan; Bode, Frank; Svendsen, Jesper Hastrup; Táborský, Miloš; Kuster, Stefan; Blomström-Lundqvist, Carina; Felk, Angelika; Hauser, Tino; Suling, Anna; Wegscheider, Karl; NORDIC ICD Trial Investigators.

in: EUR HEART J, Jahrgang 36, Nr. 37, 01.10.2015, S. 2500-2507.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

Harvard

Bänsch, D, Bonnemeier, H, Brandt, J, Bode, F, Svendsen, JH, Táborský, M, Kuster, S, Blomström-Lundqvist, C, Felk, A, Hauser, T, Suling, A, Wegscheider, K & NORDIC ICD Trial Investigators 2015, 'Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial', EUR HEART J, Jg. 36, Nr. 37, S. 2500-2507. https://doi.org/10.1093/eurheartj/ehv292

APA

Bänsch, D., Bonnemeier, H., Brandt, J., Bode, F., Svendsen, J. H., Táborský, M., Kuster, S., Blomström-Lundqvist, C., Felk, A., Hauser, T., Suling, A., Wegscheider, K., & NORDIC ICD Trial Investigators (2015). Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial. EUR HEART J, 36(37), 2500-2507. https://doi.org/10.1093/eurheartj/ehv292

Vancouver

Bibtex

@article{9f0fa6fd176c4f6f8e97ff8be6791251,
title = "Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial",
abstract = "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.",
author = "Dietmar B{\"a}nsch and Hendrik Bonnemeier and Johan Brandt and Frank Bode and Svendsen, {Jesper Hastrup} and Milo{\v s} T{\'a}borsk{\'y} and Stefan Kuster and Carina Blomstr{\"o}m-Lundqvist and Angelika Felk and Tino Hauser and Anna Suling and Karl Wegscheider and {NORDIC ICD Trial Investigators}",
note = "{\textcopyright} The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.",
year = "2015",
month = oct,
day = "1",
doi = "10.1093/eurheartj/ehv292",
language = "English",
volume = "36",
pages = "2500--2507",
journal = "EUR HEART J",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "37",

}

RIS

TY - JOUR

T1 - Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial

AU - Bänsch, Dietmar

AU - Bonnemeier, Hendrik

AU - Brandt, Johan

AU - Bode, Frank

AU - Svendsen, Jesper Hastrup

AU - Táborský, Miloš

AU - Kuster, Stefan

AU - Blomström-Lundqvist, Carina

AU - Felk, Angelika

AU - Hauser, Tino

AU - Suling, Anna

AU - Wegscheider, Karl

AU - NORDIC ICD Trial Investigators

N1 - © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - 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.

AB - 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.

UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589656/pdf/ehv292.pdf

U2 - 10.1093/eurheartj/ehv292

DO - 10.1093/eurheartj/ehv292

M3 - SCORING: Journal article

C2 - 26112885

VL - 36

SP - 2500

EP - 2507

JO - EUR HEART J

JF - EUR HEART J

SN - 0195-668X

IS - 37

ER -