The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation

Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan; Bode, Frank; Svendsen, Jesper Hastrup; Felk, Angelika; Hauser, Tino; Wegscheider, Karl

doi:10.1093/europace/euu161

Cited by 13 publications

(13 citation statements)

References 17 publications

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“…The study design and statistical considerations have been described in detail elsewhere. 13 Briefly, patients with an indication for ICD implantation according to the current European Society of Cardiology guidelines were included. Patients with hypertrophic or arrhythmogenic right ventricular cardiomyopathy were excluded because of special considerations necessary during ICD implantation.…”

Section: Methodsmentioning

confidence: 99%

“…Further inclusion and exclusion criteria are depicted in the design paper. 13 One thousand and seventy-seven patients were randomized (1 : 1) to first time ICD implantation with or without DF testing during the procedure. Patients were followed for at least 12 months through regular on-site visits, and remotely via Home Monitoring ® (HM; Biotronik SE & Co. KG, Berlin, Germany).…”

Section: Methodsmentioning

confidence: 99%

“…A standard DF testing protocol was used by all participating centres, as described previously. 13 Briefly, the initial shock for DF was programmed to 15 J. If successful, DF testing was terminated.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2015

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AimsThis 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 resultsBetween 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).ConclusionDefibrillation 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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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

et al. 2015

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“…However, small patient groups that might have a higher risk for ineffective shock deliveries such as patients with hypertrophic cardiomyopathy might not be sufficiently encompassed in this study. The results of the NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC‐ICD) trial, also randomized, further underlined that intraoperative defibrillation testing during routine left‐sided ICD implantation does not improve defibrillation efficacy …”

Section: Discussionmentioning

confidence: 99%

“…The results of the NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC-ICD) trial, also randomized, further underlined that intraoperative defibrillation testing during routine left-sided ICD implantation does not improve defibrillation efficacy. 20,21 Ineffective Shock Deliveries of the S-ICD System Ineffective shock deliveries have been described in the literature. These episodes can also occur in patients who undergo successful intraoperative defibrillation testing.…”

Section: Defibrillation Testing In Patients With Transvenous Icd Systemsmentioning

confidence: 99%

Intraoperative Defibrillation Testing of Subcutaneous Implantable Cardioverter‐Defibrillator Systems—A Simple Issue?

Frommeyer

Zumhagen

Dechering

et al. 2016

JAHA

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BackgroundThe results of the recently published randomized SIMPLE trial question the role of routine intraoperative defibrillation testing. However, testing is still recommended during implantation of the entirely subcutaneous implantable cardioverter‐defibrillator (S‐ICD) system. To address the question of whether defibrillation testing in S‐ICD systems is still necessary, we analyzed the data of a large, standard‐of‐care prospective single‐center S‐ICD registry.Methods and ResultsIn the present study, 102 consecutive patients received an S‐ICD for primary (n=50) or secondary prevention (n=52). Defibrillation testing was performed in all except 4 patients. In 74 (75%; 95% CI 0.66–0.83) of 98 patients, ventricular fibrillation was effectively terminated by the first programmed internal shock. In 24 (25%; 95% CI 0.22–0.44) of 98 patients, the first internal shock was ineffective and further internal or external shock deliveries were required. In these patients, programming to reversed shock polarity (n=14) or repositioning of the sensing lead (n=1) or the pulse generator (n=5) led to successful defibrillation. In 4 patients, a safety margin of <10 J was not attained. Nevertheless, in these 4 patients, ventricular arrhythmias were effectively terminated with an internal 80‐J shock.ConclusionsAlthough it has been shown that defibrillation testing is not necessary in transvenous ICD systems, it seems particular important for S‐ICD systems, because in nearly 25% of the cases the primary intraoperative test was not successful. In most cases, a successful defibrillation could be achieved by changing shock polarity or by optimizing the shock vector caused by the pulse generator or lead repositioning.

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Release of high-sensitive TROPonin T by implantation of an entirely subcutaneous Implantable Cardioverter-defibrillator compared to a conventional transvenous approach: the TROPIC registry

Weigand

O’Connor

Blažek

et al. 2020

J Interv Card Electrophysiol

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The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation

Abstract: NCT01282918.

Cited by 13 publications

References 17 publications

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

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

Intraoperative Defibrillation Testing of Subcutaneous Implantable Cardioverter‐Defibrillator Systems—A Simple Issue?

Release of high-sensitive TROPonin T by implantation of an entirely subcutaneous Implantable Cardioverter-defibrillator compared to a conventional transvenous approach: the TROPIC registry

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