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 P.; Blomström‐Lundqvist, Carina; Felk, Angelika; Hauser, Tino; Suling, Anna; Wegscheider, Karl

doi:10.1093/eurheartj/ehv292

Cited by 102 publications

(75 citation statements)

References 27 publications

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“…However, EEG recovery occurs within less than 30 seconds, with a [216] 540 DT ICD shocks were programmed to 40 J in all patients. Primary endpoint: first shock efficacy for all true VT and fibrillation episodes during 22.8 months of follow-up.…”

Section: Dt-related Complicationsmentioning

confidence: 99%

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

et al. 2016

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Section: Dt-related Complicationsmentioning

confidence: 99%

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

et al. 2016

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“…39 Defibrillation efficacy was not different between both groups during followup. Similarly, in the SIMPLE trial of 2500 patients, routine defibrillation testing did not result in a reduction in arrhythmic deaths during a mean follow-up of 3.1 years.…”

Section: Implantable Cardioverter Defibrillator Therapy and Implant-bmentioning

confidence: 85%

“…The development for more advanced systems is ongoing, including dual- Implantable cardioverter defibrillator testing is no longer necessary during routine and uncomplicated ICD implantation: in the Nordic ICD Trial, 1077 patients were randomly assigned to first time ICD implantation with (n = 540) or without (n = 537) testing of defibrillation threshold. 39 Defibrillation efficacy was not different between both groups during followup. Similarly, in the SIMPLE trial of 2500 patients, routine defibrillation testing did not result in a reduction in arrhythmic deaths during a mean follow-up of 3.1 years.…”

Section: Leadless Pacemakersmentioning

confidence: 85%

The year in cardiology 2015: arrhythmias and device therapy.

2016

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nor in 2015. Rotor ablation using contact phase mapping has been questioned, 10 and CAFÉ ablation is not specific enough to be convincing as demonstrated by a large meta-analysis. 11 In contrast, lifestyle modification such as weight loss is remarkably effective in reducing AF burden (10% loss translates into a sixfold AF burden reduction) and in inducing reverse remodelling on left atrial size and left ventricular septal thickness. 12 Stroke preventionDue to the results from large-scale clinical trials, the nonvitamin K antagonist oral anticoagulants (NOACs) are the preferred treatment for stroke prevention in non-valvular AF, as reflected in current ESC guidelines. 13 As the fourth NOAC, edoxaban has been approved in 2015 in many countries including the USA, Switzerland, and Europe based on the results of the ENGAGE AF-TIMI 48 trial.14 During the year 2015, several subgroup analyses of the large NOAC trials have surfaced, including bleeding management and outcome with apixaban, 15 the management of rivaroxaban around catheter ablation for AF (VENTURE-AF), 16 and the outcome of amiodarone co-medication in patients receiving edoxaban, 17 to name just a few. Virtually, all subgroups of the large NOAC trials indicate a consistent benefit and safety of these drugs compared with warfarin, further underlining their overall superiority. This is supported by important realworld data (including those from a prospective registry with rivaroxaban, XANTUS) 18 indicating efficacy and safety, which is in line with that observed in the randomized clinical trials.Arguably, the most exciting novelty in the field of NOACs comes from the development of specific reversal agents ('antidotes'). In a Phase 1 study in healthy men, the monoclonal antibody idarucizumab (specific for dabigatran) was well tolerated with no unexpected or clinically relevant safety concerns, and was associated with immediate, complete, and sustained reversal of dabigatran-induced anticoagulation. 19 Moreover, in a Phase 3 study, idarucizumab was demonstrated to effectively and immediately reverse the anticoagulant effect of dabigatran in patients presenting with serious bleeding or requiring an urgent procedure. 20 As a result, the US Food and Drug Administration has approved the drug in October 2015; the Committee for Medicinal Products for Human Use of the European Medicines Agency has also recently issued a positive opinion, and approval is expected by the end of this year or early 2016. Importantly, idarucizumab is ineffective against Xa-inhibitors; instead, different directly acting antidotes are being developed, including andexanet alfa and PER977. First results are also positive with these agents, and larger-scale clinical trials are anticipated within the year 2016. While these drugs clearly represent an important addition to our portfolio, many aspects in the practical use remain to be determined, including the type of patients and conditions requiring reversal and the time of reinstitution of anticoagulation. These and other issues are elegantly...

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“…10,12) The SIMPLE trial is a single blind, randomized, multicenter trial, evaluating the non-inferiority of non-testing versus testing using a composite outcome of arrhythmic death or failed appropriate shocks for ventricular arrhythmias. From its study, the authors concluded that routine DFT testing at the time of the ICD implantation is generally well tolerated but does not improve the shock efficacy or reduce the arrhythmic death.…”

Section: Discussionmentioning

confidence: 99%

Impact of the Relationship between the Defibrillation Threshold (DFT) and Clinical Outcomes in Recipients of Modern Era Implantable Cardioverter Defibrillator (ICD)

et al. 2017

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SummaryDefibrillation threshold (DFT) testing during implantable cardioverter defibrillator (ICD) implantations is considered necessary for appropriate shock therapy and to measure the safety margin. However, the relationship between the DFT with modern era devices and the clinical outcome, including the total mortality is limited, which may lead to DFT testing itself being questioned. This study aimed to evaluate the relationship between the DFT and clinical outcome in ICD recipients.We enrolled 81 consecutive patients (66 males, aged 64.6 ± 13.8 years) who received an ICD implantation and underwent DFT testing. The DFT was measured with a step-by-step method in the patients upon implant. Further, we evaluated the relationship between the DFT and the clinical outcome, which included major cardiac adverse events and any cause of death.The mean DFT was 11.6 ± 9.24J in total. In 40 patients (49.4%), VF was terminated by a low output (5J), whereas 11 patients (13.6%) had a high DFT. The rates of atrial fibrillation were significantly higher in the high DFT group (63.6% versus 24.2%, P = 0.007). During the observational period (median 432 days; range from 151 days to 1146 days), the incidence of clinical events occurred in 22 patients (27.2%) in total. In a multivariate analysis, a high DFT was the only predictive factor for the incidence of the clinical outcome (OR 4.54, 95% CI 1.03-21.9, P = 0.045).(Int Heart J 2017; 58: 874-879) Key words: Defibrillation threshold testing, Major adverse cardiac events, High DFT I mplantable cardioverter defibrillators (ICDs) have been shown to reduce the total mortality when used for the primary and secondary prevention of sudden cardiac death (SCD). 1,2) Therefore, ICD implantations play a key role in patients who have a risk of SCD. Defibrillation threshold (DFT) testing is performed after the ICD implantation to assure adequate sensing and defibrillation of ventricular fibrillation (VF). However, previous reports showed that the DFT testing during ICD implantations is neither effective nor beneficial. 3-9) The SIMPLE trial 10) is a single-blind, randomized, multicenter, non-inferiority trial comparing the efficacy and safety of ICD implantations with DFT or without DFT testing. Recently it demonstrated that a routine DFT test at the time of the ICD implantation does not improve shock efficacy or reduce arrhythmic death. However, Ziegelhoeffer, et al. reported that intraoperative DFT testing might still be recommended because the previous prospective clinical trials were limited to de novo implants of high-energy generators and neglected a large number of patients already implanted with an ICD system. 11) Furthermore, the determination of the actual DFT enables lower energy shocks and thus potentially reduces the energy required for defibrillation, shortens the charging time, reduces the risk of loss of consciousness, and decreases the myocardial damage.In the present study, we enrolled various types of ICD recipients (an initial ICD or cardiac resynchronization therapy devices...

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

Cited by 102 publications

References 27 publications

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

The year in cardiology 2015: arrhythmias and device therapy.

Impact of the Relationship between the Defibrillation Threshold (DFT) and Clinical Outcomes in Recipients of Modern Era Implantable Cardioverter Defibrillator (ICD)

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