Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE)

Healey, Jeff S.; Hohnloser, Stefan H.; Glikson, Michael; Neuzner, Jörg; Mabo, P.; Viñolas, Xavier; Kautzner, Josef; O’Hara, Gilles; VanErven, Lieselot; Gadler, Fredrik; Pogue, Janice; Appl, Ursula; Gilkerson, J.; Pochet, Thierry; Steín, Kenneth M.; Merkely, Béla; Chrolavicius, Susan; Meeks, Brandi; Földesi, Csaba; Thibault, Bernard; Connolly, Stuart J.

doi:10.1016/s0140-6736(14)61903-6

Cited by 222 publications

(162 citation statements)

References 31 publications

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“…Therefore, in many hospitals, dual-coil leads are favored in patients with HCM. 24 Our study showed the efficacy of a 25-J shock with the SVC coil "off", representing at least a 10-J safety margin for defibrillation.…”

Section: Disclosuresmentioning

confidence: 64%

“…22, 23 Randomized trials have now shown that left-sided ICD implantation without DFT testing is non-inferior to implantation with DFT testing. 22, 24 In addition, shock therapy may adversely affect prognosis, whether appropriate or inappropriate, although controversy persists as to whether that reflects a greater degree of underlying illness or a primary shock effect. Relationship between shock impedance and shock pulse width.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Single-Coil Defibrillator Leads Yield Satisfactory Defibrillation Safety Margin in Hypertrophic Cardiomyopathy

Okamura

Friedman

Inoue

et al. 2016

Circ J

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Section: Disclosuresmentioning

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Single-Coil Defibrillator Leads Yield Satisfactory Defibrillation Safety Margin in Hypertrophic Cardiomyopathy

Okamura

Friedman

Inoue

et al. 2016

Circ J

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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%

“…However, previous reports showed that the DFT testing during ICD implantations is neither effective nor beneficial. [3][4][5][6][7][8][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.…”

mentioning

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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“…In recent years, the advent of the biphasic waveform, better understanding of optimal shock waveform/duration, and higher-shock energy devices, have led some to question the need for defibrillation testing (DFT) [1]. Furthermore, controversy over whether to perform DFT has focused on possible adverse clinical events [1][2][3][4]. A prior systematic review by Phan et al [5] demonstrates no significant benefit for DFT in terms of mortality, ICD efficacy or 30-day post-implant complications.…”

Section: Introductionmentioning

confidence: 99%

Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

Bonanno

Rossillo

Paccanaro

et al. 2017

ijcp

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Introduction: There is an ongoing debate regarding the need to conduct intraoperative defibrillation testing (DFT) at the time of implantable cardioverter-defibrillator (ICD) implantation. To provide sufficiently strong evidence for the feasibility of omitting intraoperative DFT in clinical practice, we conducted a meta-analysis of randomized controlled trials (RCT) comparing patients with DFT and no-DFT. Methods: We systematically searched Medline (via PubMed), ClinicalTrial.gov, the Cochrane Central Register of Controlled Trials, and Embase for studies evaluating DFT vs. no-DFT on ICD implantation with regard to total mortality and arrhythmic death, efficacy of first and any appropriate shock in interrupting ventricular tachycardia (VT)/ ventricular fibrillation (VF), and procedural adverse events. Effect estimates [risk ratio (RR) with 95% confidence intervals (CI)] were pooled using the random-effects model. Results: Our meta-analysis included 4 RCTs comprising 3770 patients (1896 with DFT and 1874 without DFT). Total mortality (RR = 1.00, 95% CI 0.86-1.17; P = 0.98) and arrhythmic death (RR = 1.60, 95% CI 0.46-5.59: P = 0.46) were not statistically different. Both first (RR = 0.94, 95% CI 0.89-0.98; P = 0.004) and any appropriate ICD shock (RR = 0.97, 95% CI 0.95-1.00; P = 0.02) significantly increased the rate of VT/VF interruption in the group with no-DFT in comparison with DFT. Finally, the incidence of adverse events was lower in no-DFT patients (RR = 1.23; 95% CI 1.00-1.51; P = 0.05). Conclusions:The practice of DFT (as opposed to no-DFT) did not yield benefits in mortality or the overall rate of conversion of VT/VT. Moreover, a slightly higher incidence of perioperative adverse events was observed in the DFT group.

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Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE)

Cited by 222 publications

References 31 publications

Single-Coil Defibrillator Leads Yield Satisfactory Defibrillation Safety Margin in Hypertrophic Cardiomyopathy

Single-Coil Defibrillator Leads Yield Satisfactory Defibrillation Safety Margin in Hypertrophic Cardiomyopathy

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

Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

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