Effect of defibrillation threshold testing on effectiveness of the subcutaneous implantable cardioverter defibrillator

Peddareddy, Lakshmi; Merchant, Faisal M.; León, Angel R.; Smith, Paige; Patel, Akshar V.; El‐Chami, Mikhael F.

doi:10.1111/pace.13416

Cited by 14 publications

(15 citation statements)

References 16 publications

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“…Recent observations have reported that DT is declining also in S‐ICD owing to physician and patients' preference, despite being a Class 1 recommendation, but only scarce data on device functioning at follow‐up have been reported to date 7,10,13,16,17 …”

Section: Discussionmentioning

confidence: 99%

“…Eventually, clinical arrhythmias are different from induced ones, and frequently arise in conditions (ischemia, acidosis, heart failure, supraventricular arrhythmias) that can impact on defibrillation threshold or promote re‐initiation after a successful shock. Despite all these objections, data regarding outcomes of S‐ICD patients not undergoing DT are scarce 17 …”

Section: Discussionmentioning

confidence: 99%

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Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Ricciardi

Ziacchi

Gasperetti

et al. 2020

Cardiovasc electrophysiol

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Background Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S‐ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real‐world data show a growing trend in avoidance of DT after S‐ICD implantation. Methods All patients undergoing S‐ICD implant at nine associated Italian centers joining in the ELISIR registry (http://ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long‐term follow‐up events were recorded and compared to report the long‐term efficacy and safety of S‐ICD implantations without DT in a real‐world setting. Results A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT− group). Over a median follow‐up of 19 (11–31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S‐ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375). Conclusion Implanting an S‐ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Ricciardi

Ziacchi

Gasperetti

et al. 2020

Cardiovasc electrophysiol

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“…One analysis showed no difference in mortality between the S-ICD and transvenous ICD when no DFT was performed during implant [25]. A retrospective comparison between S-ICD with and without DFT during implant showed no effect on first shock efficacy of the device [26] and a third analysis reported successful defibrillation of all spontaneous ventricular arrhythmias (n = 6) after no DFT was performed during implant [27]. On the other hand, one study reported sustained noise oversensing during induced VF in 4% of S-ICD patients, which resulted in delay of therapy, [28] although this could be the result of oversensing of myopotentials by the diaphragmatic muscles caused by the induction of VF [29].…”

Section: Omission Of Dft In S-icd Implantsmentioning

confidence: 99%

Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?

2020

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Since the publication of the SIMPLE and NORDIC trials, defibrillation testing (DFT) is rarely performed during routine implantation of transvenous implantable cardioverter-defibrillators (ICD). However, the results of these trials cannot be extrapolated to the later introduced subcutaneous ICD (S-ICD) and a class I recommendation to perform DFT during the implantation of these devices remains in the current guidelines. Due to the high conversion success rate of DFT on one hand, and the risk of complications on the other, a significant number of physicians omit DFT in S-ICD recipients. Several retrospective analyses have assessed the safety of the omission of DFT and report contradicting results and recommendations. It is known that implant position, as well as device factors and patient characteristics, influence defibrillation success. A better comprehension of these factors and their relationship could lead to more reliable and safer alternatives to DFT. An ongoing randomised clinical trial, which is expected to end in 2023, is the first study to implement a method that assesses implant position to identify patients who are likely to fail their DFT.

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“…An episode is only terminated when VT of VF is terminated, either spontaneously or by shock delivery. Based on the first shock efficacy in EFFORTLESS and IDE the norm for shock efficacy of the S-ICD for the first shock was set at 90% (12,13,14). We assume that the shock efficacy remains unchanged for subsequent shocks.…”

Section: Non-inferiority Marginmentioning

confidence: 99%

“…This movement has already started prior to the outcome of the SIMPLE and NORDIC trials. Although DFT in S-ICD is linked with mostly similar risks of complications and logistic burden as transvenous devices there are currently only a few studies available on the efficacy of DFT in S-ICD (9)(10)(11)(12). Nevertheless, DFT is already omitted for a substantial number of patients receiving S-ICD, as was demonstrated by the Subcutaneous ICD Post-Market Approval Study (PAS).…”

Section: Introductionmentioning

confidence: 99%

Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing

Quast

Baalman

Betts

et al. 2019

American Heart Journal

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Effect of defibrillation threshold testing on effectiveness of the subcutaneous implantable cardioverter defibrillator

Abstract: A strategy that omits DFT testing at implant did not appear to compromise the effectiveness of the SICD. These data suggest that routine DFT testing at SICD implant might not be necessary. Randomized trials are needed to confirm this finding.

Cited by 14 publications

References 16 publications

Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?

Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing

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