Reassessing Risk Factors for High Defibrillation Threshold: The EF‐SAGA Risk Score and Implications for Device Testing

Shih, Michael J.; Kakodkar, Siddharth A.; Kaid, Yousef; Hassel, Jonathan; Yarlagadda, Santi; Fogg, Louis; Madias, Christopher; Krishnan, K. Ranga Rama; Trohman, Richard G.

doi:10.1111/pace.12838

Cited by 16 publications

(8 citation statements)

References 21 publications

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“…Therefore, we believe that the study results are not affected by the small absolute differences in patients' characteristics, as shown in former studies . The effects of amiodarone on defibrillation energy requirements are well reported . Nevertheless, in the present study, amiodarone use was not a detectable disadvantage in patients implanted with SC‐lead system.…”

Section: Discussionsupporting

confidence: 59%

Effectiveness of single‐ vs dual‐coil implantable defibrillator leads: An observational analysis from the SIMPLE study

Neuzner

Hohnloser

Kutyifa

et al. 2019

Cardiovasc electrophysiol

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Introduction: Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates. Methods and Results:In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SCcoil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates. Conclusion:In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients.Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients. K E Y W O R D S all-cause mortality, arrhythmic death, defibrillation shock efficacy, failed appropriate shocks, implantable cardioverter-defibrillator, intraoperative defibrillation testing, single-coil and dual-coil leads How to cite this article: Neuzner J, Hohnloser SH, Kutyifa V, et al. Effectiveness of single-vs dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study.

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Section: Discussionsupporting

confidence: 59%

Effectiveness of single‐ vs dual‐coil implantable defibrillator leads: An observational analysis from the SIMPLE study

Neuzner

Hohnloser

Kutyifa

et al. 2019

Cardiovasc electrophysiol

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“…Overall, patients identified as having high DFT accounted for 3% of our entire population with mean DFT of 32.1 ± 3.7 J and had greater incidence of nonischemic cardiomyopathy, younger age, reduced EF, and mortality. These characteristics are consistent with previous studies 7, [13][14][15] .…”

Section: Discussionsupporting

confidence: 93%

Influence of “high” defibrillation thresholds on patient survival and impact of system modification

Siddiqi

Tchou

Niebauer

et al. 2021

Cardiovasc electrophysiol

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Objective: To test whether a high defibrillation threshold (DFT) marks patients with poor outcomes which are improved when DFT is decreased by system modification (subcutaneous coil implant; SM). Background:The electrical substrate generating fast ventricular arrhythmias may generate poor outcomes among patients treated with implantable cardioverterdefibrillators (ICDs), even when arrhythmias are treated successfully. Since patients with high DFTs have increased mortality, we contrasted survival among patients with high DFT treated with and without SM. Methods:We studied consecutive patients undergoing ICD implantation and DFT testing at Cleveland Clinic over a 14-year period. High DFT was defined as successful defibrillation by shock strength >25 J or ≤10 J of maximal device output.Mortality was recorded using the Social Security Death Index. Survival was compared among those high DFT patients receiving SM versus the remainder.Results: Out of 6353 patients tested, 191 (3%) had high DFT (32.1 ± 3.7 J) versus 13.9 ± 4.9 J in the remainder ("acceptable DFT," p < .001). One hundred twenty-one high DFT patients (63%; 33.3 ± 3.4 J) underwent SM, which significantly decreased DFT (24.8 ± 5.9 J; p < .001). Seventy patients (37%; 30.3 ± 3.3 J) did not undergo SM.During follow-up, 38% (2363/6162; 7.8 yrs) patients with acceptable DFT died versus 48% high DFT patients (91/191; 5.6 yrs.; p < .001). Concomitantly, 48% patients with SM (58/121) died, as compared to 47% patients (33/70) without SM (p = .91); median follow-up 4.9 yrs). Conclusion:Patients with high DFT have a higher mortality than those with acceptable DFT. The additional subcutaneous coil implant decreases DFT to an acceptable range but does not appear to improve survival. The electrical substrate underlying high DFT appears to determine survival.

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“…The prevalence of high DFTs in recent studies ranged from 2% to 9.4%. 7,8,15 Although younger age and LVEF of 25% or less were found to be associated with high DFT, it remains difficult to predict which patients are at risk for elevated DFT before implantation. In our case, the patient was a 56-year-old man with an ischemic dilated cardiomyopathy and several ejection fraction reduction (LVEF = 25%), but only a no fatal cardiac arrest showed his high DFT.…”

Section: Discussionmentioning

confidence: 99%

Thoracoscopic Implantation of An Array Electrode in the Pericardium Transverse Sinus to Reduce Defibrillation Threshold

Curnis

Muneretto

Bisleri

et al. 2017

Innovations�(Phila)

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Among the implantable cardioverter defibrillator recipients, there is still a subgroup of patients in whom the defibrillation threshold is too high and the maximal shock output of the implantable cardioverter defibrillator can fail to terminate a ventricular arrhythmia. We report a new thoracoscopic minimally invasive approach to place a standard array electrode in the transverse pericardial sinus of a patient implanted with a cardiac resynchronization and defibrillation therapy device with persistent high defibrillation threshold. This approach was developed to achieve very low shock impedance with a consequent increase in the current flow and reduction of defibrillation threshold.

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Reassessing Risk Factors for High Defibrillation Threshold: The EF‐SAGA Risk Score and Implications for Device Testing

Cited by 16 publications

References 21 publications

Effectiveness of single‐ vs dual‐coil implantable defibrillator leads: An observational analysis from the SIMPLE study

Effectiveness of single‐ vs dual‐coil implantable defibrillator leads: An observational analysis from the SIMPLE study

Influence of “high” defibrillation thresholds on patient survival and impact of system modification

Thoracoscopic Implantation of An Array Electrode in the Pericardium Transverse Sinus to Reduce Defibrillation Threshold

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