Utilization trends and clinical outcomes in patients implanted with a single- vs a dual-coil implantable cardioverter-defibrillator lead: Insights from the ALTITUDE Study

Hsu, Jonathan C.; Saxon, Leslie A.; Jones, Paul; Wehrenberg, Scott; Marcus, Gregory M.

doi:10.1016/j.hrthm.2015.04.030

Cited by 23 publications

(9 citation statements)

References 16 publications

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“…During a mean follow‐up of 3.1 years failing rate was equally distributed in both patient groups. Previously reported nonrandomized data on a higher failing rate of SC‐leads compared to DC‐leads are limited by noncomparable study methods . The results on the incidence of structural lead failure may be biased by the short term follow‐up of the presented study.…”

Section: Discussionmentioning

confidence: 86%

“…Our study results are also supported by two large registries in more than 10 000 ICD patients, and in a subset of the ALTITUDE study. FSCR was reported in the range of 85% to 96.8% without any difference between both lead types . In a sub‐analysis of the NORDIC ICD trial a small but statistically significant higher FSCR in patients with DC‐leads was reported (SC‐lead: 92.6% vs DC‐lead: 97.8%; OR, 4.3; 95%CI: 1.9‐9.8; P = 0.001).…”

Section: Discussionmentioning

confidence: 93%

“…Since 2004, a consistent reduction in the de novo use of DC‐leads has been observed in the US; however, in 2014, DC‐leads still accounts for approximately 50% of all ICD implantations . Comparative clinical analyses of both lead types were reported in retrospective analyses of large scale ICD trials, large registries, and two meta‐analysis . There were inconsistent results regarding clinical first shock conversion rate (FSCR), DSM, and mortality.…”

Section: Introductionmentioning

confidence: 99%

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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: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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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“…[26] Noteworthy, data from ALTITUDE Study demonstrated that SC lead implantations increased from 1.9% to 55.2% between 2004 and 2014. [27] Moreover, in Israeli ICD Database, a prospective registry of all patients referred for implantation or replacement of ICD or CRT-D for primary and secondary prevention, percentage of DC ICD leads implantations has been gradually decreasing. [11] In our cohort DC ICD leads were more frequently with passive fixation and had long dwell-time which may be explained by an earlier time of implantation of these ICD systems.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of transvenous extraction of single- versus dual-coil implantable cardioverter-defibrillator leads at single-center experience

Ząbek¹,

Boczar²,

Dębski³

et al. 2019

Medicine

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The available literature lacks data concerning direct comparison of the effectiveness and safety of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads transvenous extraction. Certainly, additional shocking coil in superior vena cava adds to the amount of metal in the vascular system. Adhesions developing around the superior vena cava coil add to the difficulty of extraction of ICD lead if lead removal is required. The aim of the study was to assess the effectiveness and safety of single- and dual-coil ICD leads transvenous extraction using mechanical systems. We performed transvenous lead extraction (TLE) of 197 ICD leads in 196 patients. There were 46 (23.3%) dual-coil leads removed from 46 (23.5%) patients. Cardiovascular implantable electronic device-related infection was an indication for TLE in 25.0% of patients. The following extracting techniques were used: manual direct traction, mechanical telescopic sheaths, controlled-rotation mechanical sheaths, and femoral approach. Complete ICD lead removal and complete procedural success in both groups were similar (99.3% in single-coil vs 97.8% in dual-coil, P = .41 and 99.3% in single-coil vs 97.8% in dual-coil, P = 0.41, respectively). We did not find significant difference between major and minor complication rates in both groups (2.0% in single-coil vs 4.3% in dual-coil, and 0.7% in single-coil vs 0.0% in dual-coil, P = .58, respectively). There was 1 death associated with the TLE procedure of single-coil lead. This study shows that extraction of dual-coil leads seems to be comparably safe and effective to extraction of single-coil leads. On the other hand, it requires longer fluoroscopy time and frequent utilization of advanced tools.

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“…Now that the efficacy and safety of a strategy without routine defibrillation testing have been demonstrated in the SIMPLE and NORDIC trials, a shift toward no or selective testing has been observed in many hospitals performing implantable cardioverter defibrillator (ICD) implantations …”

Section: Introductionmentioning

confidence: 99%

Risk Factors for Inadequate Defibrillation Safety Margins Vary With the Underlying Cardiac Disease: Implications for Selective Testing Strategies

Bonnes

Westra

Bouwels

et al. 2016

Cardiovasc electrophysiol

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The present study on risk stratification for an inadequate DSM not only confirms the importance of making a distinction between IHD and non-IHD, but also shows that risk factors in an entire cohort (LV dilatation, age) may only apply to a subgroup (non-IHD). Appreciation of this concept could favorably affect current risk stratification. If confirmed, our approach may be used to optimize individualized testing decisions in an upcoming era of non-routine testing.

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Utilization trends and clinical outcomes in patients implanted with a single- vs a dual-coil implantable cardioverter-defibrillator lead: Insights from the ALTITUDE Study

Cited by 23 publications

References 16 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

Effectiveness and safety of transvenous extraction of single- versus dual-coil implantable cardioverter-defibrillator leads at single-center experience

Risk Factors for Inadequate Defibrillation Safety Margins Vary With the Underlying Cardiac Disease: Implications for Selective Testing Strategies

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