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

J Cardiovasc Electrophysiol. 2019 Jul;30(7):1078-1085. doi: 10.1111/jce.13943. Epub 2019 Apr 22.

Abstract

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 SC-coil 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.

Keywords: all-cause mortality; arrhythmic death; defibrillation shock efficacy; failed appropriate shocks; implantable cardioverter-defibrillator; intraoperative defibrillation testing; single-coil and dual-coil leads.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Aged
  • Arrhythmias, Cardiac / diagnosis
  • Arrhythmias, Cardiac / mortality
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / therapy*
  • Cause of Death
  • Death, Sudden, Cardiac / prevention & control*
  • Defibrillators, Implantable*
  • Electric Countershock / adverse effects
  • Electric Countershock / instrumentation*
  • Electric Countershock / mortality
  • Female
  • Humans
  • Male
  • Middle Aged
  • Primary Prevention / instrumentation*
  • Prosthesis Design
  • Prosthesis Failure
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Secondary Prevention / instrumentation*
  • Time Factors
  • Treatment Outcome