Clinical impact, safety, and efficacy of single- versus dual-coil ICD leads in MADIT-CRT

J Cardiovasc Electrophysiol. 2013 Nov;24(11):1246-52. doi: 10.1111/jce.12219. Epub 2013 Jul 25.

Abstract

Background: Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory.

Methods: Defibrillation threshold (DFT) at implantation and first shock efficacy were compared in patients implanted with single- versus dual-coil ICD leads in MADIT-CRT. The risk for atrial tachyarrhythmias and all-cause mortality were evaluated. Short- (< 30 days after the implantation) and long-term (throughout the entire study duration) complications were assessed.

Results: Patients with dual-coil ICD leads had significantly lower DFTs compared to patients with single-coil ICD leads (17.6 ± 5.8 J vs 19.4 ± 6.1 J, P < 0.001). First shock efficacy was similar among patients with dual and single-coil ICD leads (89.6% vs 92.3%, P = 1.00). When comparing patients with dual versus single-coil ICD leads, there was no difference in the risk of atrial tachyarrhythmias (HR = 1.57, 95% CI: 0.81-3.02, P = 0.18), or in the risk of all-cause mortality (HR = 1.10, 95% CI: 0.58-2.07, P = 0.77). Patients implanted with single- or dual-coil ICD lead had similar short and long-term complication rates (short-term HR = 0.96, 95% CI: 0.56-1.65, P = 0.88, long-term procedure-related HR = 0.99, 95% CI: 0.62-1.59, P = 1.00, long-term ICD lead related: HR = 1.2, 95% CI: 0.5-2.9, P = 0.68) during the mean follow-up of 3.3 years.

Conclusions: Patients with single-coil ICD leads have slightly higher DFTs compared to those with dual-coil leads, but the efficacy, safety, and clinical impact on atrial tachyarrhythmias, and mortality is similar. Implantation of single-coil ICD leads may be favorable in most patients.

Keywords: MADIT-CRT mortality; atrial arrhythmias; heart failure; implantable cardioverter defibrillators.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Arrhythmias, Cardiac / diagnosis
  • Arrhythmias, Cardiac / mortality
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / therapy*
  • Cardiac Resynchronization Therapy Devices*
  • Cardiac Resynchronization Therapy* / adverse effects
  • Cardiac Resynchronization Therapy* / mortality
  • Defibrillators, Implantable*
  • Electrophysiologic Techniques, Cardiac
  • Equipment Design
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Safety
  • Risk Factors
  • Time Factors
  • Treatment Outcome