Effect of ICD Therapies on Mortality in the OMNI Trial

J Cardiovasc Electrophysiol. 2016 Feb;27(2):192-9. doi: 10.1111/jce.12860. Epub 2015 Dec 11.

Abstract

Background: Analyses from primary prevention trials on implantable cardioverter defibrillator (ICD) therapy have shown an association between shocks and increased mortality. Recent data suggest a similar association with antitachycardia pacing (ATP).

Objective: The OMNI study is an observational study of pacemaker and ICD use. We aim to examine associations between ICD therapies and mortality in this setting.

Methods: A total of 2,255 OMNI patients with ICDs were included. Treated episodes were classified as appropriate or inappropriate. Patients were assigned into 1 of 3 groups depending on whether the episode required ATP only, single shock, or multiple shocks, and then followed for all-cause mortality. Additionally, we aimed to determine the frequency with which inappropriate ATP precipitated ventricular arrhythmias that led to shock, since this has been suggested as a mechanism of harm.

Results: Over a mean follow-up of 39 ± 19 months, there were a total of 470 deaths (21%). Compared to patients with no treated episodes, patients with appropriate therapy had greater risk of death. Hazard ratios were 1.46 (95% confidence interval [CI] 1.05-2.02; P = 0.023) for the ATP-only group, 2.11 (95% CI 1.51-2.96; P < 0.001) for the single-shock group, and 2.55 (95% CI 1.43-4.57; P = 0.002) for the multishock group. There was no significant association between any type of inappropriate therapy and increased mortality. We identified only 7 instances of inappropriate ATP precipitating ventricular arrhythmia resulting in shock.

Conclusions: Patients receiving appropriate therapy of all types had increased mortality compared to those with no episodes. Furthermore, inappropriate ATP rarely precipitates ventricular arrhythmias.

Keywords: ICD therapy; OMNI trial; antitachycardia pacing; implantable cardioverter defibrillator; mortality.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Cardiac Pacing, Artificial / adverse effects
  • Cardiac Pacing, Artificial / mortality*
  • Defibrillators, Implantable*
  • Electric Countershock / adverse effects
  • Electric Countershock / instrumentation*
  • Electric Countershock / mortality*
  • Electrophysiologic Techniques, Cardiac
  • Female
  • Humans
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Prosthesis Failure
  • Risk Factors
  • Tachycardia, Ventricular / diagnosis
  • Tachycardia, Ventricular / physiopathology
  • Tachycardia, Ventricular / therapy*
  • Time Factors
  • Treatment Outcome
  • United States
  • Ventricular Fibrillation / diagnosis
  • Ventricular Fibrillation / physiopathology
  • Ventricular Fibrillation / therapy*