Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications | Clinical Trial - OPTION

Dec 01, 2014
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
12/01/2014
Original Posted Date:
12/01/2014
References

Description:

The goal of the trial was to evaluate treatment with a dual-chamber defibrillator compared with a single-chamber defibrillator among participants with a primary or secondary indication for an implantable cardioverter-defibrillator (ICD) and left ventricular ejection fraction (LVEF) ≤40%.

Hypothesis:

A dual-chamber defibrillator will reduce inappropriate shocks.

Study Design

Patient Populations:

  • Participants with a primary or secondary indication for an ICD and LVEF ≤40% despite optimal medical therapy

    Number of enrollees: 453
    Duration of follow-up: 23.4 months
    Mean patient age: 63 years
    Percentage female: 15%
    EF: 30%

Exclusions:

  • Indication for permanent pacemaker or cardiac resynchronization therapy
  • Hypertrophic obstructive cardiomyopathy or acute myocarditis
  • History of percutaneous coronary intervention, coronary artery bypass grafting, or acute coronary syndrome within the last month
  • Permanent atrial tachyarrhythmia or cardioversion within the last month

Primary Endpoints:

  • Time to first occurrence of inappropriate ICD shock
  • Time to first occurrence of all-cause death or cardiovascular hospitalization

Secondary Endpoints:

  • Appropriate or inappropriate ICD shocks
  • All-cause mortality
  • Cardiovascular mortality
  • Cardiovascular hospitalization
  • Cumulative percentage of ventricular pacing
  • Complications

Drugs/Procedures Used:

Participants with a primary or secondary indication for an ICD and LVEF ≤40% underwent placement of an atrial lead and a dual-chamber defibrillator. Subjects were randomized to be programmed to a dual-chamber setting (n = 230) versus a single-chamber setting (n = 223).

The devices were programmed to minimize ventricular pacing (SafeR algorithm) and reduce inappropriate shocks using discrimination algorithms with antitachycardia pacing therapies.

Principal Findings:

Overall, 453 participants were randomized. The mean age was 63 years, 15% were women, mean LVEF was 30%, mean QRS duration was 111 msec, and 21% had diabetes. Thirty-nine participants crossed over from single-chamber to dual-chamber, whereas eight crossed over from dual-chamber to single-chamber.

An inappropriate shock occurred in 4.3% of the dual-chamber group versus 10.3% the single-chamber group (p = 0.015). The time to first inappropriate ICD shock was longer in the dual-chamber group versus the single-chamber group (log-rank p = 0.012).

All-cause death or cardiovascular hospitalization occurred in 20% of the dual-chamber group versus 22.4% of the single-chamber group (p < 0.001).

Device or procedure-related adverse events occurred in 10.0% of the dual-chamber group versus 16.1% of the single-chamber group.

Interpretation:

Among patients with an ICD for primary or secondary prevention, a dual-chamber device reduced the risk of inappropriate shocks without increasing death or cardiovascular hospitalization. Device or procedure-related adverse events were also similar between groups. Ventricular pacing was minimized with the SafeR algorithm. The high rate of crossovers may have minimized the difference detected between the groups.

References:

Kolb C, Sturmer M, Sick P, et al. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail 2014;2:611-9.

Editorial: Ellenbogen KA, Kalahasty G. Insights into defibrillator shocks: what OPTION teaches us. JACC Heart Fail 2014;2:620-2. 


Keywords: Cause of Death, Defibrillators, Diabetes Mellitus, Heart Ventricles, Hospitalization, Tachycardia, Stroke Volume


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