Ibutilide administration prior to complex fractionated atrial electrogram ablation did not significantly improve 1-year freedom from atrial arrhythmia compared with placebo (56% vs 49%, P=0.35).
RCT (n=200)
Randomized
Persistent atrial fibrillation (n=200)
Ibutilide vs Saline placebo (0.25 mg intravenous)
1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs, p=0.35
Absolute Event Rate: 56% vs 49%
p-value: p=0.35
AIMS: Complex fractionated atrial electrograms (CFAE) are targeted during persistent atrial fibrillation (AF) ablation. However, many CFAE sites are non-specific resulting in extensive ablation. Ibutilide has been shown to reduce left atrial surface area exhibiting CFAE. We hypothesized that ibutilide administration prior to CFAE ablation would identify sites critical for persistent AF maintenance allowing for improved procedural efficacy and long-term freedom from atrial arrhythmias. METHODS AND RESULTS: Two hundred patients undergoing a first-ever persistent AF catheter ablation procedure were randomly assigned to receive either 0.25 mg of intravenous ibutilide or saline placebo upon completion of pulmonary vein isolation. Complex fractionated atrial electrogram sites were then targeted with ablation. The primary efficacy endpoint was the 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs. Similar procedural characteristics (procedure, fluoroscopy, and ablation times) were observed with both strategies despite a greater reduction in left atrial surface area with CFAE sites (8 vs. 1%, P < 0.0001) and AF termination during CFAE ablation with ibutilide compared with placebo (75 vs. 57%, P = 0.007). The primary efficacy endpoint was achieved in 56% of patients receiving ibutilide and 49% receiving placebo (P = 0.35). No significant differences in peri-procedural complications were observed in both groups. CONCLUSION: Despite a reduction in CFAE area and greater AF termination during CFAE ablation, procedural characteristics and clinical outcomes were unchanged when CFAE ablation was guided by ibutilide administration. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov number: NCT01014741.
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Sheldon M. Singh
André d’Ávila
Young‐Hoon Kim
European Heart Journal
Harvard University
University of Toronto
Brigham and Women's Hospital
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Singh et al. (Thu,) conducted a rct in Persistent atrial fibrillation (n=200). Ibutilide vs. Saline placebo was evaluated on 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs (p=0.35). Ibutilide administration prior to complex fractionated atrial electrogram ablation did not significantly improve 1-year freedom from atrial arrhythmia compared with placebo (56% vs 49%, P=0.35).
synapsesocial.com/papers/6a053f2b874cea25422d70c0 — DOI: https://doi.org/10.1093/eurheartj/ehw003