Key result
Radiofrequency ablation with Ablation Index reduced the rate of arrhythmia recurrence by 59% compared to cryoballoon ablation at 12 months in patients with paroxysmal atrial fibrillation.
Why the study?
There is no direct evidence comparing the effectiveness of radiofrequency catheter ablation using Ablation Index versus cryoballoon ablation in patients with paroxysmal AF.
Does radiofrequency ablation with Ablation Index reduce recurrence of atrial arrhythmias at 12 months compared to cryoballoon ablation in patients with paroxysmal atrial fibrillation?
Does radiofrequency ablation with Ablation Index reduce recurrence of atrial arrhythmias at 12 months compared to cryoballoon ablation in patients with paroxysmal atrial fibrillation?
Effect estimate: HR 0.41 (95% CI 0.20-0.85)
Absolute Event Rate: 9% vs 17%
In a matching-adjusted indirect comparison, radiofrequency ablation guided by Ablation Index was associated with a significantly lower rate of atrial arrhythmia recurrence at 12 months compared to cryoballoon ablation in patients with paroxysmal atrial fibrillation.
May support Ablation Index-guided RF over cryoballoon for paroxysmal AF; extends indirect comparisons but leaves direct RCTs open.
INTRODUCTION: Ablation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF). METHODS: Individual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted. RESULTS: Primary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions. CONCLUSIONS: Radiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.
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Hussein et al. (2019) studied Paroxysmal atrial fibrillation (PAF) (n=350). Radiofrequency ablation with Ablation Index vs. Cryoballoon ablation was evaluated on Recurrence of atrial arrhythmias at 12 months (HR 0.41, 95% CI 0.20-0.85). Radiofrequency ablation with Ablation Index reduced the rate of arrhythmia recurrence by 59% compared to cryoballoon ablation at 12 months in patients with paroxysmal atrial fibrillation.
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