Cryoballoon vs. Radiofrequency Ablation
Is pulmonary vein isolation (PVI) with a cryoballoon catheter (CC) noninferior to radiofrequency catheter ablation (RFCA) in patients with atrial fibrillation (AF)?
Three hundred fifteen patients (mean age 61 years) with paroxysmal AF were randomly assigned to PVI using either RFCA with an irrigated-tip catheter (n = 159) or a CC (n = 156). The patients were followed for 12 months. A 7- to 14-day Holter was performed at 6 and 12 months of follow-up. The primary endpoint was freedom from AF plus the absence of a persistent complication (e.g., pulmonary vein stenosis, phrenic nerve palsy, stroke). The study was designed to test noninferiority.
The redo ablation rate was 20% in both study arms. The primary endpoint was achieved at 12 months in 70.7% of patients in the RFCA group and 73.6% of patients in the CC group, demonstrating noninferiority of the CC relative to RFCA. The procedure time was 13 minutes shorter in the CC group. The acute complication rate was significantly higher in the CC group (12.2%) than in the RFCA group (5%), but there were no persistent complications in either group.
The authors concluded that CC is noninferior to RFCA for treating patients with paroxysmal AF.
This is the largest randomized comparison of the CC and RFCA published to date. Unfortunately, because the study was initiated several years ago, the force-sensing radiofrequency ablation catheter was not used in the RFCA group and the first-generation CC was used in 86% of patients in the CC group. Therefore, whether the noninferiority endpoint still would have been met using current state-of-the-art technology is unclear.
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