AIMS: Radiofrequency (RF) ablation of the cavotricuspid isthmus (CTI) is an effective treatment for atrial flutter (AFL). However, RF may injure cardiac structures such as the atrio-ventricular node or the right coronary artery and is usually painful. This prospective, randomized study compares cryoablation (Cryo) with RF ablation regarding efficacy, safety, and perceived pain. METHODS AND RESULTS:One-hundred and fifty-three patients (78 Cryo; 75 RF) with CTI-dependent AFL--median age 65 years (range 34-82), 140 men (91%)--were randomized to Cryo or RF. Primary endpoint was demonstration of long-term efficacy defined as no symptomatic recurrence of AFL at the 6-month follow-up. Radiofrequency ablation was performed with a 3.5 mm open-irrigated-tip catheter and Cryo with a 9 F, 8 mm tip catheter. Ablation endpoint was bidirectional CTI block. Pain was evaluated with a visual analogue scale (VAS; 0-10). The acute success rate was 92% for Cryo and 95% for RF (P = 0.58). Procedural time was longer in the Cryo group (152 ± 54 min) than the RF group (116 ± 41 min) (P < 0.001). Cryoablation was considerably less painful compared with RF (mean VAS-Cryo 0.7 ± 1.2 vs. VAS-RF 4.6 ± 2.0; P < 0.001). Success rate at 6-month follow-up was 93% (73 of 78) for Cryo and 97% (73 of 75) for RF (P = 0.86). No major adverse events occurred in any group. CONCLUSION: Cryoablation of isthmus-dependent AFL is not inferior to RF but with significantly less procedure-related pain.
RCT Entities:
AIMS: Radiofrequency (RF) ablation of the cavotricuspid isthmus (CTI) is an effective treatment for atrial flutter (AFL). However, RF may injure cardiac structures such as the atrio-ventricular node or the right coronary artery and is usually painful. This prospective, randomized study compares cryoablation (Cryo) with RF ablation regarding efficacy, safety, and perceived pain. METHODS AND RESULTS: One-hundred and fifty-three patients (78 Cryo; 75 RF) with CTI-dependent AFL--median age 65 years (range 34-82), 140 men (91%)--were randomized to Cryo or RF. Primary endpoint was demonstration of long-term efficacy defined as no symptomatic recurrence of AFL at the 6-month follow-up. Radiofrequency ablation was performed with a 3.5 mm open-irrigated-tip catheter and Cryo with a 9 F, 8 mm tip catheter. Ablation endpoint was bidirectional CTI block. Pain was evaluated with a visual analogue scale (VAS; 0-10). The acute success rate was 92% for Cryo and 95% for RF (P = 0.58). Procedural time was longer in the Cryo group (152 ± 54 min) than the RF group (116 ± 41 min) (P < 0.001). Cryoablation was considerably less painful compared with RF (mean VAS-Cryo 0.7 ± 1.2 vs. VAS-RF 4.6 ± 2.0; P < 0.001). Success rate at 6-month follow-up was 93% (73 of 78) for Cryo and 97% (73 of 75) for RF (P = 0.86). No major adverse events occurred in any group. CONCLUSION: Cryoablation of isthmus-dependent AFL is not inferior to RF but with significantly less procedure-related pain.