Radiofrequency Hot Balloon Catheter Ablation of Atrial Fibrillation: Results of a Multicenter Clinical Trial in Japan

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Background: We evaluate the safety and efficacy of a radiofrequency hot balloon catheter (Toray-Satake Balloon; TSB) for the treatment of the patients with AF. Methods and Results: A total of thirty patients (26 men, 60±9 years) with drug-resistant AF (paroxysmal n=26, persistent n=4) were enrolled in this study. Under general anesthesia (n=12) or deep sedation (n=18), we performed isolation of all PVs including PV antrum, only by use of TSB. The center temperature of the balloon (60–70C) and the delivery time of RF energy (90–240 seconds) were determined by the wall thickness of each PV, measured by intra-cardiac echo. Complete PV isolation was observed in 110 of 121 PVs (91%), and decreased PV potentials were left in 4/31 (13%) at right superior PV, 4/30 (13%) at left superior PV, and 3/30 (10%) at left inferior PV. Total procedure times were (102±27 min). Total fluoroscopic times and total application times were (31±14 min) and (12±2 times), respectively. After a single procedure, twenty-seven of 30 patients (87%) were free from AF without anti-arrhythmic drugs during 6 months follow-up period. There were no complications such as stroke, esophageal fistula, symptomatic PV stenosis, phrenic nerve palsy, pyloric spasm. Conclusion: Ablation by TSB might be time-saving, safety and quite promising therapy for the patients with AF.