Radiofrequency hot balloon catheter ablation for the treatment of atrial fibrillation: A 3-center study in Japan

Abstract Background The safety and efficacy of radiofrequency hot balloon catheter (Toray-Satake balloon [TSB]) ablation for the treatment of atrial fibrillation (AF) was evaluated in a 3-center pilot study. Methods Thirty patients (24 men; age, 61±8 years) with drug-resistant AF (paroxysmal, n =24; persistent, n =6) were evaluated in this study. The pulmonary veins (PVs) and PV antrum were isolated using the TSB under general anesthesia ( n =12) or deep sedation ( n =18). Results Complete PV isolation was achieved in 110 (92%) of 120 PVs, and decreased PV potentials were observed in the right superior PV in 4 patients (13%), left superior PV in 4 patients (13%), and left inferior PV in 2 patients (7%). The mean total procedure time was 104±27 min. The mean total fluoroscopic and total application times were 32±14 min and 12±2 min, respectively. After a single session, 22 (73%) and 20 (67%) of the 30 patients were free from AF after 6 and 11.4±2.2 months of follow-up, respectively. There were no device-related severe complications such as stroke, esophageal fistula, symptomatic PV stenosis, phrenic nerve palsy, or pyloric spasm. Conclusion TSB catheter ablation might be a promising approach for the treatment of drug-resistant AF.