HotBalloon Pulmonary Vein Isolation Registry Study　― Real-World Efficacy and Safety of HotBalloon Ablation

• Published in: Circulation Journal 2022/09/21, pp.CJ-21-0994
• Main Authors: Yamasaki, Hiro, Nakahara, Shiro, Sohara, Hiroshi, Yoshida, Yukihiko, Kohno, Tsunesuke, Shimane, Akira, Miyauchi, Yasushi, Kusano, Kengo, Inden, Yasuya, Yamane, Teiichi, Aonuma, Kazutaka, HARVEST (HotBalloon Pulmonary Vein Isolation Registry) Study Investigators
• Format: Article
• Language: English
• Subjects: Anti-Arrhythmia Agents - therapeutic use; Atrial arrhythmia; Atrial Fibrillation; Catheter Ablation - adverse effects; Catheter Ablation - methods; Humans; Prospective Studies; Pulmonary vein isolation; Pulmonary Veins - surgery; Radiofrequency hotballoon ablation; Registry; Treatment Outcome
• ISSN: 1346-9843; 1347-4820; 1347-4820
• DOI: 10.1253/circj.CJ-21-0994

Background: Radiofrequency hotballoon (RHB) is an ablation device used for atrial fibrillation (AF) treatment. The efficacy and safety of RHB-based pulmonary vein isolation (PVI) in real-world practice are unknown.Methods and Results: A multicenter, prospective registry study (UMIN000029567) enrolled AF patients who underwent RHB-PVI. The primary endpoint was the AF recurrence-free survival rate at 12 months after PVI. Of the 679 patients enrolled, 613 (90.3%; paroxysmal AF, n=370; persistent AF, n=136; long-standing AF, n=107) underwent initial RHB-PVI. Acute isolation using only the RHB was successful for 55.6% of patients and 83.5% of pulmonary veins (PVs). The acute isolation rate was higher for patients with paroxysmal AF and more experienced centers. Antiarrhythmic drugs were prescribed after 3 months for 47.5% of patients. The AF recurrence-free survival rate at 12 months was 83.7%. Procedure-related complications including atrio-esophageal fistula (n=1) and phrenic nerve injury (persistent; n=4, permanent; n=2) were observed in 19 (3.1%) patients. Five (1.7%) of the 302 patients who underwent pre-procedural and post-procedural multidetector computed tomography had severe PV stenosis.Conclusions: The size-adjustable RHB has been used for the treatment of various AF types. The arrhythmia recurrence-free rate at 12 months, with the use of antiarrhythmic drugs in approximately half of the patients, was acceptable, but the acute isolation rate using the RHB requires further improvement.