{"id":"c7d2cd719175","type":"article","url":"https://hartvaat.nl/2016/12/27/hotballoon-pulmonaalvene-ablatie-bij-paroxysmaal-af-japanse-multicenter-trial/","title":"HotBalloon pulmonaalvene-ablatie bij paroxysmaal AF: Japanse multicenter trial","title_en":"HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF: A Multicenter Randomized Trial in Japan.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["katheterablatie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2016.10.037","source_url":"https://doi.org/10.1016/j.jacc.2016.10.037","authors":["Hiroshi Sohara","Tohru Ohe","Ken Okumura","Shigeto Naito","Kenzo Hirao","Morio Shoda","Youichi Kobayashi","Yasuteru Yamauchi","Yoshio Yamaguchi","Taishi Kuwahara","Haruo Hirayama","Chun YeongHwa","Kengo Kusano","Kazuaki Kaitani","Kimikazu Banba","Satoki Fujii","Koichiro Kumagai","Hisashi Yoshida","Masashi Matsushita","Shutaro Satake","Kazutaka Aonuma"],"significance":6,"published":"2016-12-27","source_date":"2016-12-27","image":"","kennis":[],"congress":"","summary_en":"This Japanese multicenter randomized trial compared HotBalloon ablation with radiofrequency ablation for pulmonary vein isolation in paroxysmal AF, evaluating a thermal balloon technology developed as an alternative to cryoballoon.","created":"2026-07-03T10:26:29Z","updated":"2026-07-03T13:25:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde multicenter trial uit Japan die HotBalloon-ablatie vergeleek met radiofrequentieablatie voor pulmonaalvene-isolatie bij paroxysmaal AF. Alternatieve energiebron voor AF-ablatie.","abstract_original":"BACKGROUND: Point-by-point catheter ablation is an established treatment for drug-refractory paroxysmal atrial fibrillation (PAF). However, it is time consuming, requires excellent technique to achieve complete pulmonary vein (PV) isolation, and is associated with severe complications. OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of a HotBalloon ablation (HBA) compared with antiarrhythmic drug therapy (ADT) for the treatment of PAF. METHODS: A prospective multicenter randomized controlled study was conducted in Japan. Patients with symptomatic PAF refractory to antiarrhythmic drugs (Class I to IV) were randomized to HBA or ADT at a 2:1 ratio and assessed for effectiveness in a comparable 9-month follow-up period. RESULTS: A total of 100 patients in the HBA group and 43 patients in the ADT group received treatment at 17 sites. HBA procedure produced acute complete PV isolation in 98.0% (392 of 400) of the PVs and in 93.0% (93 of 100) of patients in the HBA group. The chronic success rates after the 9-month effective evaluation period were 59.0% in the HBA group (n = 100) and 4.7% in the ADT group (n = 43; p < 0.001). The incidence of major complications was 11.2% (15 of 134 patients). The incidences of PV stenosis (>70%) and transient phrenic nerve injury were 5.2% and 3.7%, respectively. The mean fluoroscopy time was 49.4 ± 26.6 min (n = 134), and the mean procedure duration was 113.9 ± 31.9 min (n = 133). CONCLUSIONS: This study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile."}