# HotBalloon pulmonaalvene-ablatie bij paroxysmaal AF: Japanse multicenter trial

*geplaatst 2016-12-27 · Atriumfibrilleren · Journal of the American College of Cardiology · doi 10.1016/j.jacc.2016.10.037 · https://hartvaat.nl/2016/12/27/hotballoon-pulmonaalvene-ablatie-bij-paroxysmaal-af-japanse-multicenter-trial/*

Gerandomiseerde multicenter trial uit Japan die HotBalloon-ablatie vergeleek met radiofrequentieablatie voor pulmonaalvene-isolatie bij paroxysmaal AF. Alternatieve energiebron voor AF-ablatie.

## English: HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF: A Multicenter Randomized Trial in Japan.

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.

## Abstract (original, from the publication)

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.

Auteurs: 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

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Bron: Journal of the American College of Cardiology, https://doi.org/10.1016/j.jacc.2016.10.037. Bijgewerkt 2026-07-03T13:25:48Z. 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.