title: HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF: A Multicenter Randomized Trial in Japan.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Heart Rhythm Center, Hayama Heart Center, Kanagawa, Japan. Electronic address: hysohara@uranus.dti.ne.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sohara
authors.affiliation: Department of Cardiology, Sakakibara Heart Institute of Okayama, Okayama, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Ohe
authors.affiliation: Department of Cardiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Okumura
authors.affiliation: Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi, Japan.
authors.forename: Shigeto
authors.initials: S
authors.lastname: Naito
authors.affiliation: Heart Rhythm Center, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Kenzo
authors.initials: K
authors.lastname: Hirao
authors.affiliation: Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Morio
authors.initials: M
authors.lastname: Shoda
authors.affiliation: Division of Cardiology, Department of Medicine, Showa University Hospital, Tokyo, Japan.
authors.forename: Youichi
authors.initials: Y
authors.lastname: Kobayashi
authors.affiliation: Department of Cardiology, Musashino Red Cross Hospital, Musashino, Japan.
authors.forename: Yasuteru
authors.initials: Y
authors.lastname: Yamauchi
authors.affiliation: Heart Rhythm Center, Hayama Heart Center, Kanagawa, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Yamaguchi
authors.affiliation: Cardiovascular Center, Yokosuka Kyousai Hospital, Yokosuka, Japan.
authors.forename: Taishi
authors.initials: T
authors.lastname: Kuwahara
authors.affiliation: Department of Cardiology, Nagoya Red Cross Hospital, Daini, Nagoya, Japan.
authors.forename: Haruo
authors.initials: H
authors.lastname: Hirayama
authors.affiliation: Arrhythmia Care Center, Koseikai Takeda Hospital, Kyoto, Japan.
authors.forename: Chun
authors.initials: C
authors.lastname: YeongHwa
authors.affiliation: Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Kengo
authors.initials: K
authors.lastname: Kusano
authors.affiliation: Department of Cardiology, Tenri Hospital, Tenri, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Kaitani
authors.affiliation: Department of Cardiology, Sakakibara Heart Institute of Okayama, Okayama, Japan.
authors.forename: Kimikazu
authors.initials: K
authors.lastname: Banba
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Satoki
authors.initials: S
authors.lastname: Fujii
authors.affiliation: Heart Rhythm Center, Fukuoka Sanno Hospital, Fukuoka, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Kumagai
authors.affiliation: Department of Cardiology, Shonan Hospital, Okinawa, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yoshida
authors.affiliation: Toray Industries, Inc., Tokyo, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Matsushita
authors.affiliation: Heart Rhythm Center, Hayama Heart Center, Kanagawa, Japan.
authors.forename: Shutaro
authors.initials: S
authors.lastname: Satake
authors.affiliation: Division of Cardiovascular Medicine, University of Tsukuba, Tsukuba, Japan.
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Aonuma
mesh_terms: D055011:Ablation Techniques / Q000295:instrumentation*; D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods*; D062906:Cardiac Catheters; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006329:Heart Conduction System / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery*; D013997:Time Factors; D055815:Young Adult
keywords: HotBalloon ablation; atrial fibrillation; catheter ablation; radiofrequency