HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF A Multicenter Randomized Trial in Japan

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:68

Article

Sohara, Hiroshi¹  Ohe, Tohru²  Okumura, Ken³  Naito, Shigeto⁴  Hirao, Kenzo⁵  Shoda, Morio⁶  Kobayashi, Youichi⁷  Yamauchi, Yasuteru⁸  Yamaguchi, Yoshio¹  Kuwahara, Taishi⁹  Hirayama, Haruo¹⁰  YeongHwa, Chun¹¹  Kusano, Kengo¹²  Kaitani, Kazuaki¹³  Banba, Kimikazu²  Fujii, Satoki¹⁴  Kumagai, Koichiro¹⁵  Yoshida, Hisashi¹⁶  Matsushita, Masashi¹⁷  Satake, Shutaro¹  Aonuma, Kazutaka¹⁸ 

[1] Hayama Heart Ctr, Heart Rhythm Ctr, Hayama, Kanagawa, Japan

[2] Sakakibara Heart Inst Okayama, Dept Cardiol, Okayama, Japan

[3] Hirosaki Univ, Dept Cardiol, Grad Sch Med, Hirosaki, Aomori, Japan

[4] Gunma Prefectural Cardiovasc Ctr, Div Cardiol, Maebashi, Gunma, Japan

[5] Tokyo Med & Dent Univ, Heart Rhythm Ctr, Tokyo, Japan

[6] Tokyo Womens Med Univ, Dept Cardiol, Tokyo, Japan

[7] Showa Univ Hosp, Dept Med, Div Cardiol, Tokyo, Japan

[8] Musashino Red Cross Hosp, Dept Cardiol, Musashino, Tokyo, Japan

[9] Yokosuka Kyousai Hosp, Cardiovasc Ctr, Yokosuka, Kanagawa, Japan

[10] Nagoya Red Cross Hosp, Dept Cardiol, Nagoya, Aichi, Japan

[11] Koseikai Takeda Hosp, Arrhythmia Care Ctr, Kyoto, Japan

[12] Natl Cerebral & Cardiovasc Ctr, Dept Cardiovasc Med, Suita, Osaka, Japan

[13] Tenri Hosp, Dept Cardiol, Tenri, Nara, Japan

[14] Kurashiki Cent Hosp, Dept Cardiol, Kurashiki, Okayama, Japan

[15] Fukuoka Sanno Hosp, Heart Rhythm Ctr, Fukuoka, Japan

[16] Shonan Hosp, Dept Cardiol, Okinawa, Japan

[17] Toray Industries Ltd, Tokyo, Japan

[18] Univ Tsukuba, Div Cardiovasc Med, Tsukuba, Ibaraki, Japan

关键词: atrial fibrillation;    catheter ablation;    HotBalloon ablation;    radiofrequency;   

DOI  :  10.1016/j.jacc.2016.10.037

来源: Elsevier

【 摘 要 】

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. (C) 2016 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

【 授权许可】

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