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

详细信息    查看全文

• 作者：Hiroshi Sohara ; MD ; PhD^a ; ^{hysohara@uranus.dti.ne.jp} ; Tohru Ohe ; MD ; PhD^b ; Ken Okumura ; MD ; PhD^c ; Shigeto Naito ; MD ; PhD^d ; Kenzo Hirao ; MD ; PhD^e ; Morio Shoda ; MD ; PhD^f ; Youichi Kobayashi ; MD ; PhD^g ; Yasuteru Yamauchi ; MD^h ; Yoshio Yamaguchi ; MD^a ; Taishi Kuwahara ; MD ; PhDⁱ ; Haruo Hirayama ; MD ; PhD^j ; Chun YeongHwa ; MD^k ; Kengo Kusano ; MD ; PhD^l ; Kazuaki Kaitani ; MD^m ; Kimikazu Banba ; MD ; PhD^b ; Satoki Fujii ; MDⁿ ; Koichiro Kumagai ; MD ; PhD^o ; Hisashi Yoshida ; MD ; PhD^p ; Masashi Matsushita^q ; Shutaro Satake ; MD ; PhD^a ; Kazutaka Aonuma ; MD ; PhD^r
• 关键词：atrial fibrillation ; catheter ablation ; HotBalloon ablation ; radiofrequency
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：27 December 2016
• 年：2016
• 卷：68
• 期：25
• 页码：2747-2757
• 全文大小：1221 K
• 卷排序：68

文摘

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.ObjectivesThe 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.MethodsA 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.ResultsA 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).ConclusionsThis study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile.