Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation
Hongwu Chen, Chengzong Li, Bing Han, Fangyi Xiao, Fu Yi, Youquan Wei, Chenyang Jiang, Cao Zou, Linsheng Shi, Ma Wei, Weiming Wang, Yuegang Wang, Hong Du, Long Chen, Minglong Chen, STABLE-SR-III Investigators, Minglong Chen, Bing Han, Chenyang Jiang, Weizhu Ju, Gang Yang, Zidun Wang, Hao Yang, Jinfeng Wang, Ping Fang, Zhirong Wang, Chaoqun Zhang, Fei Li, Xiaoli Chen, Jianfei Huang, Chenhui Tai, Jie Hao, Yihe Chen, Shengjie Wu, Tingbo Jiang, Yuzhen Zhang, Mingsheng Hu, Jie Li, Miaoyang Hu, Shijie Li, Weidong Li, Xian‐Jin Li, Ling Yang, Lishang Zhai, Xiaoqing Wang, Qiang Liu, Lu Yu, Ruhong Jiang, Shiquan Chen, Shaobo Fan, Fan Zhang, Jianyong Li, Xinzhong Li, Yao‐Wu Liu, Genshan Ma, Mingfang Li, Youmei Shen, Chang Cui, Hailei Liu, Cheng Cai, Xiaohong Jiang, Nan Wu, Xingxing Sun, Qing Yan, Kexin Wang, WU Wen-xi, Fumin Zhang, Xin Yao, Yu Hao, Xiuqing Wang, Zhibin Lu, Lichun Wang, Cao Jiang
Abstract
Importance: The overall success rate of circumferential pulmonary vein isolation (CPVI) treatment in patients with paroxysmal atrial fibrillation (AF) remains suboptimal, especially in older patients. Objective: To explore the incremental benefit of low-voltage-area ablation after CPVI in older patients with paroxysmal AF. Design, Setting, and Participants: This randomized clinical trial was an investigator-initiated trial to compare the efficacy of additional low-voltage-area ablation beyond CPVI vs CPVI alone in older patients with paroxysmal AF. Participants were patients aged 65 to 80 years with paroxysmal AF who were referred for catheter ablation. They were enrolled in 14 tertiary hospitals in China from April 1, 2018, to August 3, 2020, and follow-up occurred through August 15, 2021. Interventions: Patients were randomized (1:1) to undergo CPVI plus low-voltage-area ablation or CPVI alone. Low-voltage areas were defined as areas with amplitude less than 0.5 mV in more than 3 adjacent points. If low-voltage areas existed, additional substrate ablation was performed in the CPVI plus group but not the CPVI alone group. Main Outcomes and Measures: The primary end point of the study was freedom from atrial tachyarrhythmia as documented by electrocardiogram during a clinical visit or lasting longer than 30 seconds during Holter recordings occurring after a single ablation procedure. Results: Among 438 patients who were randomized (mean [SD] age, 70.5 [4.4] years; 219 men [50%]), 24 (5.5%) did not complete the blanking period and were not included for efficacy analysis. After a median follow-up of 23 months, the recurrence rate of atrial tachyarrhythmia was significantly lower in the CPVI plus group (31/209 patients, 15%) compared with the CPVI alone group (49/205, 24%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.95; P = .03). In subgroup analyses, among all patients with low-voltage area, CPVI plus substrate modification was associated with a 51% decreased risk of ATA recurrence compared with CPVI alone (HR, 0.49; 95% CI, 0.25-0.94; P = .03). Conclusions and Relevance: This study found that additional low-voltage-area ablation beyond CPVI decreased the ATA recurrence in older patients with paroxysmal AF compared with CPVI alone. Our findings merit further replication by larger trials with longer follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT03462628.