Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation
Weidong Lin, Huimin Chu, Chuangshi Wang, Dong Chang, Xiaomeng Yin, Yuegang Wang, Chenyang Jiang, Yizhou Xu, Qiwei Liao, Jian Yang, Wenqing Zhu, Songnan Li, Weidong Gao, Yanbo Chen, Yibo Yu, Qiang Li, Hongtao Liao, Hai Deng, Wei Wei, Sijia Pu, Zhuli Guo, Dong Xu, Wei Li, Feifan Ouyang, Yumei Xue, Yumei Xue, Weidong Lin, Hongtao Liao, Hai Deng, Wei Wei, Yingjie Huang, Sijia Pu, Songnan Li, Lihong Huang, Xueyuan Guo, Yufeng Wang, Jingrui Zhang, Chenyang Jiang, Qiang Liu, Hui Cheng, Yunhe Wang, Shiquan Chen, Wenqing Zhu, Yang Pang, Ye Xu, Huimin Chu, Binhao Wang, Yibo Yu, Guohua Fu, Mingjun Feng, Xianfeng Du, Fang Gao, Yin Xu, Weidong Zhuo, Renyuan Fang, Jiaye Yu, Lipu Yu, Xiaomeng Yin, Yuanjun Sun, Chengming Ma, Shiyu Dai, Yuegang Wang, Senlin Huang, Xinzhong Li, Jianwu Zhang, Liwei He, Dong Chang, Qiang Li, Guiyang Li, Jialan Lv, Faguang Zhou, Yanqiao Chen, Xingcai Wan, Yingjian Deng, Shengsheng Zhuang, Shaolong Li, Qiwei Liao, Jing Yang, Chende He, Sen Yang, Yanbo Chen, Xuefu Han, Liang Su, Jian Yang, Zhuli Guo, Weiling Huang, Li Liu, Yizhou Xu, Xiaofei Gao, Lian Chen, Xiaohua Liu, Weidong Gao, Zuyi Fu, Yongjie Lin, Mingwei Bo
Abstract
BACKGROUND: The clinical performance of a novel nanosecond pulsed field ablation (nsPFA) system (Insight Medtech) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation remains unclear. OBJECTIVES: This trial sought to evaluate the efficacy and safety of nsPFA vs ablation index (AI)-guided radiofrequency ablation (RFA) for symptomatic atrial fibrillation. METHODS: The InsightPFA trial was a prospective, multicenter, randomized controlled trial. Patients were randomly allocated in a 1:1 ratio to receive either nsPFA or ablation index (AI)-guided RFA for pulmonary vein isolation. Participants completed a standardized 12-month follow-up protocol. The primary efficacy endpoint was defined as freedom from documented atrial tachyarrhythmia recurrence without the use of class I or III antiarrhythmic drugs. The safety assessment evaluated death, stroke, transient ischemic attack, procedure- and device-related events, and other adverse outcomes in both groups. Secondary efficacy endpoints included acute procedural success and procedural evaluations. RESULTS: Among 287 patients from 13 centers in China, 141 nsPFA patients and 142 AI-guided RFA patients completed follow-up. The proportions of conscious sedation use were 89.4% in the nsPFA group and 92.4% in the AI-guided RFA group. The primary efficacy endpoint was achieved in 93 (65.5%) patients in the nsPFA group and 93 (64.1%) in the AI-guided RFA group in the full analysis set population (adjusted rate difference: 2.0%; 95% CI: -8.7% to 12.8%; P = 0.0019 for noninferiority), demonstrating that the noninferiority was met. The 12-month Kaplan-Meier treatment success rates were 66.7% and 67.4% in the nsPFA and AI-guided RFA groups, respectively (HR in the PFA group: 0.99; 95% CI: 0.66 to 1.48; P = 0.0020 for noninferiority). There was no significant difference in the incidence of procedure-related adverse events between the 2 groups. Acute procedural success rates were 100% in both groups. The nsPFA group demonstrated significantly shorter total procedure time, left atrial dwell time, and ablation time but experienced longer fluoroscopy times and higher radiation exposure doses. CONCLUSIONS: The nsPFA exhibited noninferior efficacy and comparable safety to AI-guided RFA while obviating the need for general anesthesia. Furthermore, the study revealed that this ablation technique significantly reduced both total procedure time and left atrial dwelling time. (InsightPFA Trial of the LotosPFA Catheter [InsightPFA]; NCT06014996).