Article
作者: Shen, Wenzhi ; Xie, Shuanglun ; Chen, Jingcheng ; Yi, Fu ; Sun, Yumin ; Wu, Qiang ; Zhang, Yuzhen ; Chen, Jianshu ; Cao, Bin ; Ruan, Zhongbao ; Wang, Kexin ; Wu, Shengjie ; Lin, Yaowu ; Chen, Xiaoli ; Hu, Xiaoqing ; Jin, Caiyi ; Ding, Xiangwei ; Ji, Yuan ; Yun, Xie ; Chen, Yuyang ; Xiong, Qingsong ; Wei, Youquan ; Wang, Cheng ; Li, Jie ; Shi, Linsheng ; Li, Chengzong ; Wang, Yuegang ; Chen, Minglong ; Pan, Tong ; Xu, Qiang ; Lin, Zhiyu ; Xiao, Fangyi ; Liu, Jichun ; Zou, Cao ; Lin, Hairuo ; Wu, Liuyang ; Ju, Weizhu ; Chen, Long ; Zhou, Jing ; Zhang, Ning
Importance:Recurrence remains a challenge after ablation of outflow tract premature ventricular contractions (OT-PVCs). Although adding additional lesions next to the index effective ablation site is sometimes performed to reinforce the ablation, it remains uncertain whether this approach is effective.
Objective:To test the hypothesis that additional ablation lesions would reduce the recurrence rate compared with single-point ablation at the index effective site for the ablation of OT-PVCs.
Design, Setting, and Participants:This study was a multicenter, prospective, randomized clinical trial. Patients receiving their first catheter ablation for OT-PVCs were enrolled from 18 hospitals in China between October 2021 and February 2023. Scheduled follow-up duration was 3 months after the procedure.
Intervention:After identifying the target point and eliminating the PVC by a single-point ablation, patients were randomized 1:1 into an additional ablation group or a control group.
Main Outcomes and Measures:The primary end point of the study was freedom from PVC recurrence (≥80% reduction of PVC burden, which is the number of PVCs in 24 hours/total heartbeats in 24 hours × 100%) from baseline to 3 months postprocedure.
Results:Of 308 patients enrolled in the study, 286 (mean [SD] age, 49.2 [14.6] years; 173 female [60.5%]) were randomized to the additional ablation or the control group. The additional ablation group had a mean (SD) of 6.3 (1.1) radiofrequency applications, whereas the control group (single-point ablation group) had a mean (SD) of 1 (0) radiofrequency application. After a median (IQR) follow-up of 3.2 (0) months, the rate of freedom from PVCs was significantly higher in the additional ablation group (139 of 142 [97.9%]) compared with the control group (115 of 139 [82.7%]; P < .001). Patients in the additional ablation group also had a more substantial reduction in PVC burden than the control group (mean [SD] reduction, 23.0% [10.5%] vs 19.0% [10.4%]; P = .002). There were no severe periprocedural complications in either group.
Conclusions and Relevance:This randomized clinical trial showed a benefit of additional ablation in reducing the recurrence of OT-PVCs compared with the single-point ablation strategy, without increased complication risk. Additional ablations surrounding the index effective ablation point should be considered in OT-PVC ablation.
Trial Registration:Chinese Clinical Trials Registry Identifier: ChiCTR2200055340