Guo Qi, Sang Caihua, Lai Yiwei, Gao Mingyang, Guo Xueyuan, Dai Wenli, Li Songnan, Liu Nian, Zuo Song, Long Deyong, Dong Jianzeng, Ma Changsheng
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing, China.
Pacing Clin Electrophysiol. 2024 Dec;47(12):1670-1678. doi: 10.1111/pace.15081. Epub 2024 Oct 20.
Intracardiac echocardiography (ICE) has been widely used in the catheter ablation of atrial fibrillation (AF). However, the value of ICE in the training of transseptal puncture (TSP) is unclear.
ICE-Training Study was a single-center, parallel-group, unmasked, randomized controlled trial registered in ChineseClinicalTrials.gov. Participants were randomly assigned (1:1) to different groups (1) the ICE simulator training group (ICE-ST), in which TSP was trained and performed under the guidance of both ICE and x-ray; and (2) the conventional simulator training group (Con-ST), in which TSP was trained and performed only under the guidance of x-ray. The trainees need to undergo the training stage and the evaluation stage.
From October 2022 to December 2022, 18 consecutive fellows (age 32.4 ± 4.4 years, 12 males) without experience of TSP were included. The training period (16.9 ± 6.6 vs. 29.6 ± 8.7 times, p = 0.003) and the fluoroscopy time (120.3 ± 25.3 vs. 189.3 ± 40.2 s, p < 0.001) of the ICE-ST group was significantly shorter than that of the Con-ST group. No significant difference was found in the comprehensive performance of TSP in the ICE-ST group (composite score 96.7 ± 5.7) and the Con-ST group (composite score 95.9 ± 6.3, p = 0.62), but the selection of TSP sites in the ICE-ST group was commonly better than that in the Con-ST group.
ICE could improve the efficiency of TSP training and optimize the site of TSP to facilitate catheter manipulation in the ablation.
ChineseClinicalTrials.gov identifier: ChiCTR2200058377.
心腔内超声心动图（ICE）已广泛应用于房颤（AF）导管消融。然而，ICE在经房间隔穿刺（TSP）培训中的价值尚不清楚。
ICE培训研究是一项在中国临床试验注册中心注册的单中心、平行组、非盲法、随机对照试验。参与者被随机（1:1）分配到不同组：（1）ICE模拟器训练组（ICE-ST），在ICE和X线引导下进行TSP训练和操作；（2）传统模拟器训练组（Con-ST），仅在X线引导下进行TSP训练和操作。受训者需经历训练阶段和评估阶段。
2022年10月至2022年12月，连续纳入18名无TSP经验的学员（年龄32.4±4.4岁，男性12名）。ICE-ST组的训练次数（16.9±6.6次对29.6±8.7次，p = 0.003）和透视时间（120.3±25.3秒对189.3±40.2秒，p < 0.001）显著短于Con-ST组。ICE-ST组（综合评分96.7±5.7）和Con-ST组（综合评分95.9±6.3，p = 0.62）TSP的综合表现无显著差异，但ICE-ST组TSP部位的选择通常优于Con-ST组。
ICE可提高TSP训练效率，优化TSP部位，便于消融术中导管操作。
中国临床试验注册中心标识符：ChiCTR2200058377。
