Intracardiac vs Transesophageal Echocardiography in Atrial Fibrillation Ablation: A Randomized Clinical Trial.

Intracardiac echocardiography (ICE) is an alternative that may offer comparable safety with procedural advantages.

经心内超声心动图（ICE）是一种替代方法，可能提供与TEE相当的安全性，并具有操作上的优势。

Background

To determine whether ICE is noninferior to TEE in preventing periprocedural thromboembolic events in AF ablation.

确定在房颤消融术中，ICE是否非劣于TEE以预防围手术期血栓栓塞事件。

DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial was conducted at 10 hospitals in China from August 2022 to July 2023, with a 30-day follow-up, enrolling adults with AF scheduled for catheter ablation who met predefined eligibility criteria.

设计、场所和参与者：这项多中心随机临床试验在中国的10家医院进行，从2022年8月到2023年7月，随访30天，招募符合预定资格标准的计划进行导管消融术的成年房颤患者。

Data analysis was performed from August 2023 to December 2023.

数据分析工作从2023年8月持续至2023年12月。

Methods

Thrombus screening with ICE or TEE prior to ablation.

在消融术前使用ICE或TEE进行血栓筛查。

main_outcomes_and_measures

The primary end point was the incidenceof periprocedural thromboembolic events (stroke, transient ischemic attack, or systemic embolism).

主要终点是围手术期血栓栓塞事件（中风、短暂性脑缺血发作或全身性栓塞）的发生率。

Secondary end points included thrombus detection, procedural safety and efficiency, and patient-reported comfort.

次要终点包括血栓检测、手术的安全性和效率，以及患者报告的舒适度。

Results

A total of 1810 patients (mean [SD] age, 64.3 [9.4] years; 868 women [48.0%]; 887 patients [49.0%] with paroxysmal AF) were randomized to ICE (n = 906) or TEE (n = 904).

共有1810名患者（平均年龄[标准差]为64.3[9.4]岁；868名女性[48.0%]；887名患者[49.0%]患有阵发性房颤）被随机分配到ICE组（n = 906）或TEE组（n = 904）。

Thromboembolic events occurred in 4 of 906 patients undergoing ICE (0.4%) and 5 of 904 patients undergoing TEE (0.6%) (risk difference, -0.11%; Farrington-Manning 95% CI, -0.84% to 0.62%; P for noninferiority = .01).

在进行ICE的906名患者中有4名（0.4%）和进行TEE的904名患者中有5名（0.6%）发生了血栓栓塞事件（风险差异为-0.11%；Farrington-Manning 95%置信区间为-0.84%至0.62%；非劣效性检验的P值为.01）。

Thrombus was detected in 2.0% vs 1.5% (relative risk [RR], 1.29; 95% CI, 0.64-2.61; P = .48) with ICE vs TEE, respectively, with more non-left atrial appendage thrombi in ICE (0.6% vs 0%; P < .001).

ICE 和 TEE 分别检测到血栓的发生率为 2.0% 对 1.5%（相对风险 [RR], 1.29; 95% 置信区间, 0.64-2.61; P = .48），其中 ICE 检测到更多非左心耳血栓（0.6% 对 0%；P < .001）。

Major bleeding related to transseptal puncture was lower with ICE (0.2% vs 1.2%; RR, 0.18; 95% CI, 0.04-0.81; P = .03).

与 TEE 相比，ICE 相关的房间隔穿刺大出血发生率较低（0.2% 对 1.2%；RR, 0.18; 95% CI, 0.04-0.81; P = .03）。

ICE reduced mean (SD) fluoroscopy time (4.2 [1.5] vs 9.3 [3.0] minutes; P < .001), preprocedural waiting time (14.4 [8.0] vs 23.6 [10.5] hours; P < .001), and anxiety or depression prevalence(24.6% vs 37.5%; RR, 0.66; 95% CI, 0.56-0.76; P < .001).

在本项多中心随机临床试验中，ICE将透视时间从平均（标准差）9.3（3.0）分钟减少到4.2（1.5）分钟（P < .001），术前等待时间从平均（标准差）23.6（10.5）小时减少到14.4（8.0）小时（P < .001），并且焦虑或抑郁的发生率从37.5%降低到24.6%（相对风险，0.66；95%置信区间，0.56-0.76；P < .001）。

conclusions_and_relevance

In this multicenter randomized clinical trial, ICE was noninferior to TEE for preventing thromboembolic complications in AF ablation and offered additional advantages in safety, efficiency, and patient comfort, supporting its use as a viable alternative in clinical practice.

在这项多中心随机临床试验中，ICE在预防房颤消融术中的血栓栓塞并发症方面与TEE相当，并且在安全性、效率和患者舒适度方面提供了额外的优势，支持其作为临床实践中可行的替代方案。

trial_registration

ClinicalTrial.gov Identifier: NCT05466266.

临床试验注册号：NCT05466266。