2024 年第 12 期 第 0 卷

心房颤动导管消融术后随访评价指标及其实施方法的现状

Current status of follow-up evaluation indicators and implementation methods after catheter ablation of atrial fibrillation

作者：王雅文

英文作者：Wang Yawen

单位：国家药品监督管理局医疗器械技术审评中心，北京100076，Email：wangyw@cmde.org.cn

英文单位：Center for Medical Device Evaluation National Medical Products Administration Beijing 100076 China

关键词：

英文关键词：Atrialfibrillation;Catheterablation;Randomizedcontrolledtrial;Outcomeindicators; Follow-up

• 摘要：

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  【摘要】近年来，随着新技术、新理念的发展，心房颤动导管消融术领域涌现出大量新器械，大量的临床研究也带来了更多的临床证据。然而，相关临床研究的设计异质性较强，心房颤动导管消融术后随访使用的工具和策略不同，临床试验的结果也不一致。心房颤动复发率在不同研究中差异较大，约半数研究选择以“记录到房性心律失常”为标准，其次为“记录到房性心律失常，包括使用抗心律失常药物”。多数研究未明确规定抗心律失常药物使用和空白期内再次手术是否说明本次导管消融失败。随访实施方法中，研究多在术后3、6、12个月进行24 h动态心电图检查，但仍有部分研究未说明随访时间节点或随访方式。高质量的随机对照试验应选择合理的观察指标和能反映患者实际情况的随访实施方法，统一研究条件有利于筛选出真正有效的治疗手段。

• In recent years, with the development of new technology and new concept, a large number of new devices have emerged in the field of catheter ablation of atrial fibrillation, and a large number of clinical studies have brought more clinical evidence. However, the design of relevant clinical trials is highly heterogeneous, the tools and strategies used for follow-up after catheter ablation of atrial fibrillation are different, and the results of clinical trials are also inconsistent. The recurrence rate of atrial fibrillation varied greatly among different studies. About half of the studies chose "documented atrial arrhythmia" as the criterion, followed by "documented atrial arrhythmia including the use of antiarrhythmic drugs". Most studies did not specify whether the use of antiarrhythmic drugs and reoperation during blank-period indicated failure of catheter ablation. In terms of follow-up methods, most studies performed 24 h holter examination at 3, 6, and 12 months after surgery, but there were still some studies did not explain the follow-up time node or follow-up method. High-quality randomized controlled trials should select reasonable observation indicators and follow-up methods that can reflect the actual situation of patients. Unified research conditions are conducive to the screening of truly effective treatment.