Department of Electrophysiology, Heart Center Leipzig, Strümpellstr., Leipzig, Germany.
Clinic Electrophysiology Department, Trinity Mother Frances, Tyler, TX, USA.
Europace. 2019 Apr 1;21(4):655-661. doi: 10.1093/europace/euy191.
The objective of this study was to verify acute safety, performance, and usage of a novel ultra-high density mapping system in patients undergoing ablation procedure in a real-world clinical setting.
The TRUE HD study enrolled patients undergoing catheter ablation with mapping for all arrhythmias (excluding de novo atrial fibrillation) who were followed for 1 month. Safety was determined by collecting all serious adverse events and adverse events associated with the study devices. Performance was determined as the composite of: ability to map the arrhythmia/substrate, complete the ablation applications, arrhythmia termination (where applicable), and ablation validation. Use of mapping system in the ablation validation workflow was also evaluated. Among the 519 patients who underwent a complete (504) or attempted (15) procedure, 21 (4%) serious ablation-related complications were collected, with 3 (0.57%) potentially related to the mapping catheter. Four hundred and twenty treated patients resulted in a successful procedure confirmed by arrhythmia-specific validation techniques (83.3%; 95% confidence interval: 79.8-86.5%). A total of 1419 electroanatomical maps were created with a median acquisition time of 9:23 min per map. Of these, 372 maps in 222 (44%) patients were collected for ablation validation purposes. Following validation mapping, 162/222 (73%) patients required additional ablation.
In the TRUE HD study mapping was associated with rates of acute success and complications consistent with previously published reports. Importantly, a low percentage of events (0.57%) was attributed to the mapping catheter. When performed, validation mapping was useful for identifying additional targets for ablation in the majority of patients.
本研究旨在验证一种新型超高密度标测系统在真实临床环境中进行消融手术的患者中的急性安全性、性能和使用情况。
TRUE HD 研究纳入了所有心律失常（不包括新发心房颤动）接受导管消融并进行标测的患者，随访时间为 1 个月。安全性通过收集所有严重不良事件和与研究设备相关的不良事件来确定。性能确定为以下综合指标：标测心律失常/基质的能力、完成消融应用、心律失常终止（如有）和消融验证。还评估了标测系统在消融验证工作流程中的使用情况。在完成（504 例）或尝试（15 例）的 519 例患者中，共收集到 21 例（4%）与消融相关的严重并发症，其中 3 例（0.57%）可能与标测导管有关。420 例接受治疗的患者通过心律失常特异性验证技术确认了成功的手术（83.3%；95%置信区间：79.8-86.5%）。共创建了 1419 个电解剖图，每个图的中位采集时间为 9:23 分钟。其中，222 例患者中的 372 个图（44%）用于消融验证目的。验证标测后，222 例患者中有 162 例（73%）需要额外消融。
在 TRUE HD 研究中，标测与先前发表的报告一致，其急性成功率和并发症发生率相当。重要的是，只有极少数事件（0.57%）归因于标测导管。当进行验证标测时，它对识别大多数患者中额外的消融靶点非常有用。
