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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-03022-6

摘要内容如下：

导管消融治疗心房颤动（AF）的临床结果不理想，部分原因是在实现持久损伤方面存在挑战。尽管焦点逐点消融允许创建任何所需的损伤组，但该策略需要生成无间隙的连续损伤。能够产生宽足迹消融损伤的大尖端导管可以提高消融效果和效率。在一项随机、单盲、非劣效性试验中，420名持续性房颤患者接受了大尖端导管双脉冲场和射频能量消融术，与传统射频消融系统消融术相比。主要复合疗效终点在1年内进行评估，包括无急性手术失败和任何时间的重复消融，以及3个月空白期后的心律失常复发、药物开始或升级或心脏复律。主要安全性终点是未发生严重手术相关或器械相关的不良事件。在研究组和对照组中，分别有73.8%和65.8%的患者观察到主要有效性终点（非劣效性P<0.0001）。研究组中有3名患者和对照组中有2名患者出现主要手术或器械相关并发症（非劣效性P<0.0001）。在二次分析中，与对照组相比，研究组的手术时间较短（p<0.0001）。这些结果证明双能量导管治疗持续性房颤的安全性和有效性不差。未来需要进行大规模研究，以收集关于局灶性双能量点阵导管对更广泛的房颤患者群体的影响的真实证据。ClinicalTrials.gov标识符：NCT05120193。

英文原文如下：

Abstracts

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .

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