双能量用于肺静脉隔离,使用与三维映射系统集成的双能量焦点剥离技术:SmartfIRE 3个月的结果
Mattias Duytschaever1, Gediminas Račkauskas2, Tom De Potter3
1AZ Sint-Jan Hospital, Ruddershove 10, 8000 Bruges, Belgium.
概括
在SmartfIRE研究中,新型的双能导管有效治疗心房动 (AF),100%的急性成功. 这项技术显示出AF切除的前景,在三个月后可持续隔离肺静脉.
科学领域:
- 电子生理学 电子生理学
- 心血管医学 心血管医学
- 医疗器械 医疗器械
背景情况:
- 接触力 (CF) 感应式射频 (RF) 导管与消融指数已建立用于心房 (AF) 治疗.
- 一种新型的双能量 (DE) 焦点CF导管集成RF和脉冲场切除 (PFA) 与3D映射,以提高操作员的灵活性.
研究的目的:
- 评估新型DE焦点CF导管的安全性和有效性,用于治疗药物耐药性,症状性 Paroxysmal AF.
- 为了展示SmartfIRE研究 (ClinicalTrials.gov标识符:NCT05752487) 的3个月的废除后结果.
主要方法:
- 肺静脉隔离 (PVI) 使用DE焦点,灌的CF感应导管进行.
- 推的能量应用:PFA用于后部/下部段,RF用于前部/山脊/部段.
- 评估了安全性和有效性终点,包括不良事件,食道内镜,神经学评估和心脏成像.
主要成果:
- 在137名患者中,急性手术成功率为100%.
- 在89.1%的患者和96.8%的静脉中实现了第一通隔离.
- 主要不良事件发生率为4.4% (6/137),包括PV狭窄,坦波纳,中风和心周炎. 没有观察到食道病变.
结论:
- 带有3D映射的DE焦点CF导管显示了100%的急性成功率和可接受的安全性概况,用于 Paroxysmal AF治疗.
- 三个月的重新映射表明肺静脉隔离的显著耐用性.
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