射频导丝与射频针系统行经房间隔穿刺的随机比较。

Randomized Comparison of a Radiofrequency Wire Versus a Radiofrequency Needle System for Transseptal Puncture.

机构信息

Department of Medicine, Division of Cardiology, Electrophysiology Section, University of California-San Francisco, San Francisco, California, USA.

出版信息

JACC Clin Electrophysiol. 2023 May;9(5):611-619. doi: 10.1016/j.jacep.2022.10.017. Epub 2022 Nov 30.

DOI:10.1016/j.jacep.2022.10.017

PMID:36752451

Abstract

BACKGROUND

Transseptal puncture is a necessary component of many electrophysiology and structural heart procedures. Improving this technique has broad ramifications for the overall efficiency and safety of these interventions. A new technology uses a specialized introducer wire to cross the septum with radiofrequency (RF) energy, eliminating the need for a transseptal needle and wire/needle exchanges.

OBJECTIVES

This study sought to compare the efficacy and safety of an RF needle versus RF wire approach for transseptal puncture.

METHODS

Individuals ≥18 years of age undergoing double transseptal puncture for atrial fibrillation or left atrial flutter ablation were randomized to a transseptal approach with either an RF needle or RF wire. The primary outcome was time to achieve first transseptal puncture. Secondary outcomes included second and combined transseptal puncture time, fluoroscopy time, number of equipment exchanges, and complications.

RESULTS

A total of 75 participants were enrolled (36 RF needle, 39 RF wire). No crossovers occurred. Randomization to the RF wire resulted in a significant reduction in first transseptal time compared with the RF needle (median 9.2 [IQR: 5.7-11.2] minutes vs 6.9 [IQR: 5.2-8.4] minutes, P = 0.03). Second and combined transseptal times, and number of equipment exchanges, were also reduced with the RF wire. One participant in the RF needle group experienced transient atrioventricular block due to mechanical trauma from the sheath/dilator assembly. There were no complications in the RF wire group.

CONCLUSIONS

The RF wire technique resulted in faster time to transseptal puncture and fewer equipment exchanges compared with an RF needle with no difference in complications.

摘要

背景

经房间隔穿刺是许多电生理和结构性心脏程序的必要组成部分。改进这项技术对这些干预措施的整体效率和安全性具有广泛的影响。一种新的技术使用特殊的导引钢丝，用射频（RF）能量穿过房间隔，从而无需使用经房间隔穿刺针和钢丝/针交换。

目的

本研究旨在比较 RF 针与 RF 线方法用于经房间隔穿刺的效果和安全性。

方法

年龄≥18 岁的行双侧房间隔穿刺的房颤或左房扑动消融患者被随机分为 RF 针或 RF 线组。主要结局是首次经房间隔穿刺的时间。次要结局包括第二次和联合经房间隔穿刺时间、透视时间、设备交换次数和并发症。

结果

共纳入 75 名患者（RF 针 36 例，RF 线 39 例）。无交叉。与 RF 针相比，RF 线组的首次经房间隔穿刺时间明显缩短（中位数 9.2 [IQR：5.7-11.2] 分钟比 6.9 [IQR：5.2-8.4] 分钟，P=0.03）。RF 线组的第二次和联合经房间隔穿刺时间和设备交换次数也减少。RF 针组 1 例患者因鞘/扩张器组件的机械创伤导致短暂性房室传导阻滞。RF 线组无并发症。