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局灶性脉冲场消融治疗阵发性室上性心动过速的结果。

Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia.

机构信息

Cardiac Arrhythmia Center, The First Affiliated Hospital of Ningbo University, Ningbo, China.

Health Science Center, Ningbo University, Ningbo, China.

出版信息

Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17.

Abstract

BACKGROUND

Pulsed field ablation (PFA) is primarily used for treatment of atrial fibrillation as it provides better safety and efficacy. However, there are limited data available on the use of PFA for paroxysmal supraventricular tachycardia (PSVT). The study sought to describe the outcomes of PSVT ablation with a novel focal contact force (CF)-sensing PFA.

METHODS

In this first-in-human pilot study, a focal CF-sensing PFA catheter was used for mapping and ablation navigated with an electroanatomic mapping system (EAMS). Pulsed field energy was delivered as biphasic/bipolar electrical pulse trains with 2000 V/delivery. CF was controlled from 2 g to 10 g during PFA.

RESULTS

Procedural acute success was achieved without general anaesthesia or conscious sedation in all 10 patients, including 7 patients diagnosed with typical atrioventricular nodal re-entrant tachycardias and 3 patients with orthodromic reciprocating tachycardias. Successful target ablation time was 2.0 ± 0.5 seconds per patient, and the acute procedural success at the first single site was achieved in 5 patients. The mean skin-to-skin procedure time was 79.4 ± 15 minutes, PFA catheter dwell time was 50.1 ± 14 minutes, and fluoroscopy time was 6.2 ± 7 minutes. Maintenance of sinus rhythm was observed in all patients within 6-month follow-up. No serious adverse events occurred in any subjects during PFA or during the 6-month follow-up.

CONCLUSIONS

A focal CF-sensing PFA catheter could effectively, rapidly, and safely ablate PSVT in conscious patients.

CLINICAL TRIAL REGISTRATION

NCT05770921.

摘要

背景

脉冲场消融(PFA)主要用于治疗心房颤动,因为它提供了更好的安全性和疗效。然而,关于 PFA 用于阵发性室上性心动过速(PSVT)的应用数据有限。本研究旨在描述使用新型局灶接触力(CF)感应 PFA 治疗 PSVT 的结果。

方法

在这项首次人体的试点研究中,使用局灶 CF 感应 PFA 导管进行标测和消融,导航采用电解剖标测系统(EAMS)。以 2000 V/次的双相/双极电脉冲序列输送脉冲场能量。在 PFA 过程中,CF 控制在 2 g 至 10 g 之间。

结果

在所有 10 名患者中,均无需全身麻醉或清醒镇静即可达到程序急性成功,包括 7 名诊断为典型房室结折返性心动过速的患者和 3 名顺向型折返性心动过速的患者。每个患者的目标消融时间为 2.0 ± 0.5 秒,5 名患者在第一个单点即可实现急性程序成功。平均皮肤到皮肤的手术时间为 79.4 ± 15 分钟,PFA 导管留置时间为 50.1 ± 14 分钟,透视时间为 6.2 ± 7 分钟。所有患者在 6 个月随访期间均维持窦性心律。在 PFA 过程中或在 6 个月随访期间,没有患者发生任何严重不良事件。

结论

局灶 CF 感应 PFA 导管可有效、快速和安全地消融清醒患者的 PSVT。

临床试验注册

NCT05770921。

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