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经导管消融流出道室性心律失常时应用半倍生理盐水与生理盐水灌洗的比较(HALF):一项多中心、平行、开放标签、随机对照研究。

Half versus normal saline irrigation during catheter ablation of outflow tract ventricular arrhythmias (HALF): a multi-center, parallel, open-label, randomized controlled study.

机构信息

Section of Pacing and Electrophysiology, Division of Cardiology, the First Affiliated Hospital with Nanjing Medical University, Guangzhou Road 300, Nanjing, 210029, China.

Department of Cardiology, the Second Affiliated Hospital of Xi'an JiaoTong University, Xi'an, China.

出版信息

J Interv Card Electrophysiol. 2023 Dec;66(9):2143-2151. doi: 10.1007/s10840-023-01558-0. Epub 2023 May 19.

Abstract

BACKGROUND

Animal studies demonstrated that deeper lesions could be achieved during radio-frequency catheter ablation (RFCA) by using half saline (HS) compared to normal saline (NS) as irrigation.

OBJECTIVES

This study sought to compare the efficiency and safety of HS and NS for irrigation during RFCA of idiopathic outflow tract ventricular arrhythmia (OT-VA).

METHODS

In this multicenter, randomized controlled study, 167 patients undergoing RFCA of OT-VA were randomized 1:1 to receive HS- or NS-irrigated ablation. Acute success was defined as the absence of induced targeted premature ventricular contraction (PVC) at the end of the procedure. The 6-month success was defined as a ≥ 80% reduction of pre-procedural PVC burden.

RESULTS

There were no differences of baseline characteristics between the HS and NS group. Patients in HS group had shorter total ablation time (259.5 ± 155.5 S vs. 355.6 ± 230.7 S, P = 0.04) than that in NS group. The acute and 6-month success rates were similar between the HS and NS group (92.8 vs. 91.7%, P = 0.79; 90.9 vs. 92.1%, P = 0.79, respectively). No significant difference was observed in the incidence of steam pops between the HS and NS group (2.4 vs. 1.2%, P = 0.62).

CONCLUSIONS

The ablation using HS irrigation achieved similar success rate and safety compared to that using NS irrigation but was associated with a shorter total ablation time.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR2200059205).

摘要

背景

动物研究表明,与使用生理盐水(NS)相比,使用半盐水(HS)进行射频导管消融(RFCA)时可以获得更深的病变。

目的

本研究旨在比较 HS 和 NS 用于特发性流出道室性心律失常(OT-VA)RFCA 时的效率和安全性。

方法

在这项多中心、随机对照研究中,167 名接受 OT-VA RFCA 的患者被随机分为 1:1 接受 HS 或 NS 冲洗消融。急性成功定义为程序结束时无诱发的靶向室性期前收缩(PVC)。6 个月的成功定义为术前 PVC 负荷减少≥80%。

结果

HS 组和 NS 组的基线特征无差异。HS 组患者的总消融时间更短(259.5 ± 155.5 S 比 355.6 ± 230.7 S,P = 0.04)。HS 组和 NS 组的急性和 6 个月成功率相似(92.8%比 91.7%,P = 0.79;90.9%比 92.1%,P = 0.79)。HS 组和 NS 组蒸汽弹的发生率无显著差异(2.4%比 1.2%,P = 0.62)。

结论

与 NS 冲洗相比,HS 冲洗的消融成功率和安全性相似,但总消融时间更短。

试验注册

中国临床试验注册中心(ChiCTR2200059205)。

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