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用于室性心动过速的温控消融系统的安全性和有效性:TRAC-VT研究结果

Safety and efficacy of a temperature-controlled ablation system for ventricular tachycardia: Results from the TRAC-VT study.

作者信息

Kautzner Josef, Moreno Javier, Tondo Claudio, Anselme Frédéric, Burrell James, Becker Daniel, Peichl Petr, Patchett Ian, Dhanjal Tarvinder

机构信息

Institute for Clinical and Experimental Medicine, Prague, Czechia.

Department of Cardiology, Hospital Universitario Ramón y Cajal, Madrid, Spain.

出版信息

J Interv Card Electrophysiol. 2025 Feb 1. doi: 10.1007/s10840-025-01995-z.

DOI:10.1007/s10840-025-01995-z
PMID:39893296
Abstract

BACKGROUND

Catheter ablation using radiofrequency (RF) energy is an established treatment for ventricular tachycardia (VT). Tissue temperature is a key determinant of successful lesion creation, and yet, it is difficult to measure during conventional RF ablation because of the cooling effect of high-flow rate saline irrigation. The TRAC-VT study evaluated the safety and efficacy of a novel irrigated RF ablation system modulating power based on real-time tissue temperature.

METHODS

Patients with sustained monomorphic VT and structural heart disease (SHD) were enrolled. Catheter ablation was performed in temperature-control mode (irrigation 8 ml/min, temperature set-points 55 or 60 °C, and power output ≤ 50 W), with RF applications for ≤ 45 s. The primary safety endpoint was a composite of cardiovascular-specific serious procedure-related adverse events within 30 days post-ablation. The primary effectiveness endpoint was acute success (i.e., non-inducibility of all clinically relevant VTs).

RESULTS

Thirty-eight patients were enrolled with monomorphic VT (age 68 ± 12 years and 84% male), with an average of 1.7 ± 1.2 VTs targeted per patient. In total, 41 ± 23 RF applications per patient were delivered. Acute procedural success was 100% (95% CI, 91-100%). No primary safety endpoints were observed. Six-month follow-up was completed in 92% of patients with 81% (95% CI, 65-91%) freedom from sustained or treated VT. A repeat ablation was performed in three patients.

CONCLUSIONS

Ablation of VT in SHD, using a temperature-controlled irrigated RF catheter, was safe and effective with a low rate of VT recurrence at 6 months.

摘要

背景

使用射频(RF)能量进行导管消融是治疗室性心动过速(VT)的既定方法。组织温度是成功形成损伤的关键决定因素,然而,在传统的射频消融过程中,由于高流量盐水冲洗的冷却作用,很难进行测量。TRAC-VT研究评估了一种基于实时组织温度调节功率的新型灌注射频消融系统的安全性和有效性。

方法

纳入患有持续性单形性室性心动过速和结构性心脏病(SHD)的患者。在温度控制模式下进行导管消融(冲洗速度8 ml/min,温度设定点55或60°C,功率输出≤50 W),射频应用时间≤45秒。主要安全终点是消融后30天内与心血管相关的严重手术相关不良事件的综合指标。主要有效性终点是急性成功(即所有临床相关室性心动过速均不能诱发)。

结果

38例持续性单形性室性心动过速患者入组(年龄68±12岁,男性占84%),平均每位患者有1.7±1.2个目标室性心动过速。每位患者总共进行了41±23次射频应用。急性手术成功率为100%(95%CI,91-100%)。未观察到主要安全终点。92%的患者完成了6个月的随访,其中81%(95%CI,65-91%)无持续性或经治疗的室性心动过速。3例患者进行了再次消融。

结论

使用温度控制的灌注射频导管对结构性心脏病患者的室性心动过速进行消融是安全有效的,6个月时室性心动过速复发率较低。

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本文引用的文献

1
Ventricular Tachycardia Ablation Endpoints: Moving Beyond Noninducibility.室性心动过速消融终点:超越不能诱发
JACC Clin Electrophysiol. 2024 May;10(5):981-999. doi: 10.1016/j.jacep.2023.12.009. Epub 2024 Feb 21.
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Characterizing lesion morphology of a novel diamond-tip temperature-controlled irrigated radiofrequency ablation catheter.描述新型钻石尖端控温灌流射频消融导管的病灶形态。
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2022年欧洲心脏病学会室性心律失常患者管理和心脏性猝死预防指南
Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262.
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Initial experience of temperature-controlled irrigated radiofrequency ablation for ischaemic cardiomyopathy ventricular tachycardia ablation.温控灌流射频消融治疗缺血性心肌病室性心动过速消融的初步经验。
J Interv Card Electrophysiol. 2023 Apr;66(3):551-559. doi: 10.1007/s10840-022-01158-4. Epub 2022 Feb 22.
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The dawn of radiofrequency catheter ablation for cardiac arrhythmias.用于治疗心律失常的射频导管消融术的开端。
Heart Rhythm. 2021 Mar;18(3):485-486. doi: 10.1016/j.hrthm.2020.11.030.
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Complications of Radiofrequency Catheter Ablation: Can We Prevent Steam Pops?射频导管消融的并发症:我们能预防蒸汽泡吗?
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Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation.温度控制射频消融治疗心房颤动患者肺静脉隔离。
J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.
8
Freedom from recurrent ventricular tachycardia after catheter ablation is associated with improved survival in patients with structural heart disease: An International VT Ablation Center Collaborative Group study.导管消融术后无复发性室性心动过速与结构性心脏病患者生存率提高相关:一项国际室性心动过速消融中心协作组研究。
Heart Rhythm. 2015 Sep;12(9):1997-2007. doi: 10.1016/j.hrthm.2015.05.036. Epub 2015 May 30.
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Noninducibility in postinfarction ventricular tachycardia as an end point for ventricular tachycardia ablation and its effects on outcomes: a meta-analysis.心肌梗死后室性心动过速消融终点的不可诱导性及其对结局的影响的荟萃分析。
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Eur Heart J. 2014 Jun 7;35(22):1479-85. doi: 10.1093/eurheartj/ehu040. Epub 2014 Feb 16.