典型心房扑动患者的超高功率短程射频消融：FASD-HP随机试验的原理与设计
Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial.
作者信息
Valverde Soria Laura, Toquero Jorge, Brouzet Thomas, García Cano Laura, García Barrios Ana, Segura Domínguez Melodie, Hermón Ramírez Gloria A, Ajo Ferrer Raquel, Ajo Ferrer María, Andreu Concha Celia María, Arrarte Esteban Vicente, Sánchez Barbié Angel, Martínez-Martínez Juan Gabriel, Ibáñez Criado Alicia, Ibáñez Criado José Luis
机构信息
Arrhythmia Unit, Cardiology Department,, Hospital Universitario Doctor Balmis, Alicante, Spain.
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.
出版信息
J Interv Card Electrophysiol. 2025 Apr;68(3):497-503. doi: 10.1007/s10840-024-01969-7. Epub 2024 Dec 21.
BACKGROUND
The aim of cavotricuspid isthmus (CTI)-dependent flutter ablation is the bidirectional conduction block of the CTI. Very-high-power short-duration (vHPSD) radiofrequency ablation aims to minimize conductive heating and increase resistive heating to create shallower but wider lesions in a very short time, while reducing the risk of collateral tissue damage. Experimental studies have shown that it produces effective transmural lesions with an equal or better safety profile compared to conventional parameters. There are published and ongoing trials studying long-term outcomes of this technique for pulmonary vein isolation, but there is a lack of evidence regarding its use in flutter ablation.
METHODS AND RESULTS
Multicenter 1:1 randomized, single-blind study. Two CTI ablation strategies are compared: (1) conventional treatment arm consisting of 25-40-W applications of unlimited duration until reaching the minimum value of one of the currently accepted lesion markers (Ablation Index > 500 at the anterior half of the CTI and > 400 at the posterior half with CARTO3 system); (2) experimental treatment arm consisting of CTI block using point-by-point applications of very-high-power (90 W) short duration (4 s). The primary objective is to evaluate the non-inferiority of the efficacy and safety of vHPSD ablation in patients undergoing typical flutter ablation. Secondary objectives include comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure, and time to flutter recurrence.
CONCLUSIONS
The FASD-HP trial is the first clinical trial to investigate the non-inferiority of CTI ablation with vHPSD in patients with typical atrial flutter.
CLINICAL TRIAL REGISTRATION NUMBER
The study was registered at http://www.
CLINICALTRIALS
gov (NCT05777850) on March 21, 2023.
背景
依赖三尖瓣峡部（CTI）的房扑消融的目的是实现CTI的双向传导阻滞。超高功率短持续时间（vHPSD）射频消融旨在将传导性加热降至最低，并增加电阻性加热，以便在极短时间内形成更浅但更宽的损伤，同时降低周围组织受损的风险。实验研究表明，与传统参数相比，它能产生有效的透壁损伤，且安全性相当或更佳。目前已有关于该技术用于肺静脉隔离的长期疗效的已发表及正在进行的试验，但缺乏其用于房扑消融的相关证据。
方法与结果
多中心1:1随机单盲研究。比较两种CTI消融策略：（1）传统治疗组，采用25 - 40瓦不限时长的应用，直至达到当前公认的损伤标志物之一的最小值（使用CARTO3系统时，CTI前半部分消融指数>500，后半部分>400）；（2）实验治疗组，则采用逐点应用超高功率（90瓦）短持续时间（4秒）来实现CTI阻滞。主要目的是评估vHPSD消融在接受典型房扑消融患者中的疗效和安全性的非劣效性。次要目的包括比较总射频时间、应用次数、蒸汽泡数量、再连接百分比、手术时长、术中疼痛程度以及房扑复发时间。
结论
FASD - HP试验是首个研究vHPSD用于典型心房扑动患者CTI消融非劣效性的临床试验。
临床试验注册号
该研究于2023年3月21日在http://www.CLINICALTRIALS.gov（NCT05777850）注册。
Zotero 插件