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大功率短时间心房颤动消融技术对无症状性脑栓塞发生率的影响:一项前瞻性随机对照研究。

Impact of high-power short-duration atrial fibrillation ablation technique on the incidence of silent cerebral embolism: a prospective randomized controlled study.

机构信息

Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University, No. 288, Tianwen Avenue, Chayuan, Nan'an District, Chongqing, 400060, China.

Department of Radiology, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

BMC Med. 2023 Nov 23;21(1):461. doi: 10.1186/s12916-023-03180-3.

Abstract

BACKGROUND

High-power short-duration (HPSD) ablation strategy has emerged as a popular approach for treating atrial fibrillation (AF), with shorter ablation time. The utilized Smart Touch Surround Flow (STSF) catheter, with 56 holes around the electrode, lowers electrode-tissue temperature and thrombus risk. Thus, we conducted this prospective, randomized study to investigate if the HPSD strategy with STSF catheter in AF ablation procedures reduces the silent cerebral embolism (SCE) risk compared to the conventional approach with the Smart Touch (ST) catheter.

METHODS

From June 2020 to September 2021, 100 AF patients were randomized 1:1 to the HPSD group using the STSF catheter (power set at 50 W) or the conventional group using the ST catheter (power set at 30 to 35 W). Pulmonary vein isolation was performed in all patients, with additional lesions at operator's discretion. High-resolution cerebral diffusion-weighted magnetic resonance imaging (hDWI) with slice thickness of 1 mm was performed before and 24-72 h after ablation. The incidence of new periprocedural SCE was defined as the primary outcome. Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA) test.

RESULTS

All enrolled AF patients (median age 63, 60% male, 59% paroxysmal AF) underwent successful ablation. Post-procedural hDWI identified 106 lesions in 42 enrolled patients (42%), with 55 lesions in 22 patients (44%) in the HPSD group and 51 lesions in 20 patients (40%) in the conventional group (p = 0.685). No significant differences were observed between two groups regarding the average number of lesions (p = 0.751), maximum lesion diameter (p = 0.405), and total lesion volume per patient (p = 0.669). Persistent AF and CHADS-VASc score were identified as SCE determinants during AF ablation procedure by multivariable regression analysis. No significant differences in MoCA scores were observed between patients with SCE and those without, both immediately post-procedure (p = 0.572) and at the 3-month follow-up (p = 0.743).

CONCLUSIONS

Involving a small sample size of 100 AF patients, this study reveals a similar incidence of SCE in AF ablation procedures, comparing the HPSD strategy using the STSF catheter to the conventional approach with the ST catheter.

TRIAL REGISTRATION

Clinicaltrials.gov: NCT04408716. AF = Atrial fibrillation, DWI = Diffusion-weighted magnetic resonance imaging, HPSD = High-power short-duration, ST = Smart Touch, STSF = Smart Touch Surround Flow.

摘要

背景

高功率短时间(HPSD)消融策略已成为治疗心房颤动(AF)的一种流行方法,其消融时间更短。所使用的 Smart Touch Surround Flow(STSF)导管在电极周围有 56 个孔,可降低电极-组织温度和血栓形成风险。因此,我们进行了这项前瞻性、随机研究,以调查 AF 消融过程中使用 STSF 导管的 HPSD 策略是否比使用 Smart Touch(ST)导管的常规方法降低了无症状性脑栓塞(SCE)风险。

方法

从 2020 年 6 月至 2021 年 9 月,100 例 AF 患者被随机分为 1:1 组,分别使用 STSF 导管(功率设置为 50 W)或 ST 导管(功率设置为 30-35 W)进行 HPSD 消融。所有患者均行肺静脉隔离术,术者根据情况行其他部位消融。消融前和消融后 24-72 小时进行高分辨率弥散加权磁共振成像(hDWI),层厚 1 毫米。新的围手术期 SCE 的发生定义为主要结局。使用蒙特利尔认知评估(MoCA)测试评估认知功能。

结果

所有入组的 AF 患者(中位年龄 63 岁,60%为男性,59%为阵发性 AF)均成功消融。术后 hDWI 在 42 名入组患者中发现 106 个病灶(42%),22 名患者(44%)在 HPSD 组中有 55 个病灶,20 名患者(40%)在常规组中有 51 个病灶(p=0.685)。两组之间的平均病灶数量(p=0.751)、最大病灶直径(p=0.405)和每位患者的总病灶体积(p=0.669)均无显著差异。多变量回归分析显示,持续性 AF 和 CHADS-VASc 评分是 AF 消融过程中 SCE 的决定因素。多变量回归分析显示,在 AF 消融过程中,SCE 与术后即刻(p=0.572)和 3 个月随访(p=0.743)时的 MoCA 评分无显著差异。

结论

本研究纳入了 100 例 AF 患者,结果表明,与使用 ST 导管的常规方法相比,使用 STSF 导管的 HPSD 策略在 AF 消融过程中 SCE 的发生率相似。

试验注册

Clinicaltrials.gov:NCT04408716。AF=心房颤动,DWI=弥散加权磁共振成像,HPSD=高功率短时间,ST=Smart Touch,STSF=Smart Touch Surround Flow。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3761/10666361/0e241d53ed18/12916_2023_3180_Fig1_HTML.jpg

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