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高功率短程射频消融用于肺静脉隔离的可行性、安全性及结果:一项真实世界观察性研究

The Feasibility, Safety and Outcome of Very High-Power Short Duration Radiofrequency Ablation in Pulmonary Vein Isolation: A Real-World Observation Study.

作者信息

Mavilakandy Akash, Koev Ivelin, Sidhu Bharat, Kotb Ahmed, Antoun Ibrahim, Man Sharon H, Vali Zakariyya, Pooranachandran Vivetha, Barker Joseph, Panchal Gaurav, Li Xin, Ng G André

机构信息

Department of Cardiology, University Hospitals of Leicester NHS Trust, LE1 5WW Leicester, UK.

Department of Cardiovascular Sciences, University of Leicester, LE1 7RH Leicester, UK.

出版信息

Rev Cardiovasc Med. 2024 Jul 5;25(7):250. doi: 10.31083/j.rcm2507250. eCollection 2024 Jul.

Abstract

BACKGROUND

Pulmonary vein isolation (PVI) ablation is the established gold standard therapy for patients with symptomatic drug refractory atrial fibrillation (AF). Advancements in radiofrequency (RF) ablation, have led to the development of the novel contact force-sensing temperature-controlled very high-power short-duration (vHPSD) RF ablation. This setting delivers 90 W for up to 4 seconds with a constant irrigation flow rate of 8 mL/min. The aim of this study was to compare procedural outcomes and safety with conventional radiofrequency ablation.

METHODS

An observational study was conducted with patients who underwent first time PVI ablation between August 2020 and January 2022. The cohort was divided into: (1) vHPSD ablation; (2) High-power short duration (HPSD) ablation; (3) THERMOCOOL SMARTTOUCH™ SF (STSF). The vHPSD ablation group was prospectively recruited while the HPSD and STSF group were retrospectively collected. Primary outcomes were procedural success, PVI duration, ablation duration and incidence of perioperative adverse events. Secondary outcomes were intraprocedural morphine and midazolam requirement.

RESULTS

A total of 175 patients were included in the study with 100, 30 and 45 patients in the vHPSD, HPSD and STSF group, respectively. PVI was successfully attained in all vHPSD patients. vHPSD demonstrated significantly reduced time required for PVI and total energy application in comparison to the HPSD and STSF groups (67.7 29.7 vs. 92.9 25.7 vs. 93.6 29.1 min, 0.0001; 9.87 4.16 vs. 33.9 7.49 vs. 36.0 10.5 min, 0.0001, respectively). Intravenous morphine and midazolam requirement was lower in the vHPSD group compared to the HPSD and STSF groups (10.2 3.43 vs. 16.1 4.58 vs. 15.3 3.94 mg, 0.0001; 4.04 3.24 vs. 8.63 5.22 vs. 8.58 4.72 mg, 0.0001). One cardiac tamponade was observed in both the vHPSD and HPSD groups while the STSF group exhibited an embolic stoke and two pericardial effusions that did not require drainage.

CONCLUSIONS

In this study, vHPSD demonstrated a comparable safety profile to the other treatment arms. Procedural duration and energy application time was substantially reduced along with sedation requirement notwithstanding the limitations of observational study design, these preliminary findings are promising with respect to periprocedural outcomes and safety of vHPSD however longitudinal outcomes will be essential to assessing the overall efficacy of this novel technology.

摘要

背景

肺静脉隔离(PVI)消融术是症状性药物难治性心房颤动(AF)患者既定的金标准治疗方法。射频(RF)消融技术的进步促使了新型接触力感应温度控制的超高功率短程(vHPSD)RF消融技术的发展。此设置可在8 mL/分钟的恒定冲洗流速下提供90 W功率,持续4秒。本研究的目的是比较其与传统射频消融术的手术效果和安全性。

方法

对2020年8月至2022年1月期间首次接受PVI消融术的患者进行了一项观察性研究。该队列分为:(1)vHPSD消融组;(2)高功率短程(HPSD)消融组;(3)THERMOCOOL SMARTTOUCH™ SF(STSF)组。vHPSD消融组为前瞻性招募,而HPSD组和STSF组为回顾性收集。主要结局指标为手术成功率、PVI持续时间、消融持续时间和围手术期不良事件发生率。次要结局指标为术中吗啡和咪达唑仑需求量。

结果

本研究共纳入175例患者,vHPSD组、HPSD组和STSF组分别有100例、30例和45例患者。所有vHPSD组患者均成功实现PVI。与HPSD组和STSF组相比,vHPSD组实现PVI所需时间和总能量应用时间显著缩短(分别为67.7±29.7分钟 vs. 92.9±25.7分钟 vs. 93.6±29.1分钟,P<0.0001;9.87±4.16分钟 vs. 33.9±7.49分钟 vs. 36.0±10.5分钟,P<0.0001)。与HPSD组和STSF组相比,vHPSD组静脉注射吗啡和咪达唑仑的需求量更低(分别为10.2±3.43毫克 vs. 16.1±4.58毫克 vs. 15.3±3.94毫克,P<0.0001;4.04±3.24毫克 vs. 8.63±5.22毫克 vs. 8.58±4.72毫克,P<0.0001)。vHPSD组和HPSD组均观察到1例心脏压塞,而STSF组出现1例栓塞性中风和2例无需引流的心包积液。

结论

在本研究中,vHPSD显示出与其他治疗组相当的安全性。尽管观察性研究设计存在局限性,但手术持续时间和能量应用时间以及镇静需求均显著降低。这些初步发现对于vHPSD的围手术期结局和安全性很有前景,然而纵向结局对于评估这项新技术的整体疗效至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6245/11317307/9478c62ce301/2153-8174-25-7-250-g1.jpg

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