阵发性房颤的PVI与cf传感大尖端局灶PFA导管三维定位：omni - ire 3个月的结果。

IF 7.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Clinical electrophysiology Pub Date : 2025-08-01 DOI:10.1016/j.jacep.2025.04.008

Mattias Duytschaever MD , Massimo Grimaldi MD , Tom De Potter MD, PhD , Atul Verma MD , Laurent Macle MD , Josef Kautzner MD , Dominik Linz MD, PhD , Ante Anic MD , Hugo Van Herendael MD , Gediminas Rackauskas MD , Petr Neuzil MD , Julian Chun MD , Boris Schmidt MD , Sebastien Knecht MD , Alexandre Almorad MD , Benjamin Berte MD , Vivek Y. Reddy MD , Johan Vijgen MD

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引用次数: 0

摘要

背景：Omny-IRE (omnpulse导管加脉冲发生器治疗阵发性心房颤动[PAF]研究NCT05971693)评估了一种新型的大尖端焦点、多电极、接触式力传感、脉冲场消融导管与电解剖定位集成的安全性和有效性。目的：本研究旨在评估该平台治疗症状性阵发性心房颤动的3个月安全性和有效性。方法：采用omnpulse平台进行肺静脉分离（PVI）。主要疗效是防腺苷/异丙肾上腺素入口阻断。主要安全性是主要不良事件的发生。预先指定的患者亚群接受了系统的脑成像、食管内窥镜检查、心脏计算机断层扫描/磁共振血管造影，并进行了为期3个月的PVI耐久性评估重新测绘。结果：188例入组患者中，136例纳入了方案分析。主要有效率为100%（136 / 136）。中位（Q1-Q3）手术、左房停留、总消融和总透视时间分别为105.5（91.0-124.0）、70.0（56.0-81.5）、46.9（37.1-58.8）和5.0（3.1-9.8）分钟。主要不良事件发生率为3.0%(135例患者中有4例随访3个月；主要血管通路并发症3例，心包炎1例)。脑成像（n = 30）显示1例（3.3%）患者在出院时出现无症状的无症状脑事件，1个月后消退，无神经系统改变。未见食管损伤。计算机断层扫描/磁共振血管造影（n = 24）显示肺静脉狭窄发生率为70%。在重新定位过程中，84.5%（116例中98例）的静脉和62.1%（29例中18例）的患者的PVI是持久的。通过优化的工作流程，静脉和患者的PVI耐久性分别提高到89.3%（84 / 75）和71.4%（21 / 15）。结论：力传感、三维电解剖定位集成的大病灶脉冲场消融导管治疗阵发性心房颤动具有100%的急性成功率和良好的安全性。预先指定的重新映射显示出良好的PVI耐久性。全脉冲导管与脉冲发生器治疗阵发性心房颤动的研究NCT05971693)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF

Background

Omny-IRE (A Study For Treatment of Paroxysmal Atrial Fibrillation [PAF] With the OMNYPULSE Catheter and the TRUPULSE Generator) evaluated safety and effectiveness of a novel large-tip focal, multielectrode, contact force–sensing, pulsed field ablation catheter with electroanatomic mapping integration.

Objectives

This study sought to assess 3-month safety and effectiveness of the platform for treating symptomatic paroxysmal atrial fibrillation.

Methods

Pulmonary vein isolation (PVI) was performed using the OMNYPULSE Platform. Primary effectiveness was adenosine/isoproterenol-proof entrance block. Primary safety was occurrence of primary adverse events. Prespecified patient subsets underwent systematic brain imaging, esophageal endoscopy, cardiac computed tomography/magnetic resonance angiogram, and mandatory 3-month remapping for PVI durability assessment.

Results

Of 188 patients enrolled, 136 were included in the per-protocol analysis. Primary effectiveness was 100% (136 of 136). Median (Q1-Q3) procedure, left atrial dwell, total ablation, and total fluoroscopy times were 105.5 (91.0-124.0), 70.0 (56.0-81.5), 46.9 (37.1-58.8), and 5.0 (3.1-9.8) minutes, respectively. The primary adverse event rate was 3.0% (4 of 135 patients with 3-month follow-up; 3 major vascular access complications, 1 pericarditis). Brain imaging (n = 30) revealed 1 patient (3.3%) with an asymptomatic silent cerebral event at discharge, which resolved at 1 month without neurological change. No esophageal injury was observed. Computed tomography/magnetic resonance angiogram imaging (n = 24) showed no incidences of pulmonary vein narrowing >70%. During remapping, PVI was durable in 84.5% (98 of 116) of veins and 62.1% (18 of 29) of patients. With an optimized workflow, PVI durability improved to 89.3% (75 of 84) and 71.4% (15 of 21) of veins and patients, respectively.

Conclusions

The force-sensing, large-focal pulsed field ablation catheter with 3-dimensional electroanatomic mapping integration showed 100% acute success with a promising safety profile for treating paroxysmal atrial fibrillation. Prespecified remapping showed good PVI durability. (A Study For Treatment of Paroxysmal Atrial Fibrillation [PAF] With the OMNYPULSE Catheter and the TRUPULSE Generator; NCT05971693)

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来源期刊

JACC. Clinical electrophysiology CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

5.70%

发文量

250

期刊介绍： JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.