医学
心房颤动
肺静脉
烧蚀
导管消融
队列
不利影响
内科学
临床终点
心脏病学
导管
随机对照试验
植入式线圈记录器
临床试验
外科
作者
Tom De Potter,Massimo Grimaldi,Mattias Duytschaever,Ante Anić,Johan Vijgen,Petr Neužil,Hugo Van Herendael,Atul Verma,Allan C. Skanes,Douglas S. Scherr,Helmut Pürerfellner,Gediminas Račkauskas,Pierre Jaı̈s,Vivek Y. Reddy
出处
期刊:Circulation-arrhythmia and Electrophysiology
[Ovid Technologies (Wolters Kluwer)]
日期:2024-04-24
被引量:3
标识
DOI:10.1161/circep.123.012667
摘要
BACKGROUND: We previously presented the safety and early efficacy of inspIRE study (Pulsed-Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation by Irreversible Electroporation). With the study’s conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success. METHODS: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success. RESULTS: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA 2 DS 2 -VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%–81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%–87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%–90.9%) or 94.0% (95% CI, 90.6%–97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications/vein compared with 57.1% in patients receiving fewer PFA applications. CONCLUSIONS: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04524364
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