Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.

IF 2.1 4区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Journal of Interventional Cardiac Electrophysiology Pub Date : 2024-11-08 DOI:10.1007/s10840-024-01938-0

Ilaria My, Boris Schmidt, Laura Rottner, Shota Tohoku, Marc Lemoine, David Schaack, Fabian Moser, Lukas Urbanek, Julius Obergassel, Djemail Ismaili, Jun Hirokami, Paulus Kirchhof, Karin Plank, Bruno Reissmann, Feifan Ouyang, Andreas Rillig, Julian Chun, Andreas Metzner, Stefano Bordignon

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Abstract

Background: A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched.

Methods: Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs.

Results: A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm². AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433).

Conclusion: RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.

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射频球囊消融术：AURORA 研究的 1 年结果。

背景：最近推出了一种用于肺静脉隔离（PVI）的新型灌注射频球囊：最近，一种用于肺静脉隔离（PVI）的新型灌注射频球囊（RFB）集成到了三维绘图平台中：方法：将在德国两家高容量心房颤动（EP）中心接受首次心房颤动（AF）消融术的患者纳入前瞻性 AURORA 登记。所有患者均在消融术后 90 天、180 天和 360 天接受了临床随访（FU），包括 48 小时 Holter 心电图检查：共有 99 名患者（43/99（43.4%）为女性，中位年龄 67 岁（四分位数间距 [IQR] 59-74），43/99（43.4%）为持续性房颤（Pers-AF），中位左室射血分数（LVEF）60%（IQR 62-55））。88名患者完成了随访。383/383（100%）例 PV 实现了急性 PVI。211/383例（55.1%）PV实现了单次PVI。3%的患者发生了主要不良事件（1例术后咽部出血、1例心肌梗死、1例非心血管死亡）；未观察到心包积液、中风或膈神经麻痹。消融和手术时间中位数分别为 23 分钟（IQR 18-32 分钟）和 67 分钟（IQR 57-85 分钟）。中位剂量面积乘积为 761 (IQR 509-1534) mGycm2。中位 FU 为 361 天（IQR 261-375 天）后，阵发性房颤 (PAF) 的无房颤存活率为 78.4%，持续性房颤 (Pers-AF) 的无房颤存活率为 75.4%（P 值 = 0.828）。经多元回归分析，90 天访视时房性快速性心律失常的早期复发是房颤 1 年复发的唯一独立预测因素（危险比 [HR] 3.198；95% 置信区间 [95% CI] 1.036-10.32，P 值 = 0.0433）：结论：基于射频消融的 PVI 在急性期是成功的，似乎是安全的，其节律结果与其他单次房颤消融工具相当。90天后房颤复发可预测以后的房颤复发。

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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来源期刊

Journal of Interventional Cardiac Electrophysiology 医学-心血管系统

CiteScore

4.30

自引率

11.10%

发文量

320

审稿时长

4-8 weeks

期刊介绍： The Journal of Interventional Cardiac Electrophysiology is an international publication devoted to fostering research in and development of interventional techniques and therapies for the management of cardiac arrhythmias. It is designed primarily to present original research studies and scholarly scientific reviews of basic and applied science and clinical research in this field. The Journal will adopt a multidisciplinary approach to link physical, experimental, and clinical sciences as applied to the development of and practice in interventional electrophysiology. The Journal will examine techniques ranging from molecular, chemical and pharmacologic therapies to device and ablation technology. Accordingly, original research in clinical, epidemiologic and basic science arenas will be considered for publication. Applied engineering or physical science studies pertaining to interventional electrophysiology will be encouraged. The Journal is committed to providing comprehensive and detailed treatment of major interventional therapies and innovative techniques in a structured and clinically relevant manner. It is directed at clinical practitioners and investigators in the rapidly growing field of interventional electrophysiology. The editorial staff and board reflect this bias and include noted international experts in this area with a wealth of expertise in basic and clinical investigation. Peer review of all submissions, conflict of interest guidelines and periodic editorial board review of all Journal policies have been established.