University Hospital, Hamburg, Germany (S.W., C.M.).
Southlake Regional Health Centre, University of Toronto, Newmarket, Ontario, Canada (A.V., P.M.H.).
Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27.
Background Identification and elimination of nonpulmonary vein targets may improve clinical outcomes in patients with persistent atrial fibrillation (AF). We report on the use of a novel, noncontact imaging and mapping system that uses ultrasound to reconstruct atrial chamber anatomy and measures timing and density of dipolar, ionic activation (ie, charge density) across the myocardium to guide ablation of atrial arrhythmias. Methods The prospective, nonrandomized UNCOVER AF trial (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) was conducted at 13 centers across Europe and Canada. Patients with persistent AF (>7 days, <1 year) aged 18 to 80 years, scheduled for de novo catheter ablation, were eligible. Before pulmonary vein isolation, AF was mapped and then iteratively remapped to guide each subsequent ablation of charge density-identified targets. AF recurrence was evaluated at 3, 6, 9, and 12 months using continuous 24-hour ECG monitors. The primary effectiveness outcome was freedom from AF >30 seconds at 12 months for a single procedure with a secondary outcome being acute procedural efficacy. The primary safety outcome was freedom from device/procedure-related major adverse events. Results Between October 2016 and April 2017, 129 patients were enrolled, and 127 underwent mapping and catheter ablation. Acute procedural efficacy was demonstrated in 125 patients (98%). At 12 months, single procedure freedom from AF on or off antiarrhythmic drugs was 72.5% (95% CI, 63.9%-80.3%). After 1 or 2 procedures, freedom from AF was 93.2% (95% CI, 87.1%-97.0%). A total of 29 (23%) retreatments because of arrhythmia recurrence were performed with average time from index procedure to first retreatment being 7 months. The primary safety outcome was 98% with no device-related major adverse events reported. Conclusions This novel ultrasound imaging and charge density mapping system safely guided ablation of nonpulmonary vein targets in persistent AF patients with 73% single procedure and 93% second procedure freedom from AF at 12 months. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02825992 EU/NCT02462980 CN.
在持续性心房颤动（AF）患者中，识别和消除非肺静脉靶点可能改善临床结局。我们报告了一种新的、非接触式成像和映射系统的使用，该系统使用超声波重建心房腔解剖结构，并测量心肌中二极子、离子激活的时间和密度（即电荷密度），以指导心房心律失常的消融。
前瞻性、非随机的 UNCOVER AF 试验（利用新的偶极密度功能客观可视化心房颤动节律的病因）在欧洲和加拿大的 13 个中心进行。入选标准为年龄 18 至 80 岁、计划行初次导管消融的持续性 AF（>7 天，<1 年）患者。在肺静脉隔离之前，对 AF 进行了映射，然后进行迭代映射，以指导对每个电荷密度识别靶点的后续消融。使用连续 24 小时心电图监测在 3、6、9 和 12 个月评估 AF 复发。主要有效性结果是单次手术 12 个月时无 30 秒以上 AF，次要结果是急性手术疗效。主要安全性结果是无器械/手术相关主要不良事件。
2016 年 10 月至 2017 年 4 月期间，共纳入 129 例患者，127 例行映射和导管消融。125 例（98%）患者显示出急性手术疗效。12 个月时，单程序抗心律失常药物治疗或不治疗的 AF 无发作率为 72.5%（95%CI，63.9%-80.3%）。经过 1 或 2 次程序后，AF 无发作率为 93.2%（95%CI，87.1%-97.0%）。因心律失常复发共进行 29 次（23%）再治疗，从初始手术到第一次再治疗的平均时间为 7 个月。主要安全性结果为 98%，无器械相关的主要不良事件报告。
在持续性 AF 患者中，使用新型超声成像和电荷密度映射系统安全地指导了非肺静脉靶点的消融，12 个月时单程序和双程序的 AF 无发作率分别为 73%和 93%。
