Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, NY (M.K.T., W.W., S.R.D., V.Y.R.).
Department of Cardiology, Homolka Hospital, Prague, Czech Republic (J.P., P.N., K.K., S.K., V.Y.R.).
Circ Arrhythm Electrophysiol. 2020 Mar;13(3):e007917. doi: 10.1161/CIRCEP.119.007917. Epub 2020 Feb 12.
Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias.
In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software.
Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae.
In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03639597.
使用逐点射频能量或单次应用一次性球囊对心房颤动 (AF) 进行导管消融，要么技术上具有挑战性，要么对适应可变的患者解剖结构的能力有限，无法实现急性和持久的肺静脉 (PV) 隔离。一种新的消融系统采用低强度准直超声 (LICU) 引导的解剖图和机器人消融来隔离 PV。在这项首例人体、单中心、多操作者试验中，在阵发性心房颤动患者中进行了 VALUE 试验 (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597)，评估了该 LICU 系统的安全性、在 PV 隔离中的有效性以及无复发性心房心律失常的情况。
在入组的 52 例阵发性心房颤动患者中，成功创建了基于超声 M 模式的左心房解剖结构，并在机器人控制下沿着操作者定义的病变路径进行消融。在研究过程中，LICU 系统软件不断升级：最后 13 例患者采用增强软件进行消融。
98%的 PV 采用 LICU 实现了急性 PV 隔离，在 77.3%（153/198）的 PV 中仅使用 LICU 实现，在 22.7%（45/198）的 PV 中需要标准射频消融导管进行补点消融。在采用增强软件进行 LICU 消融的患者中，补点消融率降至 5.8%（3/52）。12 个月时无复发性心房心律失常的比例为 79.6%（49 例中有 39 例），增强软件组为 92.3%（13 例中有 12 例）。3 例患者发生重大不良事件（5.8%）：1 例出现短暂性膈肌麻痹，1 例血管入路并发症，1 例空气栓塞导致短暂性 ST 段抬高，无后遗症。
在这项首例人体研究中，低强度准直超声引导的解剖图和机器人消融可实现 PV 隔离，具有良好的慢性安全性；随着设备的改进，PV 隔离成功率在不断提高。
