使用接触力消融导管对腔静脉-三尖瓣峡部进行Amigo®机器人控制消融与手动控制消融的随机对照试验。
Randomized controlled trial of Amigo® robotically controlled versus manually controlled ablation of the cavo-tricuspid isthmus using a contact force ablation catheter.
作者信息
Hoffmayer Kurt S, Krainski Felix, Shah Sanjay, Hunter Jessica, Alegre Maylene, Hsu Jonathan C, Feld Gregory K
机构信息
Division of Cardiology, Cardiac Electrophysiology Program, UCSD Health System, University of California, San Diego, 9452 Medical Center Dr., MC7411, 3rd Floor, Room 3E-313, La Jolla, CA, 92037, USA.
出版信息
J Interv Card Electrophysiol. 2018 Mar;51(2):125-132. doi: 10.1007/s10840-018-0319-1. Epub 2018 Feb 12.
BACKGROUND
Radiofrequency catheter ablation (RFCA) of the cavo-tricuspid isthmus (CTI) is a common treatment for atrial flutter (AFL). However, achieving bi-directional CTI conduction block may be difficult, partly due to catheter instability.
OBJECTIVE
To evaluate the safety and efficacy of the Amigo® Remote Catheter System (RCS) compared to manual catheter manipulation, during CTI ablation for AFL.
METHODS
Fifty patients (pts) were prospectively randomized to robotically (25 pts) versus manually (25 pts) controlled catheter manipulation during CTI ablation, using a force-contact sensing, irrigated ablation catheter. The primary outcome was recurrence of CTI conduction after a 30-min waiting period. Secondary outcomes included total ablation, procedure, and fluoroscopy times, contact force measurement, and catheter stability.
RESULTS
Recurrence of CTI conduction 30 min after ablation was less with robotically (0/25) versus manually (6/25) controlled ablation (p = 0.023). Total ablation and procedure times to achieve persistent CTI block (6.7 ± 3 vs. 7.4 ± 2.5 min and 14.9 ± 7.5 vs. 15.2 ± 7 min, respectively) were not significantly different (p = 0.35 and p = 0.91, respectively). There was a non-significant trend toward a greater force time integral (FTI in gm/s) with robotically versus manually controlled CTI ablation (571 ± 278 vs. 471 ± 179, p = 0.13). Fluoroscopy time was longer with robotically versus manually controlled CTI ablation (6.8 ± 4.4 min vs. 3.8 ± 2.3 min, p = 0.0027). There were no complications in either group.
CONCLUSION
Robotically controlled CTI ablation resulted in fewer acute recurrences of CTI conduction compared to manually controlled CTI ablation, and a trend toward higher FTI. The longer fluoroscopy time during robotically controlled ablation was likely due to a steep learning curve.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier: NCT02467179.
背景
三尖瓣峡部（CTI）的射频导管消融术（RFCA）是心房扑动（AFL）的常见治疗方法。然而，实现双向CTI传导阻滞可能具有挑战性，部分原因是导管稳定性欠佳。
目的
评估在AFL的CTI消融术中，与手动导管操作相比，Amigo®远程导管系统（RCS）的安全性和有效性。
方法
50例患者前瞻性随机分为两组，在CTI消融术中分别采用机器人控制（25例）和手动控制（25例）导管操作，使用力接触感应式灌注消融导管。主要结局是30分钟等待期后CTI传导的复发情况。次要结局包括总消融时间、手术时间、透视时间、接触力测量以及导管稳定性。
结果
消融术后30分钟，机器人控制消融组（0/25）的CTI传导复发率低于手动控制消融组（6/25）（p = 0.023）。实现持续性CTI阻滞的总消融时间和手术时间（分别为6.7±3分钟 vs. 7.4±2.5分钟以及14.9±7.5分钟 vs. 15.2±7分钟）无显著差异（分别为p = 0.35和p = 0.91）。机器人控制与手动控制的CTI消融相比，力时间积分（FTI，单位为克/秒）有增加的趋势，但差异无统计学意义（571±278 vs. 471±179，p = 0.13）。机器人控制的CTI消融透视时间长于手动控制（6.8±4.4分钟 vs. 3.8±2.3分钟，p = 0.0027）。两组均无并发症发生。
结论
与手动控制的CTI消融相比，机器人控制的CTI消融导致CTI传导急性复发较少，且有FTI更高的趋势。机器人控制消融期间透视时间较长可能是由于学习曲线较陡。
试验注册
Clinicaltrials.gov标识符：NCT02467179。
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