Steven Daniel, Rostock Thomas, Servatius Helge, Hoffmann Boris, Drewitz Imke, Müllerleile Kai, Meinertz Thomas, Willems Stephan
University Hospital Hamburg-Eppendorf, Department of Cardiology, Hamburg, Germany.
Heart Rhythm. 2008 Nov;5(11):1556-60. doi: 10.1016/j.hrthm.2008.08.028. Epub 2008 Aug 29.
Conventional catheter ablation for common-type atrial flutter (AFL) is a widely established therapy but has not been compared with the use of a robotic navigation system (RNS) thus far.
The purpose of this study was to investigate the feasibility of a new, nonmagnetic RNS with regard to safety, efficacy, and X-ray exposure to investigator and patient compared with the conventional ablation approach in patients with AFL.
Fifty patients (65.7 +/- 9.3 years, 40 male) undergoing de novo catheter ablation for AFL were randomly assigned to conventional or RNS-guided cavotricuspid isthmus (CTI) ablation.
Complete bidirectional isthmus block was achieved for all patients without occurrence of procedure-related complications. The fluoroscopy time and the investigator X-ray exposure (8.2 +/- 4.6 vs. 5.8 +/- 3.6, P = .038; and 8.2 +/- 4.6 vs. 1.9 +/- 1.1 minutes, P<.001) as well as the mean radiofrequency (RF) duration and the energy delivered were significantly higher in the conventional than in the RNS group (321.7 +/- 214.6 vs. 496.4 +/- 213.9 seconds, P = .006; 8279 +/- 5767 vs. 16,308 +/- 6870 J, P<.001, respectively). The overall procedure time in the RNS group was significantly longer than in the conventional group (79.2 +/- 30.6 vs. 58.4 +/- 17.7 minutes; P = .04) but significantly decreased comparing the first 10 with the last 10 patients in the RNS group (105.3 +/- 34.8 vs. 60.6 +/- 6.3 minutes; P = .003). Starting ablation during AFL, bidirectional block instantly after termination was observed in 90% of the RNS and 50% of the conventionally treated patients (P = .03).
The present study demonstrates the safety and feasibility of RNS for performing CTI ablation in patients with common-type AFL for use in the clinical routine. As a result of the remote navigation, X-ray exposure and RF duration to achieve bidirectional block were significantly decreased and occurred more often immediately after AFL termination. These findings are consistent with increased catheter stability and RF application efficacy using RNS compared with conventional catheter manipulation.
常规导管消融术治疗常见类型的心房扑动（AFL）是一种广泛应用的治疗方法，但迄今为止尚未与机器人导航系统（RNS）的使用进行比较。
本研究的目的是探讨一种新型非磁性RNS在安全性、有效性以及与传统消融方法相比对术者和患者的X线暴露方面用于AFL患者的可行性。
50例接受AFL初次导管消融的患者（65.7±9.3岁，40例男性）被随机分配至传统消融组或RNS引导下的三尖瓣峡部（CTI）消融组。
所有患者均实现了完全双向峡部阻滞，且未发生与手术相关的并发症。传统消融组的透视时间、术者X线暴露时间（8.2±4.6 vs. 5.8±3.6，P = 0.038；8.2±4.6 vs. 1.9±1.1分钟，P<0.001）以及平均射频（RF）持续时间和传递的能量均显著高于RNS组（321.7±214.6 vs. 496.4±213.9秒，P = 0.006；8279±5767 vs. 16308±6870焦耳，P<0.001）。RNS组的总体手术时间显著长于传统组（79.2±30.6 vs. 58.4±17.7分钟；P = 0.04），但RNS组中前10例患者与后10例患者相比手术时间显著缩短（105.3±34.8 vs. 60.6±6.3分钟；P = 0.003）。在AFL发作期间开始消融，RNS组90%的患者及传统治疗组50%的患者在AFL终止后即刻观察到双向阻滞（P = 0.03）。
本研究证明了RNS用于常见类型AFL患者进行CTI消融在临床常规应用中的安全性和可行性。由于远程导航，实现双向阻滞的X线暴露和RF持续时间显著减少，且在AFL终止后更常立即出现。这些发现与使用RNS相比传统导管操作增加了导管稳定性和RF应用效果一致。
