Department of Electrophysiology, Heart Center University Hospital Hamburg-Eppendorf, Hamburg, Germany.
J Cardiovasc Electrophysiol. 2010 Jan;21(1):6-12. doi: 10.1111/j.1540-8167.2009.01592.x. Epub 2009 Sep 28.
Recently, a nonmagnetic robotic navigation system (RN, Hansen-Sensei) has been introduced for remote catheter manipulation.
To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial.
Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 +/- 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 +/- 7.6 years). A 3-dimensional mapping system (NavX) was used in both groups.
Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 +/- 3.4 vs 22 +/- 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 +/- 2.1 vs 22 +/- 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 +/- 2.4 vs 17 +/- 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 +/- 44.4 vs 134 +/- 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]).
The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up.
最近，一种非磁性机器人导航系统（RN，Hansen-Sensei）已被引入用于远程导管操作。
在一项前瞻性随机试验中，研究 RN 联合直观的三维绘图对阵发性心房颤动（PAF）患者肺静脉隔离（PVI）中操作人员和患者透视曝光的影响。
将 60 例患者随机分为两组，分别采用 RN 引导组（组 1，n = 30，20 例男性，62 ± 7.7 岁）和常规消融组（组 2，n = 30，14 例男性，61 ± 7.6 岁）进行 PVI。两组均使用三维绘图系统（NavX）。
所有患者均实现了同侧肺静脉（PVs）的电分离。使用 RN 显著降低了总透视时间（9 ± 3.4 与 22 ± 6.5 分钟；P < 0.001），并减少了操作人员的透视暴露（7 ± 2.1 与 22 ± 6.5 分钟；P < 0.001）。两组之间透视时间的差异在手术的消融部分最为明显（3 ± 2.4 与 17 ± 6.3 分钟；P < 0.001）。使用 RN 时，总手术时间虽然有所延长，但未达到统计学意义（156 ± 44.4 与 134 ± 12 分钟，P = 0.099）。在 6 个月的中期随访中，结果无差异（AF 自由组 1 = 73%与组 2 = 77%[P = 0.345]）。
RN 用于 PVI 似乎是有效且安全的，可显著减少总透视时间和操作人员的透视暴露，而不会影响 6 个月随访后的中期结果。
