Division of Cardiology and Pulmology, Heart Center, University of Göttingen, Göttingen, Germany.
Clin Res Cardiol. 2011 Nov;100(11):1003-11. doi: 10.1007/s00392-011-0333-0. Epub 2011 Jun 25.
Only limited data exist on the clinical utility of remote magnetic navigation (RMN) for pulmonary vein (PV) ablation. Aim of this prospective study was to evaluate the safety and efficacy of RMN for PV isolation as compared to the manual (CON) approach.
A total of 161 consecutive patients undergoing circumferential PV isolation were included. Open-irrigated 3.5 mm ablation catheters under the guidance of a mapping system were used. The catheter was navigated with the Stereotaxis Niobe II system in the RMN group (n = 107) and guided manually in the CON group (n = 54). Electrical isolation of all PVs was achieved in 90% of the patients in the RMN group and in 87% in the CON group (p = 0.6). All subjects were followed every 3 months by 7d Holter-ECG. At 12 months of follow-up, 53.5% (RMN) and 55.5% (CON) of the patients were free of any left atrial tachycardia/atrial fibrillation (AF) episode (p = 0.57). Free of symptomatic AF recurrence were 66.3% (RMN) and 62.1% (CON) of the subjects (p = 0.80). Use of RMN was associated with longer procedure duration (p < 0.0001), ablation times (p < 0.0001), and RF current application duration (p < 0.05). In contrast, fluoroscopy time was lower in the RMN group (p < 0.0001). Major complications occurred in 6 of 161 procedures (3.7%), with no significant difference between groups (p = 0.75).
RMN-guided PV ablation provides comparable acute and long-term success rates as compared to manual navigation. Procedural complication rates are similar. The use of RMN is associated with markedly reduced fluoroscopy time, but prolonged ablation and procedure duration.
仅有有限的数据表明远程磁导航(RMN)在肺静脉(PV)消融中的临床应用价值。本前瞻性研究旨在评估 RMN 与手动(CON)方法相比用于 PV 隔离的安全性和有效性。
共纳入 161 例连续行环形 PV 隔离的患者。在导航系统的引导下,使用开放灌注 3.5mm 消融导管。在 RMN 组(n=107)中,使用 Stereotaxis Niobe II 系统导航导管,在 CON 组(n=54)中手动引导导管。RMN 组中所有 PV 均达到电隔离的患者比例为 90%,CON 组为 87%(p=0.6)。所有患者在 3 个月时通过 7d 动态心电图(Holter-ECG)进行随访。12 个月时随访,RMN 组(53.5%)和 CON 组(55.5%)中无任何左房房性心动过速/心房颤动(AF)发作的患者比例相同(p=0.57)。无有症状 AF 复发的患者比例 RMN 组为 66.3%(RMN)和 CON 组为 62.1%(CON)(p=0.80)。RMN 的使用与更长的手术时间(p<0.0001)、消融时间(p<0.0001)和射频电流应用时间(p<0.05)相关。相反,RMN 组的透视时间较低(p<0.0001)。161 例手术中有 6 例(3.7%)发生重大并发症,两组间无显著差异(p=0.75)。
与手动导航相比,RMN 引导的 PV 消融具有相似的急性和长期成功率。手术并发症发生率相似。RMN 的使用与透视时间显著减少相关,但消融和手术时间延长。