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多中心、随机比较磁导航与手动引导射频消融房室结折返性心动过速(MagMa-AVNRT 试验)。

Multicenter, randomized comparison between magnetically navigated and manually guided radiofrequency ablation of atrioventricular nodal reentrant tachycardia (the MagMa-AVNRT-trial).

机构信息

Department of Electrophysiology, German Heart Center Munich, Lazarettstr. 36, 80636, Munich, Germany.

Department of Heart disease, Haukeland University Hospital, Bergen, Norway.

出版信息

Clin Res Cardiol. 2017 Dec;106(12):947-952. doi: 10.1007/s00392-017-1144-8. Epub 2017 Aug 28.

DOI:10.1007/s00392-017-1144-8
PMID:28849269
Abstract

BACKGROUND

Remote magnetic navigation (RMN) is attributed to diminish radiation exposure for both patient and operator performing catheter ablation for different arrhythmia substrates. The purpose of this prospective, randomized study was to compare RMN with manually guided catheter ablation for AV nodal reentrant tachycardia (AVNRT) regarding fluoroscopy time/dosage, acute and long-term efficacy as well as safety.

METHODS AND RESULTS

A total of 218 patients with AVNRT undergoing catheter ablation at three centers (male 34%, mean age 50 ± 17 years) were randomized to a manual approach (n = 113) or RMN (n = 105) using the Niobe magnetic navigation system. The primary study endpoint was total fluoroscopy time/dosage for patient and operator at the end of the procedure. Secondary endpoints included acute success, procedure duration, complications and success rate after 6 months. Fluoroscopy time and dosage for the patient were significantly reduced in the RMN group compared to the manual group (6 ± 6 vs. 11 ± 10 min; p < 0.001 and 425 ± 558 vs. 751 ± 900 cGycm, p = 0.002). A reduction in fluoroscopy time/dose also applied to the operator (3 ± 5 vs. 7 ± 9 min 209 ± 444 vs. 482 ± 689 cGycm, p < 0.001). Procedure duration was significantly longer in the RMN group (88 ± 29 vs. 79 ± 29 min; p = 0.03) and crossover from the RMN group to manual ablation occurred in 7.6% of patients (7.6 vs. 0.1%; p = 0.02). Acute success was achieved in 100% of patients in both groups. Midterm success after 6 months was 97 vs. 98% (p = 0.67). No complications occurred in both groups.

CONCLUSION

The use of RMN for catheter ablation of AVNRT compared to a manual approach results in a reduction of fluoroscopy time and dosage of about 50% for both patients and physicians. Acute and midterm success and safety are comparable. RMN is a good alternative to a manual approach for AVNRT ablation.

摘要

背景

远程磁导航(RMN)可减少患者和进行不同心律失常消融的操作者的辐射暴露。本前瞻性、随机研究的目的是比较 RMN 与手动引导导管消融房室结折返性心动过速(AVNRT)在透视时间/剂量、即刻和长期疗效以及安全性方面的差异。

方法和结果

共有三家中心的 218 例 AVNRT 患者(男性占 34%,平均年龄 50 ± 17 岁)被随机分配至手动组(n = 113)或 RMN 组(n = 105),使用 Niobe 磁导航系统。主要研究终点为手术结束时患者和术者的总透视时间/剂量。次要终点包括即刻成功率、手术时间、并发症和 6 个月后的成功率。与手动组相比,RMN 组患者的透视时间和剂量显著减少(6 ± 6 比 11 ± 10 分钟;p < 0.001 和 425 ± 558 比 751 ± 900 cGycm,p = 0.002)。术者的透视时间/剂量也有所减少(3 ± 5 比 7 ± 9 分钟,209 ± 444 比 482 ± 689 cGycm,p < 0.001)。RMN 组的手术时间显著延长(88 ± 29 比 79 ± 29 分钟;p = 0.03),并且有 7.6%的患者从 RMN 组交叉至手动消融组(7.6%比 0.1%;p = 0.02)。两组患者即刻成功率均为 100%。6 个月时的中期成功率为 97%比 98%(p = 0.67)。两组均无并发症发生。

结论

与手动方法相比,RMN 用于 AVNRT 消融可使患者和术者的透视时间和剂量减少约 50%。即刻和中期成功率及安全性相当。RMN 是 AVNRT 消融的一种替代手动方法的良好选择。

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