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CLINICAL TRIAL
JOURNAL ARTICLE
Initial clinical experience of remote magnetic navigation system for catheter mapping and ablation of supraventricular tachycardias.
Journal of Interventional Cardiac Electrophysiology : An International Journal of Arrhythmias and Pacing 2009 September
BACKGROUND: A remote magnetic navigation system (MNS) has been developed for mapping and catheter ablation of cardiac arrhythmias. The present study evaluates the safety and feasibility of this system to perform radiofrequency (RF) ablation in patients with supraventricular tachycardias (SVT).
METHODS: A total of 32 patients (22 female; mean age 44 +/- 16 years) with documented SVT underwent mapping and ablation using Helios II (a 4-mm-tip magnetic catheter), under the guidance of the MNS (Niobe II, Stereotaxis, Inc.).
RESULTS: Catheter ablation procedure with MNS was successful in 30/32 (94%) patients including all patients (27/27, 100%) with atrioventricular nodal reentrant tachycardia (AVNRT) and three of five patients (60%) with atrioventricular reentrant tachycardia (AVRT) without any complication. The procedural successful rate in patients with AVNRT was significantly higher than those in patients with AVRT (P < 0.001). Overall, the medium number of RF application using the MNS was 2 (mean 2.7 +/- 1.6, range 1 to 7), and the medium numbers of RF for AVNRT and AVRT were 2 and 3, respectively. There was no significant difference in the mean procedural time between patients with AVNRT and AVRT (126.3 +/- 38.6 vs. 138.0 +/- 40.3 min, P = 0.54). However, the mean fluoroscopy time was significantly shorter in patients with AVNRT than those with AVRT (5.7 +/- 3.0 vs. 16.5 +/- 2.5 min, P < 0.001). Among those patients with AVNRT, the mean procedural time (139.3 +/- 45.0 vs. 112.3 +/- 24.9 min, P = 0.07) and fluoroscopic time (3.2 +/- 1.0 vs. 8.0 +/- 2.2 min, P < 0.001) were shorter for the later 13 patients than the first 14 patients, suggesting a learning curve in using the MNS for RF ablation.
CONCLUSIONS: The Niobe MNS is a new technique that can allow safe and effective remote-controlled navigation and minimize the need for fluoroscopic guidance for ablation catheter of AVNRT. However, further improvement is required to achieve a higher successful rate for treatment of AVRT.
METHODS: A total of 32 patients (22 female; mean age 44 +/- 16 years) with documented SVT underwent mapping and ablation using Helios II (a 4-mm-tip magnetic catheter), under the guidance of the MNS (Niobe II, Stereotaxis, Inc.).
RESULTS: Catheter ablation procedure with MNS was successful in 30/32 (94%) patients including all patients (27/27, 100%) with atrioventricular nodal reentrant tachycardia (AVNRT) and three of five patients (60%) with atrioventricular reentrant tachycardia (AVRT) without any complication. The procedural successful rate in patients with AVNRT was significantly higher than those in patients with AVRT (P < 0.001). Overall, the medium number of RF application using the MNS was 2 (mean 2.7 +/- 1.6, range 1 to 7), and the medium numbers of RF for AVNRT and AVRT were 2 and 3, respectively. There was no significant difference in the mean procedural time between patients with AVNRT and AVRT (126.3 +/- 38.6 vs. 138.0 +/- 40.3 min, P = 0.54). However, the mean fluoroscopy time was significantly shorter in patients with AVNRT than those with AVRT (5.7 +/- 3.0 vs. 16.5 +/- 2.5 min, P < 0.001). Among those patients with AVNRT, the mean procedural time (139.3 +/- 45.0 vs. 112.3 +/- 24.9 min, P = 0.07) and fluoroscopic time (3.2 +/- 1.0 vs. 8.0 +/- 2.2 min, P < 0.001) were shorter for the later 13 patients than the first 14 patients, suggesting a learning curve in using the MNS for RF ablation.
CONCLUSIONS: The Niobe MNS is a new technique that can allow safe and effective remote-controlled navigation and minimize the need for fluoroscopic guidance for ablation catheter of AVNRT. However, further improvement is required to achieve a higher successful rate for treatment of AVRT.
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