Introduction:The potential benefits of remote robotic navigation for catheter ablation procedures have not been demonstrated in controlled clinical trials. The purpose of this study was to compare remote magnetic catheter navigation to manual navigation for the ablation of common supraventricular arrhythmias.Methods and Results:Patients with supraventricular arrhythmias due to atrioventricular (AV) nodal reentry, accessory pathways, or undergoing AV junctional ablation for complete heart block were randomized in a 3:1 ratio between magnetic (Niobe system and Helios II catheter, Stereotaxis, Inc., St. Louis, MO) and manual navigation for radiofrequency ablation at 13 centers. The primary endpoint of the study was total fluoroscopic time. Fifty-six patients were randomized to magnetic navigation and 15 to manual navigation. AV nodal reentry was the most common arrhythmia in both groups. Total fluoroscopy time was reduced in the magnetic navigation group (median 17.8 minutes, interquartile (IQ) range 9.9,27.8 minutes) compared to manual navigation (27.1, IQ 19.0,48.0, P < 0.05). The acute success rates (91% for magnetic and 87% for manual navigation, P > 0.05) did not differ between groups. The number of lesions delivered was less for magnetic navigation (6, IQ 4,9 vs 10, IQ 7, 26, P < 0.05). Total procedure time (median 151, IQ 111, 221 minutes magnetic and 151, IQ 110, 221 minutes manual) and complication rates (5.4% patients magnetic and 6.7% patients manual) were similar between the groups (both P > 0.05).Conclusions:Remote magnetic catheter navigation reduces fluoroscopic time and radiofrequency lesion deliveries for the ablation of common supraventricular arrhythmias compared to manual catheter navigation.
"[19–21] Although we managed to successfully treat patients in our conventional group with very low exposure to radiation as compared with previously published reports [16, 17, 22], we could still demonstrate a significant reduction in exposure when using magnetic navigation although those patients were more complex to treat. The effect of reduction of radiation exposure by using remote navigation has been previously reported by other groups [23, 24] for normal morphology patients and also for CHD patients or young patients [16, 25]. The significant reduction in radiation exposure by using RMN in our study is similar compared with that of Schwagten et al. [16, 17], but the total fluoroscopy exposure in our CVN group was already lower than their RMN group. "
[Show abstract][Hide abstract] ABSTRACT: Purpose
Although rare, children and young adults can suffer from significant cardiac arrhythmia, especially in the context of congenital malformations and after cardiac surgery.
A total of 62 patients (32 female, median age 20 years) underwent an invasive electrophysiology study between 2008–2011: half had normal cardiac anatomy, whereas the remaining patients had various types of congenital heart disease. All patients were treated using either conventional techniques (CVN) or remote magnetic navigation (RMN).
Patients treated with the RMN system differed substantially from patients in the CVN group with respect to presence of congenital heart disease (67 % vs. 37 %), previous cardiac surgery (59 % vs. 20 %) or failed previous conventional ablation (22 % vs. 9 %), respectively. Although these more complex arrhythmias resulted in longer median procedure duration (180 vs. 130 min, p = 0.034), the median overall fluoroscopy exposure in the RMN group was significantly lower (4.1 vs. 5.2 min, p = 0.020). Clinical outcome was comparable in both groups without complications caused by the ablation.
Catheter ablation using remote magnetic navigation is safe and feasible in children and young adults and is especially valuable in patients with abnormal cardiac morphologies. RMN resulted in significantly lower radiation exposure compared with the conventional technique.
Netherlands heart journal: monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 04/2013; 21(6). DOI:10.1007/s12471-013-0408-9 · 1.84 Impact Factor
"Although several pre-defined catheter curves were introduced to help appropriate lesion delivery, there are no optimal curves available for the treatment of paediatric patients with small hearts, patients with complex congenital heart defects, or some type of VTs.25 The introduction and utilization of MNS was aimed at surmounting these difficulties. It provides improvement of safety by the flexible catheter design, and no pericardial effusion or tamponade was reported related to catheter navigation using MNS.20 Magnetic navigation system also provides better navigation capability, which is not limited by preformed or evolved catheter curves.19,25,26 "
[Show abstract][Hide abstract] ABSTRACT: We aimed to evaluate the safety and long-term efficacy of the magnetic navigation system (MNS) in a large number of patients. The MNS has the potential for improving safety and efficacy based on atraumatic catheter design and superior navigation capabilities.
In this study, 610 consecutive patients underwent ablation. Patients were divided into two age- and sex-matched groups. Ablations were performed either using MNS (group MNS, 292) or conventional manual ablation [group manual navigation (MAN), 318]. The following parameters were analysed: acute success rate, fluoroscopy time, procedure time, complications [major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, and death; minor: minor bleeding and temporary AV block]. Recurrence rate was assessed during follow-up (15±9.5 months). Subgroup analysis was performed for the following groups: atrial fibrillation, isthmus dependent and atypical atrial flutter, atrial tachycardia, AV nodal re-entrant tachycardia, circus movement tachycardia, and ventricular tachycardia (VT). Magnetic navigation system was associated with less major complications (0.34 vs. 3.2%, P=0.01). The total numbers of complications were lower in group MNS (4.5 vs. 10%, P=0.005). Magnetic navigation system was equally effective as MAN in acute success rate for overall groups (92 vs. 94%, P=ns). Magnetic navigation system was more successful for VTs (93 vs. 72%, P<0.05). Less fluoroscopy was used in group MNS (30±20 vs. 35±25 min, P<0.01). There were no differences in procedure times and recurrence rates for the overall groups (168±67 vs. 159±75 min, P=ns; 14 vs. 11%, P=ns; respectively).
Our data suggest that the use of MNS improves safety without compromising efficiency of ablations. Magnetic navigation system is more effective than manual ablation for VTs.
"Our data indicate that more RF current has to be delivered when utilizing RMN-guided ablation as compared to the manual approach to achieve equally effective ablation lesions. This finding is in line with prior reports that suggest that RMN-guided ablation may produce less effective linear lesions [7, 24] but may be at least equally effective for focal ablation targets [25, 26]. The maximal endocardial force exerted by the RMN-system to the magnetic catheter tip is generally lower than that applied manually to the conventional ablation catheter tip . "
[Show abstract][Hide abstract] ABSTRACT: 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.
Clinical Research in Cardiology 06/2011; 100(11):1003-11. DOI:10.1007/s00392-011-0333-0 · 4.56 Impact Factor
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