Remote Magnetic Versus Manual Catheter Navigation for Ablation of Supraventricular Tachycardias: A Randomized, Multicenter Trial
ABSTRACT 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.
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ABSTRACT: Several reports have demonstrated that radiofrequency catheter ablation provides effective control of a variety of supraventricular tachycardias. However, the efficacy, complications, risk of arrhythmia recurrence, and follow-up survival analysis have not been reported in a large series of consecutive patients with supraventricular arrhythmias with diverse electrophysiologic mechanisms. This report details the results of radiofrequency catheter ablation in 760 consecutive patients (386 males, 374 females) with a wide variety of supraventricular tachycardias treated at one center. Arrhythmias were associated with the presence of an accessory pathway in 363 patients (384 accessory pathways), including four patients with Mahaim fibers and eight patients with the permanent form of junctional reciprocating tachycardia. The mechanism of the clinical arrhythmia was AV nodal reentrant tachycardia in 245 patients, and a primary atrial tachycardia in 20 patients (ectopic atrial tachycardia in 16 patients and sinus nodal reentry in 4 patients). Ablation of the reentrant circuit of atrial flutter within the right atrium was attempted in 13 patients. AV node ablation and permanent pacemaker implantation were performed in 119 patients with medically refractory atrial fibrillation or flutter. Radiofrequency catheter ablation was successful in 346 of 363 patients (95.3%, CI 93.1%-97.5%) with accessory pathways (367 of 384 pathways, 95.6%, CI 93.5%-97.6%) with a complication rate of 1.1% and a recurrence rate of 5.5%. Successful accessory pathway ablation was achieved for 179 of the first 192 pathways treated (93.2%, CI 89.7%-96.6%) and increased to 188 of 192 pathways (97.9%, CI 95.9%-99.9%) over the second half of the series. AV nodal reentry was successfully abolished in 244 of 245 patients (99.6%, CI 98.8%-100%) by selective ablation of the slow pathway in 234 patients and the fast pathway in 10 patients. The complication rate in this group was 2.0% with a recurrence rate of 6.5%. All 20 primary atrial tachycardias were successfully ablated with no complications and a recurrence rate of 15%. The reentrant circuit of atrial flutter was ablated successfully in 10 of 13 patients (77%) with recurrent atrial flutter in one additional patient. Complete AV block was achieved in 117 of 119 (98.3%, CI 96.0%-100%) patients with atrial fibrillation or flutter treated by AV nodal ablation with a complication rate of 0.8% and recurrence of AV conduction in 6%. The median duration of fluoroscopy exposure for the population was 23.4 minutes. The overall primary success rate for the entire population was 97.0% (737 of 760 patients, CI 95.8%-98.2%). Thus, the results of this large series of patients demonstrates the safety and efficacy of radiofrequency ablation for the treatment of a wide variety of supraventricular arrhythmias. It also appears that increasing experience with these procedures increases the rate of successful ablation and decreases the risk of complications.Journal of Cardiovascular Electrophysiology 09/1993; 4(4):371-89. · 3.48 Impact Factor
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ABSTRACT: Navigation, mapping, and ablation in the right ventricular outflow tract (RVOT) can be difficult. Catheter navigation using external magnetic fields may allow more accurate mapping and ablation. The purpose of this study was to assess the feasibility of RVOT tachycardia ablation using remote magnetic navigation. Mapping and ablation were performed in eight patients with outflow tract ventricular arrhythmias. Tachycardia mapping was undertaken with a 64-polar basket catheter, followed by remote activation and pace-mapping using a magnetically enabled catheter. The area of interest was localized on the basket catheter in seven patients in whom an RVOT arrhythmia was identified. Remote navigation of the magnetic catheter to this area was followed by pace-mapping. Ablation was performed at the site of perfect pace-mapping, with earliest activation if possible. Acute success was achieved in all patients (median four applications). Median procedural time was 144 minutes, with 13.4 minutes of patient fluoroscopy time and 3.8 minutes of physician fluoroscopy time. No complications occurred. One recurrence occurred during follow-up (mean 366 days). RVOT tachycardias can be mapped and ablated using remote magnetic navigation, initially guided by a basket catheter. Precise activation and pace-mapping are possible. Remote magnetic navigation permitted low fluoroscopy exposure for the physician. Long-term results are promising.Heart Rhythm 07/2006; 3(6):691-6. · 5.05 Impact Factor
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ABSTRACT: Steering soft, flexible catheters using an external magnetic field could have advantages for heart catheterization, especially for therapy of tachyarrhythmias. Our aims were to assess the feasibility of magnetic navigation to Koch's triangle and reliable ablation of atrioventricular nodal re-entry tachycardia (AVNRT) with a magnetic catheter. Consecutive patients with AVNRT were mapped and ablated with a magnetically enabled catheter (Helios I or II), with, respectively, one and three magnets at the tip. The catheter was remotely advanced with the Cardiodrive system and orientated with the Navigant control system. After initial positioning with the external magnets, adjustment was made in 5 degrees steps. Success rates, procedure, and fluoroscopy times were analysed, and compared with a local contemporary series of conventional AVNRT ablations. Magnetic navigation was feasible in all 20 patients. Targets were easily reached. Catheters remained stable in position during accelerated junctional rhythms. Ablation was successful in 18/20 procedures (90%). No significant complications occurred. Median patient fluoroscopy time was 12 min, median physician fluoroscopy time was 4 min. Fluoroscopy times tended to be shorter than that in the conventionally treated group. Procedure duration decreased significantly over time, median procedure time was similar to that in the conventional group. AVNRT can be successfully mapped and ablated using magnetic navigation. A learning curve was evident, unrelated to catheter type, but to increasing operator experience. Physician radiation times were one-third of patient times. No complications occurred. Procedure time is comparable with that of conventional ablation.Europace 05/2006; 8(4):225-30. · 2.77 Impact Factor