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: BACKGROUND: There has been no randomized controlled study to prospectively compare the performance and clinical outcomes of remote magnetic control (RMC) versus manual catheter control (MCC) during ablation of right ventricular outflow tract (RVOT) ventricular premature complexes (VPC) or tachycardia (VT) OBJECTIVE: This study prospectively evaluated the efficacy and safety of using either RMC versus MCC for mapping and ablation of RVOT VPC/VT METHODS: Thirty consecutive patients with idiopathic RVOT VPC/VT were referred for catheter ablation and randomized into either RMC or MCC group. A non-contact mapping system (NCM) was deployed in the RVOT to identify origins of VPC/VT. Conventional activation and pace-mapping was performed to guide ablation. If ablation performed using one mode of catheter control was acutely unsuccessful, the patient crossed over to the other group. The primary endpoints were patients' and physicians' fluoroscopy exposure and times RESULTS: Mean procedural times were similar between RMC and MCC groups. The fluoroscopy exposure and times for both patients and physicians were much lower in RMC group than in the MCC group. Ablation was acutely successful in 14/15 patients in the MCC group and 10/15 in the RMC group. Following cross-over, acute success was achieved in all patients. No major complications occurred in either group. During 22 months of follow-up, RVOT VPC recurred in 2 RMC patients CONCLUSION: RMC navigation significantly reduces patients' and physicians' fluoroscopy times by 50.5 % and 68.6 % respectively when used in conjunction with a NCM to guide ablation of RVOT VPC/VT.Heart rhythm: the official journal of the Heart Rhythm Society 05/2013; · 4.56 Impact Factor
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ABSTRACT: The aim of this study was to determine the efficacy and safety of remote magnetic navigation (RMN) with open-irrigated catheter vs. manual catheter navigation (MCN) in performing atrial fibrillation (AF) ablation. We searched in PubMed (1948-2013) and EMBASE (1974-2013) studies comparing RMN with MCN. Outcomes considered were AF recurrence (primary outcome), pulmonary vein isolation (PVI), procedural complications, and data on procedure's performance. Odds ratios (OR) and mean difference (MD) were extracted and pooled using a random-effect model. Confidence in the estimates of the obtained effects (quality of evidence) was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. We identified seven controlled trials, six non-randomized and one randomized, including a total of 941 patients. Studies were at high risk of bias. No difference was observed between RMN and MCN on AF recurrence [OR 1.18, 95% confidence interval (CI) 0.85 to 1.65, P = 0.32] or PVI (OR 0.41, 95% CI 0.11-1.47, P = 0.17). Remote magnetic navigation was associated with less peri-procedural complications (Peto OR 0.41, 95% CI 0.19-0.88, P = 0.02). Mean fluoroscopy time was reduced in RMN group (-22.22 min; 95% CI -42.48 to -1.96, P = 0.03), although the overall duration of the procedure was longer (60.91 min; 95% CI 31.17 to 90.65, P < 0.0001). In conclusion, RMN is not superior to MCN in achieving freedom from recurrent AF at mid-term follow-up or PVI. The procedure implies less peri-procedural complications, requires a shorter fluoroscopy time but a longer total procedural time. For the low quality of the available evidence, a proper designed randomized controlled trial could turn the direction and the effect of the dimensions explored.Europace 04/2013; · 2.77 Impact Factor
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ABSTRACT: Although "congenital heart disease" incorporates a broad and diverse spectrum of inborn cardiac disorders, one shared feature is the propensity for cardiac arrhythmias, albeit to varying degrees. The magnitude of this issue is underscored by its high prevalence, major impact on morbidity and disability, considerable consummation of healthcare resources, and loss of life at ages well below normative population values. Moreover, with changing demographics, arrhythmias increasingly afflict the aging and growing population of survivors with congenital heart disease. Nevertheless, the field of cardiac electrophysiology has, auspiciously, greatly matured over the past 2 decades. The fruits of this progress are largely applicable to adults with congenital heart disease. This review focuses on recent advances and emerging therapeutic options that are providing safer solutions and increasing the effectiveness with which arrhythmias may be managed in adults with congenital heart disease, spanning pharmacotherapy to innovative interventions.Progress in cardiovascular diseases 01/2011; 53(4):281-92. · 4.25 Impact Factor