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Background: Data comparing remote magnetic catheter navigation (RMN) with manual catheter navigation in combination with contact force sensing (MCN-CF) ablation of atrial fibrillation (AF) is lacking. The primary aim of the present retrospective comparative study was to compare the outcome of RMN versus (vs.) MCN-CF ablation of AF with regards to AF recurrence. Secondary aim was to analyze periprocedural risk, ablation characteristics and repeat procedures. Methods: We retrospectively analyzed 452 patients undergoing a total of 605 ablations of AF: 180 patients were ablated using RMN, 272 using MCN-CF. Results: Except body mass index there was no significant difference between groups at baseline. After a mean 1.6 ± 1.6 years of follow-up and 1.3 ± 0.4 procedures, 81% of the patients in the MCN-CF group remained free of AF recurrence compared to 53% in the RMN group (P < 0.001). After analysis of 153 repeat ablations (83 MCN-RF vs. 70 RMN; P = 0.18), there was a significantly higher reconnection rate of pulmonary veins after RMN ablation (P < 0.001). In multivariable Cox-regression analysis, RMN ablation (P < 0.001) and left atrial diameter (P = 0.013) was an independent risk factor for AF recurrence. Procedure time, radiofrequency application time and total fluoroscopy time and fluoroscopy dose were higher in the RMN group without difference in total number of ablation points. Complication rates did not differ significantly between groups (P = 0.722). Conclusions: In our retrospective comparative study, the AF recurrence rate and pulmonary vein reconnection rate is significantly lower with more favorable procedural characteristics and similar complication rate utilizing MCN-CF compared to RMN. [ABSTRACT FROM AUTHOR]

Catheter ablation (CA) is an important treatment option for ventricular arrhythmias (VA) in pediatric cardiology. Currently, various CA techniques are available, including remote magnetic navigation (RMN)-guided radiofrequency (RF) ablation. However, no studies evaluate RMN-guided ablative therapy outcomes in children with VA yet. This study aimed to compare procedural and long-term outcomes between RMN-guided and manual (MAN)-guided VA ablation in children. This single-center, retrospective study included all CA procedures for VA performed in children with or without structural heart disease from 2008 until 2020. Two study groups were defined by CA technique: RMN or MAN. Primary outcome was recurrence of VA. Baseline clinical, procedural and safety data were also evaluated. This study included 22 patients, who underwent 30 procedures, with a median age of 15 (IQR 14–17; range 1–17) years and a mean weight of 57 ± 20 kg. In total, 14 procedures were performed using RMN and 16 using MAN (22 first and 8 redo procedures). Regarding first procedures, recurrence rates were significantly lower in RMN compared to MAN (20% versus 67%, P = 0.029), at a mean follow-up of 5.2 ± 3.0 years. Moreover, fluoroscopy dosages were significantly lower in RMN compared to MAN [20 (IQR 14–54) versus 48 (IQR 38–62) mGy, P = 0.043]. In total, 20 patients (91%) were free of VA following their final ablation procedure. This is the first study to investigate the use of RMN in pediatric VA ablation. RMN showed improved outcomes compared to MAN, resulting in lower VA recurrence and reduced fluoroscopy exposure. [ABSTRACT FROM AUTHOR]

Background: Studies comparing manual catheter navigation (MCN) to remote magnetic navigation (RMN) for atrial fibrillation (AF) ablation showed variable results. Objective: The aim of this meta-analysis is to compare the safety and clinical outcomes of AF radiofrequency (RF) ablation using MCN versus RMN with irrigated tip catheters. Methods: Medline and the Cochrane Central Register of Controlled Trials (CENTRAL) were queried from inception through January 2019. Studies comparing safety and clinical outcomes of AF ablation with RF using MCN versus RMN with irrigated tip catheters were included. Random effects meta-analysis was used to pool outcomes across studies. Study endpoints included freedom of AF at the end of the study, procedure total time, fluoroscopy time, and complications. Results: A total of 14 studies (3 controlled non-randomized trials, 1 prospective observational, and 10 retrospective observational studies) involving 3375 patients (1871 in MCN and 1504 in RMN) were included in this meta-analysis. There was no significant difference between the two groups in terms of freedom of AF (OR 1.08, 95% CI 0.82–1.42, p = 0.52). The MCN group was associated with shorter procedure time (mean difference in minutes − 50.39, 95% CI − 67.99 to − 32.79, p < 0.01), longer fluoroscopy time (mean difference in minutes 18.01, 95% CI 10.73–25.29, p < 0.01), and higher complication rate (OR 2.18, 95% CI 1.24–3.82, p < 0.01). Conclusions: AF ablation utilizing MCN was associated with similar efficacy to RMN but with higher complication rates. Although the procedure time was shorter with MCN, the fluoroscopy time was more prolonged. Randomized clinical studies are needed to further verify these results. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: Catheter ablation for idiopathic ventricular arrhythmia (VA) is effective and safe, but efficacy is frequently limited due to an epicardial origin and difficult anatomy. The remote magnetic navigation (RMN) catheter has a flexible catheter design allowing access to difficult anatomy. We describe the efficacy of the RMN for ablation of idiopathic VA after failed manual ablation.Methods: Among 235 patients with idiopathic VA referred for catheter ablation, we identified 51 patients who were referred for repeat ablation after a failed manual ablation. We analyzed the clinical characteristics, including the successful ablation site and findings at electrophysiology study, in repeat procedures conducted using RMN as compared with manual ablation. Among these patients, 22 (43 %) underwent repeat ablation with the RMN and 29 (57 %) underwent repeat ablation with a manual ablation.Results: Overall, successful ablation rate was significantly higher using RMN as compared with manual ablation (91 vs. 69 %, P = 0.02). Fluoroscopy time in the RMN was 17 ± 12 min as compared with 43 ± 18 min in the manual ablation (P = 0.009). Successful ablation rate in the posterior right ventricular outflow tract (RVOT) plus posterior-tricuspid annulus was higher with RMN as compared with manual ablation (92 vs. 50 %, P = 0.03). Neither groups exhibited any major complications.Conclusions: The RMN is more effective in selected patients with recurrent idiopathic VA after failed manual ablation and is associated with less fluoroscopy time. The RMN catheters have a flexible design enabling them to access otherwise difficult anatomy including the posterior tricuspid annulus and posterior RVOT. [ABSTRACT FROM AUTHOR]

Background: The objectives of this study were to assess the procedural outcomes of persistent and long-standing persistent atrial fibrillation (PsAF and L-PsAF) ablation guided by remote magnetic navigation (RMN), and to detect factors predicting acute restoration of sinus rhythm (SR) by ablation with RMN.Methods: A total of 313 patients (275 male, age 59 ± 9.5 years) with PsAF (187/313) or L-PsAF (126/313) undergoing ablation using RMN were included. Patients' disease history, pulmonary venous anatomy, left atrial (LA) volume, procedure time, mapping plus ablation time, radiofrequency (RF) ablation time, fluoroscopy time, radiation dose, and complications were assessed. Stepwise regression was used to predict which variable could best predict acute restoration from AF to SR by ablation.Results: Compared to PsAF, procedure time and RF ablation time were significantly increased in patients with L-PsAF (P = 0.01 and P < 0.001, respectively). No major complications occurred during the procedures in either PsAF or L-PsAF patients. Fifty five of 313 patients converted directly to SR by ablation. Compared to L-PsAF, the rate of SR restoration was significantly higher in PsAF (21 vs 12%, P = 0.03). Stepwise regression analysis showed LA volume was the primary parameter affecting SR restoration (P = 0.01). The LA volume of patients without direct SR restoration by ablation was 24% greater than that of patients with SR restoration (P < 0.001).Conclusions: Catheter ablation using RMN is a safe and effective method for PsAF and L-PsAF. LA volume could be a predictor of direct restoration of SR from sustaining AF by ablation using RMN. [ABSTRACT FROM AUTHOR]

Purpose: Remote magnetic navigation (RMN) has been used in various electrophysiological procedures, including atrial fibrillation (AF) ablation. Atrial-esophageal fistula (AEF) is one of most disastrous complications of AF ablation. We aimed to evaluate the incidence of AEF during AF ablation using RMN in comparison to manual ablation. Methods: We conducted the first international survey among RMN operators for assessment of the prevalence of AEF and procedural parameters affecting the risk. Data from parallel survey of AEF among Canadian interventional electrophysiologists (CIE) using only manual catheters served as control. Results: Fifteen RMN operators (who performed 3637 procedures) and 25 manual CIE operators (7016 procedures) responded to the survey. RMN operators were more experienced than CIE operators (16.3 ± 8.3 vs. 9.2 ± 5.4 practice years in electrophysiology, p = 0.007). The maximal energy output in the posterior wall was higher in the operator using RMN (33 ± 5 vs. 28.6 ± 4.9 W; p = 0.02). Other parameters including use of preprocedural images, irrigated catheter, pump flow rate, esophageal temperature monitoring, intracardiac echocardiography (ICE), and general anesthesia were similar. CIE operators administered proton-pump inhibitors postoperatively significantly more than RMN operators (76 vs. 35 %, p = 0.01). AEF was reported in 5 of the 7016 patients in the control group (0.07 %) but in none of the RMN group ( p = 0.11). Conclusions: AEF is a rare complication and its evaluation necessitates large-scale studies. Although no AEF case with RMN was reported in this large study or previously on the literature, the rarity of this complication prevents firm conclusion about the risk. [ABSTRACT FROM AUTHOR]

Purpose: In ablation of atrial fibrillation, the single-ring method aims for isolation of the posterior wall of the left atrium (LA) including the pulmonary veins (PVs) but avoiding posterior LA lesions. The aim of this randomized prospective study was to evaluate safety and efficacy of remote magnetic navigation (RMN)-guided single-ring ablation strategy as compared to standard RMN-guided circumferential PV ablation (PVA). Methods: Eighty consecutive patients undergoing PVA were enrolled prospectively and randomized equally into two study groups. RMN using the Stereotaxis system and open-irrigated 3.5-mm ablation catheters were used with a 3D mapping system in all procedures. Forty patients underwent RMN-guided single-ring ablation, and 40 patients received RMN-guided circumferential PVA. Results: In the circumferential group, 3.3 ± 1.1 PVs were successfully isolated at the end of the procedure as compared to 3.1 ± 1.3 in the single-ring (box) group ( p = 0.38). All patients in the box group required additional posterior lesions in order to achieve electrical isolation of the PVs. Single-ring ablation was associated with longer procedure duration ( p = 0.01) and ablation time ( p = 0.001). After a single procedure, the proportion of patients free of any atrial tachycardia (AT)/atrial fibrillation (AF) episode at 12-month follow-up was 57 % in the box group and 58 % in the circ group. Using RMN, only minor complications have been observed. Conclusions: RMN-guided single-ring PVA provides comparable acute and long-term success rates as compared to RMN-guided circumferential PVA but requires additional posterior lesions to achieve PV isolation and increased procedure and ablation time. Procedural complication rates are low when using RMN. [ABSTRACT FROM AUTHOR]

Background: 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. Methods and results: 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). Conclusion: 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. [ABSTRACT FROM AUTHOR]