Remote Magnetic Versus Manual Catheter Navigation for Ablation of Supraventricular Tachycardias: A Randomized, Multicenter Trial

Pacing and Clinical Electrophysiology (Impact Factor: 1.75). 09/2008; 31(10):1313 - 1321. DOI: 10.1111/j.1540-8159.2008.01183.x

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: Catheter ablation has become a well-established, first-line therapy for atrioventricular nodal reentrant tachycardia (AVNRT), the most common reentry supraventricular tachycardia in humans. Robotic systems are becoming increasingly common in both complex and simple ablation procedures with presumed potential improvements in procedural efficacy and safety. The authors of this article conducted a systematic review and meta-analysis on the effectiveness and safety of the magnetic navigation system (MNS) in comparison with conventional catheter navigation for AVNRT ablation. An electronic search was performed using Cochrane Central database, Medline, Embase and Web of Knowledge between 2002 and 2012. References were searched manually. Outcomes of interest were: acute and long-term success, complications, total procedure, ablation and fluoroscopic times. Continuous variables were reported as standardized difference in means (SDM); odds ratios (OR) were reported for dichotomous variables. Thirteen studies (seven of which were nonrandomized controlled, four were case series and two were randomized controlled studies) involving 679 adult patients were identified. Twelve studies were based on a single center and one study was multicentral. MNS was deployed in 339 patients. The follow-up period ranged between 75 and 180 days. Acute success and long-term freedom from arrhythmia were not significantly different between MNS and control groups (98 vs 98%, OR: 0.94 [95% CI: 0.21-4.1] and 97 vs 96%, OR: 1.18 [95% CI: 0.35-4.0], respectively). A shorter fluoroscopic time was achieved with MNS; however, this did not reach statistical significance (15 vs 19 min, SDM: -0.26 [95% CI: -0.64-0.12]). Longer total procedure but similar ablation times were noted with MNS (160 vs 148 min, SDM: 3.48 [95% CI: 0.75-6.21] and 4 vs 6 min, SDM: -0.83 [95% CI: -2.19-0.53], respectively). The overall complication rate was similar between both groups (2.7 vs 1.0%, OR: 1.28 [95% CI: 0.33-4.96]). Our data suggest that the usage of MNS results in similar rates of success and complications when compared with conventional manual catheter ablation for AVNRT. MNS had a trend for reduced fluoroscopic time. Longer total procedure time was observed with MNS while the actual ablation time remained similar. Prospective randomized trials will be needed to better evaluate the relative role of MNS for catheter ablation of AVNRT.
    Expert Review of Cardiovascular Therapy 07/2013; 11(7):829-36.
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    ABSTRACT: Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein isolation (PVI), but the procedure is associated with significant X-ray exposure. Few data exist concerning the combination of remote magnetic navigation (RMN) and a new three-dimensional non-fluoroscopic navigation system (Carto(®) 3), which facilitates precise catheter navigation and limits X-ray exposure. To assess the efficacy and extent of fluoroscopic exposure associated with the combination of RMN and the Carto 3 system in patients requiring AF ablation. Between January and September 2011, catheter ablation was performed remotely using the Carto 3 system in 81 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power≤35W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation and including additional lesion lines (left atrial roof and coronary sinus defragmentation) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data, complications and freedom from atrial tachycardia (AT)/AF. Mean age was 60±9years; 20% were women; 73% had symptomatic paroxysmal AF; 27% had persistent AF. The CHA2DS2-VASc score was 1.2±1. Median procedure time was 3.5±1hours; median total X-ray exposure time was 13±7minutes; transseptal puncture and catheter positioning took 8±4minutes, left atrium electroanatomical reconstruction 1±4minutes and catheter ablation 3.5±5minutes. Recurrences were AT (n=3; 3.7%), paroxysmal AF (n=8; 9.9%) and persistent AF (n=4; 4.9%); redo ablation was performed in these 15 (19%) patients. After a median follow-up of 15±6months and a single procedure, 71% of patients were free of symptoms; 84% remained asymptomatic after two procedures. RMN with irrigated catheters combined with the Carto 3 system can be effectively performed in patients requiring AF ablation with minimal use of fluoroscopy, but larger randomized studies are warranted.
    Archives of cardiovascular diseases 07/2013; · 0.66 Impact Factor
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    ABSTRACT: Contexte Il a été démontré que la durée des procédures d’isolation des veines pulmonaires VPs était plus longue lors de l’utilisation d’un foramen ovale perméable (FOP) comparée à l’utilisation de la ponction transeptale dans le traitement par radiofréquence (RF) de la fibrillation atriale (FA) paroxystique par la technique d’ablation manuelle. Il n’y a pas, à notre connaissance, de données dans la littérature sur l’influence du FOP sur les temps ou les données opératoires lors de l’utilisation d’un robot magnétique (RM). Objectif Cette étude prospective a cherché à évaluer l’impact de l’utilisation d’un FOP avec un système de RM sur les procédures de RF de FA en comparaison avec la double ponction transeptale. Méthodes Entre décembre 2011 et décembre 2012, 167 patients consécutifs ont bénéficié d’un traitement par RF par technique du RM. L’objectif principal était l’isolement électrique des VPs confirmé par la technique du lassos et la réalisation de lignes complémentaires et/ou l’ablation de potentiels fractionnés en cas de FA persistante. Résultats Cent soixante sept patients ont été inclus (58 ± 10 ans ; 18 % de femmes), dont 107 FA paroxystiques (64 %) et 60 FA persistantes (36 %). Un FOP était présent chez 49/167 (29,3 %) au cours de la procédure mais seulement 26/167 (16 %) ont été détectés par échographie transoesophagienne. Le temps médian de procédure était de 2,5 ± 1 heures et la médiane d’exposition aux rayons X était de 14 ± 7 minutes (ponction transeptale et positionnement des cathéters 7,5 ± 5 min, reconstruction électro-anatomique de l’oreillette gauche 3 ± 2 min, et temps d’ablation robotisé 3 ± 2 min). Aucune différence de temps opératoire ou d’exposition aux rayons X n’a été observé entre les patients avec présence d’un FOP et les patients avec double ponction transeptale. Conclusions La présence et l’utilisation d’un FOP n’ont pas d’impact sur les temps opératoires et sur la durée d’exposition aux rayons X lors de l’utilisation de la technique par robot magnétique au cours des ablations de fibrillation atriale. La présence d’un FOP permet de réduire de manière significative le temps d’exposition aux rayons X en comparaison avec la double ponction transeptale.
    Archives of cardiovascular diseases 01/2014; · 0.66 Impact Factor