Remote-controlled magnetic pulmonary vein isolation combined with superior vena cava isolation for paroxysmal atrial fibrillation: a prospective randomized study.

Radiofrequency ablation (RFA) of paroxysmal atrial fibrillation (PAF) has focused on pulmonary vein isolation (PVI). However, despite initial positive results, significant recurrences have occurred, partly because of pulmonary vein (PV) reconnection or non-PV ectopic foci, including the superior vena cava (SVC). This prospective, randomized study sought to investigate the efficacy of additional SVCI combined with PVI in symptomatic PAF patients referred for ablation. From November 2011 to May 2013, RFA was performed remotely using a CARTO(®) 3 System in patients randomized to undergo PVI for symptomatic drug-refractory PAF, with (PVI+SVCI group) or without (PVI alone group) SVCI. PVI and SVCI were confirmed by spiral catheter recording during ablation. Procedural data, complications and freedom from atrial tachycardia (AT) and atrial fibrillation (AF) were assessed. Over an 18-month period, 100 consecutive patients (56±9years; 17 women) with symptomatic PAF were included in the study (PVI+SVCI, n=51; PVI, n=49); the CHA2DS2-VASc score was 0.9±1. Median duration of procedure (±interquartile), 2.5±1hours; total X-ray exposure, 13.3±8minutes; transseptal puncture and catheter positioning, 8±5minutes; left atrium electroanatomical reconstruction, 3±2minutes; and catheter ablation, 3.7±3minutes. After a median follow-up of 15±8months, and having undergone a single procedure, 84% of patients were symptom free, while 86% remained asymptomatic after undergoing two procedures. The cumulative risks of atrial arrhythmias (AT or AF) were interpreted using Kaplan-Meier curves and compared using the log-rank test. Long-term follow-up revealed no significant difference between groups, with atrial arrhythmias occurring in six (12%) patients in the PVI+SVCI group and nine (18%) patients in the PVI alone group (P=0.6). One transient phrenic nerve palsy and one phrenic nerve injury with partial recovery occurred in the PVI+SVCI group. SVCI combined with PVI did not reduce the risk of subsequent AF recurrence, and was responsible for two phrenic nerve injuries. Accordingly, the benefit-to-risk ratio argues against systematic SVCI.

Da Costa A ，Levallois M ，Romeyer-Bouchard C ，Bisch L ，Gate-Martinet A ，Isaaz K ... -  《-》

Remote-controlled magnetic pulmonary vein isolation using a new three-dimensional non-fluoroscopic navigation system: a single-centre prospective study.

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 ± 9 years; 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 ± 1 hours; median total X-ray exposure time was 13 ± 7 minutes; transseptal puncture and catheter positioning took 8 ± 4 minutes, left atrium electroanatomical reconstruction 1 ± 4 minutes 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 ± 6 months 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.

Da Costa A ，Ben H'dech M ，Romeyer-Bouchard C ，Bisch L ，Gate-Martinet A ，Levallois M ，Isaaz K ... -  《-》

Pulmonary vein isolation combined with superior vena cava isolation for atrial fibrillation ablation: a prospective randomized study.

Wang XH ，Liu X ，Sun YM ，Shi HF ，Zhou L ，Gu JN ... -  《-》

Does a patent foramen ovale matter when using a remote-controlled magnetic system for pulmonary vein isolation?

Pulmonary vein isolation (PVI) takes longer when using a patent foramen ovale (PFO) compared with a transseptal puncture in paroxysmal atrial fibrillation (AF) with manual catheter ablation. To our knowledge, no data exist concerning the impact of a PFO on AF ablation procedure variables when using a remote magnetic navigation (RMN) system. To assess the impact of a PFO when using an RMN system in patients requiring AF ablation. Between December 2011 and December 2012, catheter ablation was performed remotely using the CARTO(®) 3 system in 167 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power ≤ 35 W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation for all patients and including additional lesion lines (left atrial roof) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data. Mean age 58±10 years; 18% women; 107 (64%) patients with symptomatic paroxysmal AF; 60 (36%) with persistent AF; CHA2DS2-VASc score 1.2 ± 1. The PFO presence was evidenced in 49/167 (29.3%) patients during the procedure but in only 26/167 (16%) by transoesophageal echocardiography. Median procedure time 2.5 ± 1 hours; median total X-ray exposure time 14 ± 7 minutes; transseptal puncture and catheter positioning time 7.5 ± 5 minutes; left atrium electroanatomical reconstruction time 3 ± 2.3 minutes; catheter ablation time 3 ± 3 minutes. No procedure time or X-ray exposure differences were observed between patients with or without a PFO during magnetic navigation catheter ablation. X-ray exposure time was significantly reduced using a PFO compared with double transseptal puncture access. A PFO does not affect magnetic navigation during AF ablation; procedure times and X-ray exposure were similar. Septal catheter probing is mandatory to limit X-ray exposure and prevent potential complications.

Gate-Martinet A ，Da Costa A ，Romeyer-Bouchard C ，Bisch L ，Levallois M ，Isaaz K ... -  《-》

Impact of an Empiric Isolation of the Superior Vena Cava in Addition to Circumferential Pulmonary Vein Isolation on the Outcome of Paroxysmal Atrial Fibrillation Ablation.

The safety and efficacy of an empiric superior vena cava isolation (SVCI) in addition to circumferential pulmonary vein isolation (CPVI) in patients with paroxysmal atrial fibrillation (PAF) have not been clarified. A total of 186 consecutive patients who underwent catheter ablation of PAF were included. All patients underwent a CPVI. Patients in the first half underwent an additional SVCI only if SVC-triggered AF or rapid SVC activity was observed during the procedure (n = 93, as-needed SVCI, group I), and those in the second half underwent an empirical SVCI after the CPVI (n = 93, empiric SVCI, group II). The CPVI was successfully performed in all patients. An SVCI was performed in 8 of 93 patients (9%) in group I and 81 of the 93 patients (87%) in group II. In the remaining 12 patients in group II, an SVCI was not performed because of the lack of SVC potentials. During a mean follow-up of 27 ± 12 months, the atrial tachyarrhythmia recurrence rate after a single ablation procedure in the patients in group II was lower than that in group I (44% vs 23%, p = 0.035). A Cox regression multivariate analysis demonstrated that an empiric SVCI was an independent predictor of an atrial tachyarrhythmia recurrence after a single ablation procedure (odds ratio: 0.57, 95% confidence interval 0.31 to 0.999; p = 0.049). Neither sinus node injury nor any injury to the phrenic nerve was observed. In conclusion, an empiric SVCI in addition to the CPVI improved the outcome of AF ablation in patients with PAF without any additional adverse effects.

Ejima K ，Kato K ，Iwanami Y ，Henmi R ，Yagishita D ，Manaka T ，Fukushima K ，Arai K ，Ashihara K ，Shoda M ，Hagiwara N ... -  《-》