Safety of pulmonary vein isolation and left atrial complex fractionated atrial electrograms ablation for atrial fibrillation with phased radiofrequency energy and multi-electrode catheters.

AIMS: Recently, a multi-electrode catheter system using phased radiofrequency (RF) energy was developed specifically for atrial fibrillation (AF) ablation: the pulmonary vein ablation catheter (PVAC), the multi-array septal catheter (MASC), and the multi-array ablation catheter (MAAC). Initial results of small trials have been promising: shorter procedure times and low adverse event rates. In a large single-centre registry, we evaluated the adverse events associated with multi-electrode ablation catheter procedures with PVAC alone, or combined with MASC and MAAC. METHODS AND RESULTS: In all, 634 consecutive patients with AF had 663 procedures with multi-electrode ablation catheters, 502 patients with the PVAC alone, 128 patients with PVAC/MASC/MAAC, 29 redo procedures with the PVAC or PVAC/MASC/MAAC, and 4 patients had a complicated transseptal puncture. Major and minor adverse events during 6 month follow-up were registered. In 15 cases (2.3%), major adverse events were seen within the first month after the procedure. These included complicated transseptal puncture (4), stroke (2), transient ischaemic attack (5), acute coronary syndrome (2), femoral pseudoaneurysm (1), and arteriovenous fistulae (1). Minor adverse events were seen in 10.7% at 6 months, mostly due to femoral haematoma (3.9%), and non-significant PV stenosis (5.2%). There was no difference in the occurrence of major adverse events between PVAC alone, or PVAC/MASC/MAAC ablation. CONCLUSION: Ablation with phased RF and multi-electrode catheters is accompanied by a major adverse event rate of 2.3% within 1 month and a minor event rate of 10.7% at 6 months.

Freedom from paroxysmal atrial fibrillation after successful pulmonary vein isolation with pulmonary vein ablation catheter-phased radiofrequency energy: 2-year follow-up and predictors of failure.

AIMS: In patients with paroxysmal atrial fibrillation (PAF) the pattern of atrial fibrillation (AF) episodes and the total AF burden, may be related to the efficacy of pulmonary vein isolation (PVI). We evaluated (pre)-procedural factors explaining the long-term outcome after PVI, using a ring-shaped multielectrode ablation catheter [pulmonary vein ablation catheter (PVAC)]. METHODS AND RESULTS: A total of 120 consecutive patients with PAF were treated with the PVAC. The patients' histories were obtained by a questionnaire and the clinical charts. Follow-up was performed at 3, 6, 12, 18, and 24 months with serial electrocardiogram, and multiple day Holter at 6, 12, and 24 months, as well as event recording in case of unexplained palpitations. At 1 year, 66 of 120 (55%, 95% confidence interval (CI) [46-63%]) patients were free of any left atrial (LA) arrhythmia without class I or III anti-arrhythmics after a single procedure. At 2 years, freedom from LA arrhythmia slightly declined further to 58 of 119 (49%, 95% CI [40-58%]). The only pre-procedural predictor of long-term success was a shorter duration of the longest episode of AF (hazard ratio (HR) 0.77 95% CI [0.64-0.92]). The only procedural predictor of long-term success was no need for direct current cardioversion (DCCV) for AF (HR 0.36 95% CI [0.21-0.61]). Since other characteristics in these PAF patients were very homogeneous, no further clinical predictors were observed. CONCLUSION: Freedom from LA arrhythmia after PVI for PAF with PVAC is 49% after 2-year follow-up, with little decline between year 1 and 2. Predictors of long-term failure were a longer duration of the longest episode of AF in the pre-procedural questionnaire, and a procedural DCCV for AF.

Arrhythmia detection after atrial fibrillation ablation: value of incremental monitoring time.

BACKGROUND: After pulmonary vein isolation (PVI), patients need to be followed to analyze the effect of the treatment. We evaluated the influence of the duration of Holter monitoring on the detection of arrhythmia recurrences after a single PVI at 12 months. METHODS: Consecutive patients with paroxysmal atrial fibrillation (AF) underwent successful PVI with phased radiofrequency and pulmonary vein ablation catheter. Follow-up was performed with electrocardiogram at 3, 6, and 12 months and 7-day Holter at 12 months. Symptomatic patients received additional event recording. The 7-day Holters at 12 months were evaluated for documented left atrial tachyarrhythmia recurrences, and each individual day with AF was categorized. RESULTS: At 12 months after the procedure, 21 of the 96 (22%) patients had AF on their 7-day Holter. In the patients with AF recurrence, there was an increase in sensitivity from 53% of a 1-day Holter up to 88% with 4-day Holter, and 100% of a 7-day Holter. Monitoring with duration of less than 4 days resulted in significantly less detection of patients with AF compared to 7-day Holter. CONCLUSIONS: A 4-day Holter at 12 months has an 88% sensitivity for arrhythmia detection, and appears to provide a sufficient monitoring time. Prolonging the monitoring time to 7 days does not significantly increase the yield.

Pulmonary vein isolation and left atrial complex-fractionated atrial electrograms ablation for persistent atrial fibrillation with phased radio frequency energy and multi-electrode catheters: efficacy and safety during 12 months follow-up.

AIMS: Ablation for persistent atrial fibrillation (AF) remains a difficult and time-consuming procedure with varying degrees of success. We evaluated the long-term effects of a novel approach for ablation of persistent AF using multi-electrode catheters. METHODS AND RESULTS: In 89 patients with longstanding persistent AF (>1 year), multi-electrode ablation was performed with a pulmonary vein ablation catheter (PVAC), a multi-array septal catheter (MASC), and a multi-array ablation catheter (MAAC) for ablation of complex-fractionated atrial electrograms (CFAE) at the septum, left atrial (LA) roof, floor, posterior wall, and mitral isthmus. Follow-up was performed at 6 and 12 months with electrocardiogram, 7 days Holter, and occasionally ambulant event recordings. Average procedure and fluoroscopy times were 112 ± 32 and 21 ± 10 min. The pre-specified endpoint of pulmonary vein isolation and LA CFAE ablation was reached in all patients. No procedural complications were observed. At 12 months after a single treatment 44 of 89 (49%) remained in sinus rhythm, including direct current cardioversion in 12 patients. At 12 months, after a redo PVAC/MASC/MAAC, an additional 6 of 15 patients (40%) were free of AF. In 18 of 89 (20%) patients AF was changed to paroxysmal. CONCLUSIONS: In this single centre study, ablation for longstanding persistent AF with the PVAC/MASC/MAAC resulted in 56% freedom of AF at 1 year after 1.2 ± 0.4 procedures. This approach is time efficient and has a favourable safety profile.

Pulmonary vein anatomy and long-term outcome after multi-electrode pulmonary vein isolation with phased radiofrequency energy for paroxysmal atrial fibrillation.

AIMS: We evaluated the effect of pulmonary vein (PV) anatomical characteristics on PV isolation (PVI) and long-term efficacy of ablation with phased radiofrequency (RF) energy and pulmonary vein ablation catheter (PVAC) multi-electrode catheter. METHODS AND RESULTS: Before the procedure, PV anatomy was visualized by magnetic resonance imaging (MRI). Consecutive patients with paroxysmal atrial fibrillation were treated with the PVAC with successful acute isolation. Follow-up was performed at 3, 6, and 12 months with electrocardiogram and 7-day Holter recording at 6 and/or 12 months. Symptomatic patients received additional event recording. In 110 patients a pre-procedure cardiac MRI was performed. Ninety-seven (88%) had a separate left superior PV and separate left inferior PV, all patients had a separate right superior PV and separate right inferior PV. Fourteen (13%) had a left PV with common trunk and 27 (25%) had a separate right middle PV (RMPV). After a follow-up of 1 year, 57 of 110 (52%) patients were free of AF without anti-arrhythmic drug. No specific anatomical variable that was related to long-term failure could be found. There was a trend for patients with larger veins (>24 mm) or separate RMPV to have a lower efficacy. The number of applications per vein or procedure did not influence long-term outcome. CONCLUSIONS: In patients who have undergone PVI with phased RF energy and PVAC multi-electrode ablation, long-term efficacy is not significantly affected by PV anatomy or number of applications, although a trend for reduced efficacy is seen for PV with diameter >24 mm, and presence of RMPV.

Early recurrence of atrial fibrillation as a predictor for 1-year efficacy after successful phased RF pulmonary vein isolation: evaluation of complaints and multiple Holter recordings.

BACKGROUND: Early arrhythmia recurrences after pulmonary vein isolation (PVI) for atrial fibrillation (AF) are accepted as part of the blanking period. Their relevance for long-term efficacy is not well-known. We evaluated patients, who came to hospital with a documented recurrence of AF, or had a registered episode of AF on the 24-hour Holter 6 weeks after PVI and compared it with long-term outcome. METHODS: One hundred consecutive patients with paroxysmal AF were treated with the PVAC. In the 3-month blanking period patients who came to hospital with a documented recurrence of AF on ECG were recorded. 6 weeks after procedure a 24-hour Holter was performed. After 3 months patients were asked if they felt a relapse. Follow-up was performed at 3, 6, and 12 months with ECG, 7-day Holter at 6 and/or 12 months, and event recording if needed. RESULTS: Within the blanking period, 25/100 (25%) patients had a documented recurrence of AF while 46/100 (46%) patients felt a relapse. After the blanking period up to 12 months, 53/100 (53%) patients were free of AF without anti-arrhythmic drugs. Multivariate regression analyses revealed that absence of AF in the blanking period (OR 0.22 95%CI [0.05-0.98]) and absence of a relapse of symptoms suspect for AF during the blanking period (OR 0.21 95%CI [0.06-0.52]) were independent predictors of successful long-term outcome. CONCLUSIONS: Poor long-term outcome is strongly related to patients who experienced palpitations with ECG documented AF, AF on the 24-hour Holter at 6 weeks after PVI and a relapse in the blanking period.