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Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation: A Multinational Multicenter Randomized Clinical Trial.
- Source :
-
Circulation. Arrhythmia and electrophysiology [Circ Arrhythm Electrophysiol] 2016 Apr; Vol. 9 (4), pp. e003151. - Publication Year :
- 2016
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Abstract
- Background: Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation.<br />Methods and Results: Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA2DS2-VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P<0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P=0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA (P<0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing >50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months.<br />Conclusions: In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times.<br />Clinical Trial Registration: URL: www.clinicaltrials.gov; Unique identifier: NCT01696136.<br /> (© 2016 American Heart Association, Inc.)
- Subjects :
- Atrial Fibrillation diagnosis
Atrial Fibrillation physiopathology
Echocardiography, Transesophageal
Electrocardiography
Equipment Design
Female
Follow-Up Studies
Heart Conduction System physiopathology
Humans
Magnetic Resonance Imaging, Cine
Male
Middle Aged
Prospective Studies
Tachycardia, Paroxysmal diagnosis
Tachycardia, Paroxysmal physiopathology
Tomography, X-Ray Computed
Treatment Outcome
Atrial Fibrillation surgery
Catheter Ablation instrumentation
Electrodes
Heart Conduction System surgery
Pulmonary Veins surgery
Tachycardia, Paroxysmal surgery
Subjects
Details
- Language :
- English
- ISSN :
- 1941-3084
- Volume :
- 9
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Circulation. Arrhythmia and electrophysiology
- Publication Type :
- Academic Journal
- Accession number :
- 27071830
- Full Text :
- https://doi.org/10.1161/CIRCEP.115.003151