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Background: Point-by-point catheter ablation is an established treatment for drug-refractory paroxysmal atrial fibrillation (PAF). However, it is time consuming, requires excellent technique to achieve complete pulmonary vein (PV) isolation, and is associated with severe complications., Objectives: The purpose of this study was to evaluate the safety and effectiveness of a HotBalloon ablation (HBA) compared with antiarrhythmic drug therapy (ADT) for the treatment of PAF., Methods: A prospective multicenter randomized controlled study was conducted in Japan. Patients with symptomatic PAF refractory to antiarrhythmic drugs (Class I to IV) were randomized to HBA or ADT at a 2:1 ratio and assessed for effectiveness in a comparable 9-month follow-up period., Results: A total of 100 patients in the HBA group and 43 patients in the ADT group received treatment at 17 sites. HBA procedure produced acute complete PV isolation in 98.0% (392 of 400) of the PVs and in 93.0% (93 of 100) of patients in the HBA group. The chronic success rates after the 9-month effective evaluation period were 59.0% in the HBA group (n = 100) and 4.7% in the ADT group (n = 43; p < 0.001). The incidence of major complications was 11.2% (15 of 134 patients). The incidences of PV stenosis (>70%) and transient phrenic nerve injury were 5.2% and 3.7%, respectively. The mean fluoroscopy time was 49.4 ± 26.6 min (n = 134), and the mean procedure duration was 113.9 ± 31.9 min (n = 133)., Conclusions: This study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To determine whether atrial fibrillation (AF) alone affects the fibrinocoagulation system, we examined the relation between fibrinocoagulation activity and duration of AF in patients with paroxysmal AF (PAF)., Background: Patients with chronic AF are at higher risk for stroke and a hypercoagulative state. It is not clear whether this hypercoagulative state is attributable to AF alone or to the underlying disease. There are no reports on the fibrinocoagulation properties in PAF., Methods: Fibrinocoagulation variables in 21 patients with PAF were measured during AF and 7 days after recovery of sinus rhythm. There were positive correlations between the duration of AF and beta-thromboglobulin, platelet factor 4, thrombin-antithrombin III complex and fibrinogen. These variables increased significantly 12 h after the occurrence of PAF; thus, patients were classified into two groups according to the duration of PAF: PAF-I group (< 12 h, n = 10), PAF-II group (> or = 12 h, n = 11). Nine age-matched, healthy subjects formed the control group., Results: Levels of beta-thromboglobulin and platelet factor 4 were significantly higher (p < 0.001) by two-way repeated measures analysis of variance (ANOVA), and thrombin-antithrombin III complex and fibrinogen levels tended to be but were not significantly higher (p = 0.06, ANOVA), in the PAF-II group than in the PAF-I group. There were no significant differences between groups in activated partial thromboplastin time, D-dimer or plasmin inhibitor complex., Conclusions: These results indicate that AF itself enhances platelet aggregation and coagulation, which are influenced by the duration of AF. The acceleration of platelet activity and coagulability occurred 12 h after the occurrence of AF.