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HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF: A Multicenter Randomized Trial in Japan.
- Source :
-
Journal of the American College of Cardiology (JACC) . Dec2016, Vol. 68 Issue 25, p2747-2757. 11p. - Publication Year :
- 2016
-
Abstract
- <bold>Background: </bold>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.<bold>Objectives: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>This study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CATHETER ablation
*ATRIAL fibrillation treatment
*PULMONARY veins
*CARDIAC catheterization complications
*MYOCARDIAL depressants
*ATRIAL fibrillation diagnosis
*ABLATION techniques
*ATRIAL fibrillation
*CARDIAC catheterization
*COMPARATIVE studies
*HEART conduction system
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL cooperation
*RESEARCH
*TIME
*PRODUCT design
*EVALUATION research
*RANDOMIZED controlled trials
*VASCULAR catheters
*SURGERY
Subjects
Details
- Language :
- English
- ISSN :
- 07351097
- Volume :
- 68
- Issue :
- 25
- Database :
- Academic Search Index
- Journal :
- Journal of the American College of Cardiology (JACC)
- Publication Type :
- Academic Journal
- Accession number :
- 120141409
- Full Text :
- https://doi.org/10.1016/j.jacc.2016.10.037