Abstract
Abstract Background and Objectives A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into 3D mapping system was recently launched. Methods Patients ablated for paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (persAF) at two German high-volume electrophysiology centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180 and 360 days following ablation including 24h Holter ECGs. Results A total of 101 patients were enrolled (50 from centre A, 51 from centre B) and 86 patients (48% male, 65 ± 11 years, 55% PAF, 59 ± 7% left ventricular ejection fraction (LVEF)) completed the follow-up. Mean ablation and procedure times were 26 ± 13 min and 71 ± 20 min, respectively. Dose area product was 1501 ± 1634 mGycm2. Acute PVI was achieved in 100%. Atrial fibrillation (AF) free survival after a mean FU of 361 (219-375) days was 78.4% for PAF and 75.4% for persAF. (p= 0.828). A multiple regression analysis did not reveal any clinical or procedural predictors of AF recurrence among sex, age, BMI, left atrial diameter, LVEF, ablation time, procedure time and single shot PVI. However, early recurrence of atrial tachyarrhythmia (ERAT) was an independent predictor for AF recurrence at 1-year (Hazard Ratio [HR]: 3.198; 95% confidence interval [95% CI]: 1.036 - 10.32, p value = 0.0433). Primary adverse events occurred in 3.5% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke or phrenic nerve paralysis were observed. Conclusions RFB-based PVI is clinically effective and safe. ERAT at the first follow-up visit is an independent predictor of late AF recurrence.
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