741Procedural outcomes of pulmonary vein isolation with the pvac gold ablation catheter: results from the prospective multicenter gold af registry

Abstract

Introduction: The GOLD AF registry is a prospective, observational, multi-center international study designed to assess safety, efficacy, and efficiency of the second generation multielectrode pulmonary vein ablation catheter PVAC GOLD used in duty-cycle phased radiofrequency (RF) ablation system for the treatment of patients with atrial fibrillation (AF) in routine clinical practice. Methods: A total of 1,065 patients from 40 sites were enrolled worldwide between 2015 and 2017. The primary endpoint is the freedom from AF recurrence at 12 months after the procedure, including blanking period of 90 days. We hereby report the first analysis of baseline and procedural data. Results: In total, 901 patients from 29 sites were included in this analysis (mean age 60.4610.8, 620 (68.8%) male, BMI 27.4 6 4.0, CHA2DS2-VASc >2 in 242 patients (26.9 %). Of these, 630 (69.9 %) had paroxysmal PAF, 241 (26.7 %) persistent PersAF, and 30 (3.3%) long standing PersAF. 465 patients had hypertension, 81 diabetes, 31 chronic heart failure. Time from the first AF diagnose to the index procedure was 4.365.2 years. 55 (6.1%) patients had other catheter AF ablations prior to the index phased RF procedure. 810 (89.9%) patients received oral anticoagulation (OAC). Of these 210 (23.3 %) received VKA and 577 (64.0%) NOACs. OACs were discontinued in 458 (50.9 %) patients prior to procedure. Procedure was estimated as successful by investigators in 865 patients, acute pulmonary vein isolation was confirmed by exit and/or entrance block in 845. Number of RF applications per patient was 24.0611.5. The mean procedure time was 104.5638.6 min, CathLab time 151.8648.6 min, LA dwell time 76.9631.3 min and the mean fluoroscopy time 24.2615.6 min. System or procedure related periprocedural complications were observed in 19 patients (2.1%). Among these 1 TIA and 1 ischemic stroke, 7 vascular access complications, 2 minor venous bleeding from the groin, 1 pneumothorax, 2 vagal faintness during the ablation, 2 pericardial effusion, 1 transient ST elevation in inferior leads with spontaneous normalization on ECG, 2 cases of fever without infection signs the day after the procedure. All complications were resolved without consequences. Conclusion: This analysis demonstrates that pulmonary vein isolation with phased RF system is a safe and efficient procedure for patients with PAF and PersAF and long standing PersAF. Procedure was evaluated by physicians as successful in 865 patients (96.0 %), with confirmed acute PV isolation in 845 patients, and low periprocedural complication rate of 2.1%.