P1422Low incidence of major procedure-related adverse events of cryoballoon ablation in real practice: an interim analysis of the Russian national prospective cryoablation registry

Abstract

Abstract OnBehalf On Behalf Of the National Cryoballoon Registry Investigators Background Cryoballoon ablation (CBA) is an effective strategy for atrial fibrillation (AF) management. The Russian Cryoballoon Atrial Fibrillation Ablation Registry (NCT03040037) is a prospective observational multicenter national registry that aims to provide real-world efficacy, safety and outcomes of this technology. Methods A specialized Web-based registry platform was developed for prospective data entry. The platform consists of 8 sections: AF ablation clinic experience and operator experience, patient characteristics, CBA procedure characteristics, periprocedural patient management (including drug therapy), 12-moths follow-up with scheduled and unscheduled visits, redo procedure characteristics, early and late procedure-related complications. Patient inclusion criteria were the following: indications for AF catheter ablation, planned CBA, a signed informed consent. Results To date thirty-one clinics have joined the Registry, and 830 patients (477 males, a mean age 65.4 ± 11.3 years) were included. The mean BMI was 33.2 ± 3.3 kg/m2. Paroxysmal AF was presented in 688 pts, persistent AF – 111 pts, long standing persistent AF – 31 pts. The main underlying diseases were hypertension (75%), coronary artery disease (11%), chronic heart failure (25%); less commonly - hypertrophic cardiomyopathy (1.4%) and dilated cardiomyopathy (0.7%). The mean LA diameter was 45.4 ± 10.2 mm, and LVEF was 65.4 ± 12.6%. Periprocedural anticoagulant therapy included uninterrupted NOACs (313 pts), bridge anticoagulation (327 pts), uninterrupted warfarin (45 pts), anticoagulation initated only after CBA (32 pts). The mean temperature of cryoablation was -44.6 ± 16.3 C. Transesophageal echo-guided CBA was performed in 92 cases , intracardiac echocardiography-guided - in 465 cases. There were 5 (0.6%) cases of hemopericardium, and pericardiocentesis was required in 1 (0.1%) case only. Periprocedural TIA was diagnosed in 1 (0.1%) patient with bridge anticoagulation, no stroke occurred. Transient phrenic nerve injury was detected in 18 (2.1%) patients, persistent palsy – in 1 (0.1%) patient. Two cases of esophageal injury were reported, no surgery was required and healing was reported in both patients. The data collection is ongoing. Conclusion We report early results of the ongoing national CBA Registry. There was a low number of major procedure-related adverse events in real clinical practice among centers with different AF ablation experience. Long-term follow up of the included patients will be reported in the future. Abstract Figure. Antithrombotic therapy and CBA