Periprocedural anticoagulation in AF cryoballoon ablation in a nationwide registry: no difference in complication rates between strategies

Abstract

Abstract Background Standard treatment for patients with atrial fibrillation is pulmonary vein isolation (PVI). There are two widely adopted methods for PVI - cryoballon ablation (CBA) and radiofrequency (RF) ablation. There are several randomized studies evaluating different periprocedural anticoagulation strategies in patients undergoing PVI, and those mainly related to RF ablation procedures. However, there is a lack of data on safety of different anticoagulation strategies in CBA. Purpose To analyze the current anticoagulation approaches in patients undergoing cryoballoon ablation, the incidence and types of hemorrhagic and thromboembolic periprocedural events. The analysis was performed on data from the National cryoballoon AF ablation registry (NCT03040037). Methods Nineteen centers prospectively entered data into a web-based platform. The full data on AC therapy was available in 719 subjects. The specialists evaluated ischemic events clinically, and those included stroke, transient ischemic attack, pulmonary embolism or extracranial systemic embolism. Major bleedings were registered and classified according to the ISTH criteria. Results The mean CHA2DS2-VASc score was 2.0±1.4; mean BMI 29.5±4.8; mean GFR 92±28.9 ml/min. Periprocedurally, 574 (79.8%) subjects received direct oral anticoagulants (DOACs), 113 (15.7%) anti-vitamin K drugs (mainly warfarin); 16 (2%) patients received antiplathelet therapy. Uninterrupted DOAC therapy was used in 251 (34.9%) cases. Uninterrupted warfarin therapy was used in 36 (2%) patients. Bridging therapy was used in 325 (45.2%) patients. The total number of major adverse events was 25 (3.5%): 24 of them hemorrhagic and 1 transient ischemic attack (1 female patient on rivaroxaban with bridging). Five (0.7%) patients had hemopericardium: 3 - on uninterrupted rivaroxaban, 1 – rivaroxaban with bridging, 1 – interrupted apixaban. Seventeen (2.5%) patients had groin vascular complications and 1 -hemoptysis. Three patients died within 30 days following CBA from non-cardiovascular causes. There were no statistically significant differences in complications between patients receiving different periprocedural anticoagulation. Conclusions About 45% of patients referred for CBA receive bridging anticoagulation therapy in the periprocedural period. Although this is not in line with the current guidelines, we found no meaningful difference in complication rates between different anticoagulation approaches. CBA might be associated with different from RF ablation safety profile and requires randomized trials on periprocedural anticoagulation. Funding Acknowledgement Type of funding source: Other. Main funding source(s): RF President's council grant