A Study Of Postoperative Anticoagulation Regimen Of One-stop Therapeutic Strategy For Patients With Atrial Fibrillation Undergoing Radiofrequency Ablation Combined With Left Atrial Appendage Closure

Objective:To investigate and compare the efficacy and safety of dabigatran and rivaroxaban in the blanking period（3 months）for patients with atrial fibrillation undergoing radiofrequency ablation combined with the left atrial appendage closure,as a one-stop therapeutic strategy.To analyse the influencing factors of device-related thrombosis and compare the changes of residual shunt at immediate post-surgry,3-month and 6-month follow-up.Method:A total of 100 patients with atrial fibrillation,who were treated with radiofrequency ablation combined with left atrial appendage closure from June 2019 to March 2021,were enrolled into this study.Those patients were randomly divided into 2 groups:dabigatran group（n=50）and rivaroxaban group（n=50）.Dabigatran,rivaroxaban were administered during the blanking period.After 3 months,oral anticoagulants were replaced by dual antiplatelet therapy with aspirin and clopidogrel.After 6 months,aspirin was permanently replaced with dual antiplatelet therapy.General data,the date of patients’disease of atrial fibrillation,the date of structure and function of heart were collected of the 2 groups.All patients were followed up for at least 12 months.The incidences of hemorrhagic events,ischemic events,device-related thrombus events,and atrial fibrillation recurrence,were recorded in the groups during the blanking period.The effects of left atrial appendage closure were recorded during the follow-up.The influencing factors of device-related thrombosis after operation were studied.The incidence and size of residual shunt at immediate post-surgry,3-month and 6-month follow-up were compared.Result:1.There was no statistical difference in general data of 2 groups,such as age,sex,height,weight,BMI,type of atrial fibrillation,CHA₂DS₂-VASc score,HAS-BLED score,cardiac function grade,left ventricular ejection fraction,and left atrial diameter（P>0.05）.2.There was no statistical difference in the relevant data of surgery of 2 groups,such as the operation time,the time to complete the left atrial appendage closure,the size of the left atrial appendage closure device,compression ratio,the incidence and size of immediate residual shunt（P>0.05）.There was no significant difference in the incidence of local bleeding and pericardial effusion without treatment（P>0.05）.No complications such as death,stroke/TIA,systemic embolism,device-related thrombosis,air embolism,myocardial infarction,arteriovenous fistula,systemic bleeding,pericardial tamponade,and cardiac perforation occurred during the surgical procedure.3.At follow-up at 3 months after surgery,there was no statistically significant difference between the 2 groups in the comparison of the incidence of the residual shunt,the size of the residual shunt and the incidence of the device-related thrombosis（P>0.05）.During the follow-up process,there was no statistical difference in the incidence of systemic bleeding,local bleeding,and atrial fibrillation recurrence between 2 groups（P>0.05）.No systemic embolic events,TIA,stroke,or death occurred.4.Logistic regression analysis showed that patients with residual shunt at 3 months after surgery had a higher risk of device-related thrombosis than in patients without residual shunt（OR=12.722,P=0.010）.5.Patients with an intraoperative immediate residual shunt had significantly higher rates of residual shunt at 3 months and 6 months after surgery than in patients with no intraoperative residual shunt（P=0.001,P=0.004）.The size of the residual shunt was significantly reduced in patients with residual shunt at 3 months compared with during surgery（P=0.013,P=0.027）.Conclusion:1.It is safe and effective to be treated with dabigatran or rivaroxaban in the blanking period for treating patients undergoing a one-stop therapeutic strategy.2.Persistent residual shunt is a risk factor for device-related thrombus,while it is not relative with the anticoagulants.3.Compared to patients without an intraoperative residual shunt,patients with an intraoperative residual shunt had a higher incidence of a residual shunt during follow-up.