Efficacy And Safety Of LAmbre And Watchman Devices For Left Atrial Appendage Closure In Patients With Nonvalvular Atrial Fibrillation

Objective:To evaluate the efficacy and safety of left atrial appendage closure with LAmbre and Watchman devices for patients with nonvalvular atrial fibrillation.Methods:The research subjects were patients with non-valvular atrial fibrillation admitted to Northern Jiangsu People’s Hospital from January 1,2019 to June 30,2021.A total of 82 patients underwent left atrial appendage closure according to inclusion and exclusion criteria,including 60 patients implanted LAmbre devices and 22 patients implanted Watchman devices,respectively.Female,age,height,weight,history of coronary heart disease,smoking history,CHA2DS2-VASC score,HAS-BLED score and preoperative echocardiography were collected from the medical record system.Short-term and long-term postoperative antithrombotic strategies were formulated for both groups according to guidelines,relevant research experience,and risk assessment of embolic bleeding.Echocardiography and Cardiac Computer tomography angiography（CCTA）results were recorded 3 months and 1 year after surgery.Predefine primary efficacy endpoint:stroke/systemic embolism/transient ischemic attack（TIA）and cardiovascular/unexplained death;primary safety endpoint:major peri-procedural complications（death;devide embolism;Pericardial tamponade;vascular access-related complications）and major bleeding events at follow-up;and the combined hazard endpoint:a composite of primary efficacy endpoint and primary safety endpoint.Results:1.At baseline,there were no significant differences in age,female proportion,body mass index（BMI）,and smoking between the two groups.The proportion of patients with coronary heart disease in LAmbre group was significantly higher than that in Watchman group（80%vs 40.9%,P=0.002）.CHA2DS2-VASC scores of patients in the two groups were 4.32±1.30（LAmbre）and 4.09±1.41（Watchman）,respectively,p>0.05,showing no statistical difference.The HAS-BLED scores of the two groups were 3.55±0.89（LAmbre）and 3.32±0.57（Watchman）,respectively,p>0.05,and the difference was not statistically significant.2.Device success rate in the two groups were 100%（LAmbre）and 100%（Watchman）,p>0.05;Technical success rates were 100%（LAmbre）and 100%（Watchman）,p>0.05.Procedural success rate were 98.3%（LAmbre）and 90.9%（Watchman）,respectively,p>0.05,with no statistical significance.A total of 45 patients in the two groups completed follow-up echocardiography 3 months after LAAC,and there was no significant difference in preoperative left atrial diameter,left ventricular ejection fraction,mitral regurgitation,tricuspid regurgitation,and aortic valve regurgitation in all 45 patients compared with those 3 months after LAAC,P>0.05;a total of 22 patients in the two groups completed 1-year follow-up echocardiography,and there were no significant differences in preoperative left atrial diameter,left ventricular ejection fraction,mitral regurgitation,tricuspid regurgitation,and aortic valve regurgitation in all 22 patients compared with those 1 year after LAAC,P>0.05.A total of 19 patients and 8 patients in the two groups completed CCTA 3 months or 1 year after LAAC,respectively.No peridevice leakage was found and 3-month follow-up CCTA showed that 1（5.3%）patient developed device related thrombus.3.The incidence of primary efficacy endpoint event was 0%（0/60）in the LAmbre group and 4.5%（1/22）in the Watchman group,p>0.05;the incidence of the primary safety endpoint event was 5.0%（3/60）in the LAmbre group and 13.6%（3/22）in the Watchman group,p>0.05;the incidence of the combined endpoint was 5.0%（3/60）and 13.6%（3/22）for the two groups,p>0.05.The Kaplan-Meier method was used for graphical assessment of primary endpoints.For comparison of event curves,the log-rank test was used.Patients in the LAmbre group had a primary efficacy endpoint event rate of 0%/year and a survival rate of 100.0%,patients in the Watchman group had a primary efficacy endpoint rate of 2.7%/year（1/37）and the survival rate was 87.5%,（HR,0.00;95%CI,0.00-7.8,p>0.05）;patients in the LAmbre group had a primary safety endpoint event rate of 3.8%/year（3/79）and a survival rate of 95.8%,patients in the Watchman group had a primary safety endpoint rate of 9.7%/year（3/31）and the survival rate was 95.0%,（HR,0.70;95%CI,0.05-9.0,p>0.05）;patients in the LAmbre group had a combined endpoint rate of 3.8%/year（3/79）and a survival rate of 95.8%,patients in the Watchman group had a combined endpoint rate of 8.1%/year（3/37）and the survival rate was 95.0%.There were no significant differences in the primary efficacy end points,primary safety end points,or combined end points between the two groups.4.Female,coronary heart disease,smoking,heart failure,hypertension,age>75 years of age,diabetes,stroke or TIA or embolism,vascular disease,abnormal liver and kidney function,history of bleeding,and INR fluctuations were not statistically associated with the incidence of the primary efficacy end point event,the primary safety end point event,or combined hazard endpoint events.Conclusions:1.Both groups showed high success rates,the LAmbre group had a higher procedural success rate numberically,although it was not statistically significant.2.Among the patients who received follow-up echocardiography results 3 months or 1 year after LAAC,no significant effect of LAAC on the cardiac structure and cardiac function was observed.3.Both groups had high primary end point event survival,the LAmbre group had numerically higher survival of primary end point event,although it was not statistically significant.4.In this study,female,coronary heart disease,smoking,heart failure,hypertension,age>75 years of age,diabetes,history of stroke or TIA or embolism,vascular disease,abnormal liver or kidney function,history of bleeding,and INR fluctuation were not independent predictors of the primary end point events.