Long-Term Safety And Effectiveness Of Watchman And Lambre Occluders For Occlusion Of Left Atrial Appendage

[Objective] Through the retrospective analysis of the follow-up results of patients with non-valvular atrial fibrillation who underwent left atrial appendage occlusion in our center,the long-term safety and effectiveness of left atrial appendage closure were discussed,and the related factors of adverse events and the advantages and disadvantages of equipment were analyzed.[Methods] Patients who underwent transcatheter closure of left atrial appendage(Left Atrial Appendage Closure,LAAC)in the first affiliated Hospital of Kunming Medical University from 2017 to 2022 and completed at least one outpatient imaging follow-up were selected to retrospectively analyze the hospitalization and follow-up results of patients with non-valvular atrial fibrillation(Nonvalvular Atrial Fibrillation,NVAF)who underwent LAAC,and to conduct a cohort study of two groups of patients with Watchman and LAmbre occluders:1.The general clinical data,preoperative imaging examination and preoperative laboratory examination of all the subjects were collected through the medical record system.The intraoperative conditions and perioperative complications were recorded in detail.2.During the follow-up,the patients were asked in detail about the use of antithrombotic drugs in the short and long term after operation,cardiac computed tomography(Cardiac Computed Tomography Angiograph,CCTA)and or transesophageal echocardiography(Transesophageal Echocardiography,TEE),transthoracic echocardiography(Transthoracic Echocardiography,TTE)and electrocardiogram(ECG)were reexamined according to the condition,and the related data were recorded for device-related thrombus(Device-Related Thrombus,DRT),peri-device residual leakage(Peri-Device Leak,PDL)and iatrogenic atrial septal defect(Iatrogenic Atrial Septal Defect).IASD)was not closed and other indicators were evaluated.3.Follow-up observation events: bleeding,TIA or all-cause stroke,systemic thromboembolism,cardiac death,all-cause death,etc.4.The data were analyzed by SPSS26,and the statistical difference between the two groups was compared.[Results]1.This study included 108 patients who underwent percutaneous left atrial appendage occlusion in the first affiliated Hospital of Kunming Medical University from 2017 to 2022.The average follow-up period was 501(106-1686)days,of which65 cases were implanted with LAmbre occluder and 43 cases with Watchman occluder.The average CHA2DS2-VASC score was 4.39 ± 1.91 and the average HAS-BLED score was 2.49 ±1.41.There was no significant difference between the two groups.Comparison of baseline data between LAmbre and Watchman groups:there were significant differences in the proportion of women(62.80% vs.36.90%),smoking(9.30 vs.35.40)and pacemaker implantation history(16.30% vs.16.30%).There was no significant difference in baseline characteristics of TEE between the two groups.2.There was no significant difference in preoperative TTE baseline characteristics:LVEF,LVEDV,LVESV,left atrial diameter,right atrial length,right atrial transverse diameter,cardiomyopathy and congenital heart disease.Pericardial effusion(23.80%vs.5.00%),mitral regurgitation(35.70% vs.13.30%),tricuspid regurgitation(31.10%vs.10.00%).There was significant difference in distribution between the two groups.3.Most of the patients underwent LAAC under general anesthesia and esophageal ultrasound assistance,and the implantation position was correct and the release success rate was 100%.One case in each group had immediate residual leakage ≥5mm,and the operation success rate(correct implantation position and release,no residual leakage > 5mm)was 98.15%.The differences between the two groups were97.67%(LAmbre)and 98.46%(Watchman),respectively.The probability of perioperative major complications was 3.70%,including vascular access complications in 2 cases(1.85%)and stroke in 2 cases(1.85%).There was no significant difference between the two groups.The probability of bleeding event was3.70%,including 1 case of massive hemorrhage(0.93%)and 3 cases of small hemorrhage(2.78%).There was no statistical difference between the two groups.During the perioperative period,there were no complications such as pericardial tamponade,device embolization,occluder falling off,instrument surface thrombosis,severe renal injury or death.Most of the short-term antithrombotic schemes in our center chose to take only one anticoagulant,and there was no significant difference between LAmbre and Watchman groups.4.During follow-up,all patients received at least one CCTA and or TEE examination,focusing on the evaluation of IASD,DRT and other indicators.A total of 5 DRT events were found,with an overall probability of 4.63%,and no stroke or TIA occurred.The survival curve of DRT endpoint events was drawn by Kaplan-Meier method,and the survival curve showed that the event-free survival rate was high for a long time,and there was no significant difference between the two groups.Multivariate Logistics regression analysis was used to analyze the influencing factors of IASD healing,and it was found that smoking and height were independent predictors of IASD non-healing.5.During the long-term follow-up,the average follow-up period was 501(106-1686)days,and the incidence of major adverse events was 8.3%.The probabilities of allcause death,cardiogenic death,systemic embolism,all-cause stroke or TIA were2.8%,1.90%,0.005% and 6.48%,respectively.The probability of bleeding events was 3.70%,in which the incidences of massive bleeding events and small bleeding events were 1.90% and 1.90% respectively,both of which were kept at a low incidence,and there was no significant difference between the two groups.[Conclusion]1.LAAC has high success rate and long-term effectiveness.As an intervention to prevent stroke,LAA occlusion is safe and effective.2.Both LAmbre and Watchman groups maintained a high event-free survival rate during long-term follow-up,suggesting that LAAC had a good event prevention rate in patients with NVAF,and there was no significant difference among different devices.3.Smoking and height were independent predictors of IASD non-healing.4.There was no significant difference in DRT among different occluders.