Comparison Of The Clinical Effect Of Domestic Cl-V And Imported Bileaflet Valve In Aortic Valve Replacement

Objective: To evaluate the clinical efficacy of domestic CL-V and Imported bileaflet valve in aortic valve replacement（AVR）,explore the clinical value and application prospect of domestic CL-V bileaflet artificial heart valve.Methods: Patients undergoing mechanical AVR in The First Hospital of Lanzhou University from January 2019 to December 2019 were retrospectively enrolled,and their valve selection,preoperative and postoperative clinical data and follow-up data were collected.They were divided into CL-V and Import groups according to the types of valves used during surgery.The follow-up time was up to December 31,2021,and the end point event was designed as a composite index.Including :（1）Death;（2）Cardiac arrest;（3）Perivalvular leakage or valve failure;（4）Life-threatening thromboembolism or bleeding events;（5）Postoperative Ⅲ degree atrioventricular block or AF;（6）Severe infection or organ dysfunction;（7）Readmission for heart failure.Kaplan-Meier method was used to draw the survival curve,and Log-Rank test was used to evaluate the statistical difference.COX proportional risk regression model was used to analyze the risk factors for the occurrence of outcome events,and the rosette model was constructed.The C-index was calculated by internal verification,and the ROC curve was drawn to calculate the area under the ROC curve to evaluate the prediction ability of the rosette.Results: A total of 153 patients were enrolled,including 79 patients in the domestic CL-V group and 74 patients in the Import group.During the 2-year follow-up,16 patients in the Cl-V group and 23 patients in the Import group had end-point events.Survival curve showed that there was no statistical difference in the occurrence of end point events between the two groups.COX model showed that preoperative PLT level,total time of CPB,and ICU time were independent risk factors for the occurrence of end point events.After the construction of the line graph model,the consistency index was calculated to be between 0.71-0.90 by internal validation,which was of medium accuracy.Area under ROC curve was 0.6-0.7.It shows that the model has high value.Conclusion: The study found that domestic CL-V valve reached Imported valve of the same type in many performance indexes to a certain extent,which is expected to break the monopoly situation of Chinese artificial heart valve market almost dominated by imported artificial heart valve.The study also found that preoperative platelet level,total CPB time,and ICU time were independent risk factors for adverse events after mechanical AVR,suggesting that attention should payed to perioperative monitoring of patients undergoing surgery.