| Background:Aortic stenosis(AS)is a common chronic progressive disease.As reported in people over 75 years old,morbidity is 5%,and it increases with age.Traditionally,surgical aortic valve replacement(SAVR)represented the single definitive cure to this condition,and clinical outcomes of decreased mortality and morbidity following operative intervention have been proved durable over time.However,with the establishment and development of transcatheter aortic valve replacement(TAVR),TAVR is an alternative treatment of SAVR.In the past 15 years,more than 350000 cases of TAVR have been performed in more than 70 countries.In China,the proportion of bicuspid aortic valve(BAV)morphology in severe AS patients receiving TAVR was40–50%,which was much higher than the proportion of 1.6–9.3% in western patients.Furthermore,severe AS patients in China often has a higher Calcium volume,leading to more challenges for TAVR.The Venus-A valve,a self-expandable valve,which approved by the China Food and Drug Administration in 2017,was used in this study.This study is to evaluate the efficacy of transcatheter aortic valve replacement by using Venus-A valve for patients with severe aortic valve stenosis,and to evaluate the efficacy and safety of PCI in TAVR.Objective: This study is to evaluate the efficacy of transcatheter aortic valve replacement by using Venus-A valve for moderate and high-risk patients with severe aortic valve stenosis,and to evaluate the efficacy and safety of PCI in TAVR.Methods:In this study,57 consecutive severe aortic stenosis patients with moderate and high surgical risk(Society of Thoracic Surgeon(STS)score ≥4%)from October 2018 to October 2020 were enrolled,and Venus-A valves were used in TAVR for these patients,including 7 patients underwent PCI + TAVR Retrospective analysis was used to collect and analyze the data of patients.Cardiac function,mean pressure gradient,aortic regurgitation,LVEF,creatinine and BNP were used to evaluate the therapeutic effect of TAVR.The patients were followed up for 1,3 and 12 months after the operation.The primary endpoints of the study was all-cause death,the secondary endpoints included efficacy and safety of TAVR.Telephone follow-up is the main method,and outpatient echocardiography was examined.51 patients with severe aortic stenosis who underwent surgical aortic valve replacement(SAVR)were enrolled,including 9 patients who underwent coronary artery bypass grafting(CABG)+ SAVR.The endpoints were compared between TAVR group and SAVR group.And the age,total intervention time,total length of hospital stay,all-cause death and stroke after operation were compared between PCI + TAVR group and CABG + SAVR group.SPSS 24.0 software was applied for statistical analysis.Normal distribution data were presented as mean ±standard deviation.Comparison of quantitative variables was performed with an unpaired Student t test or Mann-Whitney U test,depending on variable distribution.Categorical data were presented as the number(percentage)and compared using theχ2-test or Fisher’s exact test.Kaplan-Meier method was used to analyze the cumulative survival rate,and the survival curve was drawn.P<0.05,the difference was statistically significant.Results:TAVR was completed successfully in 57 patients,and the symptoms of aortic stenosis such as angina were significantly improved or disappeared after TAVR.The mean pressure gradient(53.8±17.3mm Hg vs.12.5±6.1mm Hg,P<0.001),LVEF(51.2±10.1% vs.54.7±6.7%,P=0.036),aortic regurgitation(23cases vs.0cases,P<0.001),BNP(3848±2602.6pg/m L vs.2259.1±1757.3pg/m L,P<0.001),creatinine(98.3 ±27.9μmol/L vs.69.6 ±16.3μmol/L,P =0.031)and NYHA functional class Ⅲ / IV(46 cases vs.3cases,P < 0.001)were significantly improved compared with preoperative condition.Mortality at 1 year was 7.0%,which was caused by severe stroke and acute kidney injury.Complications included severe atrioventricular block needing permanent pacemaker implantation in 5 patients and stroke in 4 patients.There were no statistical difference between the TAVR group and SAVR group in the risk for all-cause mortality.Compared with CABG + SAVR group,patients in PCI + TAVR group were older,and the total intervention time,total length of hospital stay were shorter,but there were no statistical difference between the CABG + SAVR group and PCI + TAVR group in all-cause mortality,stroke and other serious complications.Conclusion:TAVR by using Venus-A valve for moderate and high-risk patients with severe aortic stenosis is effective and safe in the early and medium term after operation.And PCI is a safe therapy for TAVR patients with severe coronary artery disease. |
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