Efficacy And Safety Of Transcatheter Aortic Valve Replacement In The Patients With Bicuspid Aortic Valve Stenosis

BackgroundTranscaheterter aortic valve replacement（TAVR）is a method to treat the severe aortic valve stenosis.Compared with surgical aortic valve replacement,TAVR has the benifit of less trauma,less loss of blood,faster recovery,shorter hospital stay.However,due to being made from the materials of biological origin,the lifespan of the biological valve is limited.This procedure provides a valve replacement opportunity for some elderly patients with poor cardiopulmonary function who cannot tolerate surgery.Since Academician Ge Junbo successfully implemented the first case of TAVR in China in 2010,The Zhengzhou No.7People’s Hospital completed the first case in Henan Province in 2017.In China,bicuspid aortic valves（BAV）are present in approximately 40%-50%of patients with severe aortic stenosis.However,there are several unfavorable anatomical factors for BAV patients to TAVR,such as elliptical annulus,asymmetric leaflet calcification,and widening of ascending aorta.BAV patients have been excluded from some early large-scale TAVR studies.Based on the above research background,this study investigated the efficacy and eafety after TAVR in patients with BAV severe stenosis.ObjectiveThis study was to investigate the improvement of postoperative cardiac function,hemodynamic changes,ventricular remodeling,Kansas City Cardiomyopathy Questionnaire（KCCQ）,Minnesota Living with Heart Failure Quality of Life Scale（MLHFQ）and incidence of related adverse events.MethodsWe selected patients with severe aortic stenosis who underwent TAVR in Zhengzhou No.7 People’s Hospital and Henan chest hospital from January 2020 to June 2021.A total of 107 patients were divided into tricuspid aortic valve group（TAV group）and 48 patients were divided into bicuspid aortic valve group（BAV group）according to the aortic valve leaflets.The patients in the two groups were randomly treated with venus-A valve and Vita Flow valve.The clinical baseline data,1-month follow-up data and 6-month follow-up data were collected.Compared the differences between the two groups in the improvement of cardiac function,the incidence of perivalvular leakage（PVL）,hemodynamic changes,myocardial remodeling,KCCQ score,MLHFQ score and postoperative complications.Moreover,the safety and effrctiveness of in patients with BAV was analyzed.Results1.The baseline data of the BAV group and the TAV group is no statistical difference,such as in the gender,body mass index（BMI）,hypertension,diabetes,coronary heart disease,atrial fibrillation/atrial flutter,abnormal liver function,abnormal renal function,New York Hear Association（NYHA）classification,inner diameter of the mid-section of the ascending aorta,and type of implanted valve.The age of patients in the BAV group[（71.59±4.83）years vs（75.06±5.78）years]was lower than that in the TAV group（P<0.05）.The ascending aorta[（42.07±5.42）mm vs（38.81±6.65）mm]in the BAV group was larger than that in the TAV group,and the Society of Thoracic Surgeons（STS）in the BAV group[（7.28±4.12）vs（9.66±5.47）]was lower than that in the TAV group.The two comparisons showed that the difference was statistically significant（P<0.05）.2.In the BAV group,62.5%were implanted with the Vita Flow valve and 37.5%with the Venus A valve;In TAV group,56.1%were implanted with the Vita Flow valve and43.9%with the Venus A valve.There was no significant difference between the two groups（P>0.05）.3.The incidence rate of moderate and severe PVL in the BAV group at 1 month after operation（4.3%vs 1.9%）was higher than that in the TAV group（P<0.05）.No moderate PVL occurred in the two groups 6 months after operation.There were 10 cases of mild PVL in the BAV group,which was higher than that 8 cases in the TAV group,and the difference was statistically significant（P<0.05）.4.The proportion of NYHA I～II in BAV group and TAV group after operation was respectively（89.4%vs 86.9%,P=0.660）,and there was no significant difference in the improvement of cardiac function between BAV group and TAV group.5.Before operation,there is no significant difference such as in the AVA,aortic valve mean transvalvular gradient（m PG）,Left ventricular ejection fraction（LVEF）,Left ventricular end diastolic diameter（LVDd）,Relative wall thicknss（RWT）,Left ventricular mass index（LVMI）,Kansas City Cardiomyopathy Questionnaire（KCCQ）,and Minnesota Living with Heart Failure（MLHFQ）between BAV group and TAV group.But,the V_max[（5.03±0.61）m/s vs（4.73±0.45）m/s]in the BAV group was greater than that in the TAV group（P<0.05）.One month after the operation,the m PG and LVDd in the BAV group were larger than those in the TAV group,and there was no significant differences in other indexes.There was no significant difference in AVA,m PG,V_max,LVEF,LVDd,RWT,LVMI,KCCQ and MLHFQ between BAV group and TAV group at 6 months after operation（P>0.05）.6.The incidence of new-onset atrial fibrillation atrial flutter,coronary artery obstruction,stroke,acute kidney injury,acute myocardial infarction,and major vascular complications in the two groups were all lower than 10%after operation,and the follow-up was up to 6 months after operation.There was no significance difference between the two groups（P>0.05）.In terms of permanent pacemaker implanted,the permanent pacemaker implanted in BAV group was greater than that in the TAV group（8.1%vs 1.0%,P=0.014）.There were no significant differences in the composite endpoint between the two groups.ConclusionsTAVR is safety and effective in patients with severe bicuspid aortic valve stenosis,which can improve the quality of life of patients after operation.