摘要
Objective:Patients with untreated severe aortic regurgitation(AR)have a high risk of mortality.Transfemoral transcatheter aortic valve replacement(TF-TAVR)is a treatment option for AR;however,the safety and efficacy of this technique have not been sufficiently established.This study aimed to evaluate the clinical and anatomical variables correlating with device success of TF-TAVR using a self-expanding valve system for pure AR.Methods:Patients with pure native severe AR who underwent TF-TAVR using a self-expanding valve system were registered at 5 Chinese centers.The primary endpoint was device success at 1 month after TAVR.The secondary endpoint was the composite of major adverse cardiovascular events(MACE)at 6 months,including all-cause death,ischemic stroke,emergency conversion to cardiac surgery,and permanent pacemaker implantation.Echocardiography was used to analyze the left ventricular function before the TAVR procedure and during follow-up.Multivariable logistic regression and Cox regression analyses were performed to find relevant independent risk factors.Results:Between September 2019 and February 2022,79 patients with AR were enrolled in the study.At 1 month,device success was achieved in 60(75.9%)patients.By 6 months,29(36.7%)patients had MACE.Echocardiography revealed improved left ventricular function after TAVR.Multivariate regression analysis demonstrated that the Society of Thoracic Surgeons risk score(odds ratio 0.760,95%confidence interval(Cl):0.584-0.989;P=0.041)and annulus perimeter(odds ratio 0.888,95%Cl:0.796-0.992;P=0.035)were 2 predictors of device success.Moreover,annulus perimeter(<80.2mm),but not Society of Thoracic Surgeons risk score,was associated with a significant reduction in MACE at 6 months(hazard ratio 2.223,95%Cl:1.060-4.659;P=0.028).Conclusions:TF-TAVR using a self-expanding valve system appears to be a safe and feasible treatment for patients with pure native severe AR,particularly those with a less enlarged annulus.
基金
supported by the National Natural Science Foundation of China(81970307,82100357,and 82270344)
jointly supported by Six Talent Peaks Project of Jiangsu Province(2019-WSN-156)
Jiangsu Health Committee(H2019077)
Nanjing Health Committee(JQX22007)
National Key R&D Program of China(2020YFC2008100).