Transcatheter Aortic Valve Replacement in Patients with Pure Native Aortic Regurgitation: Results from a Multicenter Registry Study

Abstract

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 (STS) risk score (odds ratio (OR) 0.760, 95% confidence interval (CI): 0.584–0.989; P = 0.041) and annulus perimeter (OR 0.888, 95% CI: 0.796–0.992; P = 0.035) were 2 predictors of device success. Moreover, annulus perimeter (<80.2 mm), but not STS risk score, was associated with a significant reduction in MACE at 6 months (hazard ratio (HR) 2.223, 95% CI: 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.