Abstract
Background
This article compares the real-world performance and safety of the three transcatheter aortic valve implantation (TAVI) platforms: Myval, Sapien, and Evolut in patients with severe symptomatic aortic stenosis and low to moderate surgical risk.
Patients and methods
Between September 2019 and September 2023, 1053 TAVI procedures were performed in the University Medical Centre Ljubljana, Slovenia. We used propensity-score match analysis to compare the Myval, Sapien, and Evolut platforms. 180 patients were enrolled in the propensity-score matching study, 60 for each platform. The study endpoints included haemodynamic outcomes compared to baseline, in-hospital clinical safety outcomes, and all-cause mortality at 30 days and one year.
Results
Changes in peak aortic valve velocity, mean aortic gradient, effective orifice area, and left ventricular ejection fraction were comparable between the platforms. After propensity score matching (tri-match), the rates of stroke (3.4% vs. 3.4% vs. 0.0%, p = 0.548), life-threatening bleeding (1.7% vs. 1.7% vs. 1.7 %), periprocedural myocardial infarction (3.3% vs. 0.0% vs. 0.0%, p = 0.330), postprocedural permanent pacemaker implantation rate (11.9% vs. 10.2% vs. 15.0%, p = 0.719), all-cause mortality at 30 days (3.3% vs. 5.0% vs. 3.3%; p = 1.000) and at 1 year (8.3% vs. 8.3% vs. 10.0%, p = 0.934) were comparable between the Myval, Sapien, and Evolut series, respectively. 2 cases of moderate paravalvular regurgitation were reported, one in Myval, and one in Sapien series.
Conclusions
The tri-match analysis of the real-world aortic stenosis patients with low to moderate surgical risk treated with the Myval, Sapien, and Evolut series showed comparable performance, safety, efficacy, and survival.