One-Year Outcomes of “off-label” Transcatheter Devices in Native Aortic Regurgitations

Background In mainland China, there is a lack of “on-label” transfemoral aortic valves for aortic regurgitation (AR). Consequently, this study sought to assess the safety and feasibility of “off-label” TAVR devices in AR patients. Methods This was a retrospective study utilizing our institutional TAVR database between January 2020 and June 2024. The study compared outcomes of “off-label” TAVR devices in patients with isolated aortic stenosis (AS) vs patients with pure native AR (moderate or greater). The outcome measure was 1-year all-cause mortality, the incidence of major adverse events (MAEs) and the New York Heart Association (NYHA) functional improvement. Results Total 445 consecutive patients received transfemoral TAVR treatment for aortic valve disease at our department, of which 177 were excluded due to concomitant severe comorbidities and other special situations. No inter-group statistical differences were found in basic patient characteristics. The 1-year all-cause mortality rate, cardiovascular mortality, new permanent pacemaker implantation, valve-related reintervention, PVL (moderate or greater) was higher in the AR group than in the AS group,but there were no significant differences among these parameters. And the incidence of composite MAE (7.02% AS vs 5.89% AR) and the NHNA classifications ≤ II (84.11% AS vs 84.15% AR) were similar. LVEF, LV, IVST and LVPWT improved in both groups, except that the former two improved more significantly in AR group and the latter two improved more significantly in AS group, which may be attributed to both pathophysiologic features. Conclusions This single-center study demonstrated the short-term safety and feasibility of the “off-label” TAVR device in patients with AR. In addition, it showed different degrees of improvement in LV structural and functional parameters in the two groups, which may be attributed to both pathophysiologic features.