Transcatheter Aortic Valve Replacement Use in Young Patients Before and After Low-Risk Indication Approval

Transcatheter aortic valve replacement (TAVR) use in young patients has recently increased following FDA approval for use in low-risk patients. How TAVR use among young patients may have accelerated in the interval between the FDA approval and the guideline publication remain unknown. We sought to characterize the national trends in aortic valve replacement (AVR) among young patients before and after the low-risk indication approval. Using the National Inpatient Sample data, we conducted a cross-sectional study of patients younger than 65 years of age who underwent TAVR, SAVR, or Ross operations between January 1, 2016, and February 29, 2020. We compared in-hospital mortality before and after the low-risk indication approval to infer whether the expansion occurred among lower-risk strata within the TAVR group in relation to SAVR. We identified 106,340 AVRs, including 13,095 TAVR (12.3%), 63,620 bioprosthetic SAVR (59.8%), 28,370 mechanical SAVR (26.7%), and 1,255 Ross (1.2%). The mean age was 54 (10.9), including 32,775 (30.8%) women. Before and after the low-risk approval, the TAVR share increased at 0.25 (0.03%) and 0.60 (0.09%) per month, respectively (interaction term p-value <0.001). Expansion of TAVR use among young patients around the time of FDA approval in low surgical risk patients serves as a case study to highlight the potential importance of specifying the indicated age group in future FDA approvals of transcatheter valve intervention devices.