Expanding Transcatheter Aortic Valve Replacement Use in Younger Patients and Bicuspid Valves: Risks, Evidence Gaps, and Regulatory Action.

Abstract

This expert review examines the expanding use of transcatheter aortic valve replacement (TAVR) in younger patients with bicuspid aortic valves (BAV), highlighting midterm outcomes, including elevated mortality, stroke, and pacemaker dependency, compared with surgical aortic valve replacement. The untested and unproven long-term effectiveness and durability of TAVR in patients aged <70 years and the growing use of "valve-in-valve" for surgical aortic valve replacement bioprosthetic degeneration and TAVR failure are also highlighted. Summarizing recent observational studies, registry data, and the limited randomized evidence available, the author calls for new rigorous, long-term randomized controlled trials before broader adoption of TAVR and valve-in-valve TAVR in these populations, and urges the United States Food and Drug Administration and Centers for Medicare and Medicaid Services to align policy with evidence challenging the erosion of guideline-directed care driven by market forces.