Emerging Longer-Term Evidence on Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis in Low-Risk Patients: A Call for Caution.

Abstract

The expanding use of transcatheter aortic valve implantation (TAVI) in low-risk patients with severe aortic stenosis, including populations underrepresented in pivotal trials and often beyond established guideline recommendations, makes extended follow-up from TAVI versus surgical aortic valve replacement (SAVR) trials central to assessing valve durability and late adverse events and to informing lifetime management strategy. Although Evolut Low Risk 6- to 7-year follow-up showed no statistically significant difference in the primary composite of death or disabling stroke, the signals of later mortality accrual, more myocardial infarction events, and higher aortic valve reintervention rates with TAVI raise concerns about durability and stability of the early treatment effect. In PARTNER 3, 7-year outcomes appeared broadly similar when comparing the reported composite endpoints, but their interpretation is limited by heterogeneous endpoint construction, non-prespecified hierarchical analysis, incomplete follow-up, and the influence of post hoc vital-status ascertainment on late mortality estimates. In an intermediate-risk population, PARTNER 2A showed lower 10-year survival and higher aortic valve reintervention rates with TAVI than with SAVR. Together with the presented UK-TAVI, meta-analyses, and large observational studies, these findings underscore uncertainty about durability and reintervention burden of TAVI and future treatment strategies. By integrating extended follow-up from pivotal trials with other new data, this review calls for a more rigorous and transparent long-term evidence framework before further expanding TAVI, particularly in younger, low-risk patients. Treatment decisions should remain individualized within a structured Heart Team framework, with explicit discussion of expected survival, anatomical suitability, valve durability, reintervention options, and lifetime-management implications.