Clinical Performance and Reproducibility of the LIRA Method for TAVR in Bicuspid Anatomy: The SUBLIME Study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) anatomy remains challenging, with heterogeneous outcomes and no standardized sizing strategy. The LIRA (level of implantation at the raphe) method is a bicuspid-dedicated approach that complements standard annular sizing with a single perimeter measurement at the raphe level. A previous single-center experience suggested favorable results.

OBJECTIVES: The aim of this study was to evaluate clinical performance and reproducibility of the LIRA method for TAVR sizing in a large BAV multicenter cohort.

METHODS: A total of 215 BAV patients undergoing TAVR with the LIRA method at 6 centers were retrospectively analyzed. Procedural and clinical outcomes were adjudicated according to Valve Academic Research Consortium 3 criteria and assessed at 30 days and 1 year. Available full-cycle computed tomographic data sets from external centers were reanalyzed in a blinded centralized core laboratory to assess reproducibility of the LIRA method.

RESULTS: The application of the LIRA method led to prosthesis downsizing in 74.4% of cases. At 30 days, device success was 93%, and moderate or greater paravalvular leak had occurred in 4.6% of patients, new permanent pacemaker implantation in 10.7%, and stroke in 1.9%. At 1 year, all-cause mortality was 5.7%, and clinical efficacy was observed in 92.8% of patients. Clinical outcomes were consistent across centers. Prosthesis sizing agreement was excellent (κ = 0.85; 95% CI: 0.74-0.96), and perimeter concordance was good (intraclass correlation coefficient = 0.76; 95% CI: 0.63-0.85).

CONCLUSIONS: In this large multicenter cohort, the LIRA method demonstrated good reproducibility across centers and was associated with favorable procedural and clinical outcomes in BAV patients undergoing TAVR. These findings support its clinical applicability as a bicuspid-dedicated sizing strategy.