Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement.

Abstract

Background: Data on the long-term incidence and clinical impact of bioprosthetic valve failure (BVF) after transcatheter aortic valve replacement remain limited. This study aimed to assess the incidence, predictors, and clinical impact of BVF following transcatheter aortic valve replacement.

Methods: We analyzed data from an international, multicenter registry including consecutive patients undergoing transcatheter aortic valve replacement at 13 centers. The primary outcome was BVF according to Valve Academic Research Consortium-3 criteria. The cumulative incidence of BVF was estimated using a competing-risk approach. The association between BVF and clinical outcomes was assessed using competing-risk models with BVF as a time-dependent covariate.

Results: Among 7501 patients, BVF occurred in 380 (5.1%) patients over a median follow-up of 4 (interquartile range, 2-5) years. The cumulative incidence of BVF increased over time, reaching 1.4% at 1 year, 4.6% at 5 years, and 8.3% at 10 years. Independent predictors of BVF included younger age, smoking, balloon-expandable valve, prosthesis size <26 mm, valve-in-valve procedure, mean gradient at discharge ≥15 mm Hg, moderate or severe aortic regurgitation at discharge, and early hemodynamic valve deterioration. BVF was independently associated with an increased risk of all-cause mortality (adjusted hazard ratio, 1.72 [95% CI, 1.47-2.01]; P<0.001), cardiovascular mortality (adjusted hazard ratio, 3.23 [95% CI, 2.73-3.82]; P<0.001), stroke (adjusted hazard ratio, 2.08 [95% CI, 1.08-4.23]; P=0.043), and heart failure hospitalization (adjusted hazard ratio, 1.43 [95% CI, 1.03-1.98]; P=0.032). Consistent findings were observed in different sensitivity analyses.

Conclusions: BVF is a clinically relevant event associated with adverse long-term outcomes. These findings support the implementation of tailored surveillance and preventive strategies to mitigate BVF-related risk.