Bioprosthetic valve failure after transcatheter aortic valve replacement

Background A comprehensive understanding of the incidence, mechanisms, and clinical consequences of bioprosthetic valve dysfunction after transcatheter aortic valve replacement (TAVR) is increasingly needed given the expansion of indications toward younger and lower-risk patients with longer life expectancy. The Valve Academic Research Consortium-3 (VARC-3) has introduced the concept of bioprosthetic valve failure (BVF) as a patient-oriented clinical endpoint that integrates the downstream consequences of bioprosthetic valve dysfunction, irrespective of its underlying mechanism. However, data on the long-term incidence and clinical impact of BVF after TAVR remain limited. Purpose To assess the incidence, predictors, and clinical impact of BVF following TAVR. Methods We analyzed the data of an international, multicenter registry including patients undergoing TAVR at 13 centers. The primary outcome was BVF according to VARC-3 criteria. The cumulative incidence of BVF was estimated using a competing risk approach. The association between BVF and clinical outcomes was assessed using multivariable Cox models with BVF as a time-dependent covariate. Results Among 7,501 patients, BVF occurred in 380 patients (5.1%) over a median follow-up of 4 (IQR 2-5) years. The cumulative incidence of BVF increased over time, reaching 1.4% at 1 year, 4.5% at 5 years, and 8.0% at 10 years. Independent predictors of BVF included younger age, balloon-expandable valve, prosthesis size <26 mm, valve-in-valve procedure, mean gradient at discharge ≥15 mmHg, moderate or severe AR at discharge, and early hemodynamic valve deterioration (Table 1). BVF was independently associated with an increased risk of all-cause mortality (adjusted hazard ratio (aHR) 1.72 [95% CI, 1.48-2.01], p<0.001), cardiovascular mortality (aHR 2.68 [95% CI, 2.15-3.34], p<0.001), stroke (aHR 1.88 [95% CI, 1.12-3.14], p=0.016) and heart failure hospitalization (aHR 1.74 [95% CI, 1.20-2.51], p=0.003) (Figure 1). Consistent findings were observed in different sensitivity analyses. Conclusions In this study, the 10-year cumulative incidence of BVF following TAVR was 8.0%. BVF was associated with adverse clinical outcomes during follow-up, including increased risks of death, stroke and heart failure hospitalization. These findings underscore that BVF is not merely a structural or hemodynamic endpoint, but a clinically meaningful event with important implications for patient prognosis. These results support the implementation of tailored surveillance and preventive strategies to mitigate BVF-related risk.