Balloon-Expandable Valve Performance Beyond 10 Years After Transcatheter Aortic Valve Implantation

Data on very long-term bioprosthesis durability after transcatheter aortic valve implantation (TAVI) are lacking. We sought to assess bioprosthetic valve durability beyond 10 years after TAVI with balloon-expandable valves.

This was a prospective single-centre registry that included the data of 431 consecutive patients who underwent TAVI with first-, second-, and third-generation balloon-expandable valves between 2007 and 2015 who were alive at 1 year post TAVI. The primary outcome was the valve-related long-term clinical efficacy according to Valve Academic Research Consortium 3 (VARC-3) consensus. Death was treated as a competing risk.

The median follow-up was 5 years (interquartile range, 3-8 years) for the overall population, and 10 years (interquartile range, 8-12 years) for the survived patients, with the longest follow-up reaching 15 years. The overall 10-year mortality rate was 87%. At 10 years, the cumulative incidence of the composite end point of valve-related long-term clinical efficacy (bioprosthetic valve failure, stroke and bleeding secondary to antithrombotics used for valve-related concerns) was 29%. Conversely, 71% remained free from the composite outcome after accounting for death as a competing risk. The cumulative incidence of moderate or severe hemodynamic valve deterioration (HVD) was 17%. The independent factors associated with moderate or severe HVD were age (subdistribution hazard ratio [sHR], 0.96 for each increase of 1 year; 95% confidence interval [CI], 0.94-0.99; P = 0.009), severe patient-prosthesis mismatch (sHR, 5.26; 95% CI, 1.44-19.2; P = 0.012), and the absence of anticoagulant therapy at discharge (sHR, 1.96; 95% CI, 1.12-3.45; P = 0.018). Bioprosthetic valve failure occurred in 9.1% of the population, and aortic valve reintervention in 4.4%. Echocardiographic parameters of bioprosthesis hemodynamic performance showed a slight progressive deterioration over time, with an increase in mean transaortic gradient (+0.54 mm Hg per year; 95% CI, 0.44-0.65) and a corresponding decrease in effective orifice area (-0.016 cm² per year; 95% CI, -0.023 to -0.009).

These findings provide reassuring evidence to support the very long-term durability of balloon-expandable valves after TAVI, although some signs of HVD were observed in approximately one-fifth of patients. The protective effects of anticoagulation therapy on valve durability need further evaluation.