Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement

Abstract

Objectives: To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). Background: PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. Methods: PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). Results: The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95–0.99], P = 0.002), history of myocardial infarction (2.09 [1.00–4.34], P = 0.049), annulus maximum diameter (0.84 [0.77–0.92], P < 0.001), and THV oversizing (0.90 [0.87–0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23–8.53], P = 0.017 and 5.79[2.33–14.36], P < 0.001). Conclusions: The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing