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

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.