Stent and leaflet stresses across generations of balloon-expandable transcatheter aortic valves.

OBJECTIVES

Transcatheter aortic valve replacement (TAVR) is established therapy for severe aortic stenosis patients with intermediate-, high- and prohibitive-risk for surgery. A significant challenge when expanding TAVR to low-risk and younger patients is the unknown long-term durability. High leaflet stresses have been associated with surgical bioprosthetic valve degeneration. In this study, we examined the impact of changes in valve design across 3 generations of same-sized TAVR devices on stent and leaflet stresses.

METHODS

The 26-mm Edwards SAPIEN, 23, 26 and 29 mm SAPIEN XT (XT) and 26 mm SAPIEN 3 (S3) (n = 1 each) underwent micro-computed tomography (micro-CT) scanning. Dynamic finite element computational simulations of 23-26 mm SAPIEN, 23-29 mm XT and 23-29 mm S3 were performed with physiological loading and micro-CT or scaled geometries.

RESULTS

Peak stresses were concentrated in the commissure area and along the bottom of the suture, representing areas most likely to develop structural valve degeneration across TAVR generations. Latest-generation S3 showed greatest 99th percentile principal stress on commissural leaflets for 26 and 29 mm, and increased stresses over XT for 23 mm. Percentage of higher stress areas within the leaflets steadily increased across generations, 3.8%, 3.9% and 5.7%, respectively, for 26 mm SAPIEN, XT and S3 with similar trend for 29-mm valves.

CONCLUSIONS

Using computational simulations based on high-fidelity modelling of balloon-expandable TAVRs, our study demonstrated that maximum stress areas existed in similar leaflet locations across SAPIEN generations, while the latest model S3 had the highest magnitude for both 26- and 29-mm valves. S3 also had the largest area of higher stresses than other generations, which would be prone to degeneration. Our study coupled with future long-term clinical outcomes >10 years will provide insight on biomechanics of TAVR degeneration.