Evidence of bioprosthetic valve dysfunction during three-year follow-up following TAVR.

Objective: Transcatheter aortic valve replacement (TAVR) has increased significantly in younger patients and patients at lower surgical risk. In this retrospective multicenter study, we aimed to assess for bioprosthetic valve dysfunction (BVD) during three-year follow-up (FU) and potential differences between self-expandable (SEV) and balloon-expandable valves (BEV) under real-world conditions.

Methods: Endpoints were defined according to VARC-3 criteria, including VARC composite endpoints during three-year FU.

Results: A total of 1233 patients with tricuspid aortic valve stenosis, who underwent TAVR with contemporary transcatheter heart valve (THV) devices from three different tertiary care centers were included. One-fifth of the study population showed BVD at three-year FU (BVD[-]: n = 957;77.6%; BVD[+]: n = 276;22.4%). Non-structural valve deterioration (NSVD) was the most represented category (8.5%) followed by structural valve deterioration (SVD, 5.3%). BVD was more common in association with BEV as compared with SEV (60.9% vs 39.1%; p < 0.001) owing to higher rates of SVD (13.5% vs 9.5%; p = 0.028) and NSVD (17.9% vs. 13.8%; p = 0.048). Subclinical leaflet thrombosis was only documented in BEV (1.7%, p < 0.001). At three years, all-cause mortality was higher in BVD+ patients (BVD[-] vs. BVD[+]: 13.2% vs. 22.5%; HR: 1.99; 95%-CI: 1.39-2.85; p < 0.001*) but did not differ between THV platform.

Conclusion: BVD after TAVR is common and associated with higher all-cause mortality. Despite a preponderance of BVD in association with balloon-expandable valves, mortality rates remain similar between THV platforms.

Clinical Trial Registration: NCT01805739.