The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) transcatheter heart valve (THV), used in TAVR procedures, is associated with lower mean gradients and lower rates of paravalvular leak (PVL) when compared to outcomes from the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, according to a study presented at CRT 2024 and simultaneously published in JACC: Cardiovascular Interventions.

Curtiss T. Stinis, MD, FACC, et al., used STS/ACC TVT Registry data from Jan. 1, 2021 to June 30, 2023, to compare procedural, in-hospital and 30-day outcomes of the S3UR valve vs. the earlier S3U and S3 models. They included 10,314 S3UR patients who were then propensity matched with 10,314 patients selected from a pool of 150,539 S3U or S3 patients captured by the registry.

Results showed no statistically significant differences in death, stroke or bleeding between the groups at 30-days post procedure; however, there was a higher hospital readmission rate among S3UR patients (8.5% vs. 7.7%; p=0.04).

When investigating S3UR patients at discharge, researchers found significantly lower mean gradients (9.2 ± 4.6 mm Hg vs. 12.0 ± 5.7 mm Hg; p<0.0001) and larger aortic valve area (2.1 ± 0.7 cm­² vs. 1.9 ± 0.6 cm²; p<0.0001) when compared to the patients who received the S3U or S3 valve. They also noted a significant reduction in mild PVL with the S3UR 29-mm valve size (5.3% vs. 9.4%; p<0.0001).

“The present study demonstrates a significant reduction in PVL for the 29-mm S3UR valve size in comparison to the previous generation 29-mm S3 valve, which is undoubtably due to the incorporation of the Ultra sealing skirt design,” state the authors. “Importantly, this reduction in PVL was accomplished without any obvious tradeoffs with respect to hemodynamic performance, permanent pacemaker rates, or other procedural complications in this real-world population.”