Why is the study important?

Previous studies leveraging data from the Transcatheter Valve Therapy (TVT) registry suggest that there are no differences in 1-year mortality between patients who undergo transcatheter aortic valve replacement (TAVR) using a 20mm balloon-expandable transcatheter heart valve (THV) compared to those who receive larger  THVs (23mm, 26mm or 29mm). It remains unclear if these findings hold true with longer follow-up and whether or not the latest SAPIEN 3 Ultra RESILIA THV offers additional clinical benefit in these patients. 

Should I change my practice because of these findings?

The study’s retrospective methodology of the TVT registry limits its broader clinical application.

What question was the study supposed to answer?

How well does the 20mm perform compared to larger-sized THVs (23mm, 26mm, or 29mm) with regards to all-cause mortality and hemodynamic performance at three years? What differences exist when comparing the SAPIEN 3/SAPIEN 3 Ultra to the SAPIEN 3 Ultra RESILIA THV? 

What did the study show?

This retrospective propensity score-matched analysis of the TVT registry leveraged data from 16,200 patients undergoing TAVR using a balloon-expandable THV between 2015 and 2023. Those receiving a 20mm balloon-expandable valve were more likely to be female (96.5% vs. 60.0%; p<0.0001) and have a higher Society of Thoracic Surgeons (STS) score (6.2% vs. 4.7%; p<0.0001) compared to those receiving larger THVs. After propensity-score matching, those receiving a 20mm THV saw higher gradients (16.2mmHg vs. 11.8mmHg; p<0.0001) and higher rates of at least moderate paravalvular leak (PVL) (1.7% vs. 0.5%; p<0.0001). Rates of PVL dramatically decreased over the study period, and when examining patients who underwent TAVR in 2023 alone (of which 26.2 received a SAPIEN 3 Ultra RESILIA THV), there were no differences in moderate or greater PVL (0.75% vs. 0.46%; p=1.0). There were no differences in death (31.5% vs. 32.5%; p=0.46), stroke (7.9% vs. 8.6%; p=0.65) or the composite, of the two (35.1% vs. 35.5%; p=0.64) when comparing those receiving a 20mm THV vs. those receiving a larger THV. A subset of these patients, between 2021 and 2023, were analyzed in an additional propensity score-matched study, published simultaneously in JACC: Cardiovascular Interventions, specifically examining the performance of the SAPIEN 3 Ultra RESILIA compared to the earlier-generation SAPIEN 3 and SAPIEN 3 Ultra THVs. This sub-analysis demonstrated that at discharge, those receiving a SAPIEN 3 Ultra RESILIA THV saw lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve areas (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001). 

How good was the approach/methodology?

This was a retrospective propensity-matched analysis of data from the TVT registry, which inherently carries several limitations, including selection bias, but is thought-provoking. Prospective and ideally randomized data will be needed to validate these early retrospective findings.