5th Generation Balloon Expandable Valve in a Real World US Population: One-Year Outcomes

Transcatheter aortic valve replacement (TAVR) has consolidated as treatment for severe symptomatic aortic stenosis, even in low risk patients. In this context, valve hemodynamic state and durability are key factors when choosing the type of valve prosthesis. Recently, several studies have shown the short term hemodynamic benefits of the latest generation SAPIEN 3 Ultra RESILIA (S3UR). However, to this day there are no long term studies on this device. 

The aim of this study was to compare one year clinical and echocardiographic outcomes of TAVR with native S3UR vs its predecessors, valves SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U), using data from the Transcatheter Valve Therapy Registry (TVT) from the American Society of Thoracic Surgeons (STS) and the American School of Cardiology.

The primary outcome was mortality rate, stroke and the combination of both at one year. The secondary end point included echocardiographic and functional outcomes.  

The study included 4,598 patients treated with S3UR, propensity score matched with with 4,598 and 32,536 patients treated with S3 and S3U, respectively. A discharge, S3UR patients showed larger effective orifice areas (p < 0,0001). This groups also presented the lowest mean gradient, both by the end of procedure, at 30 days and one year (p < 0,0001 in all cases).

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After one year, S3UR patients showed lower all-cause mortality (7,6 % vs. 9,7 %; HR: 0,8; CI 95 %: 0,67–0,93; p = 0,004), lower incidence of mild or grater paravalvular leak (15,6 % vs. 18,5 %; HR: 0,82; CI 95 %: 0,69–0,97; p = 0,02) and lower rate of life threatening bleeding (2,0 % vs. 2,7 %; HR: 0,7; CI 95 %: 0,54–0,94; p = 0,03). Both the use of S3UR and the presence of mild or grater paravalvular leak were independent predictors of one-year mortality in the general cohort and low risk patients. The need for valve reintervention at one year was rare (0,6 % vs. 0,4 %; HR: 1,46; CI 95 %: 0,77–2,78; p = 0,25).

Conclusion 

TAVR with S3UR was associated to better clinical and echocardiographic outcomes at one year vs. S3 and S3U, especially in low risk patients. There were lower rates of paravalvular leak, larger effective orifice area, lower echocardiographic gradients and low need for reintervention. However, longer followup is required to assess durability of RESILIA in the SAPIEN valve platform. 

Original Title: 1-YearReal-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States.

Reference: Annapoorna S. Kini, MD et al JACC Cardiovasc Interv. 2025; 18: 785–797.