1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States

Background: Longer term outcomes of transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA (S3UR) valve over its predecessors have not been reported in a national registry. Objectives: The aim of this study was to compare the 1-year clinical and echocardiographic outcomes of the S3UR with those of the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Methods: From September 2022 to March 2023, patients who underwent native TAVR with the S3UR or the S3 or S3U valve were propensity matched and compared. Predictors of 1-year outcomes were identified. The median follow-up time was 358 days (Q1-Q3: 47-365 days) for the S3UR and 364 days (Q1-Q3: 80-365 days) for the S3 and S3U. Results: A total of 4,598 S3UR patients were propensity matched with 4,598 and 32,536 S3 and S3U patients. At discharge, effective orifice areas were larger in the S3UR group (P < 0.0001). The lower discharge mean gradient in the S3UR group was maintained at 30 days and 1 year (P < 0.0001 for all). At 1 year, all-cause mortality (7.6% vs 9.7%; HR: 0.8; 95% CI: 0.67-0.93; P = 0.004), mild or greater paravalvular leak (PVL) (15.6% vs 18.5%; HR: 0.82; 95% CI: 0.69-0.97; P = 0.02), and life-threatening bleeding (2.0% vs 2.7%; HR: 0.7; 95% CI: 0.54-0.94; P = 0.03) were lower in the S3UR group. S3UR and mild or greater PVL were predictive of 1-year mortality in the overall cohort and in low-risk patients. Valve reintervention remained rare at 1 year (0.6% vs 0.4%; HR: 1.46; 95% CI: 0.77-2.78; P = 0.25). Conclusions: TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention. Longer follow-up will determine the durability of the RESILIA technology in the SAPIEN valve platform.