Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States.

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited 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) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

Evaluation of the OpSens OptoWire III and Novel TAVR Algorithm to Measure Pressure Gradient During TAVR.

Background: We aim to establish the degree of agreement related to gradient measurement during transcatheter aortic valve replacement (TAVR) between the OpSens OptoWire III and its new proprietary TAVR algorithm and hemodynamic value derived by catheterization and echocardiogram (transthoracic echocardiogram and transesophageal echocardiogram). Methods: The current study was a prospective, single-arm, single-center study. All subjects underwent hemodynamic assessment before and after TAVR using standard hemodynamic assessment using 2 pigtails, transthoracic echocardiogram, transesophageal echocardiogram, and the OpSens OptoWire III. The primary end point was the final post-TAVR mean gradient correlation between OpSens OptoWire III and hemodynamic values derived by catheterization. Results: Between July 2021 and September 2021, 20 patients were enrolled. The median age was 79 [6.5] years, and 9 (45%) patients were female. The mean gradient before TAVR derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (35 ± 14 mm Hg vs 35 ± 14 mm Hg, P = 1.00), with an absolute mean difference of 2.2 ± 3.5 mm Hg and a strong correlation (r = 0.96, P < .0001). After TAVR, the mean gradient derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (2.2 ± 3.5 vs 2.8 ± 2.7, P = .16), with an absolute mean difference of 1.2 ± 1.3 mm Hg and a strong correlation (r = 0.89, P < .0001). Conclusions: Hemodynamic assessment derived by the OpSens OptoWire III wire and its new TAVR algorithm demonstrated excellent correlation with measurements derived by 2 pigtails both before and after TAVR. Integration of this new technology within a dedicated TAVR wire with live hemodynamic assessment could bring meaningful value to TAVR operators.