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Comparative Study
. 2024 Apr 22;17(8):1032-1044.
doi: 10.1016/j.jcin.2024.02.015. Epub 2024 Mar 8.

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

Curtiss T Stinis  1 , Amr E Abbas  2 , Paul Teirstein  3 , Raj R Makkar  4 , Christine J Chung  5 , Vijay Iyer  6 , Philippe Généreux  7 , Robert M Kipperman  8 , John K Harrison  9 , G Chad Hughes  9 , Jefferson M Lyons  10 , Ayaz Rahman  11 , Nikolaos Kakouros  12 , Jennifer Walker  13 , David K Roberts  14 , Pei-Hsiu Huang  14 , Biswajit Kar  15 , Abhijeet Dhoble  15 , Daniel P Logsdon  16 , Puneet K Khanna  16 , Joseph Aragon  17 , James M McCabe  18
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Free article
Comparative Study

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

Curtiss T Stinis et al. JACC Cardiovasc Interv. .
Free article

Abstract

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.

Keywords: bioprostheses; heart valve prosthesis; propensity score; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Stinis has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Shockwave Medical; and serves on an advisory board for Boston Scientific. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Teirstein has received research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic; and serves on advisory boards for Boston Scientific and Medtronic. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St. Jude Medical; and has received consultant fees/honoraria and served on the Speakers Bureaus of Abbott Vascular, Cordis Corporation, and Medtronic. Dr Généreux has been a consultant for Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, CARANX, Cardiovascular Systems Inc (for the PI Eclipse Trial), Edwards Lifesciences, GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Siemens, Soundbite Medical Inc, Teleflex, and 4C Medical (for the PI Feasibility study). Dr Huang has received speaker honoraria from Abbott Vascular; and has received consulting fees from Edwards Lifesciences. Dr Aragon received has consultant fees from Edwards Lifesciences. Dr McCabe has received fees from Edwards Lifesciences, Boston Scientific, and Teleflex outside the submitted work. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), or the STS/ACC TVT Registry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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