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

Curtiss T Stinis; Amr E Abbas; Paul Teirstein; Raj R Makkar; Christine J Chung; Vijay Iyer; Philippe Généreux; Robert M Kipperman; John K Harrison; G Chad Hughes; Jefferson M Lyons; Ayaz Rahman; Nikolaos Kakouros; Jennifer Walker; David K Roberts; Pei-Hsiu Huang; Biswajit Kar; Abhijeet Dhoble; Daniel P Logsdon; Puneet K Khanna; Joseph Aragon; James M McCabe

doi:10.1016/j.jcin.2024.02.015

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

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

Authors

Curtiss T Stinis¹, Amr E Abbas², Paul Teirstein³, Raj R Makkar⁴, Christine J Chung⁵, Vijay Iyer⁶, Philippe Généreux⁷, Robert M Kipperman⁸, John K Harrison⁹, G Chad Hughes⁹, Jefferson M Lyons¹⁰, Ayaz Rahman¹¹, Nikolaos Kakouros¹², Jennifer Walker¹³, David K Roberts¹⁴, Pei-Hsiu Huang¹⁴, Biswajit Kar¹⁵, Abhijeet Dhoble¹⁵, Daniel P Logsdon¹⁶, Puneet K Khanna¹⁶, Joseph Aragon¹⁷, James M McCabe¹⁸

Affiliations

¹ Division of Cardiology, Scripps Clinic, La Jolla, California, USA. Electronic address: STINIS.CURTISS@SCRIPPSHEALTH.ORG.
² Corewell Health East, William Beaumont University Hospital, Royal Oak, Michigan, USA.
³ Division of Cardiology, Scripps Clinic, La Jolla, California, USA.
⁴ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁵ University of Washington Medical Center, Department of Medicine, Division of Cardiology, Seattle, Washington, USA.
⁶ Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, New York, USA.
⁷ Gagnon Cardiovascular Institute at Morristown Medical Center, Morristown, New Jersey, USA.
⁸ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁹ Division of Cardiology, Department of Medicine, Duke University Hospital, Durham, North Carolina, USA.
¹⁰ OhioHealth Heart, Lung, and Vascular Surgeons, Columbus, Ohio, USA.
¹¹ Cardiology Associates of East Tennessee, Knoxville, Tennessee, USA.
¹² Division of Cardiology, University of Massachusetts School of Medicine, Worcester, MA, USA.
¹³ Department of Medicine, Division of Cardiology, University of North Carolina at Chapel Hill, North Carolina, USA.
¹⁴ Sutter Medical Center, Sacramento, California, USA.
¹⁵ Division of Cardiology, Department of Internal Medicine, University of Texas Health Science Center, Houston, Texas, USA.
¹⁶ Eisenhower Medical Center, Rancho Mirage, California, USA.
¹⁷ Santa Barbara Cottage Hospital, Santa Barbara, California, USA.
¹⁸ Division of Cardiology, University of Washington Medical Center, Seattle, Washington, USA.

PMID: 38456883
DOI: 10.1016/j.jcin.2024.02.015

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.

Publication types

Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aortic Valve Stenosis* / diagnostic imaging
Aortic Valve Stenosis* / physiopathology
Aortic Valve Stenosis* / surgery
Aortic Valve* / diagnostic imaging
Aortic Valve* / physiopathology
Aortic Valve* / surgery
Balloon Valvuloplasty* / adverse effects
Female
Heart Valve Prosthesis*
Hemodynamics
Humans
Male
Postoperative Complications / etiology
Prosthesis Design*
Recovery of Function*
Registries*
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement* / adverse effects
Transcatheter Aortic Valve Replacement* / instrumentation
Transcatheter Aortic Valve Replacement* / mortality
Treatment Outcome
United States