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

Autor:	Stinis CT; Division of Cardiology, Scripps Clinic, La Jolla, California, USA. Electronic address: STINIS.CURTISS@SCRIPPSHEALTH.ORG., Abbas AE; Corewell Health East, William Beaumont University Hospital, Royal Oak, Michigan, USA., Teirstein P; Division of Cardiology, Scripps Clinic, La Jolla, California, USA., Makkar RR; Cedars-Sinai Medical Center, Los Angeles, California, USA., Chung CJ; University of Washington Medical Center, Department of Medicine, Division of Cardiology, Seattle, Washington, USA., Iyer V; Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, New York, USA., Généreux P; Gagnon Cardiovascular Institute at Morristown Medical Center, Morristown, New Jersey, USA., Kipperman RM; Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA., Harrison JK; Division of Cardiology, Department of Medicine, Duke University Hospital, Durham, North Carolina, USA., Hughes GC; Division of Cardiology, Department of Medicine, Duke University Hospital, Durham, North Carolina, USA., Lyons JM; OhioHealth Heart, Lung, and Vascular Surgeons, Columbus, Ohio, USA., Rahman A; Cardiology Associates of East Tennessee, Knoxville, Tennessee, USA., Kakouros N; Division of Cardiology, University of Massachusetts School of Medicine, Worcester, MA, USA., Walker J; Department of Medicine, Division of Cardiology, University of North Carolina at Chapel Hill, North Carolina, USA., Roberts DK; Sutter Medical Center, Sacramento, California, USA., Huang PH; Sutter Medical Center, Sacramento, California, USA., Kar B; Division of Cardiology, Department of Internal Medicine, University of Texas Health Science Center, Houston, Texas, USA., Dhoble A; Division of Cardiology, Department of Internal Medicine, University of Texas Health Science Center, Houston, Texas, USA., Logsdon DP; Eisenhower Medical Center, Rancho Mirage, California, USA., Khanna PK; Eisenhower Medical Center, Rancho Mirage, California, USA., Aragon J; Santa Barbara Cottage Hospital, Santa Barbara, California, USA., McCabe JM; Division of Cardiology, University of Washington Medical Center, Seattle, Washington, USA.
Jazyk:	angličtina
Zdroj:	JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2024 Apr 22; Vol. 17 (8), pp. 1032-1044. Date of Electronic Publication: 2024 Mar 08.
DOI:	10.1016/j.jcin.2024.02.015
Abstrakt:	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 cm 2 vs 1.9 ± 0.6 cm 2 ; 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. Competing Interests: 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. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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