Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial).

Autor: Lim DS; Departments of Medicine & Pediatrics, University of Virginia, Charlottesville, Virginia. Electronic address: SL9PC@virginia.edu., Kim D; Pediatric Cardiology, Children's Healthcare of Atlanta, Atlanta, Georgia., Aboulhosn J; Department of Pediatrics, University of California, Los Angeles, California., Levi D; Department of Pediatrics, University of California, Los Angeles, California., Fleming G; Department of Pediatrics, Duke University Medical Center, Durham, North Carolina., Hainstock M; Departments of Medicine & Pediatrics, University of Virginia, Charlottesville, Virginia., Sommer R; Department of Pediatrics, Columbia University Medical Center, New York, New York., Torres AJ; Department of Pediatrics, Columbia University Medical Center, New York, New York., Zhao Y; Department of Biostatistics, Edwards Lifesciences, Irvine, California., Shirali G; Department of Pediatrics, Children's Mercy Hospital, Kansas City, Missouri., Babaliaros V; Department of Medicine, Emory University Hospital, Atlanta, Georgia.
Jazyk: angličtina
Zdroj: The American journal of cardiology [Am J Cardiol] 2023 Mar 01; Vol. 190, pp. 102-109. Date of Electronic Publication: 2023 Jan 04.
DOI: 10.1016/j.amjcard.2022.12.010
Abstrakt: Significant pulmonary regurgitation (PR) and pulmonary stenosis are common after surgical repair of some congenital heart defects. This prospective, single-arm, multicenter trial enrolled patients who underwent transcatheter heart valve (THV) implantation with a SAPIEN 3 valve to treat dysfunctional right ventricular outflow tract (RVOT) conduits or pulmonic surgical valves (≥ moderate PR and/or mean RVOT gradient ≥35 mm Hg). The primary end point was a nonhierarchical composite of THV dysfunction at 1 year comprising RVOT reintervention, ≥ moderate total PR, and mean RVOT gradient >40 mm Hg. A performance goal of <25% of upper confidence interval (CI) was prespecified for the primary end point, using a 95% exact binomial CI. Patients (n = 58) were enrolled between July 5, 2016 and July 17, 2018, with mean age of 32 years. Prestenting was performed in 53.4%. At discharge, the device success was 98.1% (single valve without explant, < moderate PR, gradient <35 mm Hg). At 30 days, there were no major adjudicated adverse clinical events. At 1 year, the primary end point composite was 4.3% (95% CI 0.5 to 14.5). The composite components were 0% (0 of 56) RVOT reintervention, 2.1% (1 of 47) ≥ moderate PR, and 2.1% (1 of 48) mean RVOT gradient >40 mm Hg. No mortality, endocarditis, thrombosis, or stent fracture were reported at 1 year. In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year. Clinical trial registration: NCT02744677; https://clinicaltrials.gov/ct2/show/NCT02744677.
(Copyright © 2022. Published by Elsevier Inc.)
Databáze: MEDLINE
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