Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial).
Document Type
Article
Publication Date
3-1-2023
Identifier
DOI: 10.1016/j.amjcard.2022.12.010
Abstract
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 of40 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.
Journal Title
The American journal of cardiology
Volume
190
First Page
102
Last Page
109
MeSH Keywords
Humans; Adult; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Prospective Studies; Empathy; Cardiac Catheterization; Treatment Outcome; Prosthesis Design; Time Factors; Pulmonary Valve; Pulmonary Valve Insufficiency
Keywords
Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Prospective Studies; Empathy; Cardiac Catheterization; Treatment Outcome; Prosthesis Design; Time Factors; Pulmonary Valve; Pulmonary Valve Insufficiency
Recommended Citation
Lim DS, Kim D, Aboulhosn J, et al. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023;190:102-109. doi:10.1016/j.amjcard.2022.12.010
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