Key result
The Harmony transcatheter pulmonary valve demonstrated stable position and good function at 3 years among 20 patients, with 0 deaths, 2 early explants, and 2 requiring valve-in-valve treatment.
Why the study?
The Harmony transcatheter pulmonary valve was designed to treat postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts.
Does the Harmony transcatheter pulmonary valve provide stable valve function and safety at 3 years in patients with postoperative pulmonary valve regurgitation and repaired right ventricular outflow tracts?
Population
20 patients with postoperative pulmonary valve regurgitation and repaired right ventricular outflow tracts
Comparison
Harmony transcatheter pulmonary valve implantation
Design
Prospective, multicenter, nonrandomized feasibility study
Follow-up
3 years (maximum: 4.1 years)
Authors
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Supports Harmony TPV evaluation in repaired RVOT; leaves open durability and reintervention rates in larger cohorts.
Does the Harmony transcatheter pulmonary valve provide stable valve function and safety at 3 years in patients with postoperative pulmonary valve regurgitation and repaired right ventricular outflow tracts?
The Harmony transcatheter pulmonary valve shows good 3-year function and stability in patients with repaired right ventricular outflow tracts, though neointimal proliferation may require reintervention in some.
Lee Benson (2020) studied postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts (n=20). Harmony transcatheter pulmonary valve (TPV) was evaluated on 3-year outcomes including echocardiographic gradient, paravalvular leak, and device integrity. The Harmony transcatheter pulmonary valve demonstrated stable position and good function at 3 years among 20 patients, with 0 deaths, 2 early explants, and 2 requiring valve-in-valve treatment.
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