Evaluation of the Venus P-valve for transcatheter pulmonary valve replacement in patients with right ventricular outflow tract dysfunction.

Right-ventricular outflow tract dysfunction is a common late sequela of congenital heart disease, particularly after tetralogy of Fallot repair. Balloon-expandable valves such as Melody and Sapien have transformed care for conduits and bioprostheses, but until recently most patients with large or irregular outflow tracts were not candidates for percutaneous therapy. This review appraises the Venus P-Valve, the first self-expanding transcatheter pulmonary valve for large right-ventricular outflow tracts, summarizing evidence on efficacy, safety, and regulatory status. We performed a narrative review of feasibility studies, multicenter registries, national databases, and comparative analyses reporting outcomes with this device. More than 600 implantations have been reported worldwide. Procedural success consistently exceeds 95%, with immediate restoration of pulmonary valve competence, low residual gradients, and right-ventricular reverse remodeling within 6-12 months. Follow-up to five years demonstrates durable performance and a low need for reintervention. Comparative studies suggest hemodynamic outcomes similar to surgical pulmonary valve replacement, with shorter hospitalization and lower morbidity in appropriately selected patients; pediatric series confirm feasibility with sustained benefit. Reported adverse events have been infrequent. The Venus P-Valve expands transcatheter options for large native or patched outflow tracts and currently holds CE marking in Europe and NMPA approval in China.