Key result
Venus P-Valve achieves ~98% procedural success in patients with irregular right ventricular outflow tracts.
Why the study?
Most patients with large or irregular right-ventricular outflow tracts were historically not candidates for balloon-expandable percutaneous valves, prompting evaluation of the self-expanding Venus P-Valve.
Does the Venus P-Valve provide a safe and effective transcatheter pulmonary valve replacement option for patients with large or irregular right ventricular outflow tracts?
Does the Venus P-Valve provide a safe and effective transcatheter pulmonary valve replacement option for patients with large or irregular right ventricular outflow tracts?
The Venus P-Valve is a highly effective and safe self-expanding transcatheter option that successfully expands minimally invasive pulmonary valve replacement to patients with large or irregular RVOTs previously ineligible for balloon-expandable devices.
Supports Venus P-Valve feasibility in large/irregular RVOTs; leaves open randomized confirmation of long-term outcomes.
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.
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Ayyash et al. (2026) conducted a review in Right ventricular outflow tract (RVOT) dysfunction (n=466). Venus P-Valve was evaluated on Technical success. The Venus P-Valve achieved a pooled procedural success rate of 98.1% across 466 patients with large or irregular right ventricular outflow tracts, demonstrating sustained valve competence.
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