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

## TL;DR

The Venus P-valve is a new catheter-based heart valve for patients with large or irregular pulmonary outflow tracts, showing high success rates and long-term durability.

## Contribution

The Venus P-valve is the first self-expanding transcatheter pulmonary valve designed for large and irregular outflow tracts.

## Key findings

- Procedural success exceeds 95% with immediate improvement in pulmonary valve function.
- Follow-up to five years shows durable performance and low reintervention rates.
- The valve has been successfully used in children and teenagers with sustained benefits.

## Abstract

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.

A catheter-based heart valve option for patients with a damaged pulmonary valve

The pulmonary valve helps move blood from the right side of the heart to the lungs. In people born with heart defects, particularly tetralogy of Fallot, this valve or the pathway leading to it is often damaged. Even after childhood surgery, the valve may begin to leak or become narrow again. Over time, this can cause the right side of the heart to enlarge and weaken.

For many years, treatment required repeat open-heart surgeries. While effective, surgical valves do not last forever, meaning patients often need multiple operations over their lifetime.

In recent years, doctors have been able to replace pulmonary valves using a catheter inserted through a blood vessel, avoiding open-heart surgery. Some catheter-based valves work well when the valve opening is small and regular, but many patients with tetralogy of Fallot have a much wider and uneven pathway, making these valves unsuitable.

The Venus P-valve was developed specifically for these patients. It is designed to fit larger and irregular valve pathways. Studies from multiple centers show that the valve can be implanted successfully in most patients, quickly reduces valve leakage, and allows the right side of the heart to recover. Since the first use in 2013, more than 3200 patients worldwide have been treated according to manufacturer-reported data. Follow-up of up to five years shows the valve continues to work well.

Problems after implantation are uncommon. When they occur, they may include infection, temporary heart rhythm changes, or changes seen on scans that usually do not affect valve function. The Venus P-valve has also been used successfully in selected children and teenagers.