Pulmonary regurgitation (PR) is a common condition in patients who have undergone surgical repair of Tetralogy of Fallot or other pathologies involving the right ventricular outflow tract (RVOT). PR leads to progressive right ventricular (RV) dilation and dysfunction. Traditionally, this condition has been managed through surgical pulmonary valve replacement; however, this approach may require multiple reoperations over a patient’s lifetime. While associated with low mortality, it carries significant morbidity.
The solution developed to reduce the risks associated with reintervention was transcatheter pulmonary valve implantation (TPVI) using balloon-expandable valves, which is now recognized as a valid therapeutic alternative. A recent multicenter study demonstrated a lower incidence of complications with the SAPIEN valve compared to surgery. Percutaneous valves currently approved in Europe, such as Melody (Medtronic) and SAPIEN, have been used for the past two decades with acceptable results, although their application is limited by size, as the largest available diameter is 29 mm. For this reason, patients with an RVOT larger than 29 mm have been excluded from such studies.
A recent alternative is the use of self-expanding valves or a combination of self-expanding stents with balloon-expandable valves, such as the Harmony (Medtronic) valve and the Alterra stent combined with the SAPIEN valve.
In this context, the VenusP (VenusMedtech) valve is a new self-expanding alternative, specifically designed to fit right ventricular outflow tracts unsuitable for the Melody or SAPIEN valves. Both preclinical studies in animal models and initial clinical experience have shown excellent valve functionality.
The aim of this multicenter study was to evaluate the short-term and three-year follow-up outcomes of self-expanding VenusP valve.
The primary safety endpoint (PSE) was the incidence of valve- or procedure-related death, reoperation within 12 months, and major adverse cardiovascular or cerebrovascular events (MACCE) at one month. The performance endpoint included successful valve implantation, hemodynamic parameters at one month, improvement in PR during follow-up, and evidence of structural deterioration at 6 months.
The study included a total of 81 patients. Their average age was 26 years, and most subjects were men. Tetralogy of Fallot was the most prevalent congenital heart disease. In all cases, the VenusP valve was successfully implanted. There were no procedure-related deaths, either early or late. One patient experienced pulmonary artery branch perforation during guidewire advancement, resulting in hemoptysis; another had ventricular tachycardia at the end of the procedure. During follow-up, one patient developed ventricular tachycardia requiring an implantable cardioverter-defibrillator and RVOT ablation five months after implantation. There was a case of endocarditis 11 months after the procedure; after medical treatment, valve function remained adequate. Finally, one patient developed a thrombus at the distal end of the valve three years after implantation, which was managed with anticoagulation therapy.
At the three-year follow-up, valve function remained stable, and all patients showed signs of right ventricular remodeling.
Conclusion
This study presents the outcomes of VenusP valve implantation in patients with severe pulmonary regurgitation following prior RVOT repair. The valve has proven to be safe and effective, with confirmed durability at three years. Further studies are required to assess its long-term performance.
Original Title: Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System 3-Year CE Study Results.
Reference: Shakeel A. Qureshi, MD et al JACC Cardiovasc Interv. 2025.
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