Percutaneous implantation of self-expanding pulmonary valves: results from real-life experience of the Venus-P valve Registry of the Italian Society of Pediatric Cardiology (SICPED)

• Published in: International journal of cardiology congenital heart disease Vol. 21; p. 100609
• Main Authors: Pilati, M., D'Aiello, F.A., Chessa, M., Santoro, G., Donti, A., Mariucci, E., Marrone, C., Annoni, G., Gaio, G., Rebonato, M., Piccinelli, E., Cheli, M., Formigari, R., Butera, G.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2025; Elsevier
• Subjects: Autoexpandable valves; Cardiovascular; Dysfunctional right ventricular outflow tract; Original; Venus P valve; Venus P valve; Autoexpandable valves; Dysfunctional right ventricular outflow tract
• DOI: 10.1016/j.ijcchd.2025.100609
• ISSN: 2666-6685

Self-expandable valves may have a significant impact on the feasibility of transcatheter treatments of RVOT dysfunction. Venus P valve is the first autoexpadable Valve that received CE mark in 2022. Here, we are reporting on a multicenter data collection about patients undergoing Venus P valve implantation in Italy. Seven italian centers were included in the study. Data were collected from patients treated with a venus P valve between July 2022 and May 2024. Indication for percutaneous valve implantation were in accordance with published guidelines. During the study period, a total of 65 patients were considered eligible to percutaneous implantation of a Venus P valve. Median age at procedure was 35 years (IQR 12–63 years) median weight 63 Kg (IQR 33–103 Kg). Indication for PPVI was severe regurgitation in all subjects but one where ventricular pressure was increased because of stenosis on a homograft conduit and pulmonary arteries which needed previous bilateral stenting. Venus P valve was implanted successfully in 61/65(94 %) patients. Four procedural complications occurred(6 %): 1 artero-venous fistula, 1 pulmonary bleeding, 1 hemothorax and a pulmonary oedema. During follow up (median 13 months,1–20months), all patients experienced a significant improvement of functional class. Neither deaths or re-intervention occurred. CT Scan showed hypoattenuating leaflet thickness (HALT) in 4 patients and one of them experienced endocarditis 12 months after the procedure. Our study shows that Venus P valve implantation is safe and results are stable during a short-to-medium term follow-up. Endocarditis and HALT are inducing some concern and larger studies are needed.