Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract

Abstract

IntroductionThe Venus p‑valve (MedTech, Shanghai, China) is a self-expanding percutaneous heart valve designed to be implanted in a native patched right ventricle outflow tract. The worldwide clinical experience with this valve is just beginning and the results have so far been encouraging. We present our initial early experience implanting the Venus p‑valve in the native right ventricle outflow tract of patients with Tetralogy of Fallot repaired with a transannular patch.MethodsIn 10 selected patients a procedure for percutaneous pulmonary valve implantation was performed using the Venus p‑valve. The patients mean age was 32 years (13–57), mean weight 59.6 kg (40–80). All patients had Tetralogy of Fallot with moderate to severe pulmonary regurgitation and an indication for pulmonary valve replacement.ResultsThe implantation procedure was successful in all the patients resulting in an immediately functional valve. No procedure-related complications were observed. Follow-up after 12 months (4–21) resulted in an improvement in NYHA class. There was a reduction of the mean right ventricle diastolic volume from 139 ml/m2 (105–179) to 78 ml/m2 (65–100) and improvement in the regurgitation fraction from 42% (29–58) to 1% (0–5), as seen on routine cardiac magnetic resonance 6 months after the implantation. No stent fractures have been observed so far.ConclusionPercutaneous pulmonary valve implantation with the Venus p‑valve resulted in a safe and effective procedure. The valve has predictable and sustained functional competence, resulting in clinical improvement in the patients.

Transcatheter Pulmonary Valve Replacement: The Venus P valve-Current Status

“…In 2017, Garay et al reported successful implantation of the Venus P-valve in 10 patients (seven female) [25]. The patients' mean age was 32 years and mean weight was 59.6 kg.…”

Percutaneous Implantation of Venus P-Valve and Melody Valve in a Patient with Dysfunctional Native and Artificial Right Ventricular Outflow Tracts

“…In addition, a drop (from 125 mm Hg to 90 mm Hg) of the aortic arterial pressure was observed during test balloon occlusion of the Gore-Tex tube indicating that the blood flow through native RVOT was not sufficient enough to maintain by itself a normal cardiac The valve implantation was performed under general anesthesia using the previously described technique. [2][3][4] Based on the angiographic measurements and the anatomic characteristics of the RVOT, a 36 mm diameter and 35 mm length flared Venus P-valve was successfully implanted from the RVOT to MPA bifurcation through a 24 F delivery system. (Figure 1 A,B,C,D).…”

“…However, only < 20% of patients following tetralogy Fallot repair are candidates for these two valves as they cannot be used in large patched right ventricular outflow tracts (RVOTs) [1]. The Venus P-valve (Venus Medtech, Shanghai, China) is a new self-expanding tri-leaflet porcine pericardial tissue percutaneous pulmonary valve designed specifically for implantation in large (up to 32 mm diameters) native RVOT [2][3][4]. Early clinical experience with implantations in humans has shown its safety and satisfactory early results.…”

“…Early clinical experience with implantations in humans has shown its safety and satisfactory early results. [2][3][4] In this short communication, we report the first-in-man use of Venus P-valve and Mel-ody® transcatheter valves on separate occasions in a patient with dysfunctional native and artificial RVOT.…”

Percutaneous pulmonary valve implantation: It's not like the aortic valve

“…Future pulmonary valves in the pipeline include the Medtronic Harmony valve with a self‐expanding hourglass design and a recent positive early feasibility study . Other self‐expandable valves such as the Venous p‐valve (Medtech, Shanghai, China) have been successfully implanted . Additionally, the Edwards Altera adaptive prestent device is undergoing feasibility to allow for a right ventricular outflow tract landing zone in preparation for transcatheter pulmonary valve placement.…”