Key result
Percutaneous pulmonary valve implantation using the Venus P-valve was successful in 37 of 38 procedures with no valve failure at 25 months, though frame fractures occurred in 27% of patients.
Why the study?
The study was conducted to evaluate the international procedural and short-term to midterm experience with the new percutaneous Venus P-valve.
Does percutaneous pulmonary valve implantation using the Venus P-valve improve pulmonary regurgitation and right ventricular volumes in patients requiring pulmonary valve replacement?
Observational (n=38)
Yes
Does percutaneous pulmonary valve implantation using the Venus P-valve improve pulmonary regurgitation and right ventricular volumes in patients requiring pulmonary valve replacement?
The Venus P-valve provides satisfactory midterm results with high procedural success and significant improvements in pulmonary regurgitation and right ventricular volumes, despite a 27% incidence of frame fractures.
Supports Venus P-valve feasibility in observational data; leaves open durability and fracture risks pending prospective trials.
AIMS: The aim of this study was to assess the international procedural and short-term to midterm experience with the new percutaneous Venus P-valve. METHODS AND RESULTS: Retrospective data of patient characteristics, clinical and imaging follow-up of Venus P-valve implantation outside China were collected. Thirty-eight patients underwent attempted Venus P-valve implantation between October 2013 and April 2017. Thirty-seven valves were successfully implanted during 38 procedures. There was one unsuccessful attempt and there were two valve migrations, one of which required surgical repositioning. The mean follow-up was 25 months with no short-term or midterm valve failure or deterioration in performance. Frame fractures occurred in 27% of patients. The cohort demonstrated a statistically significant reduction in pulmonary regurgitation fraction and indexed right ventricular diastolic volumes at six and 12 months. CONCLUSIONS: Implantation of the Venus P-valve has provided satisfactory short-term to midterm results with high success and low complication rates in an inherently challenging patient substrate.
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Morgan et al. (2019) conducted an observational in Pulmonary valve disease requiring implantation (n=38). Venus P-valve was evaluated on Procedural success, valve performance, and complications. Percutaneous pulmonary valve implantation using the Venus P-valve was successful in 37 of 38 procedures with no valve failure at 25 months, though frame fractures occurred in 27% of patients.