Early Outcomes of Self-expanding VenusP-valve Implantation in Dysfunctional Right Ventricular Outflow Tracts in Pediatric Patients: A Single-Center Evolving Experience

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Abstract
Recent introduction into clinical practice of large self-expanding valves addressees the issue of dilated dysfunctional right ventricular outflow tracts (RVOTs). The purpose of this study was to determine the safety and short-term efficacy of the VenusP-valve (Venus MedTech) implantation in the pulmonary position in the pediatric group of patients with emphasis on the evolving qualification criteria and implantation techniques. Over a 14-month period, 15 patients < 18 years-old with severe pulmonary regurgitation underwent successful PPVI with the self-expanding VenusP-valve. All types of RVOT anatomies were represented in the study group. Desired valve position during the first attempt was achieved in 13 patients (87%). When compared between the first and second half of the study period, there was a significant difference toward less oversizing: 3.3 ± 1.4 mm versus 1.8 ± 0.7 mm, p = 0.039. On final angiography, trivial pulmonary regurgitation was present in 9 patients (60%). In the remaining 6 patients (40%), the valve was competent. Adverse events were limited to two patients (13.3%) with transient rhythm disturbances without any clinical sequelae. During a median follow-up of 11.5 months (range 7.9–21 months), all the valves remained normally functioning with no need for reinterventions and no episodes of infective endocarditis. The VenusP-valve implantation was safely and effectively performed in pediatric patients with all types of large dysfunctional RVOTs. With modified techniques of implantation, limited femoral vein access or stented pulmonary artery branches, the valves can be successfully implanted.

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