Aims: The aim of the study was to evaluate the midterm safety and efficacy of a self-expanding valve (Venus P-valve) in the treatment of patients with pulmonary regurgitation and a native right ventricular outflow tract (RVOT) in China.
Methods and results: Patients who had moderate or severe pulmonary regurgitation after surgical repair of the RVOT with a transannular or RVOT patch were included in the study. Fifty-five patients (67% female; average age 28.7±12.4 years) from six different hospitals in China were enrolled. The procedure success rate was 98.2%. In the one failure, the patient experienced valve dislodgement two days after the procedure. During the 12-month follow-up, two patients died, one due to infective endocarditis. Three other patients developed infective endocarditis. Two patients developed atrial flutter, and one patient had a pulmonary embolism. Echocardiography examinations at 12 months showed that two patients had mild pulmonary regurgitation, and 19 patients had trace pulmonary regurgitation. No paravalvular regurgitation occurred. The mean peak pulmonary gradient was 16.3±7.4 (range 4-38) mmHg. Compared with the baseline data, the right ventricular end-diastolic volume index (RVEDVI) was reduced from 137.6±15.8 mL/m2 to 83.9±16.0 mL/m2 (p<0.001), and the New York Heart Association (NYHA) class was significantly improved (p<0.01).
Conclusions: The one-year results of the China Venus P-valve study show considerable promise for a hitherto unmet need in patients with pulmonary regurgitation and an enlarged native RVOT.