A self-expanding percutaneous valve for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract: one-year results.

AIMS: To assess the safety and efficacy of the Venus p-valve.

METHODS AND RESULTS: Patients who had moderate or severe pulmonary regurgitation after surgical repair of the right ventricular outflow tract (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 6 different hospitals in China were enrolled. The procedure success rate was 98.2%. One 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 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 ventricle end-diastolic volume index (RVEDVI) was reduced from 137.6±15.8mL/m2 to 83.9±16.0mL/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 shown considerable promise for a hither to unmet need in patients with pulmonary regurgitation and an enlarged native RVOT.