Multicenter Comparison of Percutaneous and Surgical Pulmonary Valve Replacement in Large RVOT

Abstract Background A percutaneous approach for pulmonary valve replacement (PVR) is a feasible alternative to surgical PVR in selected patients with severe pulmonary regurgitation after repair of tetralogy of Fallot. However, large right ventricular outflow tract (RVOT, diameter > 25mm) remains challenging. Methods This retrospective multicenter study enrolled consecutive patients with large RVOT who underwent percutaneous PVR (Venus P-valve; n=35) or surgical PVR (homograft valve; n=30) between May 2014 and April 2017. Patients were followed up at 1, 3, 6 and 12 months, and yearly thereafter. Main study outcomes were pulmonary valve function and right ventricular function at discharge and midterm follow-up. Results PVR was successful in all patients. Percutaneous compared with surgical PVR group had: similarly distributed baseline characteristics; shorter hospitalization, intensive care unit stay, and endotracheal intubation duration; lower cost; lower pulmonary valve gradient before discharge; and lower pulmonary valve regurgitant grade (mean difference: -0.63; 95% CI:-1.11 to -0.20, p=0.022), pulmonary valve gradient (mean difference:-5.7 mmHg; 95% CI:-9.4 to -2.2 mmHg, p=0.005), and right ventricular end-diastolic volume index (mean difference:-9.5 ml/m2; 95% CI:-16.9 to -3.1 ml/m2, p=0.022); and greater right ventricular ejection fraction (mean difference:5.4%; 95% CI:2.4 to 8.3%, p=0.002) at median 36 months follow-up, without deaths in either group. Conclusions Percutaneous PVR using Venus P-valve appeared to be a safe, efficacious and minimally invasive alternative to surgical PVR in selected patients with large RVOT yielding better right ventricular and pulmonary valve function at midterm follow-up.