Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system

Abstract

Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the right ventricular outflow tract (RVOT) or pulmonary valve. To prolong the need for additional open heart interventions, percutaneous pulmonary valve implantation (PPVI) may be performed as a less invasive alternative. No multi-patient studies currently report the feasibility and safety of this procedure using the new generation SAPIEN 3 (S3) transcatheter heart valve. Pulmonic S3 is a multicentre observational registry of patients undergoing PPVI with the S3 valve across Europe, and Canada started in March 2016. Until end of January 2018, data for 81 patients with a mean age of 26.5 years was obtained. The most common underlying diagnosis was Tetralogy of Fallot (ToF) (58.0%), with only 16.3% of patients having native RVOT anatomy. 90% received pre-stenting. Procedural success was 100%. Prosthesis dislodgement (without need for open surgery) occurred in one patient, with another experiencing conduit perforation. Both were successfully resolved and no other procedural complications, endocarditis, stent fracture or mortality were reported up to two years. The peak systolic gradient over the RVOT fell from 45.6 mmHg pre-procedurally to 16.2 mmHg post-procedurally, the proportion of patients with moderate/severe pulmonary regurgitation from 89.2% to 0.0% and those with an NYHA class ≥ II from 86.8% to 15.9%. PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes. Longer-term outcomes remain to be described. Clinicaltrials.gov identifier NCT02777892.