Safety and efficacy of Sapien 3 valve for percutaneous pulmonary valve implantation

Purpose Efficacy of Sapien XT valve has been reported for percutaneous pulmonary valve implantation (PPVI). Implantation is complex given the rigidity and the of the Novaflex ® delivery system. Sapien 3 valve is the latest evolution of Edwards valves with a more flexible Commander ® delivery system. We report our results of off-label use of Sapien 3 for PPVI. Methods Between September 2016 and April 2017, 16 procedures were performed with the Sapien 3 and compared to 26 procedures performed with the Sapien XT between January 2015 and July 2016. Results Sapien 3 were implanted in 16 patients [26 years old (23–38)]. Conduit were native patched valves ( n  = 6), bioprosthesis ( n  = 4), tube ( n  = 4), homograft ( n  = 1) and Melody valve ( n  = 1). All patients had pulmonary prestenting (Andrastent XXL, n  = 12; eV3 LDmax, n  = 4). Valve implantation was performed during a second procedure in 5 cases. Valve diameters were 23 ( n  = 3), 26 ( n  = 4) and 29 mm ( n  = 9). Valves were successfully implanted in all cases. After procedure, one patient had minor pulmonary valve regurgitation. Peak-to-peak gradient across the valves was ≤ 15 mmHg in 14 cases. Two patients had minor valve mismatch. Nor valve dysfunction nor infective endocarditis was reported during follow-up. Procedure duration, fluoroscopy time, dose-length product and kerma were lower with Sapien 3 compared to Sapien XT procedures (0.002, 0.01, 0.006, and 0.007 respectively). Conclusion Sapien 3 valve implantation in pulmonary position with the Commander delivery system is efficient and faster. However, the lack of valve covering onto the delivery system remains an issue.