Modified technique of percutaneous pulmonary valve implantation with the Sapien 3: Impact on procedure and early outcome

Abstract

Percutaneous pulmonary valve implantation (PPVI) with Sapien 3 valve is effective to treat right ventricle outflow (RVOT) dysfunction. Issues related to presenting and tricuspid valve injuries were reported with the initial implantation method. A modified technique was developed without pre-stenting and with a protective delivery method for valve implantation. We aimed to compare procedural results in the modified technique group (MTG) to matched patients in a conventional technique group (CTG). All consecutive procedures performed in the MTG over 9 months were matched based on RVOT type and size to consecutive procedures performed before. 27 patients were included in each group. Size of the Sapien 3 valves were 23 mm (n = 9), 26 mm (n = 9), 29 mm (n = 36). The two groups were similar regarding demographic data, RVOT type, pre-procedure hemodynamics. PPVI was performed in a single procedure in all patients of the MTG, whereas six (22.2%) patients of the CTG group had pre-stenting as a first step and valve implantation later (P = 0.02). Procedures were successful in all cases. Stent embolization was reported in two patients (7.4%) in the CTG, which were impacted in pulmonary arteries. Instability of a valve was observed in one case (3.7%) in the MTG, stabilized with two stents and an additional valve-in-valve implantation. Hemodynamics results were good in all cases without significant difference among the two groups (Table 1). Procedure duration and fluoroscopy times were significantly reduced in the MTG (48.1 versus 82.6 minutes, P < 0.0001; 15.2 versus 29.8 minutes, P = 0.0002). During follow-up, no stent fracture or valve dysfunction was noticed in both groups. PPVI without pre-stenting and with a protective delivery method of the Sapien 3 valve reduces significantly the procedure complexity, procedure duration and irradiation, while maintaining excellent hemodynamics results.