The PULSTA valve in native right ventricular outflow tract: initial experience in 3 Spanish hospitals

Abstract

Introduction and objectives: Surgery for congenital heart defects with right ventricular outflow tract (RVOT) stenosis often results in significant pulmonary regurgitation, requiring pulmonary valve replacement in the long term. Despite the development of balloon-expandable prostheses, the native RVOT frequently dilates beyond the maximum diameters allowed for these valves. To allow percutaneous pulmonary valve implantation (PPVI) in these patients, clinical trials have been initiated with self-expanding prostheses, including the PULSTA valve. The aim of this study was to report the initial experience with this valve at three Spanish hospitals. Methods: Descriptive study presenting the results of PPVI with the PULSTA prosthesis in patients with native RVOT and pulmonary regurgitation. Results: We included 10 patients with a mean age of 15 ± 2.8 years. The implantation was successful in all patients, with no major complications occurring during the procedure. The mean length of follow-up was 18 [range, 2-35] months. In 8 patients, cardiac magnetic resonance was performed at 6 months, revealing a reduction in mean end-diastolic volume (131.7 ± 31.7 mL/m 2 vs 100.3 ± 28.9 mL/m 2 ) and end-systolic volume (68 ± 20.8 mL/m 2 vs 57 ± 18.5 mL/m 2 ). Conclusions: The PULSTA prosthesis offers a safe, feasible, and effective alternative for PPVI in patients with native dilated RVOT. Due to the limited available follow-up data, further studies are needed to assess its long-term safety and durability.