Transthoracic Salus Valve Feasibility Study: Short-Term Outcomes of a Transcatheter Self-Expandable Pulmonary Valve

Objective: The size and morphology of the right ventricular outflow tract (RVOT) in patients suffering from long-term pulmonary regurgitation (PR) after native RVOT (NRVOT) reconstruction are important factors affecting the feasibility, safety, and effectiveness of transcatheter pulmonary valve replacement. The purpose of this study was to evaluate the feasibility, safety, and effectiveness of a transthoracic Salus valve (Balance Medical Technology Co., Ltd, Beijing, China) in patients with moderate-to-severe PR after NRVOT reconstruction. Methods: Patients with moderate-to-severe PR after NRVOT reconstruction were selected between June 2021 and November 2021 at Beijing Anzhen Hospital. Demographic data as well as preoperative, intraoperative, and follow-up data were reviewed. Results: Ten patients with moderate-to-severe PR after NRVOT reconstruction underwent physical examination, transthoracic echocardiography, and cardiovascular magnetic resonance imaging. Seven patients were selected for transthoracic Salus valve replacement. Six patients underwent implantation of the Salus valve successfully. One valve migrated and was embolized during recovery of the delivery device; the Salus valve was surgically explanted and sutured to the inner wall of the main pulmonary artery. At a mean follow-up of (5.5 ± 1.1) months, dysfunction or migration of the Salus valve embolism was not observed. Conclusions: This early feasibility study demonstrates the feasibility, safety, and effectiveness of transthoracic implantation of a Salus valve in patients with moderate-to-severe PR after NRVOT reconstruction. The short-term effectiveness is clear, medium and long-term effectiveness requires longer follow-up.