Novel Transthoracic Pulmonary Valve Implantation Using Self-Expanding Salus Valve: A Prospective Study of Safety and Mid-Term Outcomes.

Abstract

Background: Transcatheter pulmonary valve replacement (TPVR) has emerged as a valuable treatment for severe pulmonary regurgitation (PR). The Salus valve (Balance Medical Technology Co. Ltd., Beijing, China) represents a novel self-expanding valve stent designed for deployment through a transthoracic approach with a small subxiphoid incision.

Aims: The objective of this study was to evaluate the medium-term safety and efficacy of Salus valve stents in this patient population.

Methods: This prospective cohort study enrolled patients who underwent transthoracic pulmonary valve stenting at Guangdong Provincial People's Hospital from September 2021 to September 2024. Inclusion criteria included moderate-to-severe PR following RVOT reconstruction, age ≥ 14 years, and specific clinical/imaging parameters. Primary endpoints were pulmonary regurgitation fraction < 20%, freedom from reintervention at 12 months, and major adverse events (MAE). MAE were defined as death, reintervention, recurrent severe PR, worsening heart failure, cardiac arrest, new severe ventricular arrhythmias, and third-degree AV block.

Results: Among 38 patients (mean age 24.08 ± 8.12 years), all procedures were successfully completed, although intraoperative valve displacement occurred in three cases. During a median follow-up period of 24 months, significant improvements were observed in right ventricular volumes: Right Ventricular End-Diastolic Volume Index (RVEDVI) decreased from 141.45 to 109.98 mL/m² and Right Ventricular End-Systolic Volume Index (RVESVI) decreased from 74.27 to 56.62 mL/m² (both p < 0.01). No mortality or need for reintervention was observed during the follow-up period. The estimated freedom from major adverse events at 36 months was 87.2%.

Conclusion: The Salus valve demonstrated safety and efficacy for severe PR treatment through its transthoracic approach, which offers unique advantages in terms of direct access and immediate complication management. Longer follow-up is needed to assess long-term durability.