Key result
Hybrid TPVI with the Salus valve is linked to ~38-mL/m² lower RVEDVI at 1 year.
Why the study?
Managing pulmonary regurgitation in patients with a large, dysplastic native RVOT is challenging for percutaneous intervention. This study evaluated the safety and efficacy of a hybrid transcatheter pulmonary valve implantation strategy using a self-expanding valve in this population.
Does a hybrid transcatheter pulmonary valve implantation strategy using the self-expanding Salus valve safely and effectively improve right ventricular remodeling in patients with moderate-to-severe pulmonary regurgitation and a large, morphologically complex right ventricular outflow tract?
Observational (n=102)
Yes
Does a hybrid transcatheter pulmonary valve implantation strategy using the self-expanding Salus valve safely and effectively improve right ventricular remodeling in patients with moderate-to-severe pulmonary regurgitation and a large, morphologically complex right ventricular outflow tract?
Absolute Event Rate: 109.73% vs 147.72%
p-value: p=<0.001
Hybrid TPVI using the self-expanding Salus valve with tailored surgical access and MPA downsizing is a safe, feasible alternative that promotes favorable right ventricular reverse remodeling at 1 year in patients with severe pulmonary regurgitation and native RVOTs too large or complex for standard percutaneous TPVI.
Background Management of pulmonary regurgitation (PR) in patients with a large and dysplastic native right ventricular outflow tract (RVOT) remains a significant challenge for percutaneous intervention. Given the limitations of percutaneous intervention in patients with a large and morphologically complex RVOT, this study aimed to evaluate the safety and efficacy of a hybrid transcatheter pulmonary valve implantation (TPVI) strategy using a self-expanding valve in this patient population. Methods Between June 2021 and December 2023, 102 patients with moderate-to-severe PR and dilated RVOT from 11 centers underwent hybrid TPVI with the Salus transcatheter pulmonary valve (TPV). Procedural strategies, including surgical access and concomitant procedures, were tailored based on comprehensive preoperative assessment. Results The mean age was 22.37 ± 11.15 years (range, 9–66), and 56.9% were male. The most common RVOT morphologies were pyramidal (37.2%) and tubular (30.4%). All procedures were successful. Twenty cases required cardiopulmonary bypass support. There were no intraoperative deaths. One in-hospital death occurred on postoperative day 12 in a high-risk patient with severe preoperative right ventricular dysfunction. All patients completed at least 1 year of follow-up, with a median follow-up duration of 1 year. During this period, significant improvements in right ventricular volumes (RVEDVI and RVESVI) and QRS duration were observed, whereas RVEF did not change significantly. There were no instances of coronary artery compression, valve embolization, or stent fracture. One suspected case of endocarditis was reported. Conclusions In patients with a large and morphologically complex RVOT, hybrid TPVI with the Salus TPV is a safe and effective therapeutic strategy, associated with high procedural success and encouraging short-term outcomes. A patient-specific approach, guided by meticulous preoperative imaging to determine the optimal access and the need for concomitant procedures, is key to minimizing complications. This hybrid technique offers a valuable alternative for patients who are not candidates for percutaneous intervention.
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Dong et al. (2026) conducted an observational in Moderate-to-severe pulmonary regurgitation with a dilated native right ventricular outflow tract (n=102). Hybrid transcatheter pulmonary valve implantation with the Salus self-expanding valve vs. Preoperative baseline was evaluated on Right ventricular end-diastolic volume index (RVEDVI, mL/m2) at 1-year follow-up vs preoperative baseline (p=<0.001). Hybrid TPVI with the Salus valve achieved 100% procedural success and significantly reduced RVEDVI from 147.72 to 109.73 mL/m2 (p<0.001) at 1 year in patients with a large native RVOT.
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