Objective To evaluate the safety, efficacy, and mid-term clinical outcomes of the Salus? transthoracic interventional self-expanding pulmonary valve stent system in the treatment of patients with pulmonary regurgitation. Methods The clinical data of patients who underwent transthoracic pulmonary valve stent implantation at Huazhong Fuwai Hospital between September 2021 and August 2023 were retrospectively analyzed. All procedures were performed via a small subxiphoid incision, with the delivery access established through the acute margin of the right ventricle. Results A total of 10 patients with moderate-to-severe pulmonary regurgitation were enrolled, comprising 8 males and 2 females. The mean age was (21.32±11.48) years, and the mean body weight was (59.16±19.92) kg. The preoperative median right ventricular end-diastolic volume index (RVEDVI) and right ventricular end-systolic volume index were 152.95 (121.97, 174.25) mL/m2 and 86.74 (70.29, 117.73) mL/m2, respectively. All patients successfully underwent transthoracic self-expanding pulmonary valve stent implantation. Intraoperative stent displacement occurred in 1 patient, who was successfully managed by extending the incision, performing an incision on the right ventricular outflow tract, and manually fixing the valve. In a patient with heart failure and concomitant renal insufficiency requiring intermittent dialysis, renal function did not significantly improve after surgery, who subsequently demonstrated improvement following the initiation of continuous renal replacement therapy and continued to require maintenance dialysis at the time of the last follow-up. The mean follow-up duration was (33.40±7.93) months. During the follow-up period, there were no deaths or recurrence of severe pulmonary regurgitation, while frequent premature ventricular contractions occurred in 1 patient. Compared to the baseline, the RVEDVI significantly decreased to 106.49 (91.32, 121.69) mL/m2 at 1 year postoperatively (P=0.008). At the last follow-up, the left ventricular end-diastolic diameter significantly increased, the right ventricular longitudinal diameter significantly decreased, the severity of pulmonary regurgitation markedly improved, and the QRS duration significantly shortened compared to the preoperative baseline (all P<0.05). ConclusionTransthoracic implantation of the Salus? pulmonary valve stent system is safe and effective in treating patients with pulmonary regurgitation, demonstrating satisfactory mid-term outcomes. It may serve as a potential complementary alternative to percutaneous pulmonary valve implantation.
