Objective To analyze and summarize the early and medium-term outcomes of self-expanding interventional pulmonary valve stent (SalusTM) for right ventricular outflow tract dysfunction with severe pulmonary valve regurgitation. Methods We established strict enrollment and follow-up criteria. Patients who received interventional pulmonary valve in transthoracic implantation in Guangdong Provincial People’s Hospital from September 2, 2021 to July 18, 2023 were prospectively included, and all clinical data of patients were collected and analyzed. ResultsA total of 38 patients with severe pulmonary regurgitation were included, with 23 (60.5%) males and 15 (39.5%) females. The mean age was 24.08±8.12 years, and the mean weight was 57.66±13.54 kg. The preoperative mean right ventricular end-diastolic volume index (RVEDVI) and right ventricular end-systolic volume index (RVESVI) were 151.83±42.84 mL/m2 and 83.34±33.05 mL/m2, respectively. All patients successfully underwent transcatheter self-expandable pulmonary valve implantation, with 3 (7.9%) patients experiencing valve stent displacement during the procedure. Perioperative complications included 1 (2.6%) patient of postoperative inferior wall myocardial infarction and 1 (2.6%) patient of poor wound healing. The median follow-up time was 12.00 (6.00, 17.50) months. During the follow-up period, there were no deaths or reinterventions, and no patients had recurrent severe pulmonary regurgitation. Three (7.9%) patients experienced chest tightness and chest pain, and 1 (2.6%) patient developed frequent ventricular premature beats. Compared with preoperative values, the right atrial diameter, right ventricular diameter, and tricuspid annular plane systolic excursion were significantly reduced at 6 months and 1 year postoperatively, with improvement in the degree of pulmonary regurgitation (P<0.01). Compared with preoperative values, RVEDVI and RVESVI decreased to 109.51±17.13 mL/m2 and 55.88±15.66 mL/m2, respectively, at 1 year postoperatively (P<0.01). Conclusion Self-expanding interventional pulmonary valve in transthoracic implantation is safe and effective for severe pulmonary valve regurgitation and shows good clinical and hemodynamic results in one-year outcome.
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.
