IMMEDIATE OUTCOMES OF TRANSCATHETER PULMONARY ARTERY VALVE IMPLANTATION IN THE TREATMENT OF PATIENTS AFTER SURGICAL CORRECTION OF COMPLEX CONGENITAL HEART DEFECTS

Highlights

• This study by the A.N. Bakulev NMRC of Cardiovascular Surgery reports for the first time in Russia on domestic clinical experience with transcatheter pulmonary valve implantation. Against the backdrop of the widespread adoption of this minimally invasive alternative to open surgery, the study provides a detailed analysis of the immediate results, efficacy, and safety of the technique at the A.N. Bakulev NMRC of Cardiovascular Surgery, which has performed the largest number of implants in the country.

Aim. Evaluation of the safety and efficacy of transcatheter pulmonary valve implantation in the 30-day postoperative period.

Methods. A prospective single-center study included 55 patients aged 9 to 32 years (mean age 14.7 ± 3.36 years, male – 43 (78.2%)), operated on at the A.N. Bakulev National Medical Research Center of Cardiovascular Surgery in the period from June 2023 to November 2025 (1 patient – in 2008, assessed retrospectively). The most common initial diagnosis was tetralogy of Fallot (n = 29 (52.72%)). In 32 patients (58.18%), valve implantation was performed in the native right ventricular outflow tract (RVOT), 17 (30.91%) – in a conduit, 6 (10.91%) – in an allograft. In 9 cases (16.36%), implantation was performed into a stented conduit, in 3 cases (5.45%) – into a previously installed pulmonary valve prosthesis. The predominant pathophysiological mechanism was a combination of stenosis and regurgitation (56.37% (n = 31)); isolated pulmonary regurgitation was detected in 20 patients (36.36%), and isolated pulmonary valve stenosis was found in 4 patients (7.27%). The median lumen area in the implantation zone was 482.3 (279.1; 601.4) mm².

Results. Valves were implanted in all 55 (100%) patients. The following stent valves were implanted: 38 (69.1%) Myval, 13 (23.64%) Pulsta, 2 each (3.63%) VenusP-Valve and Melody. The median stent-valve diameters were 27.5 (23; 32) mm. The median intervention time was 85 (65; 135) min. The invasive RVOT systolic pressure gradient decreased from 15 (10; 29) to 9 (4; 15) mmHg after the surgery, and the noninvasive peak gradient decreased from 40 (26; 60) to 14 (8; 20) mmHg. Pulmonary regurgitation was eliminated or became minimal in 100% of patients. Technical success of the procedure was achieved in 94.5% (n = 52) of cases, and clinical success was achieved in 96.36% (n = 53). 3 (5.45%) complications occurred, 1 of which (1.82%) was intraoperative and required surgical stent removal (prestenting). There were no cases of valve displacement or dysfunction during the follow-up period, and the mortality rate was 0%.

Conclusion. Transcatheter pulmonary valve implantation is an effective and safe alternative to repeated cardiac surgery in the treatment of patients who have underwent multi-stage surgical correction of congenital heart disease.

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