Early-Term Outcomes of Percutanous Pulmonary Valve Implantation With the Meril's Myval Pulmonary Valve—Single Center Experience From Turkey

Abstract

Background: Recurrent interventions are required following surgical treatment of congenital heart diseases involving pathologies of the right ventricular outflow tract (RVOT). Percutaneous pulmonary valve implantation (PPVI) is one of the most commonly employed catheter-based interventions for this purpose. Aims: The aim of this study is to share the early-term feasibility, effectiveness, and hemodynamic outcomes of PPVI using Meril's Myval pulmonary valve in the largest patient series from a single center. Methods: This study included patients with congenital heart disease who had RVOT dysfunction following surgical repair or balloon valvuloplasty (e.g., after pulmonary stenosis intervention). Among the 132 patients planned for PPVI with the Meril's Myval between January 2021 and February 2024, five were excluded due to coronary compression risk identified during balloon sizing. The procedure was initiated in the remaining 127 patients. In three of these cases, the procedure could not be completed due to intra-procedural complications (stent embolization in two patients and valve embolization in one). As a result, a total of 124 patients (97.6%) underwent successful PPVI. Hemodynamic data before and after the procedure and early follow-up outcomes were recorded. Results: Seventy-three patients (59%) were male, with a median age of 16.1 years (range 5.0 to 68.6 years) and a median weight of 52 kg (range 17–112 kg). The most common underlying diagnosis was tetralogy of Fallot (n = 91, 73%), and 82 patients (66%) had a native RVOT or transannular patch repair. PPVI was performed for predominantly regurgitant lesions in 73 patients (59%), predominantly stenotic lesions in 27 (22%), and mixed lesions in 24 (19%). Bioprosthetic valve dysfunction was present in 12 patients (10%) and homograft/conduit dysfunction in 30 patients (24%). The median interval between the last cardiac surgery and PPVI was 12.3 years (range 1.1–36.2 years). A hybrid approach with lateral thoracotomy was required in three patients due to unfavorable venous access or anatomy. Pre-stenting was performed in 114 cases (92%), of which 12 were conducted in separate sessions. The median valve size was 27.5 mm (range 20–32 mm), and valves ≥ 29 mm were implanted in 60 cases (48%). In all cases, the largest feasible valve was selected to facilitate future interventions. Following implantation, a significant reduction was observed in systolic right ventricular pressure (RVP) (from 41.9 ± 23.5 to 29.1 ± 8.9 mmHg, p < 0.001) and RVOT gradient (from 20.9 ± 23.8 to 7.6 ± 5.5 mmHg, p < 0.001). The median hospital stay was 3 days (range 1–9 days). Over a median follow-up period of 1.6 years (range 0.3–3.6 years), no endocarditis, stent fractures, or deaths were reported. A total of 122 patients (98%) had none or only mild pulmonary regurgitation during follow-up. An additional patient developed valve regurgitation approximately 1.5 years after the procedure, and a reintervention is being considered. Conclusions: The initial experience with the Meril's Myval valve in the pulmonary position demonstrates excellent safety and procedural success. Its favorable profile, particularly in patients with prior prosthetic material or significantly dilated RVOTs, highlights its potential as a reliable and preferred alternative with minimal complication rates.