Percutaneous Pulmonary Valve Replacement in Native Right Ventricular Outflow Tract.One-Step Technique Using a Balloon-Expandable Valve: Initial Experience in Argentina

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Abstract

Background: The adverse impact of pulmonary valve incompetence (PVI) has been extensively studied in patients with TOF after surgical repair. Percutaneous pulmonary valve replacement (PPVR) with balloon-expandable and self-expanding valves
is an alternative to surgical reintervention.
Objective: The aim of this study is to report on the initial experience of PPVR using a one-step implantation technique with a balloon-expandable heart valve in Argentina.

Methods: We conducted an observational and descriptive study of all consecutive patients treated with PPVR due to severe and/or free PVI with signs of right ventricular dilation/dysfunction who underwent transannular patch repair as part of the initial correction of their congenital heart disease. The one-step technique was defined as valve implantation in the native right ventricular outflow tract (RVOT) without prior stent placement to prepare the landing zone. A balloon-expandable Myval® valve (Meril LifeScience, India) was implanted in all cases.

Results: From July 2023 to April 2025, 10 patients (8 males) underwent PPVR. Three patients had previously required stenting of the left pulmonary artery branch. Median age and weight were 20 years (interquartile range, IQR, 12.5–34.3) and 61.3 kg (33.7-77.2), respectively. All patients were in functional class II. Valve implantation was successful in all cases. None of the patients exhibited significant RVOT gradient or PVI immediately after valve implantation. One patient presented mild paravalvular leak immediately after valve implantation and another increased the gradient 7 months after implantation. After a median follow-up of 6.7 months (1.2-15.7), PVI remained grade 0 in all patients and mean peak systolic gradient across the
valve, estimated by color Doppler, was 21.8 mm Hg (15-30.1). There were no cases of valve displacements and/or fractures, episodes of arrhythmias, infective endocarditis, need for valve explantation, or deaths during short- and mid-term follow-up.
Conclusions: Percutaneous pulmonary valve replacement in native RVOT using a one-step technique with a balloon-expandable valve is feasible, safe and efficient in this preliminary experience in Argentina. Immediate restoration of pulmonary valve competence was observed after implantation.