Early Outcomes and Mid-Term Follow-Up of Melody TPV Implantation: A Ten-Year Single-Center Retrospective Observational Study.

Introduction

The Melody transcatheter pulmonary valve (TPV) was the first percutaneous bioprosthetic valve approved for transcatheter pulmonary valve implantation (TPVI). We report our single-centre experience with Melody TPV implantation in patients with congenital heart disease (CHD).

Methods

This retrospective observational single-centre study included all patients evaluated in the catheterization laboratory for Melody TPV implantation. Early outcomes included procedural failure, life-threatening adverse events, and mortality. Long-term outcomes assessed during follow-up included infective endocarditis, transcatheter reintervention, and surgical reintervention.

Results

Between 2015 and 2025, 50 consecutive patients were evaluated for TPVI with the Melody TPV at our institution. In four patients (8%), the procedure was aborted because of coronary artery compression detected during balloon interrogation of the right ventricular outflow tract (RVOT). One patient (2%) died of septic shock following acute pulmonary oedema in the immediate post-procedural period. The remaining 45 patients (90%) underwent successful Melody TPV implantation and were discharged from hospital. In six patients, the Melody TPV was implanted off-label: in the tricuspid position (n = 2) and in small conduits (<16 mm) (n = 4). Mean follow-up duration was 5.8 ± 3.6 years. One patient was lost to follow-up. Among the remaining 44 patients, seven (15.9%; 2.7% per patient-year) developed infective endocarditis, seven (15.9%; 2.7% per patient-year) underwent transcatheter reintervention (six balloon dilatations of the Melody valve and one valve-in-valve implantation), and four (9.1%; 1.5% per patient-year) required surgical replacement of the Melody TPV.

Conclusions

Transcatheter implantation of the Melody TPV is an effective treatment for RVOT dysfunction. At mid-term follow-up, the majority of implanted Melody valves demonstrated satisfactory function, and only a minority of patients required surgical valve replacement.