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

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.