OBJECTIVES. Melody TPV is the first percutaneous valvular bio-prosthesis approved for trans-catheter pulmonary valve implantation (TPVI). We describe our ten-years experience about Melody TPV implantation in patients with congenital heart disease (CHD).
METHODS. This is an observational retrospective single-center study. All patients undergone Melody TPV implantation were included. The early outcomes analyzed were: procedural failure, death of patient, life-threating adverse events. The long-term outcomes analyzed during follow-up were: infective endocarditis, trans-catheter redo-procedure, and surgical redo-procedure.
RESULTS. From 2012 to 2022, 39 patients were evaluated in our catheterization laboratory for TPVI with Melody TPV. Mean age and weight were 21,31±11,58 (range 8-66) years and 57,5±16,24 (range 23-96) kilograms. The patients were affected by the following CHD: tetralogy of Fallot (22 pts, 56,4%), pulmonary atresia with ventricular septal defect (VSD) (4 pts, 10,3%), aortic stenosis s/p Ross surgery (4 pts, 10,3%), transposition of the great arteries with VSD and PS (3 pts, 7,7%), pulmonary stenosis (PS) (2 pts, 5,1%), truncus arteriosus (2 pts, 5,1%), double outlet right ventricle (1 pt, 2,5%), Ebstein’s anomaly (1 pt, 2,5%) In 4 cases (10,3%), the procedure failed because of coronary compression during balloon RVOT interrogation. One patient (2,5%) died due to post-procedural septic shock. In the other 34 patients (87,2%), the Melody TPV was implanted effectively. No life-threating adverse events were recorded. In 3 cases, the Melody TPV was implanted off-label: in tricuspid position (one case) and in “small conduits” (<16 mm) (two cases). The mean follow-up was 4,41±2,82 years. During follow-up, 5 patients (14,7%) developed an infective endocarditis, 7 patients (20,6%) required a trans-catheter procedure (6 Melody balloon dilation and 1 Melody valve-in-valve), and 2 patients (5,9%) underwent surgical Melody TPV replacement.
CONCLUSION. Trans-catheter Melody TPV implantation is effective to deal RVOT dysfunction. At a mid-term follow-up, the most of the implanted Melody TPV worked properly and only a few patients required surgical valve replacement.