C48 TEN–YEARS, SINGLE–CENTER EXPERIENCE WITH MELODY TPV IMPLANTATION: EARLY OUTCOMES AND MID–TERM FOLLOW–UP

Abstract

Abstract 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.