Key result
The Melody valved stent demonstrated an overall graft survival of 78% at 10 years, with endocarditis being the primary cause of graft failure.
Why the study?
What are the long-term clinical outcomes and valve function up to 11 years after Melody valved stent implantation in the pulmonary position?
Observational (n=186)
No
What are the long-term clinical outcomes and valve function up to 11 years after Melody valved stent implantation in the pulmonary position?
The Melody valved stent demonstrates well-preserved leaflet function up to 11 years after implantation, with endocarditis being the primary cause of graft failure.
May support Melody durability to 11 years with endocarditis surveillance; leaves open randomized confirmation.
AIMS: The aim of the study was to report up to 11 years of follow-up after Melody valve implantation in the pulmonary position. METHODS AND RESULTS: This was a single-institution non-randomised prospective observational study of all Melody valves in the pulmonary position after discharge between 2006 and 2017 (n=188). Mean age was 19.4 years (SD 13.2). The indication was stenosis (45%), regurgitation (33%) and mixed (22%). Pre-stenting was performed in all except the initial four patients. In stenotic lesions the peak gradient was 36 mmHg PIG (SD 12.0) after 11 years and in regurgitant lesions the maximal regurgitation was 2/4. Stent fractures were observed in 8.6%; only one grade III fracture required redo PPVI. Surgical removal was carried out in seven (3.7%), redo PPVI in five (2.7%). Endocarditis was diagnosed in 19 (10.2%) patients at a median of 2.3 years (0.7-8.8) after Melody implantation. Three were surgically removed early because of persistent infection, 16 were sterilised; six required replacement (three surgical, three redo PPVI). There were no valve- or procedure-related deaths. CONCLUSIONS: The Melody valve shows a good preserved leaflet function up to 11 years after implantation. The main reason for graft failure was endocarditis, although in half of those patients no reintervention was needed. After pre-stenting, stent fractures led very exceptionally to reintervention.
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Cools et al. (2018) conducted an observational in Right ventricular outflow tract dysfunction (n=186). Melody valved stent was evaluated on Overall graft survival at 10 years. The Melody valved stent demonstrated an overall graft survival of 78% at 10 years, with endocarditis being the primary cause of graft failure.
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