Fifteen years of experience with the melody™ TPV for percutaneous pulmonary valve replacement.

Abstract

Background: The Melody^™ TPV has been used as an alternative to surgical pulmonary valve replacement; limited medium-term follow-up data are available.

Aims: To report the follow-up data of all Melody^™ TPVs implanted locally over a 15-year period (2006-2021).

Methods: Single-centre non-randomised prospective observational study of all implanted Melody^™ valves in the pulmonary position.

Results: 234 Melody^™ valves were implanted at a mean age of 20.8 ± 24.6y. Indications for valve implantation included: pulmonary stenosis (47.2%,) regurgitation (30.9%), and mixed pathology (21.9%). The implant zone substrate consisted of homograft in 52.6%, patched right ventricular outflow tract in 33.8%, and bioprostheses in 13.6% of the cases. Valve survival at 10 years was 89% and 72% at 15 years follow-up. Pulmonary stenosis and pulmonary and tricuspid valve regurgitation demonstrated no significant evolution over the 15-year follow-up. Over the study period, there were 7 deaths at a mean age of 54.2 ± 21.1y; none was valve related. Valve failure was observed in 22 cases (9.4%), mainly due to endocarditis 13/22 (59.0%). The overall incidence of endocarditis was 1.5% per patient-year and occurred in 10.2% (n = 24) of patients 2.7 ± 1.6y after TPV, mostly in younger men (median 18.3, range 8.1 - 49.5 y). Balloon dilatation to accommodate for somatic growth was successful in all 17 (7.3%) attempted cases.

Conclusion: The Melody^™ valve had a low risk for valve failure with overall well-preserved valve function over up to 15 years of follow-up. Endocarditis remains a concern. The Melody^™ valve is competitive with other surgical and percutaneous conduits.