Open Access

ARTICLE

Leaflet morphology classification of the Melody Transcatheter Pulmonary Valve

by

The Heart Center, Nationwide Children’s Hospital, Columbus, Ohio

* Corresponding Author: Brian Boe, The Heart Center, Nationwide Children’s Hospital, 700 Children’s Drive, Columbus, OH 43205‐2664. Email:

Congenital Heart Disease 2019, 14(2), 297-304. https://doi.org/10.1111/chd.12728

Abstract

Objective: We sought to describe the leaflet morphology variation in the Melody Transcatheter Pulmonary Valve (TPV) and evaluate associated outcomes. The Melody TPV is constructed from harvested bovine jugular venous valves which have been rigorously tested. Natural anatomic leaflet variations are seen in the Melody TPV but have not been evaluated.
Design: A Melody TPV leaflet morphology classification system was devised after reviewing a subset of photographed and implanted TPVs. All images were blindly re‐ viewed by implanters and classified. Midterm hemodynamic outcomes and complica‐ tions of the Melody TPVs were compared by leaflet morphology.
Results: Photographed Melody TPVs implanted between 2011 and 2016 (n = 62) were categorized into the following leaflet morphology types: A—symmetric trileaflet (47%); B—asymmetric trileaflet with a single small leaflet (32%); C—asymmetric trile‐ aflet with a single large leaflet (16%); D—rudimentary leaflet with near bicuspid ap‐ pearance (5%). Acceptable hemodynamic function at 6 months postimplantation was seen in 97.5% of valves. Over a median follow‐up of 1.5 years (range 0‐4.4 years), two TPVs (Type A) had > mild regurgitation. Nine TPVs developed complications (endo‐ carditis, 3; stent fracture, 2; refractory arrhythmia, 1; conduit replacement, 2; death, 1), of which 6 required reintervention. There was no significant difference in out‐ comes based on Melody TPV leaflet morphology type.
Conclusions: The Melody TPV can be classified into one of four categories based on leaflet morphology. Study outcomes were not associated with leaflet morphology. Further documentation and evaluation of Melody TPV morphology may lead to bet‐ ter understanding of this technology.

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