@Article{chd.12728,
AUTHOR = {Brian A. Boe, Sharon L. Cheatham, Aimee K. Armstrong, Darren P. Berman, Joanne L. Chisolm, John P. Cheatham},
TITLE = {Leaflet morphology classification of the Melody Transcatheter Pulmonary Valve},
JOURNAL = {Structural and Congenital Heart Disease},
VOLUME = {14},
YEAR = {2019},
NUMBER = {2},
PAGES = {297--304},
URL = {http://www.techscience.com/schd/v14n2/38774},
ISSN = {3071-1738},
ABSTRACT = {<b>Objective:</b> 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.<br/>
<b>Design:</b> 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.<br/>
<b>Results:</b> 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.<br/>
<b>Conclusions:</b> 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.},
DOI = {10.1111/chd.12728}
}