Leaflet morphology classification of the Melody Transcatheter Pulmonary Valve

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 reviewed by implanters and classified. Midterm hemodynamic outcomes and complications 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 trileaflet with a single large leaflet (16%); D-rudimentary leaflet with near bicuspid appearance (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 (endocarditis, 3; stent fracture, 2; refractory arrhythmia, 1; conduit replacement, 2; death, 1), of which 6 required reintervention. There was no significant difference in outcomes 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 better understanding of this technology. K E Y W O R D S congenital catheterization, transcatheter valve implantation 1 | INTRODUC TI ON The Melody Transcatheter Pulmonary Valve (TPV) (Medtronic, Dublin, Ireland) is designed to treat right ventricular outflow tract (RVOT) conduit dysfunction and was the first implanted transcatheter heart valve in 2000. 1 Since the United States Investigational Device Trial in 2007, the Melody TPV has been utilized in a variety of patients and anatomic locations. As of 2016, more than 10 000 | 303 BOE Et al. center study, which is in large part due to the excellent midterm function and low rate of complications of the Melody TPV. Our study provides a Melody TPV morphologic classification system on which to base further research. Prospective classification of morphology type and further study of Melody valve morphology may lead to better understanding of associated outcomes. -conception and design, analysis and interpretation of data, drafting of the manuscript, critically revising the manuscript, final approval of the submitted manuscript. Aimee K. Armstrong-conception and design, critically revising the manuscript, final approval of the submitted manuscript. Darren P. Berman-critically revising the manuscript, final approval of the submitted manuscript. Joanne L. Chisolm-analysis and interpretation of data, critically revising the ...

Unmet Clinical Needs for Transcatheter Pulmonary Valves

“…2). Melody valve retains different leaflet morphology that are not all axisymmetric tri-leaflet as in the bioprosthetic valves, but it has been shown that the difference in variations does not affect function [8]. The stent measures 34 mm in length in its crimped configuration and 28-29 mm in length when expanded in full [36].…”