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. Author manuscript; available in PMC: 2018 Aug 1.
Published in final edited form as: Cardiol Young. 2016 Nov 10;27(6):1090–1097. doi: 10.1017/S1047951116002092

Table 4.

Adverse events associated with “off-label” Melody® valve implantation

Native RVOT (n=124) Tricuspid (n=108) Mitral (n=51) RVOT in children < 30kg (n=26)
Procedural
 Vascular complication - 1 5 1
 Conduit tear 1 - - 5
 AP fistula 1 - - -
 Guidewire perforation - - 1 1
 Hemo / pneumothorax 3
 Embolization - - 5 -
 Complete AV block - 3 1 -
 Procedural mortality - - 1 1*
Post-procedural - - - -
 Stent fracture 6 2 - 2
 Endocarditis 3 1 - 2
 Early valve failure 1 7 - -
 Paravalvar leak - - 2 -

RVOT: Right ventricular Outflow Tract;

*

Melody® valve implantation was performed in a patient on ECMO following PA laceration during a previous procedure. Mortality was not felt to be directly attributable to the Melody® implantation.