Valve Implant

MELODY® VALVE IMPLANT FOR NATIVE OUTFLOW TRACT DYSFUNCTION


SCREENING CRITERIA


  • Clinical indication for intervention
  • Evidence of significant right ventricular outflow dysfunction:
    • Moderate to severe regurgitation and/or
    • Moderate to severe stenosis
  • Cardiac MRI or CT findings:
    • An area within the right ventricular outflow tract (RVOT) measuring ≤ 22 mm diameter (preferably in systole
    • Narrowest RVOT segment ≥ 1 cm from origin of branch pulmonary arteries


CASE EXAMPLE


Contrast injection in main pulmonary artery demonstrates severe pulmonary regurgitation and an irregular RVOT consistent with prior transannular patch repair for Tetralogy of FallotThree-dimensional rotational angiography allows for quantitative and qualitative assessment of the irregular RVOT from limitless angles.
Inflation of a 24 mm diameter balloon reveals that the narrowest diameter of the RVOT in two planes ranges from 21 to 22 mm.Inflation of a 24 mm diameter balloon reveals that the narrowest diameter of the RVOT in two planes ranges from 21 to 22 mm.
After implantation of bare metal and covered stents, right ventricular injection demonstrates that the irregular RVOT has been converted into a tubular conduit.Main pulmonary arteriogram demonstrates a competent, symmetrical, unobstructed RVOT after implantation of a Melody valve on a 22 mm Ensemble® transcatheter valve delivery system.