Background Information 

Disorders involving the right ventricular outflow tract (RVOT) and main pulmonary artery (MPA) are common in congenital heart disease, particularly in Tetralogy of Fallot and variants of pulmonary valve stenosis/atresia. Initial palliation involves surgical augmentation of the RVOT/MPA resulting in progressive dilation over time, precluding transcatheter pulmonary valve replacement (TPVR) using standard valve systems. In order to allow for TPVR, several RVOT size reducing systems have been developed to constrain the RVOT to dimensions that allow for TPVR. The Medtronic Harmony transcatheter pulmonary valve system is an integrated size reducing frame with an incorporated porcine pericardial leaflet valve. On behalf of a multi-institutional North American study, Dr. Daniel Levi reported the one-year outcomes of the Harmony Transcatheter Pulmonary Valve system. 

Why is this study important? 

  • RVOT disorders are among the most common dealt with in congenital cardiology. 
  • The Harmony TPV is the first FDA-approved RVOT size reducing/pulmonary valve replacement system developed for restoration of pulmonary valve function in patients with dilated RVOTs. 
  • One year effectiveness data of size-reducing RVOT valve systems have not been previously reported. 
  • Transcatheter pulmonary valve replacement systems potentially allow for avoidance of repeat open surgical procedures in a population of patients where repeated sternotomies were previously the only option. 

What questions are this study supposed to answer? 

  • What is the freedom from mortality and pulmonary valve dysfunction for the Harmony TPV system at one year? 
  • What are the hemodynamic profiles of the various sizes of the Harmony TPV system? 

What did the study show?

  • Pooled data from the Harmony Native Outflow Tract Early Feasibility Study, Pivotal Trial, and Continued Access study were evaluated.  
  • The primary indication for treatment was severe pulmonary regurgitation, verified by cardiac MRI. 
  • 106 Harmony TPV implants were evaluated representing three variations of the Harmony TPV system 
  • 6 month data revealed no mortality and 87.5% freedom from transcatheter pulmonary valve dysfunction. Over 90% of implanted valves had none/trace paravalvular leak. 

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