Ten-year results display strong safety and efficacy profile for TPV device

May 15, 2020

WASHINGTON - Ten-year follow-up results of the U.S. Investigational Device Exemption (IDE) Trial of the Melody transcatheter pulmonary valve (TPV) were presented today during the SCAI 2020 Scientific Sessions Virtual Conference. Findings showed favorable outcomes for long-term function, safety, and efficacy for congenital patients who underwent Melody valve implantation within an existing dysfunctional right ventricular outflow tract (RVOT) conduit or bioprosthetic pulmonary valve.

The study evaluated the safety and performance of the Melody TPV at 10-year follow-up in the IDE cohort (n=150). TPV dysfunction, defined as reoperation, catheter reintervention, or hemodynamic dysfunction (ie. moderate or greater pulmonary regurgitation [PR] and/or mean RVOT gradient >40 mmHg) was assessed. Safety outcomes included serious device-related adverse events, stent fracture, catheter reintervention, surgical conduit replacement, and death.

The investigators reported that the median age of patients in the study was 19 years old; 71 patients were younger than 18 years. Tetralogy of Fallot was the original diagnosis in 51% of the patient population. The primary indication for intervention was PR in 53%, RVOT obstruction in 26%, and both in 21% of patients. Discharge mean RVOT gradient was 17 mmHg (3-36).

At 10 years of follow-up:"Having long-term data now available is an important milestone especially for the pediatric patient population who are growing and changing so rapidly during a ten-year period," said Thomas K. Jones, M.D., director of cardiac catheterization at Seattle Children's in Seattle, Wash. "While the data reinforces the longevity, durability, and efficacy of the Melody TPV, it will also serve as a study model for future evaluations of novel pediatric congenital heart disease technologies."

The investigators conclude that this data set is a unique contribution to understanding the natural history of TPV replacement for patients with dysfunctional RVOT. The study also provides a model for future evaluations of novel technologies and overcoming challenges in study design and execution in populations with congenital heart disease.
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About the Society for Cardiovascular Angiography and Interventions

The Society for Cardiovascular Angiography and Interventions (SCAI) is a professional member organization representing 5,000 invasive and interventional cardiologists in approximately 75 nations. SCAI's mission is to promote excellence invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. For more information about SCAI, visit http://www.scai.org and http://www.secondscount.org. Follow @SCAI on Twitter for the latest heart health news.

Society for Cardiovascular Angiography and Interventions

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