The Melody Transcatheter Pulmonary Valve: 10-Year Outcomes in the Original US Investigational Device Exemption Trial Cohort
Presenter
Thomas K. Jones, M.D., MSCAI, Seattle Children’s Hospital, Seattle, WA
Thomas K. Jones, M.D., MSCAI, Seattle Children’s Hospital, Seattle, WA, Doff B. Mcelhinney, M.D., FSCAI, Lucile Packard Children's Hospital at Stanford, Los Altos, CA, Julie A. Vincent, M.D., FSCAI, Columbia University Medical Center, New York, NY, William E. Hellenbrand, M.D., Yale University, New Haven, CT, John P. Cheatham, M.D., MSCAI, Nationwide Children's Hospital, Plymouth, MA, Darren P. Berman, M.D., FSCAI, Nationwide Children's Hospital, Columbus, OH, Evan M. Zahn, MD, MSCAI, Cedars-Sinai Medical Center, Los Angeles, CA, Danyal M. Khan, M.D., Miami Children's Hospital, Miami, FL, John F. Rhodes Jr., M.D., Medical University of South Carolina, Charleston, SC, Shicheng Weng, MS, -, Mounds View, MN and Lisa Bergersen, M.D., MPH, FSCAI, Children's Hospital Boston, Boston, MA
Keywords: TPVR/Pulmonary Valve
Background
Acute and short-term results of the US Investigational Device Exemption (IDE) Trial of the Melody transcatheter pulmonary valve (TPV) were first reported in 2009, followed by publication of mid-term outcomes. Ten-year follow-up data will be available in Spring 2020.
Methods
This study evaluates the safety and performance of the Melody TPV at 10-y 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) will be assessed. Safety outcomes will include serious device-related adverse events, stent fracture, catheter reintervention, surgical conduit replacement, and death.
Results
Median age was 19 y (range 7-53); 71 patients were ≤18 y old. Tetralogy of Fallot was the original diagnosis in 51%. 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). As reported at mid-term (median 4.5 y), 32 patients received RVOT reintervention for obstruction (n=27), endocarditis (n=2), RV dysfunction (n=1), or other reasons (n=2). Rates of freedom from reintervention and explantation at 5 y were 76±4% and 92±3%, respectively. The presentation will report 10-y functional and safety outcomes in the IDE cohort for the first time.
Conclusions
Ten-year outcomes from this study will provide valuable information about the long-term function, safety, and effectiveness of the Melody TPV. Further, this data set is a unique contribution to our understanding of the natural history of TPV replacement for patients with dysfunctional RVOT conduits. 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.