O-4
The Harmony Transcatheter Pulmonary Valve: 1-Year Outcomes from the Pivotal Trial and 30-Day Outcomes from the Continued Access Study
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, Matthew J. Gillespie, M.D., FSCAI, Children's Hospital of Philadelphia, Philadelphia, PA, Doff B. Mcelhinney, M.D., FSCAI, Lucile Packard Children's Hospital at Stanford, Palo Alto, CA, Daniel S. Levi, M.D., FSCAI, David Geffen School of Medicine at UCLA, Pacific Palisades, CA, Robert G. Gray, M.D., The University of Utah, Salt Lake City, UT, Jeremy D. Asnes, M.D., Yale University, New Haven, CT, Tomoyuki Fujita, M.D., Ph.D, National Cerebral and Cardiovascular Center,, Osaka, Japan, Allison K. Cabalka, M.D., FSCAI, Mayo Clinic Health System Rochester, Rochester, MN, Henri Justino, M.D., FSCAI, Rady Children's Hospital, San Diego, CA, Shicheng Weng, MS, -, Mounds View, MN and John P. Cheatham, M.D., MSCAI, Nationwide Children's Hospital, Plymouth, MA
Keywords: Congenital Heart Disease (CHD), Right Ventricular Outflow Tract (RVOT), Structural Heart Disease (SHD) and TPVR/Pulmonary Valve
Background: The Harmony transcatheter pulmonary valve (TPV) was developed as a less invasive alternative to surgical pulmonary valve placement (SPVR) in patients with patched or native right ventricular outflow tracts and severe pulmonary regurgitation (PR).
Methods: The Pivotal trial is a prospective, nonrandomized study conducted at 10 sites in the US, Canada, and Japan. Inclusion criteria includes severe PR on echocardiogram or PR fraction ≥30% by magnetic resonance imaging and who meet accepted indications for SPVR. The primary safety endpoint is freedom from procedure- or device-related mortality at 30 days. The primary effectiveness endpoint is the percentage of patients with acceptable hemodynamic function at 6 months (mean RVOT gradient ≤40 mm Hg AND PR fraction <20% by CMR or <moderate PR by core laboratory echo review) and no Harmony valve intervention. Two valve sizes are evaluated, a 22-mm valve (TPV22) and a modified version of the original 25-mm valve (mTPV25). A Continued Access Study (CAS) following the same protocol as the Harmony IDE Pivotal study is underway. Follow-up is planned through 5 years.
Results: In the Pivotal Trial, 21 patients received the TPV22, and 10 received the mTPV25. In the CAS, 1 patient received a TPV22, and 35 received an mTPV25 for 67 total implanted subjects. In the Pivotal Trial, median (Q1, Q3) age was 29 years (19, 39), 45% of patients were female, 94% had an original diagnosis of tetralogy of Fallot, and the median number of previous open-heart surgeries was 1 (1, 2). At 6 months in the Pivotal Trial, there were no deaths, reoperations, catheter reinterventions, endocarditis, major stent fractures, or embolizations. All patients had none or trace PR. This presentation will report 1-year outcomes for the Pivotal Trial, the 30-day outcomes for the CAS and for both cohorts combined.
Conclusions: Procedural and 6-month safety and hemodynamic results of the Harmony TPV demonstrate excellent short-term outcomes. Outcomes through 1 year of follow-up for the Pivotal cohort, and early, one-month data from the CAS, will add to the growing body of evidence about Harmony TPV replacement in this patient population.