OR13-1
Midterm Outcomes in an Expanded Cohort of Harmony Transcatheter Pulmonary Valve Recipients
Presenter
Brian H. Morray, M.D., Seattle Children’s Hospital, Seattle, WA
Brian H. Morray, M.D.1, Matthew J. Gillespie, M.D., FSCAI2, John P. Cheatham, MD, MSCAI3, Arash Salavitabar, M.D., FSCAI4, Lynn F. Peng, M.D., FSCAI5, Thomas K. Jones, M.D., MSCAI1, Daniel S. Levi, M.D., FSCAI6, Robert G. Gray, M.D.7, Jeremy D. Asnes, M.D.8, Allison K. Cabalka, M.D., FSCAI9, Kazuto Fujimoto, MD10, Athar M. Qureshi, M.D., FSCAI, FSCAI11, Lisa Bergersen, M.D., MPH12, Lee N. Benson, M.D., MSCAI13, Daniel Haugan14 and Doff B. McElhinney, M.D., FSCAI15, (1)Seattle Children’s Hospital, Seattle, WA, (2)Children's Hospital of Philadelphia, Philadelphia, PA, (3)The Ohio State University, Columbus, OH, (4)Nationwide Children's Hospital, Columbus, OH, (5)Stanford University, Palo Alto, CA, (6)David Geffen School of Medicine at UCLA, Pacific Palisades, CA, (7)The University of Utah, Salt Lake City, UT, (8)Yale University, New Haven, CT, (9)Mayo Clinic Health System Rochester, Rochester, MN, (10)National Cerebral and Cardiovascular Center, Suita city, Japan, (11)Texas Children's Hospital, Bellaire, TX, (12)Children's Hospital Boston, Boston, MA, (13)The Hospital for Sick Children, Toronto, ON, Canada, (14)Medtronic, Minneapolis, MN, (15)Stanford University Medical Center, Stanford, CA
Keywords: Congenital Heart Disease (CHD), Right Ventricular Outflow Tract (RVOT) and TPVR/Pulmonary Valve
Background:
The Harmony transcatheter pulmonary valve (TPV) is the first FDA-approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). Our objective was to evaluate midterm outcomes in Harmony clinical trial participants who have now completed at least 3 years of follow-up.
Methods:
The analysis included patients who received a commercially available TPV22 or TPV25 device (Medtronic, Minneapolis, MN) as part of the Native Outflow Tract Early Feasibility Study (EFS), Harmony TPV Pivotal Trial, and Continued Access Study (CAS). Eligible patients had severe PR by echocardiography or PR fraction ≥30% by cardiac MRI and a clinical indication for pulmonary valve replacement. Previously presented 2-year outcomes are reported here, and a new midterm assessment of valve function and remodeling with at least 3 years of follow-up will be presented for the first time at SCAI 2024.
Results:
There were 86 patients in the implanted cohort (42 TPV22; 44 TPV25). Median (Q1, Q3) patient age at treatment was 29 (18, 39) years and 87% had an original diagnosis of tetralogy of Fallot. At 2 years, 2 patients had died from causes unrelated to the device or procedure. Freedom from TPV dysfunction (defined as ≥moderate PR, mean RVOT gradient >40 mmHg, device-related RVOT reoperation, or catheter reintervention) was 95% in the TPV22 group and 91% in the TPV25 group. Two-year freedom from major stent fracture was 98% in the TPV22 group and 100% in the TPV25 group. None/trace or mild PR was present in 97% of TPV22 and 96% of TPV25 patients at 2 years. Five implanted patients had a surgical or catheter reintervention: 2 TPV22 patients were explanted on Day 2 and Day 39, respectively, and 3 TPV25 patients underwent a valve-in-valve procedure on Days 303, 444, and 610, respectively. At 2 years, there were 2 patients with thrombosis and none with endocarditis. There was no new ventricular tachycardia at 2 years. New comparative MRI data to evaluate ventricular remodeling will be presented.
Conclusions:
Harmony TPV patients in this expanded analysis cohort had excellent outcomes through 2 years, and the upcoming analysis will provide important new data on valve function and patient experience.